Neuspera Neurostimulation System (NNS)

K202781 · Neuspera Medical, Inc. · GZF · Aug 27, 2021 · Neurology

Device Facts

• Record ID: K202781
• Device Name: Neuspera Neurostimulation System (NNS)
• Applicant: Neuspera Medical, Inc.
• Product Code: GZF · Neurology
• Decision Date: Aug 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neuspera Neurostimulation System (NNS) 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 Neuspera Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

Device Story

System provides peripheral nerve stimulation for chronic intractable pain. Components: miniature implantable pulse generator (IPG) with electrode array, surgical implant tools, externally worn wireless transmitter, clinician programmer, and patient controller. IPG (17mm x 2.3mm) contains receiver, energy bank, and ASIC; harvests energy from wireless transmitter via mid-field powering. Transmitter worn externally; controlled by iPad (clinician) or iPod Touch (patient) running proprietary software. Physician uses clinician programmer to set stimulation parameters; patient uses controller to adjust amplitude, select programs, and monitor battery. Therapy uses pulsed electrical current to inhibit pain signal transmission. Used in hospital or home settings. Benefits include therapeutic pain relief via minimally invasive implant.

Clinical Evidence

No clinical data. Evidence consists of bench testing (visual, dimensional, tensile, mechanical, electrical, EMC, MRI) and two GLP animal studies evaluating implant/removal safety and wireless transmitter performance. Compliance with ISO 10993-1 (biocompatibility) and IEC 60601-1 series (safety/performance) demonstrated.

Technological Characteristics

Implantable pulse generator (IPG) with 4-electrode array (Platinum-iridium 90:10). Insulation: Pellethane 2363-55D. Power: RF wireless mid-field powering. Waveform: charge-balanced, delayed, biphasic asymmetrical. Frequency: 4-130 Hz. Pulse width: 105-960 µs. Connectivity: Wireless transmitter to IPG; Bluetooth/proprietary app on Apple iOS devices for programming. Sterilization: Ethylene Oxide. Software: Moderate level of concern.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin, excluding craniofacial region. Used as sole therapy or adjunct in multidisciplinary approach. Includes trial stimulation (≤30 days) to assess efficacy prior to permanent implant.

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

• Nalu Neurostimulation System (K183579)

Reference Devices

• Bioness StimRouter Neuromodulation System (K200482)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2021

Neuspera Medical Inc. Alexander Yeh Founder and Chief Technology Officer 51 Daggett Dr. San Jose, California 95134

Re: K202781

Trade/Device Name: Neuspera Neurostimulation System (NNS) Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: August 25, 2021 Received: August 25, 2021

Dear Alexander Yeh:

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/cdrh/cfdocs/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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202781

Device Name Neuspera Neurostimulation System (NNS)

#### Indications for Use (Describe)

The Neuspera Neurostimulation System (NNS) 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 Neuspera Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## SECTION 8: 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### 510(k) Number: K202781

#### Applicant Information:

| Owner Name: | Neuspera Medical Inc |
|-----------------|--------------------------------------|
| Address: | 51 Daggett Dr.<br>San Jose, CA 95134 |
| Contact Person: | Alexander Yeh, Ph.D |

| Contact Person: | Alexander Yeh, PE |
|-----------------|-------------------|
| Phone Number: | [phone] |
| Date Prepared: | 9/21/2020 |

#### Device Information:

Trade/Proprietary Name: Neuspera Neurostimulation System Common/Usual Name: Neuspera Neurostimulation System Product Code: GZF Requlation number: 21 CFR 882.5870: Stimulator, peripheral nerve, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology

#### Predicate Devices:

The Neuspera Neurostimulation System is substantially equivalent in intended use and method of operation to the cleared Nalu Neurostimulator System (K183579).

### Device Description:

The Neuspera Neurostimulation System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer and a patient controller. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.

{4}------------------------------------------------

Similar to the predicate, the Neuspera Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the targeted nerve to inhibit the transmission of pain signals to the brain. The Neuspera Neurostimulation System may also be used during the trial period before recommendation for permanent implant.

The Neuspera Neurostimulation System (NNS) System is comprised of the following components:

| System<br>Component | Description |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Neuspera<br>Implanted Pulse<br>Generator (IPG)<br>Or<br>Neuspera<br>Implanted<br>Microstimulator | The implanted Neuspera Neurostimulation System (NNS) includes a<br>miniaturized implantable neurostimulator (approximately 17mm long by<br>2.3 mm diameter at its widest point) combining a receiver and a<br>hermitically sealed pulse generator.<br>The IPG/Microstimulator is a hermitically sealed electronic package<br>(0.02 cc) consisting of a highly integrated electronic circuit with a<br>custom ASIC (application specific integrated circuit) and a flex circuit<br>interconnect. This package harvests the received energy, charges an<br>internal energy bank, and manages power/communication. The<br>energy bank is used by the internal stimulation waveform generator to<br>generate stimulation pulses based upon the digitally received<br>programming parameters.<br>Hermetic feedthroughs conduct the stimulation waveform from the<br>stimulation implantable pulse generator to the electrode array<br>described below. |
| Electrode Array | The electrode array is an implantable and attached to the IPG<br>through hermetic feedthroughs connectors. The electrode array is<br>designed to deliver electrical pulses to the nerve via an array of four<br>cylindrical electrodes at the distal end of the device. |
| Surgical/Implant<br>Tools | The tools provided in the Neuspera Neurostimulation System (NNS)<br>Kit are used to introduce and implant the neurostimulator.<br>A needle along with imaging guidance is used to locate the targeted<br>nerve. Next, the needle is replaced with a guidewire. An incision is<br>made at the skin surface adjacent to the guidewire. Next, a pre-<br>dilator is inserted around the guidewire to dilate the path to the nerve.<br>The pre-dilator is then removed and replaced with an introducer and<br>dilator. The dilator and guidewire are then removed. The implant is<br>tunneled through the introducer (sheath) using a connected pushrod.<br>The PTFE tether at the proximal end of the implant is cut and placed<br>in a subcutaneous pocket. |
| System<br>Component | Description |
| Externally Worn<br>Wireless<br>Transmitter | The charging system consists of an externally worn wireless<br>transmitter that is rechargeable. Power is delivered to the implanted<br>neurostimulator using Neuspera's proprietary mid-field powering<br>technology. The Wireless Transmitter is worn in proximity to the<br>implanted neurostimulator and held in position by custom designed<br>garments.<br>The Wireless Transmitter is controlled by custom software<br>applications (referred to as the Clinician Programmer and the Patient<br>Controller) running on off-the-shelf portable hardware (i.e., Apple<br>iPad and Apple iPod Touch, respectively). The rechargeable battery<br>of the Wireless Transmitter is charged by an off-the-shelf charging<br>pad. |
| Clinician<br>Programmer and<br>Patient Controller | The clinician programmer (Programmer) enables management of the<br>Wireless Transmitter associated with the patient's neurostimulator,<br>programming a patient's stimulation therapy, review of the patient's<br>therapy statistics, and connection of a patient controller (Controller) to a<br>patient's Wireless Transmitter. The Programmer runs Neuspera's<br>propriety programmer software on a commercially available Apple iPad.<br>The iPad runs in kiosk mode, which disables non-essential programs<br>and functions.<br>The Patient Controller is an Apple iPod Touch which runs the<br>Neuspera patient controller software application ("Neuspera App").<br>The iPod Touch comes with its own USB/wall charging accessories.<br>The iPod runs in kiosk mode, which disables non- essential programs<br>and functions. The Controller is used by the patient to turn his/her<br>Wireless Transmitter on/off, adjust stimulation amplitude (within limits<br>set by the physician), and select which of the physician pre-<br>programmed stimulation programs to use. The user can also monitor<br>the Wireless Transmitter battery level, view his/her program use<br>history, and adjust the Wireless Transmitter for airplane and<br>international travel. |

{5}------------------------------------------------

{6}------------------------------------------------

## Intended Use:

The Neuspera Neurostimulation System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitiqating 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 Neuspera Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

## Summary of Technological Characteristics in Comparison to Predicate Device:

Neuspera Neurostimulation System (NNS and the predicate device Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579) have similar indication for use, technological characteristics and performance. Both the subject device and the predicate devices are designed to provide 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. Both systems are not intended to treat pain in the craniofacial region. The minor differences in wording for intended use statements of the respective products do not alter the intended patient or clinical effect, and, therefore, the Neurostimulator System is substantially equivalent with respect to intended use. In addition, the differences listed in tables below do not present any new issues of safety or effectiveness. Moreover, performance testing demonstrates that the Neuspera Neurostimulation System performs in a substantially equivalent manner.

