Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

K183579 · Boston Scientific Neuromodulation · GZF · Mar 29, 2019 · Neurology

Device Facts

• Record ID: K183579
• Device Name: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZF · Neurology
• Decision Date: Mar 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Device Story

Nalu Neurostimulation System provides peripheral nerve stimulation for chronic, intractable pain. System includes miniature implantable pulse generator (IPG), leads, surgical tools, externally worn Therapy Disc, and clinician/patient software. IPG (ceramic/polyurethane/silicone) delivers pulsed electrical current to peripheral nerves via 8-electrode leads to inhibit pain signals. Therapy Disc (rechargeable Li-ion) powers IPG wirelessly via 40.68 MHz RF; worn by patient via adhesive clip or belt. Clinician Programmer (Android tablet) configures therapy parameters via secure Bluetooth Low Energy (BLE). Patient Remote Control (iOS/Android app) allows basic control (on/off, program selection) via BLE. Used in hospital/home settings by physicians and patients. System benefits patients by providing therapeutic pain relief through adjustable, patient-controlled stimulation.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical, mechanical, software verification/validation), biocompatibility testing (ISO 10993-1), and a 90-day porcine animal study evaluating surgical usability, RF communication, device stability, and tissue response. All devices performed as expected.

Technological Characteristics

Implantable neurostimulator (IPG) with ceramic/polyurethane/silicone housing. Leads: 8-electrode Pt/Ir array, polyurethane insulation. Power: 40.68 MHz RF wireless coupling. Connectivity: BLE for clinician/patient apps. Sterilization: Ethylene Oxide. Standards: ISO 14708-1/3, IEC 60601-1, IEC 60601-1-2, IEC 62304. Software: Moderate level of concern.

Indications for Use

Indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin, as sole therapy or adjunct in multidisciplinary approach. Not for craniofacial pain. Trial devices limited to 30 days for efficacy determination.

Regulatory Classification

Identification

An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• StimQ Peripheral Nerve Stimulator (PNS) System (K171366)

Reference Devices

• StimQ Peripheral Nerve Stimulator (PNS) System (K152178)
• Stimwave Freedom SCS (K150517)
• Medtronic Mattrix 3271/3272 (K934065)
• Medtronic Xtrel 3425 (K883780)
• ANS Renew (K000852)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.

March 29, 2019

Nalu Medical, Inc Michele Chin-Purcell, Ph.D. Vice President Regulatory Affairs and Quality Assurance 2320 Faraday Ave.. Suite 100 Carlsbad, CA 92008

Re: K183579

Trade/Device Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: February 26, 2019 Received: February 27, 2019

Dear Michele Chin-Purcell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdr/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Pamela D. Scott-S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183579

Device Name

Nalu Neurostimulation System for Peripheral Nerve Stimulation

Indications for Use (Describe)

This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
|----------------------------------------------|-------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> |

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## 5.1. Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: [phone] Fax: [phone] Contact: Michele Chin-Purcell, Vice President of Regulatory Affairs and Quality Assurance

## 5.2. Date Prepared

March 22, 2019

### 5.3. Device Identification

Trade/Proprietary Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation Common/Usual Name: Peripheral Nerve Stimulator Product Code: GZF Regulation number: 21 CFR 882.5870: Stimulator, peripheral nerve, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology

## 5.4. Legally Marketed Predicate Device(s)

StimQ Peripheral Nerve Stimulator (PNS) System (K171366) by StimQ LLC Hereafter, also referred to as the StimQ PNS System or StimQ

For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K171366), substantial equivalence to other reference devices in this same product code is demonstrated. These reference devices were used as part of the predicate history to the primary predicate in this submission. The history of the predicates is summarized in Table 5-1:

| Device | 510(k) | Predicate(s) used for clearance |
|--------------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------|
| StimQ Peripheral Nerve<br>Stimulator (PNS) System | K152178 | Stimwave Freedom SCS (K150517)<br>Medtronic Mattrix 3271/3272 (K934065)<br>Medtronic Xtrel, 3425 (K883780)<br>ANS Renew (K000852) |
| StimQ Peripheral Nerve<br>Stimulator (PNS) System<br>(Primary Predicate) | K171366 | K152178 |

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The 510(k) history of the StimQ system includes design changes over time. The original Medtronic and ANS devices are part of the predicate history of the StimQ device and are also used as references devices in this 510(k).

