Neuspera Sacral Neuromodulation System

P240031 · Neuspera Medical, Inc. · EZW · Jun 17, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: P240031
• Device Name: Neuspera Sacral Neuromodulation System
• Applicant: Neuspera Medical, Inc.
• Product Code: EZW · Gastroenterology, Urology
• Decision Date: Jun 17, 2025
• Decision: APPR
• Regulation: 21 CFR 876.5270
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

The Neuspera Sacral Neuromodulation System (“Neuspera SNM System”) is indicated for the treatment of the symptoms of urinary urge incontinence (UUI) in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.

Device Story

Neuspera SNM System is an implantable sacral nerve stimulation device for UUI treatment. System includes an implantable neurostimulator (INS) with four electrodes, an externally worn Wireless Transmitter (WT) for power/communication, a Clinician Programmer, and a Patient Controller. The INS is implanted in the sacral foramen; it receives power and programming signals from the WT via RF (902-928 MHz). Patients wear the WT over the implant site for 2 hours of daily therapy. The WT is controlled by the patient to adjust amplitude and select programs. The system includes a trial kit with a temporary lead and external stimulator to verify efficacy before permanent implantation. The device helps control bladder function by delivering electrical pulses to the sacral nerve. Healthcare providers use the Clinician Programmer to manage therapy settings. The system is intended for use in clinic and home settings. Benefits include reduction in UUI episodes; risks include device migration, fracture, pain, and infection.

Clinical Evidence

Pivotal prospective, multi-center, single-arm study (SANS-UUI) of 130 subjects with attempted implants. Primary endpoint: ≥50% reduction in UUI episodes at 6 months. Results: 82.9% responder rate at 6 months (95% CI: 76.4%-89.4%, p<0.0001) and 77.7% at 12 months. Safety: No serious device-related AEs; 16.2% device-related AEs (most common: migration 3.1%, stimulation issues 2.3%, fracture 1.5%). 21 explants and 5 revisions reported through 12 months.

Technological Characteristics

Implantable neurostimulator (44 mm length, 2.3 mm diameter) with 4 Pt/Ir electrodes. Materials: Thermoplastic polyurethane, PEEK, ePTFE. Energy: RF-powered (902-928 MHz) via external WT. Stimulation: 0.2-4.8 V, 105-945 μs, 5-100 Hz. Connectivity: Bluetooth (2.4-2.5 GHz) for programming. Sterilization: Ethylene oxide. Software: IEC 62304 compliant.

Indications for Use

Indicated for treatment of urinary urge incontinence (UUI) in patients ≥22 years old who failed, could not tolerate, or were not candidates for conservative treatments. Contraindicated in patients with sacral depth >10 cm, those without appropriate response to test stimulation, those unable to operate the neurostimulator, and men with BPH or other lower urinary tract obstructions.

Regulatory Classification

Identification

An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

I. GENERAL INFORMATION

Device Generic Name: Implanted electrical urinary continence device

Device Trade Name: Neuspera Sacral Neuromodulation (SNM) System

Device Procode: EZW

Applicant’s Name and Address: Neuspera Medical, Inc.
51 Daggett Drive
San Jose, CA 95134

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P240031

Date of FDA Notice of Approval: June 17, 2025

II. INDICATIONS FOR USE

The Neuspera Sacral Neuromodulation System (“Neuspera SNM System”) is indicated for the treatment of the symptoms of urinary urge incontinence (UUI) in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.

III. CONTRAINDICATIONS

- Patients with sacral depth measured from skin to the S3 foramen greater than 10 cm as confirmed by imaging.
- Patients who have not demonstrated an appropriate response to test stimulation.
- Patients who are unable to operate the neurostimulator.
- Men who have Benign Prostatic Hyperplasia (BPH) or patients with other lower urinary tract obstructions that leads to significant obstructive symptoms or pathology.

After implantation of the Neurostimulator, the following contradictions apply:

- Electrical treatments where the conducted current is induced into the body from an external source in the area of the Neurostimulator (this may permanently damage the Neurostimulator).
- Medical treatments or procedures utilizing effects caused by electric fields (such as diathermy) unless the treatment or procedure is identified within as acceptable (such as MRI).

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# IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the Neuspera SNM System labeling.

# V. DEVICE DESCRIPTION

The Neuspera Sacral Neuromodulation System ("Neuspera SNM System") consists of the following components (names in parentheses are trade names). See Figure 1:

- Neuspera Sacral Nerve Stimulator Implant Kit, including the Implantable Neurostimulator ("Implant Kit")
- External Components
- Wireless Transmitter and Accessories (Charging Pad and Magnet)
- Clinician Programmer
- Patient Controller
- Undergarment
- Trial System
- Trial System Kit ("Trial Lead Kit")
- Trial Lead Kit ("Extra Trial Lead")
- Procedural Accessories Kit
- External Procedural Kit ("External Nerve Stimulator Kit")

The Implantable Neurostimulator is an implantable neurostimulator with four programmable electrodes. The programmable electrodes deliver stimulation to the sacral nerve.


Figure 1. Neuspera SNM System

A. Implantable Sacral Nerve Stimulator Kit, B. Undergarment, C. Magnet, D. Wireless Transmitter, E. Charging Pad, F. Clinician Programmer, G. Patient Controller, and H. Implantable Neurostimulator

1. Implantable Neurostimulator

The neurostimulator (see Figure 2) delivers pulses of energy to the sacral nerve that helps control the bladder. The distal portion is pre-formed with a curvature and contains four electrodes for stimulation. The proximal end has an encapsulated antenna to

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receive the signal from the Wireless Transmitter. Circuitry within the neurostimulator takes the signal from the Wireless Transmitter and sends programmable electrical pulses to the stimulation electrodes. The radial tines are designed to maintain the position of the implant after implantation. Specifications of the neurostimulator are provided in Table 1 and Table 2.

Figure 1. Neuspera Implantable Neurostimulator

Table 1. Neurostimulator Dimensions and Materials

| Feature | Neurostimulator Material |
| --- | --- |
| Dimensions | |
| Electrode size | 3 mm |
| Electrode spacing | 3 mm |
| Neurostimulator length (excluding tether) | 44 mm |
| Neurostimulator diameter | 2.3 mm |
| Materials | |
| Electrodes, Feedthrough Flanges, Proximal Circuitry Housing | Platinum/Iridium 90/10 |
| Distal Nose, Distal Electrode Array Body, and Tines | Thermoplastic polyurethane |
| Adhesive connecting device segments | Epoxy |
| Push Rod Keying feature | Polyetheretherketone (PEEK) |
| Tethered Suture | Expanded Polytetrafluoroethylene |

Table 2. Neurostimulator Specifications

| Stimulation Parameter | Neurostimulator Specification |
| --- | --- |
| Amplitude | 0.2-4.8 V |
| Pulse width duration | 105-945 μs |
| Pulse frequency | 5-100 Hz |
| Mode | Continuous or Cycling |

# 2. External Components

a) Wireless Transmitter (WT) and Accessories (Charging Pad and Magnet)

The Wireless Transmitter (WT) is an externally worn device used to power and communicate to the neurostimulator and is programmed and controlled using the

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Clinician Programmer and Patient Controller. It contains a rechargeable battery that is recharged on the charging pad. Patients are instructed to complete two hours of therapy daily, and the WT needs to be worn for the duration of the daily therapy session. Specifications of the Wireless Transmitter are provided in Table 3. Stimulation of the neurostimulator only occurs while the WT is placed over the implant site.

The Charging Pad is used to recharge the Wireless Transmitter, and the Magnet is used to reset the Wireless Transmitter and to turn the Wireless Transmitter off to conserve battery power.

Table 3. Wireless Transmitter Specifications
| Feature | Wireless Transmitter Specification |
| --- | --- |
| Battery capacity | ≥2000 mAh |
| Battery capacity (therapy time) | ~2 hours (will vary with RF power control settings) |
| Time for full recharge | ≤5 hours |
| Frequency range (powering) | 902-928 (ISM compliant band) |
| Frequency range (Bluetooth) | 2.4-2.5GHz |

b) Clinician Programmer (CP)

The Clinician Programmer is used by the clinician to manage the Wireless Transmitter associated with the patient's neurostimulator and program a patient's stimulation therapy.

c) Patient Controller (PC)

The Patient Controller is used by the patient to turn the Wireless Transmitter on/off, adjust stimulation amplitude, and select pre-configured stimulation programs.

d) Undergarment

The Neuspera Undergarment is used to place and hold the Wireless Transmitter in the correct position for therapy. The specifically designed pocket will also pad and insulate the Wireless Transmitter against the body. The Undergarment is intended to be worn under general clothing (i.e. pants, shirts, and jackets). It is also compatible with pads and diapers. The Undergarment is available in six sizes, from Extra-Small to XXX-Large in Men's Briefs or Women's Low-Rise Hipster designs.