{7}------------------------------------------------

| | Table 1: Predicate Device Comparison Matrix | | | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--|
| | Neuspera Neurostimulation<br>System (Subject Device) | Nalu Neurostimulation<br>System (Primary Predicate) | Bioness StimRouter<br>Neuromodulation System<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate | |
| 510(k) | K202781 | K183579 | K200482 | N/A | |
| Product Code and class | GZF, Class II | Same | Same | Same | |
| Regulation number | 21 CFR §882.5870 | Same | Same | Same | |
| Classification name | Stimulator, Peripheral Nerve, Implanted (pain<br>relief) | Same | Same | Same | |
| Intended Use | Stimulation of peripheral nerves for chronic,<br>intractable pain | Same | Same | Same | |
| Indications for Use | The Neuspera Neurostimulation System (NNS) is<br>indicated for pain management in adults who have<br>severe intractable chronic pain of peripheral nerve<br>origin, as the sole mitigating agent, or as an<br>adjunct to other modes of therapy used in a<br>multidisciplinary approach. The Neuspera<br>Neurostimulation System (NNS) is not intended to<br>treat pain in the craniofacial region.<br>The Neuspera Neurostimulation System (NNS) is<br>also used for trial stimulation (no longer than 30<br>days) to determine efficacy before recommendation<br>for a permanent (long term) implant. | This system is indicated for pain<br>management in adults who have severe<br>intractable chronic pain of peripheral nerve<br>origin, as the sole mitigating agent, or as an<br>adjunct to other modes of therapy used in a<br>multidisciplinary approach. The system is<br>not intended to treat pain in the craniofacial<br>region. The trial devices are solely used for<br>trial stimulation (no longer than 30 days) to<br>determine efficacy before recommendation<br>for a permanent (long term) device. | The StimRouter Neuromodulation<br>System™ is indicated for pain<br>management in adults who have severe<br>intractable chronic pain of peripheral<br>nerve origin, as an adjunct to<br>other modes of therapy (e.g.,<br>medications). The StimRouter is not<br>intended to treat pain in the craniofacial<br>region. | Differences in wording do not affect<br>safety and effectiveness of intended<br>use | |
| Prescription Use? | Yes | Same | Same | Same | |
| Implant site | Adjacent to nerves peripheral to central<br>nervous system, excluding craniofacial region | Same | Same | Same | |
| Environmental Use | Hospital, Home | Same | Same | Same | |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Same | Same | Same | |
| Intended User | Physician, Layperson | Same | Same | Same | |
| Mode of Action | Radio Frequency (RF) wireless transmission<br>of energy to charge implanted energy source<br>with stimulation pulse generator to produce<br>stimulation at stimulator electrodes. | Radio Frequency (RF) wireless<br>transmission of energy to produce<br>stimulation at stimulator electrodes | DC conductive coupling from<br>external patch pulse generator to<br>implanted lead | Differences do not affect safety and<br>effectiveness of intended use | |
| Software Level of<br>Concern | Moderate | Same | Same | Same | |
| | Table 2: Implanted Components | | | | |
| | Neuspera Neurostimulation<br>System ( <i>Subject Device</i> ) | Nalu Neurostimulation<br>System ( <i>Primary Predicate</i> ) | Bioness StimRouter<br>Neuromodulation System<br>( <i>Reference Device</i> ) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate | |
| Dimensions | IPG: 2.33mm diameter, electrode<br>array 1.3mm diameter, 5.1 cm total<br>length | Lead = 1.30 mm diameter, 40 or 60 cm<br>length, IPG = 28 x 11 x 4.9 mm | Lead = 1.20 mm diameter, 15 cm<br>length | Differences do not affect safety and<br>effectiveness of intended use | |
| Configuration | Implanted antenna receiver, energy<br>storage capacitor, stimulation pulse<br>generator coupled with electrode<br>arrays | Embedded receiver, flexible circuit<br>board | Implanted electrode array and<br>external pulse generator | Differences do not affect safety and<br>effectiveness of intended use | |
| Implant site | Peripheral nerves, excluding<br>craniofacial region | Same | Same | Same | |
| Electrical<br>components | Embedded receiver, flexible circuit<br>board with energy storage and<br>stimulation pulse generator | Same | Embedded receiver | Differences do not affect safety and<br>effectiveness of intended use | |
| Power Delivery | Radio frequency transmission receiver | Coupled receiver radio frequency<br>transmission | DC transcutaneous coupling | Differences do not affect safety and<br>effectiveness of intended use | |
| Electrode Material | Platinum-iridium 90:10 | Same | Same | Same | |
| Insulation Body<br>Material | Pellethane 2363-55D | Same | Silicone | Differences do not affect safety and<br>effectiveness of intended use | |
| Electrode Array<br>Diameter | 1.30 mm | 1.30 mm | 1.20 mm | Differences do not affect safety and<br>effectiveness of intended use | |
| Electrode Array<br>length | 21mm | 52 mm | 5 mm | Differences do not affect safety and<br>effectiveness of intended use | |
| No. of Electrodes<br>per array | 4 | 8 | 3 | Differences do not affect safety and<br>effectiveness of intended use | |
| Individual<br>Electrode length | 3mm | Same | Same | Same | |
| Electrode surface<br>area | 12.25 mm2 | 12.25 mm3 | 6.3 mm2 | Same | |
| Sterilization | Ethylene Oxide | Same | Same | Same | |
| | Table 3: Therapy | | | | |
| | Neuspera<br>Neurostimulation<br>System ( <i>Subject Device</i> ) | Nalu<br>Neurostimulation<br>System ( <i>Primary<br/>Predicate</i> ) | Bioness<br>StimRouter<br>Neuromodulation<br>System ( <i>Primary<br/>Predicate</i> ) | Analysis of<br>Technological<br>Differences from<br><i>Primary Predicate</i> | |
| Pulse Frequency | 4 to 130 Hz | 2 to 1500 Hz | 1 to 200 Hz | Differences do not affect safety and<br>effectiveness of intended use | |
| Pulse Width | 105 to 960 µs | 12 to 1000 µs | 70 to 500µs | Differences do not affect safety and<br>effectiveness of intended use | |
| Current/Voltage<br>Regulated | Voltage | Current | Current (dependent<br>on pick-up ratio at<br>implant) | Differences do not affect safety and<br>effectiveness of intended use | |
| Output Current (300<br>Ohms) | 0 to 5.73 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety and<br>effectiveness of intended use | |
| Output Current (500<br>Ohms) | 0 to 5.44 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety and<br>effectiveness of intended use | |
| Output Current (800<br>Ohms) | 0 to 5.20 mA*…