## 5.5. Device Description

The Nalu Neurostimulation System (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation System is comprised of 5 elements:

| 1. | Nalu<br>Implantable<br>Pulse<br>Generator | The implantable pulse generator (IPG) provides electrical<br>stimulation pulses that are transmitted through the leads to the<br>desired peripheral nerve. The IPG is available in two different<br>implant architectures: an “integrated" system with pre-attached leads<br>and a "ported" system where leads may be attached, via connector<br>ports. In addition, both of these versions are available in single or<br>dual lead configurations. The hermetic IPG housing includes a<br>ceramic enclosure and a feedthrough connected internally to a<br>printed circuit board assembly. Wires leaving the IPG are<br>encapsulated in polyurethane and a silicone over mold forms the<br>final biocompatible surface of the IPG for direct patient tissue<br>contact. |
|----|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Leads | Leads are implantable and are designed to deliver electrical pulses to<br>the peripheral nerve via an array of eight cylindrical electrodes at the<br>distal end. Leads may be integrated with or connected to the IPG.<br>Both Trial and Permanent Implant leads are available for use. The<br>leads use polyurethane insulation with Pt/Ir electrodes. The leads<br>may be secured in place with the Nalu Lead Anchor. |
| 3. | Surgical and<br>Trial Tools | Implantation of the Nalu IPG and lead components for Peripheral<br>Nerve Stimulation (PNS) is performed via standard PNS surgical<br>techniques. The desired implant location is accessed via needle<br>placement, followed by lead placement through an introducer. The<br>leads are anchored and the IPG is placed in a subcutaneous pocket.<br>Patient contacting materials include medical grade stainless steel,<br>thermoplastic elastomers, ABS, silicone, and Urethane. |
| 4. | Externally<br>worn | Two types of Therapy Disc are available. One is to be used during<br>the trial phase (Trial Therapy Disc), and one is to be used after<br>permanent IPG implantation (Therapy Disc). Both devices are worn<br>by the patient using one of the Nalu-provided options The Therapy |

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| Therapy<br>Discs | Discs house a rechargeable lithium ion battery, and electronics<br>including a microcontroller running software for therapy control,<br>patient interaction and communication with Nalu's Clinician<br>Programmer and Remote Control devices. The Therapy Disc used to<br>power and command the implant does so wirelessly using Radio<br>Frequency (RF) and is held in place by an adhesive clip applied to<br>the skin or a belt/cuff worn over clothing. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. Clinician<br>Programmer<br>and Remote<br>Control | A Clinician Programmer Application is provided to configure the<br>Trial Therapy Disc and Therapy Disc devices during surgery and<br>programming. A Patient Remote Control Application is available to<br>provide the patient with a convenient secondary option to control<br>their system in addition to built-in controls on the Therapy Disc.<br><br>The Clinician Programming Application runs on an Android tablet<br>and communicates over a secure Bluetooth Low Energy link with<br>the Trial Therapy Disc and Therapy Disc devices. The programmer<br>is responsible for configuring the devices to deliver therapy<br>according to clinician defined levels and patient preferences, and for<br>managing patient and session records.<br><br>The Patient Remote Control Application runs on iOS and Android<br>platforms and offers basic control of the Trial Therapy Disc and<br>Therapy Disc through a secure Bluetooth Low Energy link. The<br>controls include selecting between clinician-defined therapy options<br>(programs), turning stimulation on and off, and managing alerts. |

#### Indications for Use Statement 5.6.

"This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. "

The Indications for Use statement for the Nalu Neurostimulation System is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the stimulation of peripheral nerves for treatment of chronic, intractable pain.

## 5.7. Substantial Equivalence Discussion

The following tables compare the Nalu Neurostimulation System to the predicate device with respect to intended use, technological characteristics and principles of operation,

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providing more detailed information regarding the basis for the determination of substantial equivalence.