3. Implantable Sacral Nerve Stimulation (SNS) Tool Kit

The Implantable SNS Tool Kit contains the following tools needed to introduce and implant the neurostimulator:

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- The foramen needle is used to locate the foramen, test stimulate the implantation location using the Intraoperative Cable and Ground Pad, and External Stimulator, and introduce the guidewire.
- The pre-dilator provides initial dilation of the neurostimulator introduction pathway.
- The dilator/sheath assembly introduces the sheath to the correct location in the foramen and the sheath introduces the neurostimulator.
- The guidewire is used to place the pre-dilator and dilator/introducer sheath assembly.
- The push rod is a tool used to place the neurostimulator correctly in the foramen through the sheath. The neurostimulator is pre-loaded on the push rod.

## 4. Trial System

The Trial System is used for trial stimulation to determine efficacy before recommendation for a permanent implant and to test the implant location prior to deployment of the Implantable Neurostimulator. See Figure 3 for Trial System components.

The Trial System consists of the following kits:
- Trial Lead Kit
- Extra Trial Lead
- Procedural Accessories Kit
- External Nerve Stimulator Kit

Figure 2. Neuspera Trial System Components

A. Trial Lead with Stylet; B. 3.5" Foramen Needle (protective cap not shown); C. Intraoperative Ground Pad; D. External Stimulator with Ground Pad; E. Intraoperative Cable; F. Wireless Transmitter Magnet; G. Wireless Transmitter; H. Charging Pad; I. Clinician Programmer; J. Patient Controller. Procedural Accessories not shown.

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# a) Trial Lead with Stylet

The Trial Lead is a temporary lead with a single electrode that allows the electrical pulses from the External Stimulator to be delivered to the sacral nerve. The Trial Lead is placed using a percutaneous procedure. The Trial Lead is introduced through the sacral foramina to allow the electrode at its tip to stimulate the sacral nerve root; the remainder of the Trial Lead exits the skin to be connected to the External Stimulator.

# b) External Stimulator with Trial Ground Pad

The External Stimulator is a single-use, non-rechargeable, external device, that provides electrical pulses to stimulate the sacral nerve root by the Trial Lead for up to 7 days. The External Stimulator is placed on an adhesive ground pad on the patient's back for the trialing period (up to 7 days). The Trial System is intended to be used continuously during the stimulation trial. The stimulation parameter ranges for the External Stimulator are listed in Table 4. The stimulation parameters, ranges, and waveform from the External Stimulator are identical to the output of the Neuspera implantable neurostimulator.

Table 4. External Stimulator Specifications

| Stimulation Parameter | External Stimulator Specification |
| --- | --- |
| Amplitude | 0.2 – 4.8 V |
| Pulse width duration | 105-945 μs |
| Pulse frequency | 5-100 Hz |
| Mode | Continuous or Cycling |

# VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the treatment of urinary urge incontinence (UUI). Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

Non-invasive treatment options should be discussed with all patients, including incontinence management strategies, bladder training, behavioral therapies, pelvic floor exercises, maintaining a healthy weight, and fluid consumption management.

Medications for treatment of UUI may also be considered and include antimuscarinic medications or beta-3 agonists. These medications are taken daily and may have short- or long-term side effects that may affect a patient's ability to take or tolerate them.

For patients that fail to have improvement, cannot tolerate or are not candidates for these treatment options, they may consider minimally invasive therapies. These include sacral neuromodulation, percutaneous tibial nerve stimulation, implantable tibial nerve

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stimulation and/or intradetrusor botulinum toxin injection. Percutaneous tibial nerve stimulation provides stimulation of the posterior tibial nerve to send signals to the bladder to reduce UUI episodes. It is an in-office procedure using a percutaneous needle; this technique requires multiple, on-going office visits. Implantable tibial nerve stimulation requires an in-office or hospital surgical procedure to place a stimulator along the posterior tibial nerve to stimulate the nerve. Patients may also receive injections of Botox into the bladder wall. This treatment lasts typically 6-9 months. In some cases, it may lead to urinary retention requiring self-catheterization until the treatment begins to wear off.

## VII. MARKETING HISTORY

The Neuspera Sacral Neuromodulation System has not been marketed in the United States or any foreign country.

## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device, which are risks beyond those normally associated with surgery, some of which may necessitate surgical intervention.

- Adverse change in voiding function (bowel and/or bladder)
- Allergic or immune system response to the implanted materials that could result in device rejections
- Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients
- Implant erosion
- Implant fracture/failure
- Implant migration
- Electrical shock
- Heating or burn at implant site or site of Wireless Transmitter placement
- Infection
- Lack of effectiveness
- Pain or irritation at implant site
- Reoperation/Revision
- Seroma, hemorrhage, and/or hematoma
- Nerve injury (including numbness)
- Technical device malfunction leading to an adverse event
- Transient electric shock or tingling
- Vulvovaginal pain or pelvic pain
- Unintended nerve activation

For the specific adverse events that occurred in the clinical study, please see Section X below.

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IX. SUMMARY OF NON-CLINICAL STUDIES

A. Laboratory Studies

Bench testing described in this section were conducted to evaluate the safety and performance of the Neuspera SNM system.

1. Implantable Neurostimulator and Implantable Sacral Nerve Stimulation (SNS) Tool Kit

Key testing for the Implantable Neurostimulator and Implantable Sacral Nerve Stimulation (SNS) Tool Kit is summarized in the tables below. For every requirement, the acceptance criteria were met (i.e., device passed testing).

The test results summarized below demonstrate that all applicable Implantable Neurostimulator and Implantable Sacral Nerve Stimulation (SNS) Tool Kit requirements have been verified and that the design outputs meet the design input requirements.

Table 5. Bench Testing Summary – Implantable Neurostimulator – Electrical and Mechanical Requirements

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Implant – Stimulation Voltage Amplitude Programmability | The characteristics of the output pulses shall be within specified tolerances. | Acceptance criteria will be met if the implant is able to deliver stimulation with a leading-edge pulse amplitude between 0.2 V and 1.0V in steps of 0.1 V with a tolerance of 0.1 V for each programmable value and between 1.0 V and 4.8 V in steps of 0.2 V with a tolerance of 10% for each programmable value into a nominal 1 kΩ load. | Pass |
| Implant – Stimulation Pulse Duration Programmability | The characteristics of the output pulses shall be within specified tolerances. | Acceptance criteria will be met if the implant stimulation pulse duration is programmable between 105-945 μs in steps of 15us with a tolerance of 10% for each programmable value. | Pass |
| Implant – Stimulation Pulse Frequency Programmability | The characteristics of the output pulses shall be within specified tolerances. | Acceptance criteria will be met if the implant stimulation pulse frequency is programmable between 5 and 100 Hz in steps of 1Hz with a tolerance of 10% for each programmable value. | Pass |
| Implant – Polarity Configuration | To verify the implant is capable of specified output configurations. | Acceptance criteria will be met if all 4 electrodes are configurable to +, -, and off. | Pass |

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| Implant – Data Integrity Check | To verify the Implant does not respond to corrupted communication signals. | Acceptance criteria will be met if during reception from the WT, the implant utilizes the data integrity code transmitted by the WT to disregard data that does not pass a data integrity check. | Pass |
| --- | --- | --- | --- |
| Implant - Electrodes | To verify the Implant electrodes meet dimensional requirements. | Acceptance criteria will be met if the implant electrodes are measured to have a diameter between 1.25 – 1.45 mm and a length between 2.7 – 3.3 mm. | Pass |
| Implant – Electrode Spacing | To verify the Implant electrode spacing meet dimensional requirements. | Acceptance criteria will be met if the spacing between each implant electrode is measured to be between 2.7 – 3.3 mm. | Pass |
| Implant – Maximum Allowable Charge Imbalance | To verify the leakage current is in an acceptable range. | Acceptance criteria will be met if the net DC current stimulation density is ≤ 0.75 μA/mm². | Pass |
| Implant – Maximum Allowable Stimulation | To verify the stimulation charge density is in an acceptable range. | Acceptance criteria will be met if the implant does not allow > 30 μC/cm² to or from the implant can regardless of the stimulation setting. | Pass |
| Implant – X-Ray | To demonstrate implant functionality after X-ray and compatibility with fluoroscopic procedures. | Acceptance criteria will be met if all test articles pass subsequent verification tests for requirements after exposure to 100 mSv or greater of radiation. | Pass |
| Implant – Insulation Durability | To demonstrate that the electrode array meets mechanical flexure requirements for the specified service life | Acceptance criteria will be met if the electrode array insulation materials are intact after running through a specified number of cycles equivalent to the service life. | Pass |
| Implant – Hermeticity | To demonstrate that the implant hermetic package leak rate is below limit to maintain functionality for the specified service life | Acceptance criteria will be met if the circuit housing of the implant is hermetic with an acceptable leak rate. | Pass |
| Implant – Damage Resistance to Maximum WT Power | To demonstrate that the implant shall not be damaged and remains functional after exposure to maximum WT power | Acceptance criteria will be met if the implant meets the acceptance criteria after exposure to 11.55 dBm or greater. | Pass |

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Where noted, the bench testing in Table 6 was conducted per ISO 14708-3:2017, Implants for surgery — Active implantable medical devices, Part 3: Implantable Neurostimulators.

