Nalu Neurostimulation System

K203547 · Boston Scientific Neuromodulation · GZB · Mar 25, 2021 · Neurology

Device Facts

• Record ID: K203547
• Device Name: Nalu Neurostimulation System
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Mar 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Spinal Cord Stimulation This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. 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. For Peripheral Nerve Stimulation 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 day) to determine efficacy before recommendation for a permanent (long term) device.

Device Story

Nalu Neurostimulation System provides therapeutic relief for chronic, intractable pain via pulsed electrical current. System components: Implantable Pulse Generator (IPG), leads with 4 or 8 cylindrical electrodes, and Therapy Disc (houses battery/RF electronics). Physician implants IPG/leads using standard surgical techniques. Therapy Disc powers IPG via RF wireless transmission; patient uses remote programmer to control therapy. Device inhibits pain signal transmission to brain. Software updates allow expanded dosage time parameters (On/Off cycles). System used in hospital or home settings. Benefits include chronic pain management through adjustable stimulation patterns.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing performed per 21 CFR 820.30, ISO 14971, and ISO 13485:2016. Software and firmware verification testing confirmed that expanded therapy options meet functional specifications and remain within safety limits of predicate and reference devices.

Technological Characteristics

Implantable neurostimulator; RF-powered via external Therapy Disc. Pulse frequency: 2-1500 Hz; Pulse width: 12-2000 µs. Current-regulated output (0-10.2 mA). Waveform: charge-balanced, delayed biphasic, asymmetrical. Connectivity: 40.68 MHz RF wireless transmission. Software level of concern: Moderate.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin or chronic intractable pain of the trunk/limbs (unilateral or bilateral). Used as sole agent or adjunct in multidisciplinary therapy. Not for craniofacial pain. Trial devices limited to 30 days for efficacy determination.

Regulatory Classification

Identification

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

Predicate Devices

• Nalu Neurostimulation System (K201618)

Reference Devices

• Medtronic Xtrel Model 3425 (K883780 and K982902)

Submission Summary (Full Text)

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March 25, 2021

Nalu Medical, Inc. Pauline Lieu Principle Regulatory Affairs Associate 2320 Faraday Ave. Suite 100 Carlsbad, California 92008

Re: K203547

Trade/Device Name: Nalu Neurostimulation System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB, GZF Dated: December 4, 2020 Received: December 4, 2020

Dear Pauline Lieu:

### (NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)

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

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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 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 (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 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,

Jitendra Virani Acting 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

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### Indications for Use

510(k) Number (if known) K203547

Device Name Nalu Neurostimulation System

Indications for Use (Describe) For Spinal Cord Stimulation

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. 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.

For Peripheral Nerve Stimulation

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 day) to determine efficacy before recommendation for a permanent (long term) device.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

# K203547

# 1. Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: [phone] Fax: [phone] Contact Pauline Lieu, Ph.D. Principle Regulatory Affairs Associate

Date Prepared: March 23吋, 2021

# 2. Device Names and Classification

| Primary Product Code | |
|---------------------------|---------------------------------------------------------------------|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Spinal-Cord Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5880; Stimulator, Implanted Spinal-cord (Pain<br>Relief) |
| Product Code | GZB |
| Review Panel | Division of Neurological and Physical Medicine Devices |

| Secondary Product Code | |
|---------------------------|--------------------------------------------------------------------------|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Peripheral Nerve, Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5870 Stimulator, Peripheral Nerve Stimulator<br>(Pain Relief) |
| Product Code | GZF |
| Review Panel | Division of Neurological and Physical Medicine Devices |

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### 3. Predicate and Reference Devices:

Predicate Device: Nalu Neurostimulation System (K201618)

Reference Devices: Medtronic Xtrel Model 3425 (K883780 and K982902)

## 4. Device Description

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).

## 5. Indications for Use

### Spinal Cord Stimulation (SCS)

This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

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.

### Peripheral Nerve Stimulation (PNS)

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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.

# 6. Comparison with the Predicate and Reference Device:

The following tables illustrate the substantial equivalence between the subject, predicate, and reference devices.

| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate<br>Device, K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference<br>Device, K883780<br>and K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K203547 | K201618 (SCS and<br>PNS) | K883780 (SCS)<br>K982902 (PNS) | NA |
| Product Code and<br>class | GZB and GZF,<br>Class II | GZB and GZF,<br>Class II | GZB and GZF, Class<br>II | Same |
| Regulation<br>number | 21 CFR 882.5880<br>(GZB)<br>21 CFR 882.5870<br>(GZF) | 21 CFR 882.5880<br>(GZB)<br>21 CFR 882.5870<br>(GZF) | 21 CFR 882.5880<br>(GZB)<br>21 CFR 882.5870<br>(GZF) | Same |
| Classification<br>name | Implanted spinal<br>cord stimulator<br>for pain relief.<br>(GZB)<br>Implanted<br>peripheral nerve<br>stimulator for<br>pain relief (GZF) | Same | Same | Same |
| Intended Use | Stimulation of<br>spinal cord for<br>chronic,<br>intractable pain<br>(GZB)<br>Stimulation of<br>peripheral nerves<br>for chronic | Same | Same | Same |
| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate<br>Device, K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference<br>Device, K883780<br>and K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| | intractable pain<br>(GZF) | | | |
| Indications for<br>Use | SCS:<br>The Nalu<br>Neurostimulation<br>System is<br>indicated as the<br>sole mitigating<br>agent, or as an<br>adjunct to other<br>modes of therapy<br>used in a<br>multidisciplinary<br>approach for<br>chronic,<br>intractable pain<br>of the trunk<br>and/or limbs,<br>including<br>unilateral or<br>bilateral pain.<br>PNS:<br>This system is<br>indicated for pain<br>management in<br>adults who have<br>severe intractable<br>chronic pain of<br>peripheral nerve<br>origin, as the sole<br>mitigating agent,<br>or as an adjunct<br>to other modes<br>of therapy used<br>in a<br>multidisciplinary<br>approach. The<br>system is not<br>intended to treat<br>pain in the<br>craniofacial<br>region.<br>Both SCS and<br>PNS:<br>The trial devices<br>are solely used<br>for trial<br>stimulation (no<br>longer than 30<br>days) to | Same | The X-trel<br>Transmitter is part<br>of a system for<br>Spinal Cord<br>Stimulation or<br>Peripheral nerve<br>Stimulation. The<br>system is<br>indicated in the<br>management of<br>chronic,<br>intractable pain of<br>the trunk or limbs | Same |
| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate<br>Device, K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference<br>Device, K883780<br>and K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| | determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term)<br>device. | | | |
| Prescription Use? | Yes | Same | Same | Same |
| Implant site, leads | Epidural space<br>(SCS) or<br>peripheral nerve<br>areas (PNS) | Same | Same | Same |
| Environmental<br>Use | Hospital, Home | Same | Same | Same |
| Intended Clinician | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Same | Same | Same |
| Intended User | Physician,<br>Layperson | Same | Same | Same |
| Mode of Action | Radio Frequency<br>(RF) wireless<br>transmission of<br>energy to<br>produce<br>stimulation at<br>stimulator<br>electrodes. | Same | Same | Same |
| Software Level of<br>Concern | Moderate | Moderate | Unreported | Same |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate Device,<br>K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference Device,<br>K883780 and<br>K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| Pulse<br>Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | 5 to 1400 Hz | Same as predicate |
| Pulse Width | 12 to 2000 µs | 12 to 1000 µs | 50 to 1000 µs | Available<br>programmable pulse<br>width will be capped<br>to maintain Maximum<br>Phase Charge and<br>Maximum Charge<br>Density within limits<br>of Medtronic Xtrel<br>reference device limit.<br>No impact to safety<br>and effectiveness. |
| Current/Volta<br>ge Regulated | Current | Same | Voltage | Same as predicate |
| Output<br>Voltage (300<br>Ohms) | 0 to 3.1 V | 0 to 3.1 V | 0 to 5.4 V | Same as predicate |
| Output<br>Voltage (500<br>Ohms) | 0 to 5.1 V | 0 to 5.1 V | 0 to 7.1 V | Same as predicate |
| Output<br>Voltage (800<br>Ohms) | 0 to 8.2 V | 0 to 8.2 V | 0 to 8.4 V | Same as predicate |
| Output<br>Current (300<br>Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 18.0 mA | Same as predicate |
| Output<br>Current (500<br>Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 14.2 mA | Same as predicate |
| Output<br>Current (800<br>Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 10.5 mA | Same as predicate |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate Device,<br>K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference Device,<br>K883780 and<br>K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| Waveform | charge balanced<br>(delayed) biphasic<br>asymmetrical | Same | Same | Same as predicate |
| Pulse Shape | Decaying<br>Exponential | Same | Same | Same as predicate |
| Maximum<br>phase charge<br>(300 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 18.0 µC/pulse | Same as Medtronic<br>Xtrel reference device |
| Maximum<br>phase charge<br>(500 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 14.2 µC/pulse | Same as Medtronic<br>Xtrel reference device<br>at 300 Ohms.<br>Maximum Phase<br>Charge constant in<br>current controlled<br>system and enforced<br>below maximum<br>reference device value<br>(at 300 Ohms). No<br>impact to safety and<br>effectiveness. |
| Maximum<br>phase charge<br>(800 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 10.5 µC/pulse | Same as Medtronic<br>Xtrel reference device<br>at 300 Ohms.<br>Maximum Phase<br>Charge constant in<br>current controlled<br>system and enforced<br>below maximum<br>reference device value<br>(at 300 Ohms). No<br>impact to safety and<br>effectiveness. |
| Maximum<br>charge density<br>(300 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 150.0 µC/cm² | Within maximum limit<br>as set by Medtronic<br>Xtrel reference device. |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate Device,<br>K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference Device,<br>K883780 and<br>K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| Maximum<br>charge density<br>(500 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 118.3 µC/cm² | Same as Medtronic<br>Xtrel reference device<br>at 300 Ohms.<br>Maximum Phase<br>Charge constant in<br>current controlled<br>system and enforced<br>below maximum<br>reference device value<br>(at 300 Ohms). No<br>impact to safety and<br>effectiveness. |
| Maximum<br>charge density<br>(800 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 87.5 µC/cm² | Same as Medtronic<br>Xtrel reference device<br>at 300 Ohms.<br>Maximum Phase<br>Charge constant in<br>current controlled<br>system and enforced<br>below maximum<br>reference device value<br>(at 300 Ohms). No<br>impact to safety and<br>effectiveness. |
| Maximum<br>current<br>density (300<br>Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 150.0 mA/cm² | Same as predicate |
| Maximum<br>current<br>density (500<br>Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 118.3 mA/cm2 | Same as predicate |
| Maximum<br>current<br>density (800<br>Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 87.5 mA/cm² | Same as predicate |
| Net Charge | 0 μC | Same | Same | Same as predicate |
| Average Phase<br>Power (300<br>Ohms) | 0.031 W/phase | 0.031 W/phase | 0.068 W/phase | Same as predicate |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Predicate Device,<br>K201618) | Medtronic Xtrel<br>Model 3425<br>(Reference Device,<br>K883780 and<br>K982902) | Analysis of<br>Technological<br>Differences from<br>Predicate |
| Average Phase<br>Power (500<br>Ohms) | 0.052 W/phase | 0.052 W/phase | 0.074 W/phase | Same as predicate…