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## Table 5-2: Substantial Equivalence Table – General and Implanted Components

| | Nalu Neurostimulation System<br>(Subject Device) | StimQ PNS<br>System<br>(Primary<br>Predicate) | StimQ PNS<br>System<br>(Reference<br>Device) | Medtronic<br>Mattrix<br>3271/3272<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(Reference<br>Device) | ANS Renew<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) | K183579 | K171366 | K152178 | K934065 | K883780 | K000852 | NA |
| Product Code<br>and class | GZF, Class II | Same | Same | GZF and GZB | GZB | GZF and GZB | Same |
| Regulation<br>number | 21 CFR §882.5870 | Same | Same | Same, plus 21<br>CFR 882.5880 | Same | Same, plus 21 CFR<br>§882.5880 | Same |
| Classification<br>name | Stimulator, Peripheral Nerve,<br>Implanted (pain relief) | Same | Same | Same plus<br>Stimulator,<br>Spinal Cord,<br>Implanted (Pain<br>Relief) | Same | Same plus<br>Stimulator, Spinal<br>Cord, Implanted<br>(Pain Relief) | Same |
| Intended Use | Stimulation of peripheral nerves<br>for chronic, intractable pain | Same | Same | Same, plus<br>Stimulation of<br>spinal cord for<br>chronic,<br>intractable pain | Same | Same, plus<br>Stimulation of spinal<br>cord for chronic,<br>intractable pain | Same |
| Indications for<br>Use | This system is indicated for pain<br>management in adults who have<br>severe intractable chronic pain of<br>peripheral nerve origin, as the<br>sole mitigating agent, or as an<br>adjunct to other modes of<br>therapy used in a<br>multidisciplinary approach. The<br>system is not intended to treat<br>pain in the craniofacial region. | The StimQ Peripheral Nerve<br>Stimulator (PNS) System is<br>indicated for pain management<br>in adults who have severe<br>intractable chronic pain of<br>peripheral nerve origin, as the<br>sole mitigating agent, or as an<br>adjunct to other modes of<br>therapy used in a<br>multidisciplinary approach. The<br>StimQ PNS System is not | | Indicated as an aide in the<br>management of chronic,<br>intractable pain of the trunk or<br>limbs | | Indicated for the<br>treatment of chronic<br>pain of trunk and<br>limbs, either as the<br>sole mitigating<br>agent, or as an<br>adjunct to other<br>modes of therapy<br>used in a | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| | Nalu Neurostimulation System<br>(Subject Device) | StimQ PNS<br>System<br>(Primary<br>Predicate) | StimQ PNS<br>System<br>(Reference<br>Device) | Medtronic<br>Mattrix<br>3271/3272<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(Reference<br>Device) | ANS Renew<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| | The trial devices are solely used<br>for trial stimulation (no longer<br>than 30 days) to determine<br>efficacy before recommendation<br>for a permanent (long term)<br>device. for a permanent (long<br>term) device. | intended to treat pain in the<br>craniofacial region.<br>The StimQ Trial Lead Kit is only<br>used in conjunction with the<br>StimQ Stimulator Receiver Kit.<br>The trial devices are solely used<br>for trial stimulation (no longer<br>than 30 days) to determine<br>efficacy before<br>recommendation for a<br>permanent (long term) device. | | | | multidisciplinary<br>approach. | |
| Prescription<br>Use? | Yes | Same | Same | Same | Same | Same | Same |
| Implant site | Peripheral nerves, excluding<br>craniofacial region | Same | Same | Same | Same | Same | Same |
| Environmental<br>Use | Hospital, Home | Same | Same | Same | Same | Same | Same |
| Intended<br>Clinician | Orthopedic, Neurosurgeon,<br>Anesthesiologist | Same | Same | Same | Same | Same | Same |
| Intended User | Physician, Layperson | Same | Same | Same | Same | Same | Same |
| Mode of Action | Radio Frequency (RF) wireless<br>transmission of energy to<br>produce stimulation at stimulator<br>electrodes. | Same | Same | Same | Same | Same | Same |
| Software Level<br>of Concern | Moderate | Moderate | Moderate | Unreported | Unreported | Moderate | Same |
| | Nalu Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference<br>Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| IPG | | | | | | | |
| Dimensions | Lead = 1.30 mm diameter<br>IPG = 28 x 11 x 4.9 mm | Integrated with lead body,<br>1.35 mm diameter | Integrated with<br>lead body, 1.35<br>mm diameter | Details unavailable. See Section 12.2.1 below | | | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Housing<br>material | Silicone and Pellethane<br>2363-55D | Pellethane 2363-55D | Pellethane 2363-<br>55D | Details unavailable. See Section 12.2.1 below | | | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Implant site | Peripheral nerves,<br>excluding craniofacial<br>region | Same | Same | Same | Same | Same | Same |
| Electrical<br>components | Embedded receiver,<br>flexible circuit board | Same | Same | Sealed<br>electronic<br>circuits | Sealed<br>electronic<br>circuits | Sealed<br>electronic<br>circuits | Same |
| Power Delivery | Coupled receiver radio<br>frequency transmission | Same | Same | Same | Same | Coupled<br>receiver,<br>hardwired<br>with<br>connector | Same |
| Lead | | | | | | | |
| Electrode<br>Material | Platinum-iridium 90:10 | Same | Same | Same | Same | Same | Same |
| Insulation Body<br>Material | Pellethane 2363-55D | Same | Same | Same | Same | Same | Same |
| Cable features | Multilumen tube | Same | Same | Coiled Wires | Coiled Wires | Braided Wire | Same |
| | Nalu Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference<br>Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| Lead length | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Diameter | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Electrode Array<br>length | 52 mm | 24 mm (FRE-4)<br>52 mm (FRE-8) | 24 mm | 24 mm | 24 mm | 24 mm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| No. of<br>Electrodes, per<br>lead | 8 | 4 (FRE-4)<br>8 (FRE-8) | 4 | Same | Same | 4 or 8 | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Individual<br>Electrode<br>length | 3.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode<br>spacing | 4.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode<br>surface area | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | ~13 mm² | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Lead extension | Lead extension available | NA | NA | Lead extension<br>available | Lead extension<br>available | Lead<br>extension<br>available | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| | Nalu Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference<br>Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| Lead Anchor | Molded silicone anchor<br>with Ti locking mechanism | Suture Sleeve Cap,<br>Pellethane 55-D, placed<br>over proximal end of<br>stimulator | Suture Sleeve Cap,<br>Pellethane 55-D,<br>placed over<br>proximal end of<br>stimulator | Molded silicone<br>anchor | Molded<br>silicone anchor | Molded<br>silicone<br>anchor | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Configurations | Integrated and with Ports | Integrated | Integrated | With Ports | With Ports | With Ports | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Sterilization | Ethylene Oxide | Same | Same | Same | Same | Same | Same |