Table 6. Bench Testing Summary – Implant &amp; Implant Kit ISO 14708 Requirements

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Implant – Electrode Insulation Dielectric Strength | To test that the implant has effective functional electrical insulation between conductors | Acceptance criteria will be met if the voltage between each of the four electrodes (E0, E1, E2, E3) and the circuit housing shall be ≤ X mV, where X is calculated based on the following formula: X = Measured Resistor Value X 0.001 mA | Pass |
| Implant – No Sharp Features | To demonstrate implant has no sharp features per 14708-3 §15.2. | Acceptance criteria will be met if the implant does not have any surface features which contain sharp corners or edges. | Pass |

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| Implant – Maximum Temperature | To verify the implant outer surface temperature shall comply with ISO 14708-3 §17.1. | Implant surface temperature shall be ≤ 39°C. | Pass |
| --- | --- | --- | --- |
| Implant – Resistance to Pressure | To demonstrate that the implant is resistant to pressure changes per ISO 14708-3 §25.1. | Implant meets the essential performance requirements following completion of the pressure changes. | Pass |
| Implant – Resistance to Temperature | To demonstrate that the implant is resistant to temperature per ISO 14708-3 §26.2. | Implant meets the essential performance requirements following completion of the temperature changes: | Pass |
| Implant – Resistance to Mechanical Forces | To demonstrate that the implant is resistant to mechanical forces per ISO 14708-3 §23.2. | Implant meets essential performance requirements following completion of the mechanical forces. | Pass |
| Implant – Resistance to Mechanical Shock | To demonstrate that the implant is resistant to mechanical shock per ISO 14708-3 §23.7. | Implant meets essential performance requirements following mechanical shock. | Pass |
| Implant – Compatibility with Defibrillators | To demonstrate implant is compatible with external defibrillators. | Implant meets essential performance requirements following exposure to defibrillation waveform. | Pass (Note: As described in the device labeling, external defibrillati on can cause induced currents in the lead or other system components that can injure the patient.) |
| Implant – Ultrasound Compatibility | To demonstrate implant is compatible with diagnostic ultrasound | Implant shall remain functional after exposure to diagnostic ultrasound. | Pass |

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| Implant – EM Disturbance | To demonstrate the implant complies with applicable 14708-3 Section 27 (27.104; 27.105; 27.105.1; 27.106; 27.107) requirements. | Implant shall be functional through demonstration of stimulation through all electrodes, implant stimulation, if active, must not increase beyond maximum output (4.8 V), and implant output, if active, maintains charge recovery phase of stimulation equal to positive phase for charge. | Pass (Note: As described in the labeling, electromagnetic interference (EMI) from various sources may damage the device, interfere with device operation, or cause harm to the patient.) |
| --- | --- | --- | --- |
| Implant – MRI Compatibility | To demonstrate implant can be safely scanned with MRI under labeled conditions. | The implant shall be MRI Conditional for 1.5 T and 3.0 T normal mode scans up to 1 hour per ISO 14708-3 §22.2. | Pass (Please see paragraph below for additional MRI compatibility testing conducted on the implant.) |
| Implant – Particulates | To verify there is no unacceptable release of particulate matter when the device is used as intended. | 1) Particle counts of size 10 mm or greater are less than or equal 6000 particles in all extracts performed. 2) Particle counts of size 25 mm or greater are less than or equal 600 particles in all extracts performed. | Pass |

MR compatibility testing was conducted to demonstrate that the Implant can be safely used in MRI environments (1.5 T and 3.0 T normal mode scans up to 1 hour) and to support MR Conditional labeling, with regards to the potential hazards for a patient undergoing an MRI while implanted with the device. Where appropriate, test methods were derived from the ISO Technical Specification 10974:2018: Assessment of the safety of magnetic resonance imaging for patients with active implantable medical devices (AIMDs) and FDA-2019-D-2837 and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. MRI RF heating evaluation was also conducted according to ISO/TS 10974 guidelines using the Tier 2 approach for electrically short device.

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The results of this testing demonstrate that patients with the Implant can undergo an MRI at $1.5\mathrm{T}$ and $3\mathrm{T}$ for up to 1 hour and support an MR Conditional label for the Implant.

Table 7. Implant Kit Tools - General Requirements

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Foramen Needle – Insulation Stability | To demonstrate the needle has effective electrical insulation between the distal electrode and proximal contact. | Following completion of ≥ 24 hours of immersion in 9.0g/L of saline at 37°C ± 2, the 3.5” needle shall withstand ≥ 500 VDC for 60 seconds with < 2.5 mA of leakage current. | Pass |
| Foramen Needle – Typical Forces | To demonstrate the foramen needle can withstand multiple insertion cycles. | The foramen needle shall be undamaged and mechanically functional after undergoing 3 cycles of at least a 5N compressive load. | Pass |
| Foramen Needle – Lateral Stiffness | To demonstrate that the needle has sufficient lateral stiffness | With the stylet installed to the needle cannula, the lateral stiffness of the 3.5” needle shall be ≥ 8.7 N/m. | Pass |
| Guidewire – Typical Forces | To demonstrate the guidewire can withstand multiple insertion cycles. | Acceptance criteria will be met if the guidewire withstands at least a 5N insertion force for 3 consecutive cycles without visible or permanent damage. | Pass |
| Pre-Dilator – Typical Forces | To demonstrate the pre-dilator can withstand multiple insertion cycles. | Acceptance criteria will be met if the pre-dilator withstands at least a 22N insertion force for 3 consecutive cycles without visible or permanent damage. | Pass |
| Implant Tools – Tine Deployment | The pushrod and implant, when assembled, shall deploy the tines when the implant is placed through the sheath. | Acceptance criteria will be met if the tines deploy after passing through the sheath. | Pass |
| Foramen Needle – Stimulation Parameters | The foramen needle shall be able to deliver the full range of stimulation parameters. | The foramen needle shall deliver at least a 5 mA stimulation pulse with a 945 μs pulse width, 100 Hz pulse frequency, and voltage drop less than 100mV. | Pass |

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| Foramen Needle – Insertion Force | To demonstrate the needle insertion force does not exceed acceptable limits | Needle insertion force shall be less than 4 N when inserted into a tissue surrogate polyurethane film | Pass |
| --- | --- | --- | --- |
| Foramen Needle – Charge Density | To demonstrate that the uninsulated distal needle electrode has sufficient surface area to not allow unacceptable density charge | With at least a 5 mA stimulation amplitude, the charge density of the distal electrode of the needle shall be <= 30 C/cm². | Pass |

2. Wireless Transmitter (WT)

Key testing for the Wireless Transmitter (WT) and accessories is summarized in the tables below. For every requirement, the acceptance criteria were met (i.e., device passed testing).

The test results summarized below demonstrate that all applicable Wireless Transmitter (WT) and accessories requirements have been verified and that the design outputs meet the design input requirements.

Where noted, the bench testing in Table 8 was conducted per the following:

- Federal Communications Commission requirements,
- IEC 60601-1:2005, Medical Electrical Equipment -- Part 1: General Requirements Basic Safety and Essential Performance, 3rd edition,
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- IEC 60601-1-11:2015: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Table 8. FCC, IEC 60601-1, IEC 60601-1-2, And IEC 60601-1-11 Compliance Testing

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| WT-EnclosureElectricalSafety | To demonstrate the WT complies with applicable IEC 60601-1 electrical enclosure requirements. | The WT enclosure shall comply with the following IEC 60601-1 material integrity requirements: i. be at least 0.4 mm thick between interior and exterior per IEC 60601-1 8.8.2 ii. Withstand 3000 V AC Hipot, Dielectric testing per IEC 60601-1 8.8.3 | Pass |

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| | | iii. Include 3.4 mm creepage distance and 1.6 mm air clearance at seams | |
| --- | --- | --- | --- |
| WT - Enclosure Heat and Environmental Stress Resistance | To demonstrate the WT complies with applicable IEC 60601-1 Enclosure Heat and Environmental Stress requirements. | The WT enclosure shall be resistant to heat per 60601-1 8.8.4.1 and environmental stresses per 60601-1 8.8.4.2. | Pass |
| WT- Enclosure Mechanical Safety | To demonstrate the WT complies with applicable IEC 60601-1 mechanical requirements. | The WT shall withstand: i. Push, per IEC 60601-1 §15.3.2 ii. Impact, per IEC 60601-1 §15.3.3 iii. Drop, per ISO 14708-3 §23.1, IEC 60601-1 §15.3.4.1, IEC 60601-1 §15.3.4.2 iv. Mold stress relief per IEC 60601-1 §15.3.6 v. Shock and vibration per IEC 60601-1-11 §10.1.2 | Pass |
| WT - Applied Part | To demonstrate the WT complies with applicable body worn floating device requirements. | The WT shall be subjected to the requirements for applied parts (Class BF). | Pass |
| WT- Transportable and Storage Conditions per IEC 60601-1-11 | To demonstrate the WT complies with applicable IEC 60601-1 requirements. | The WT shall remain functional following transportation and storage conditioning for up to 1 month in the following environmental conditions after the WT has been removed from its protective packaging and subsequently between uses per IEC 60601-1-11 §4.2.2. • -10 °C to +5°C • +5 °C to + 35°C at relative humidity (RH) up to 90%, non-condensing • >35 °C to 55 °C at a water vapor pressure up to 50 hPa | Pass |
| WT- Environmental Operating Conditions | To demonstrate the WT complies with applicable IEC 60601-1 requirements. | The WT shall comply with its specifications under the following environmental conditions per IEC 60601-1-11 §4.2.3.1 • +5 °C to +40 °C; • a RH range of 15% to 90%, noncondensing and not requiring a vapor partial pressure greater than 50 hPa; and • an atmospheric pressure range of 700 hPa to 1060 hP | Pass |

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| WT-Flammability Rating | To demonstrate the WT complies with applicable IEC 60601-1 enclosure flammability requirements. | The WT enclosure and PCB shall have a flammability rating FV-2 or better per IEC 60601-1 §11.3. | Pass |
| --- | --- | --- | --- |
| WT-Enclosure Material Insulation | To demonstrate the WT complies with applicable IEC 60601-1 enclosure material insulation requirements. | The WT enclosure material shall be typical insulating electronic enclosure material such as ABS or polycarbonate with no exposed electrical conductors [to limit leakage currents] per IEC 60601-1 §8.7.4. | Pass |
| WT - Battery Protection | To demonstrate the WT battery complies with applicable IEC 60601-1 requirements. | The WT battery shall be equipped with protection circuitry preventing excessive discharge to be compliant with IEC 60601-1 ed3 §15.4.3 | Pass |
| WT-Electrostatic Discharge (ESD) | To demonstrate the WT complies with applicable IEC 60601-1-2 requirements | The WT shall meet essential performance requirements following exposure to ESD per 60601-1-2 test, ESD 61000-4-2 class 4. | Pass |
| WT - Electromagnetic Compatibility (EMC) IEC 60601-1-2 Compliance | To demonstrate the WT complies with applicable IEC 60601-1-2 requirements | The WT shall be EMC compliant per IEC 60601-1-2, class B. | Pass |
| WT- EMC IEC 60601-4-2 compliance | To demonstrate the WT complies with applicable requirements of IEC/TR 60601-4-2 Ed. 1.0 en:2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | The WT shall be EMC compliant per IEC 60601-4-2 | Pass |
| WT - Maximum Touch Temperature during Therapy | To demonstrate that the WT maximum enclosure surface during therapy with the garment does not become too hot | The WT maximum enclosure surface touch temperature during therapy with the garment shall not exceed 60 °C at any time per IEC 60601-1. | Pass |

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Table 9. Wireless Transmitter Bench Testing

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| WT - Charge Battery Temperature Controls | To verify WT temperature limits operation within the battery's specifications. | The WT shall limit battery temperature in accordance with the battery manufacturer's specifications. | Pass |
| WT - Temperature Control Loop | To verify the WT shuts down stimulation if the temperature control loop malfunctions to ensure thermal safety | The WT shall detect and not allow stimulation if temperature control loop is not functional. | Pass |
| WT - Discharge Temperature Controls | To demonstrate the WT has adequate temperature controls to cease stimulation if the WT becomes too hot | The WT shall cease therapy delivery until the battery temperature has dropped below the overheat threshold of 60°C and shall automatically resume therapy delivery when the temperature drops to below <=58°C. | Pass |
| WT - Battery Operation Duration | To demonstrate the WT's battery operation duration is acceptable for the duration of treatment | The WT's battery shall be sufficient for at least 2 hours of operation under typical use conditions. | Pass |
| WT - Service Life Durability | To demonstrate the WT performs as intended during its service life | The WT shall have a minimum operational service life of 1 year based on 1 battery full discharge and full recharge cycle per day. | Pass |

Table 10. WT Charger and Battery Verification

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| WT Charger- WT Battery Charge Time | To demonstrate the WT charges within the specified time | Acceptance criteria will be met if the charger is able to charge the WT to a state of charge level of 95% or greater in 5 hours. | Pass |

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| WT- Lithium Ion Battery IEC 62133-2 Compliance | To demonstrate WT battery complies with requirements of IEC 62133-2 Ed. 1.1 b:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems. | The WT batteries shall comply with requirements of IEC 62133-2. | Pass |
| --- | --- | --- | --- |

3. System, Clinician Programmer, and Patient Controller

Key system testing, including the Clinician Programmer and Patient Controller, is summarized in the tables below. System testing included testing of all components together. For every requirement, the acceptance criteria were met (i.e., device passed testing).

The test results summarized below demonstrate that all applicable system testing, including the Clinician Programmer and Patient Controller requirements have been verified and that the design outputs meet the design input requirements.

Table 11. Bench Testing Summary - System

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| System - IEC 60601-1, 60601-1-2, and 60601-1-11 Compliance | To demonstrate basic safety and essential performance of medical electrical equipment | The system shall be compliant with IEC 60601-1, 60601-1-2, 60601-1-11. | Pass |
| System - ISO 14708-1 and 14708-3 Compliance | To demonstrate the system requirements for active implantable medical devices are acceptable per ISO 14708-1 and 14708-3. | The system shall be compliant with ISO 14708-1 and 14708-3. | Pass |

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| System - WT Offset Distance | The system shall provide therapy stimulation with an WT offset distance of 3cm at nominal settings. | The system shall provide nominal stimulation settings under the following use conditions for at least 5 cm depth in phantom (including 5mm shell and >45mm fluid phantom fluid):
• 30 degree radial angle
• WT-implant displacement conditions: +30mm X-displacement, -30mm X displacement, +30mm Y-displacement, 30mm Y-displacement
• +60 and -60 degree axial angle
• at nominal stimulation settings (1V Amplitude, 14Hz Freq, 210us Pulse Width) | Pass |
| --- | --- | --- | --- |
| System - Continuous Stimulation During Therapy | The system shall be able to provide continuous stimulation for the treatment duration | The system shall be able to provide daily 4 hours of continuous stimulation (with the exception of the WT replacement after 2 hours of therapy). | Pass |
| System - RF Power Setting | To demonstrate the system can set the average WT RF output power needed to power the implant. | The system shall be capable of setting the average WT RF output power used for powering the implant. | Pass |
| System - Clinician Programmer Stimulation Settings | The clinician programmer and WT placed adjacent to the trial stimulator, stimulation settings parameters can change settings parameters | Using the clinician programmer and WT placed adjacent to the trial stimulator, stimulation settings parameters shall be changed including:
• Change from left to right lead stimulation output
• Start and Stop stimulation
• Adjust stimulation frequency, amplitude, pulse width | Pass |

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| System - Patient Controller Stimulation Settings | To demonstrate the patient programmer and WT placed when adjacent to the trial stimulator, stimulation settings parameters can change settings parameters | Using the patient programmer and WT placed adjacent to the trial stimulator, stimulation settings parameters shall be changed including: • Change from left to right lead stimulation output • Start and Stop stimulation • Adjust stimulation amplitude | Pass |
| --- | --- | --- | --- |

# 4. Trial System

Key system testing for the Trial System, including the Trial System Kit, Trial Lead Kit, Procedural Accessories Kit, and External Procedure Kit is summarized in the tables below. For every requirement, the acceptance criteria were met (i.e., device passed testing).