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Table 5-3: Substantial Equivalence Table – Therapy

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| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------|
| Pulse Frequency | 2 Hz to 1500 Hz1 | 5 to 1500 Hz | 5 Hz to 1500 Hz | 5 to 240 Hz | 5 to 1400 Hz | 10 to 1500 Hz | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Pulse Width | 12 to 1000 µs | 50 to 500 µs | 50 to 500 µs | 50 to 500 µs | 50 to 1000 µs | 50 to 500 µs | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Current/Voltage<br>Regulated | Current | Current | Current | Voltage | Voltage | Current | Same |
| Output Voltage<br>(300 Ohms) | 0 to 3.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Voltage<br>(500 Ohms) | 0 to 5.1 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Voltage<br>(800 Ohms) | 0 to 8.2 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Current<br>(300 Ohms) | 0 to 10.2 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Output Current<br>(500 Ohms) | 0 to 10.2 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Current<br>(800 Ohms) | 0 to 10.2 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Waveform | charge balanced<br>(delayed) biphasic<br>asymmetrical | Same | Same | Same | Same | Same | Same |
| Pulse Shape | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Same |
| Maximum phase<br>charge (300 Ohms) | 10.2 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum phase<br>charge (500 Ohms) | 10.2 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum phase<br>charge (800 Ohms) | 10.2 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum charge<br>density (300 Ohm) | 83.3 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | StimQ PNS System<br>(K171366)<br>(Primary Predicate) | StimQ PNS System<br>(K152178)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Maximum charge<br>density (500 Ohm) | 83.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum charge<br>density (800 Ohm)…