The test results summarized above demonstrate that all applicable system testing, including the Clinician Programmer and Patient Controller requirements have been verified and that the design outputs meet the design input requirements.

Table 12. Bench Testing Summary - Trial System Kit

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Trial Foramen Needle - Lateral Stiffness | To demonstrate that the needle has sufficient lateral stiffness | The foramen needle lateral stiffness range shall be greater than 8.7 N/m with stylet installed. | Pass |
| Trial Foramen Needle - Insulation Stability | To demonstrate the needle has effective electrical insulation between the distal electrode and proximal contact. | After immersion in 9.0 g/L saline for a minimum of 24 hours at 37 °C, the insulated region shall withstand 500 volts DC for 60 seconds minimum without dielectric breakdown. | Pass |
| Trial Foramen Needle - Typical Forces | To demonstrate the foramen needle is compatible with the lead and can withstand multiple insertion and removal cycles. | The foramen needle shall withstand typical insertion forces (5N) up to three times | Pass |
| Trial Foramen Needle - Stimulation Parameters | The foramen needle shall be able to deliver the stimulation parameters. | The foramen needle shall be able to deliver up to 5 mA stimulation pulse amplitude, 945 μs pulse width, and 100 Hz pulse frequency. | Pass |
| Trial Foramen Needle - Typical Forces | The foramen needle shall withstand typical insertion forces | The foramen needle shall withstand typical insertion forces (5N) up to three times. | Pass |

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| Trial Foramen Needle – Charge Density | The uninsulated distal needle electrode has sufficient surface area to not allow unacceptable charge density | The uninsulated distal needle electrode shall be sufficient in surface area to not allow > 30 uC/cm² to or from the needle at 5mA stimulation amplitude | Pass |
| --- | --- | --- | --- |
| Trial Lead - Insertion Force in Needle | To demonstrate that the lead and needle meet specified interface requirements for insertion force | Trialing lead shall fit through the 3.5" foramen needle with less than 1.5 N of force. | Pass |
| Trial Lead - Foramen Needle Compatibility – Insertion and Removal | To demonstrate the trial lead is compatible with the foramen needles and can withstand multiple insertion and removal cycles. | Trial Lead shall be able to withstand three cycles of insertion and removal from the foramen needle | Pass |
| Trial Lead - Markers for Electrode Exit from Needle | To verify that the trial lead meets user interface requirements for lead placement. | The Trial lead shall have visual markers to denote that when the distal portion of the trial lead marker is at the needle hub, the distal tip of the trial lead electrode and distal needle tip match. | Pass |
| Trial Lead - Stylet from Lead Retention Force | To demonstrate that the lead and stylet meet specified interface requirements for insertion force | The force to remove the stylet from the trialing lead shall be < 1 N. | Pass |
| Trial Lead – Stylet Lateral Stiffness | To demonstrate that the stylet lateral stiffness is acceptable | The stylet lateral stiffness shall be greater than 3.8 N/m with the applied force applied at a stylet length of 1 cm and a displacement of 1 cm. | Pass |
| Trial Lead - DC Resistance | To demonstrate the DC resistance of the lead is within specification. | The DC resistance from proximal tip to the distal electrode shall be ≤ 250 ohms. | Pass |
| Trial Lead - Proximal Pin Insertion Cycles | To demonstrate the number of connection cycles with the External Stimulator | The trial lead connector shall be capable of insertion and removal from the trial stimulator for a minimum of 3 cycles. | Pass |
| Trial Lead - Stimulation Output | To demonstrate the trial lead is capable of delivering maximum stimulation parameters | The trialing lead shall be able to deliver up to 5 mA stimulation pulse amplitude, 945 μs pulse width, and 100 Hz pulse frequency. | Pass |

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| Trial Lead - Distal Cyclic Flexure Strength | To demonstrate the distal lead body can withstand repeated flexure. | The trial lead shall withstand flexure cycling (90 degrees) at a rate of 2 Hz for > 1,000 cycles without mechanical or electrical damage. | Pass |
| --- | --- | --- | --- |
| Trial Lead - Maximum Tensile Force, elongation | To demonstrate the lead remains electrically and mechanically intact after sustained elongation and the lead has adequate tensile strength | The Trial Lead shall withstand 20% elongation for ≥ 1 minute. DC resistance shall be ≤ 250 ohms after the testing. The proximal electrode tip shall be secured to the coiled lead body with a tensile force of ≥ 5 N | Pass |
| Trial Lead - Proximal Cyclic Flexure Strength | To demonstrate the proximal lead body can withstand repeated flexure. | The proximal region at the proximal contact junction shall withstand flexure cycling (+ 45 degrees) at a rate of 2 Hz for a minimum of 2,000 cycles without mechanical or electrical damage. | Pass |
| Trial Lead - Leakage Current | To test that the lead has effective functional electrical insulation between conductors | The insulation of the trial lead shall withstand immersion in saline for a minimum of 10 days at 37°C, such that the leakage current between the conductor and a reference electrode shall be < 9 uA when tested to a minimum of 10 volts DC per ISO 14708-1 clause 16.3 | Pass |
| Trial Lead - Crush Resistance | To demonstrate the lead remains mechanically intact and capable of normal operation following exposure to a crush force. | The trial lead shall remain mechanically intact and maintain electrical conductivity without insulation damage following a 200 lb load. | Pass |
| Trial Lead - Abrasion Resistance | To demonstrate the lead remains mechanically intact and capable of normal operation following exposure to abrasion. | The trial lead shall remain mechanically intact and maintain electrical conductivity without insulation damage following typical 7-day abrasion forces. | Pass |

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Table 13. Bench Testing Summary – External Procedure Kit

| Test | Test Performed | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| External Stimulator - Crush Resistance | To demonstrate the External Stimulator remains mechanically intact and capable of normal operation following exposure to a crush load. | The external stimulator remains mechanically intact and capable of normal operation after application of 200lb load on top surface. | Pass |
| External Stimulator - Case Deflection Resistance | To demonstrate the External Stimulator remains mechanically intact and capable of normal operation following exposure to an enclosure deflection load. | The external stimulator remains mechanically intact and capable of normal operation after application of 200lb deflection load at center of top surface applied with circular, flat deflection source <30mm diameter. | Pass |
| External Stimulator - Abrasion Resistance | To demonstrate the External Stimulator remains mechanically intact and capable of normal operation following exposure to an enclosure abrasion. | The external stimulator remains mechanically intact and capable of normal operation after application typical 7-day abrasion mechanical forces. | Pass |
| External Stimulator - Size and Weight | To demonstrate External Stimulator meets volume and weight requirements. | External Stimulator excluding cable shall be less than 33 cc in volume and less than 53.9g in weight | Pass |
| External Stimulator - Change Balance | To verify the leakage current is in an acceptable range. | The external stimulator shall not allow net DC current stimulation current density in excess of 0.75 uA / mm2 | Pass |
| External Stimulator - Current Density | To verify the stimulation charge density is in an acceptable range. | The external stimulator shall not allow >30 uC/cm2 to or from the lead regardless of stimulation setting. | Pass |
| External Stimulator - Configurations | To verify the External Stimulator is capable of specified configurations. | The external stimulator shall be configurable for the following: Left lead anode, right lead cathode Left lead cathode, right lead anode Left lead cathode, ground pad anode Right lead cathode, ground pad anode | Pass |

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| External Stimulator - Stimulation Voltage Amplitude Programmability | The characteristics of the output pulses shall be within specified tolerances. | The external stimulator shall deliver stimulation with a leading-edge pulse amplitude between 0.2 V and 1.0V in steps of 0.1 V with a tolerance of 0.1 V for each programmable value and between 1.0 V and 4.8 V in steps of 0.2 V with a tolerance of 10% for each programmable value into a nominal 1 kΩ load. | Pass |
| --- | --- | --- | --- |
| External Stimulator - Stimulation Pulse Duration Programmability | The characteristics of the output pulses shall be within specified tolerances. | The external stimulator pulse duration shall be programmable between 105-945 μs in steps of 15us with a tolerance of 10% for each programmable value. | Pass |
| External Stimulator - Stimulation Pulse Frequency Programmability | The characteristics of the output pulses shall be within specified tolerances. | The external stimulator pulse frequency shall be programmable between 5 and 100 Hz in steps of 1Hz with a tolerance of 10% for each programmable value. | Pass |
| External Stimulator - E-Stop | To verify the External Stimulator is capable of being turned off through an alternative means. | The External Stimulator shall include an additional mechanism to stop stimulation without WT and Patient Controller | Pass |
| External Stimulator - Continuous Operation | To verify the External Stimulator meets specifications for up to 7-day service life. | The external stimulator shall be capable of continuous stimulation for at least 7 days (24 hours/day) of operation under 4.8V, 210us pulse with, 14 Hz, 1k ohm impedance stimulation. | Pass |
| External Stimulator - Data Integrity Check | To verify the External Stimulator does not respond to corrupted communication signals. | During reception from the WT, the External Stimulator will use the data integrity code transmitted by the WT to disregard data that does not pass a data integrity check. | Pass |
| External Stimulator - No sharp edges | To demonstrate the External Stimulator complies with applicable IEC 60601-1 requirements. | The External Stimulator shall have no rough surfaces or sharp edges/corners per ISO 60601-1 §9.3. | Pass |

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| External Stimulator - Enclosure Electrical Safety | To demonstrate the External Stimulator complies with applicable IEC 60601-1 requirements. | The External Stimulator enclosure shall comply with the following IEC 60601-1 material integrity requirements: i. be at least 0.4 mm thick between interior and exterior IEC 60601-1 8.8.2 ii. Withstand 3000 V AC Hipot, Dielectric testing per IEC 60601-1 §8.8.3 iii. Include 3.4 mm creepage distance and 1.6 mm air clearance at seams | Pass |
| --- | --- | --- | --- |
| External Stimulator - Enclosure Material Insulation | To demonstrate the External Stimulator complies with applicable IEC 60601-1 requirements. | The External Stimulator enclosure material shall be typical insulating electronic enclosure material such as ABS or polycarbonate with no exposed electrical conductors per IEC 60601-1 §8.7.4. | Pass |
| External Stimulator - Enclosure Mechanical Safety | To demonstrate the External Stimulator complies with applicable IEC 60601-1 mechanical requirements. | The External Stimulator shall withstand: i. Push, per IEC 60601-1 §15.3.2 ii. Impact, per IEC 60601-1 §15.3.3 iii. Drop, per ISO 14708-3 §23.1, IEC 60601-1 §15.3.4.1, IEC 60601-1 §15.3.4.2 iv. Mold stress relief per IEC 60601-1 §15.3.6 v. Shock and vibration per IEC 60601-1-11 §10.1.2 | Pass |
| External Stimulator - Environmental Operating Conditions | To demonstrate the External Stimulator complies with applicable IEC 60601-1-11 requirements. | The External Stimulator shall comply with its specifications under the following environmental conditions per IEC 60601-1-11 §4.2.3.1: +5 °C to +40 °C; a RH range of 15% to 90%, non-condensing and not requiring a vapor partial pressure greater than 50 hPa; and an atmospheric pressure range of 700 hPa to 1060 hP | Pass |
| External Stimulator - No removable small parts per IEC 60601-1-11 | To demonstrate the External Stimulator complies with applicable IEC 60601-1-11 requirements. | The External Stimulator shall have no removable small parts per 60601-1-11 Section 9. | Pass |

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| External Stimulator - Applied Part BF | To demonstrate the External Stimulator complies with applicable requirements for body worn floating devices. | The External Stimulator shall be subjected to the requirements for applied parts (Class BF). | Pass |
| --- | --- | --- | --- |
| External Stimulator - Maximum Temperature during Therapy | To demonstrate the External Stimulator complies with applicable IEC 60601-1 requirements. | The External Stimulator maximum temperature during therapy shall not exceed 43 °C at any time per IEC 60601-1 | Pass |
| External Stimulator - Transportable and Storage Conditions per IEC | To demonstrate the External Stimulator complies with applicable IEC 60601-1-11 requirements. | The External Stimulator shall remain functional following transportation and storage conditioning for up to 1 month in the following environmental conditions after the External Stimulator has been removed from its protective packaging and subsequently between uses per IEC 60601-1-11 §4.2.2.
• -10 °C to +5 °C
• +5 °C to + 35 °C at RH up to 90%, non-condensing
• >35 °C to 55 °C at a water vapor pressure up to 50 hPa | Pass |
| External Stimulator - ESD | To demonstrate the External Stimulator complies with applicable IEC 60601-1-2 requirements. | The External Stimulator shall meet essential performance requirements following exposure to ESD per 60601-1-2 test, ESD 61000-4-2 class 4. | Pass |
| Trial Test Stimulation Cable - Resistance | To demonstrate the DC resistance of the cable is within specification. | The test stimulation cable shall have a resistance of <150 ohms. | Pass |

5. Sterility

Several of the Neuspera components are provided in sterile packaging:

- Implantable Sacral Nerve Stimulator Kit ("Implant Kit")
- Foramen Needle
- Trial Lead/Stylet
- Intraoperative Cable

All components are sterilized by ethylene oxide (EO). The Implant Kit is provided in a Tyvek breather bag with a Tyvek tray lid. The remaining components are provided in a double barrier Tyvek pouch system.

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The Neuspera components that are provided sterile are terminally sterilized using a 100% ethylene oxide (EO) sterilization cycle. Validation of the sterilization process demonstrates a Sterility Assurance Level (SAL) of 10⁻⁶ and complies with ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Sterilant residuals conform to the maximum allowable limits of EO and Ethylene Chlorohydrin (ECH) residuals specified in ISO 109937: 2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. The bacterial endotoxin limits are based on FDA’s Guidance for Industry - Pyrogen and Endotoxins Testing: Questions and Answers (June 2012) and were verified using Limulus Amebocyte Lysate (LAL) testing.

## 6. Reprocessing

All other Neuspera manufactured system components, that are not sterile, are provided non-sterile and do not need to be sterilized prior to use. Reprocessing instructions in the labeling are in accordance with 2015 FDA guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” and 2001 FDA guidance document, “Guidance on Medical Device Patient Labeling.”

## 7. Biocompatibility

Biocompatibility testing was performed for all the patient-contacting materials of the Neuspera SNM System in accordance with the FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58.

The following biocompatibility endpoints were assessed:

- The Implantable Sacral Nerve Stimulator (Implant) is an implant device, contacting tissue/bone for long-term duration (&gt;30 days)
- Cytotoxicity
- Sensitization
- Intracutaneous Irritation
- Material Mediated Pyrogenicity
- Implantation
- Genotoxicity
- Chronic systemic toxicity
- Chemical characterization followed by Toxicological Risk Assessment of compounds extracted from the device to evaluate acute and subacute/subchronic systemic toxicity, and carcinogenicity

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- All Implant Tools are external communicating devices, contacting tissue/bone for limited duration (&lt;24 hours)
- Cytotoxicity
- Intracutaneous Irritation
- Material Mediated Pyrogenicity
- Sensitization
- Acute Systemic Toxicity

- Trial Lead and Stylet are considered external communicating devices, contacting tissue/bone for prolonged duration (&gt;24 hours, up to 7 days)
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization
- Material Mediated Pyrogenicity
- Implantation
- Chemical characterization followed by Toxicological Risk Assessment of compounds extracted from the device to evaluate acute and subacute/subchronic systemic toxicity, and genotoxicity

- Wireless Transmitter is a surface device contacting intact skin for long-term duration (&gt;30 days)
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization

- Trial ground pad is a surface device contacting intact skin for prolonged contact (&gt;24 hours, up to 7 days)
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization

- Intraoperative ground pad is a surface device contacting intact skin for limited contact (&lt; 1 hour)
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization

- Undergarment is a surface device contacting intact skin for long-term contact (&gt;30 days)
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization

The results of testing demonstrate that all components of the Neuspera SNM System are biocompatible.

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8. Packaging and Shelf Life

The shelf life of Neuspera SNM System kits containing sterile components are provided in Table 14 below. Packaging was conducted per ISO 11607-1: 2019, Packaging for Terminally Sterilized Medical Devices. The results demonstrate that the packaging maintains the sterility of the device components. Shelf life testing demonstrated that the device adequately maintains its performance and the packaging maintains its sterility over the claimed shelf life (Table 14).

All other components of the Neuspera SNM System do not have a designated shelf life.

Table 14. Shelf Life of Neuspera SNM System Kits with Sterile Components

| Component | Shelf Life |
| --- | --- |
| Implant Kit | 1 year |
| Trial System Kit | 4 months |
| Trial Lead Kit | 4 months |
| Procedural Accessories Kit | 4 months |
| External Procedure Kit | 4 months |

9. Software Verification and Validation

Software development was based on IEC 62304:2006, Medical device software -- Software life cycle processes and is controlled in a lifecycle consistent with this standard. The software documentation were provided in accordance with the FDA Guidance Document entitled, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023.

Software and firmware were tested to ensure that the functional requirements as defined in the product software, and firmware requirements were met.

10. Cybersecurity

Cybersecurity assessment and evaluation of the Neuspera SNM System was conducted in accordance with the FDA Guidance Document entitled, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," issued on September 27, 2023, and AAMI TIR 57:2016, Principles for medical device security – Risk management.

11. Wireless

Wireless testing of the Neuspera SNM System was conducted in accordance with the FDA Guidance Document entitled, "Radio Frequency Wireless Technology in Medical Devices" issued on August 14, 2013.

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# B. Animal Studies

Animal studies were conducted to determine the safety and performance of the proposed device design prior to clinical use. Testing demonstrated that the device met the study endpoints. Key information from the animal studies is summarized in Table 15 below.

Table 15. Summary of Pre-Clinical Animal Studies

| Study | Objective | Results & Conclusions |
| --- | --- | --- |
| A GLP, 90 Days Chronic Study in Ovine to Evaluate the Final Device Design | Evaluate the safety and performance of the final device design in a GLP study. | Overall implant and removal of the non-functional devices at 2-weeks and 90-days was completed without sequelae. The results from the chemistry, hematology and histopathology reports were all within normal limits. The histopathology data and lack of adverse events observed in this study supported the subject device safety for clinical use. |
| A non-GLP, Chronic, Awake, Urodynamic Baseline Study in Ovine | Assess the in vivo functional performance (i.e., ambulatory stimulation) of the sacral nerve neurostimulator for the study duration (110 days). A secondary objective was to monitor for any potential chronic safety issues (>2 month) related to the implant(s). | Two neurostimulators were implanted following the Implant Kit IFU developed for the pivotal study. Both implants could be successfully powered with the mid-field powering technology through at least one week post-operatively. The implant in the right S3 foramen remained functional through at least the first 14 days post-operatively and could be powered using a prototype Wireless Transmitter (same hardware, same core firmware) for up to at least 8 hours. The devices were still functional at 110 days post-implant. |
| A GLP Study in Ovine to Evaluate a Novel Wireless Implantable Device for Sacral Nerve Stimulation | Assess the Neuspera wireless implantable device system and evaluate the ability to implant and remove the device, as well as to ensure that the device works as intended after implantation. | After implantation, once the sheep was standing, testing was performed using the wireless transmitter (WT) and clinician programmer. The device could be adequately implanted and activated, demonstrating acceptable thresholds using the two controllers. The device could be adequately removed without significant tissue trauma, signs of hemorrhage or other overt pathological findings. This was an acute study (recovered from anesthesia, assessed, then euthanized). |

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C. Additional Studies

1. Human Factors and Usability

Two usability studies for the intraoperative workflow steps related to the Trial System were conducted with patient and clinical users. The first trial system usability study included 17 clinicians who currently implant sacral neuromodulation systems to test the clinician use flows. The second trial system usability study included 15 lay people to test the patient use flows. The validation testing showed that the manuals, training, and system use steps for the trial system allowed the users to complete the critical tasks with no use errors or problems that could result in serious harm.

Additionally, a Usability study for the permanent system was conducted with patient users. This study included 20 lay people to test patient use flows. This validation included a knowledge assessment of warnings and cautions, some of which were defined as critical tasks. The validation testing shows that the manuals, training, and system use steps were adequate to demonstrate that the device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. Users were able to complete the critical tasks with no use errors or problems that could result in serious harm.

A separate Usability study for the permanent system was conducted as a knowledge assessment for clinicians. For this study, 16 clinicians were recruited who watched a training video focused on the permanent system and associated critical tasks. These steps included the identification of correct and incorrect placement of the implant. The clinicians then were asked to complete a knowledge assessment. This validation testing showed that the video was sufficient to train clinicians on the correct placement of the device and the identification of critical tasks for the permanent system. To address some use-related errors, clinicians are required to be trained on the use of the device. Additionally, trained Field Clinical Engineers (FCEs) must be present at each trial procedure and permanent implant to ensure that clinicians understand both the device and the procedure. FCE training consists of one-on-one didactic training with the FCE manager, shadowing at least two procedures with an experienced FCE, and then being proctored by an experienced FCE prior to attending procedures alone. FCE clinical checklists will be required to be completed for each procedure.

X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of sacral electrical stimulation with the Neuspera SNM System for treatment of the symptoms of urinary urge incontinence (UUI) in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments in the US and EU under IDE # G190064. Data from this clinical study were the basis for the PMA approval decision. A summary of the pivotal clinical study, Clinical Study of

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Neuspera’s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI) (the SANS-UUI study), is presented below.

## A. Study Design

Subjects were enrolled in the pivotal study beginning on June 8, 2022, and treated between September 28, 2022, and December 5, 2023. The database for this PMA reflected data collected through January 16, 2025, at the 12-month data lock, and included 242 subjects with 130 of those subjects undergoing attempted implant placement. There were 34 investigational sites activated, 31 investigational sites that enrolled and 25 investigational sites that implanted subjects.

The study was a prospective, multi-center, single-arm clinical study designed to evaluate the safety and effectiveness of the Neuspera SNM System. The study included patients with UUI who have failed, could not tolerate, or were not a candidate for more conservative treatments.

## 1. Clinical Inclusion and Exclusion Criteria

Enrollment in the study was limited to subjects who met the following inclusion criteria:

1. Is willing and able to understand and has voluntarily signed and dated the current approved informed consent.
2. Is male or female 22 years of age or older.
3. Has a Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m².
4. Is a good surgical candidate and is capable of participating in all testing and follow-up clinic visits associated with this clinical study and is capable of independently using the system components as described in the Patient Manual.
5. Is ambulatory and able to use toilet without assistance.
6. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
7. Has typical residual bladder volume &lt;150 cc tested within 6 months prior to the screening baseline visit date or is willing to have a test at screening baseline visit.
8. Has urodynamic testing (uroflowmetry, cystometry, and pressure flow) completed within 6-months prior to the screening baseline visit date or is willing to have testing at the screening baseline visit.
9. Has cystoscopy testing completed within 6 months prior to the screening baseline visit date or is willing to have a test at the screening baseline visit.
10. Has failed or was not a candidate for more conservative treatment (e.g., pelvic floor exercise, biofeedback, behavioral modification)
11. Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined

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by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.

12. Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the 12-month follow-up visit.
13. Has appropriate sacral anatomy as determined by sponsor's and investigator's analysis of radiographic imaging. (The distance from the surface of the skin in the prone and seated position to the bone edge of the S3 foramen must be within the capabilities of the system).

Baseline Bladder Diary Inclusion Criteria:

14. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.

Subjects were not permitted to enroll in the SANS-UUI study if they met any of the following exclusion criteria:

1. Has a hemoglobin A1c of &gt;8%, or has diabetes mellitus with glucosuria.
2. Has diabetic neuropathy.
3. Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.
4. Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.
5. Has broken, blistered skin or compromised circulation in the area of the neurostimulator implant.
6. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
7. Has documented urinary retention within 6 months prior to the screening baseline visit date.
8. Has clinically significant bladder outlet obstruction.
9. Is currently undergoing or has previously undergone pelvic irradiation.
10. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer.
11. Has current grade 3 or 4 pelvic organ prolapse including cystocele, rectocele, enterocele, procidentia, or vaginal vault prolapse.
12. Has symptomatic urinary tract infection (UTI); the subject may be considered for study enrollment if the subject is symptom-free after a full course of treatment prior to beginning the baseline bladder diary. If an asymptomatic bacteriuria is detected during the urinalysis performed at screening, a subject may be enrolled without a waiting period relative to UTI treatment.
13. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date.

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14. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for 12-month period following implant.

15. Has received treatment of urinary symptoms with any botulinum neurotoxin type-A (BoNTA) agent in the past 12 months; (e.g. obotulinumtoxinA, Botox®, abobotulinumtoxinA, Dysport®, IncobotulinumtoxinA, Xeomin®).

16. Is a woman who is pregnant or planning to become pregnant during this clinical study or is a woman of child-bearing potential who is not using a medically acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with clear negative result.

17. Has active substance abuse, including alcohol.

18. Has a known hypersensitivity or contraindication to procedural or post-procedural medications which cannot be adequately managed medically.

19. Has a known hypersensitivity to Neuspera’s SNS System device components.

20. Has previously failed SNS therapy.

21. Has active implantable medical devices such as neurostimulators, drug pumps, pacemakers, or internal defibrillators since compatibility has not been assessed.

22. Has known needs for diathermy (shortwave, microwave, or therapeutic ultrasound), and radiofrequency ablation in the vicinity of the neurostimulator since these procedures have not been evaluated.

23. Has a known need for therapeutic ultrasound in the area of the sacral nerve neurostimulator as the device can inadvertently concentrate the ultrasound field and cause harm.

24. Has a known need for therapeutic ionizing radiation as can damage the electrical components of the sacral nerve stimulator and any damage may not be immediately detectable.

25. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study.

26. The investigator is unable to elicit an appropriate motor response in the subject during the intra-operative testing of the implant procedure.

2. Follow-up Schedule

All subjects were scheduled to return for follow-up examinations at 7, 14, 21, and 28-days after implantation. Subjects then returned for clinic evaluation at 2, 3, 4, 5, 6, 9 and 12 months post implant, then every six months thereafter, estimated to be up to 36 months. Subjects were scheduled for a telephone visit at 5.5 months post implant procedure.

Preoperatively, subjects underwent cytoscopy, urodynamics, and sacral anatomy assessment. Postoperatively, a neurostimulator position confirmation image was performed at Day 28 or 42 along with a response rate assessment. The objective parameters measured during the study included a 72 hour bladder diary that was collected at baseline and 6 and 12 months after implantation. Subjects also completed daily stimulation diaries for the first 12 months and a weekly

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stimulation diary after 12 months. Additionally, the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol) and Patient Global Impression of Improvement (PGI-I) questionnaires were performed at Month 3, 6 and 12 months after implantation. Adverse events and complications were recorded at all visits.

The key timepoints are shown below in the tables summarizing safety and effectiveness.

## 3. Clinical Endpoints

With regards to safety, the primary safety endpoint was defined as the incidence of device-related severe adverse events (SAEs) through the 6-month post-implant visit. Safety was evaluated by review of all adverse events that occurred during the study.

With regards to effectiveness, the primary effectiveness endpoint was defined as the percentage of all subjects with an attempted implant who experience ≥50% reduction in the number of UUI episodes at 6 months post-implant, relative to the number of UUI episodes at baseline (therapy responder). This endpoint was also evaluated at 12-months post-implant.

The following secondary effectiveness endpoints were evaluated at 6 and 12 months:

- Change from baseline in mean number of UUI episodes
- Change from baseline in ICIQ-OABqol score
- The percentage of subjects who experience an improvement in ICIQ-OABqol of at least 10 points
- Change in urgent episodes per day from baseline. Calculated across all diary episodes with at least mild urgency
- Change in average number of daily voids from subjects with at least 8 voids at baseline

With regard to success/failure criteria, greater than 50% of subjects with an attempted implant should have achieved greater than 50% reduction in UUI episodes at 6 and 12 months compared to baseline for the study to be considered a success with respect to effectiveness.

## B. Accountability of PMA Cohort

At the time of database lock, of 242 subjects enrolled in the PMA study, 130 subjects had implants attempted and 128 subjects were successfully implanted. 104 subjects were available for analysis at the completion of the study, the 12-month post-operative visit.

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Figure 4: Subject Accountability – Post Implant Period

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The analysis sets were pre-specified in the protocol as follows:

- Intent-to-Treat (ITT) Analysis Set: The ITT analysis set is defined as all subjects who have signed informed consent.
- Modified Intent-to-Treat (mITT) Analysis Set: The mITT analysis set is defined as all subjects for whom an initial implant is attempted.
- Implanted Analysis Set: The Implanted analysis set is defined as all subjects who are implanted with the Neuspera SNS system.
- Responder Analysis Set: The Responder analysis set is defined as subjects who are implanted with the system and are defined as responders at the Day 28 or Day 42 clinic visit post-implant.

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- Per Protocol (PP) Analysis Set: The Per Protocol analysis set is defined as implanted subjects who have no protocol deviations that may significantly affect the primary endpoints. The determination of subjects excluded from the Per Protocol analysis set was made prior to analysis.
- Worst Case Analysis Set: The Worst Case analysis set assumes that all subjects with missing data were failures.

## C. Study Population Demographics and Baseline Parameters

The demographics of the study population are typical for a pivotal study performed in the US.

There were 242 consented subjects in 29 US clinical sites and 2 sites in Europe. At 25 sites, 130 subjects had implants attempted, and 128 subjects were successfully implanted. Table 16 shows the baseline demographics of the mITT subjects.

Table 166. Baseline Demographics

| Baseline Characteristics | mITT Analysis Set (n = 130) |
| --- | --- |
| Age (years) | |
| N | 130 |
| Mean ± SD | 60.4 ± 10.2 |
| Median | 61.0 |
| Min, Max | 21.0, 83.0 |
| BMI | |
| N | 130 |
| Mean ± SD | 29.5 ± 5.1 |
| Median | 29.0 |
| Min, Max | 18.0, 39.0 |
| Sex (n/N (%)) | |
| Female | 128/130 (98.5) |
| Male | 2/130 (1.5) |
| Race (not mutually exclusive, n/N (%)) | |
| American Indian or Alaska Native | 0/130 (0.0) |
| Asian | 0/130 (0.0) |
| Black or African American | 5/130 (3.8) |
| Native Hawaiian or Other Pacific Islander | 0/130 (0.0) |
| White | 124/130 (95.4) |
| Other | 2/130 (1.5) |
| Ethnicity (n/N (%)) | |
| Hispanic or Latino | 10/130 (7.7) |
| Not Hispanic or Latino | 120/130 (92.3) |

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Table 17 below presents the subjects' incontinence history as reported at baseline visit.

Table 17. Incontinence History

| Incontinence History
(Not mutually exclusive)
n/N (%) | mITT Analysis Set
(n = 130) |
| --- | --- |
| Overactive bladder (OAB) | 122/130 (93.8) |
| Stress urinary incontinence (SUI) | 52/130 (40.0) |
| Urinary urge incontinence (UUI)* | 116/130 (89.2) |
| Mixed incontinence | 50/130 (38.5) |
| UUI predominates | 50/130 (38.5) |
| SUI predominates | 0/130 (0.0) |
| Other urinary incontinence | 1/130 (0.8) |
| Fecal incontinence | 13/130 (10.0) |
| Urinary Frequency | 66/130 (50.8) |
| Nocturia | 58/130 (44.6) |

*Note: Multiple options are allowed to be selected for the same patient. In this table, 116 mITT subjects out of 130 had a diagnosis of UUI for their incontinence history. An additional eight (8) subjects had mixed incontinence with UUI predominating, indicating that they also had UUI. The remaining six (6) subjects that did not have UUI or mixed incontinence did have an OAB diagnosis; given that the subjects also had to have four UUI episodes in 72 hours, they would need to have OAB with associated UUI. Consequently, all subjects in the mITT analysis had a history of UUI.

Table 18 below presents mITT subjects categorized by severity of their UUI symptoms at baseline. Subjects in the mITT analysis set had a baseline of 4.5 (± 2.5 SD) UUI episodes per day.

Table 18. Baseline UUI episodes per day

| Baseline UUI episodes per day | mITT Analysis Set
(n = 130) |
| --- | --- |
| Mild (<3 UUI episodes per day) | 41/130 (31.5%) |
| Moderate (3-5 UUI episodes per day) | 42/130 (32.3%) |
| Severe (>5 UUI episodes per day) | 47/130 (36.2%) |

Table 19 presents subjects' UUI treatment history as reported at baseline.

Table 19. UUI Treatment History at Ba…