Nalu Neurostimulation SCS system

K201618 · Boston Scientific Neuromodulation · GZB · Jul 15, 2020 · Neurology

Device Facts

• Record ID: K201618
• Device Name: Nalu Neurostimulation SCS system
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Jul 15, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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) 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 therapeutic relief for chronic, intractable pain via pulsed electrical current. System components: implantable pulse generator (IPG), leads with 4 or 8 cylindrical electrodes, Trial Therapy Disc/Therapy Disc, and remote programmer. IPG implanted via standard surgical techniques; delivers electrical pulses to spinal cord or peripheral nerves to inhibit pain signal transmission. Therapy Disc houses battery and electronics for RF power; controls IPG. Clinician uses programmer to configure therapy; patient uses remote control to adjust levels, select profiles, and monitor status. System used in clinical/home settings. Benefits include pain management through targeted neurostimulation.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by previously cleared performance testing and design validation (K183047, K183579, K191435) conducted per 21 CFR 820.30, ISO 14971, and ISO 13485:2016.

Technological Characteristics

Implantable pulse generator (IPG) (27.7mm x 9.3mm x 4.2mm); Platinum-iridium 90:10 leads; RF wireless power transmission; PC ABS housing; hydrocolloid skin adhesive. Software-controlled waveform parameters. System includes clinician programmer and patient remote control.

Indications for Use

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

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 for Spinal Cord Stimulation (K183047)

Reference Devices

• Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
• Nalu Neurostimulation System for Peripheral Nerve Stimulation (K191435)

Submission Summary (Full Text)

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July 15, 2020

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

Re: K201618

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: June 12, 2020 Received: June 15, 2020

Dear Pauline Lieu:

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.

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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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K201618

Device Name Nalu Neurostimulation System

#### Indications for Use (Describe)

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)

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.

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

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|

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### 510(k) Summary

### K201618

# Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92009 Phone: [phone] Fax: [phone] Contact Pauline Lieu, Regulatory Affairs

Date Prepared: June 12, 2020

# Device Names and Classification

| Predicate Device | |
|---------------------------|---------------------------------------------------------------------|
| 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 |

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

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## Predicate Device

Nalu Neurostimulation System for Spinal Cord Stimulation (K183047)

Reference Devices: Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579 and K191435)

### Device Description

The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) 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 five 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 (K183047, K183579, and K191435).

### 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)

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.

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# Comparison with the Predicate Device

| Device | Nalu Neurostimulation<br>System (Predicate<br>Device: K183047) | Nalu Neurostimulation<br>System (Subject Device) | Analysis of<br>Technological<br>Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | Nalu Neurostimulation<br>System | Nalu Neurostimulation<br>System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu<br>Neurostimulation system<br>is intended for the<br>stimulation of the spinal<br>cord for treatment of<br>chronic, intractable pain. | The Nalu<br>Neurostimulation system<br>is intended for the<br>stimulation of the spinal<br>cord for treatment of<br>chronic, intractable pain. | Same |
| Indications for<br>Use | This system is indicated<br>as the sole mitigating<br>agent, or as an adjunct to<br>other modes of therapy<br>used in a<br>multidisciplinary<br>approach for chronic,<br>intractable pain of the<br>trunk and/or limbs,<br>including unilateral or<br>bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no longer<br>than 30 days) to<br>determine efficacy before<br>recommendation for a<br>permanent (long term)<br>device. | This system is indicated as<br>the sole mitigating agent,<br>or as an adjunct to other<br>modes of therapy used in<br>a multidisciplinary<br>approach for chronic,<br>intractable pain of the<br>trunk and/or limbs,<br>including unilateral or<br>bilateral pain.<br>The trial devices are solely<br>used for trial stimulation<br>(no longer than 30 days)<br>to determine efficacy<br>before recommendation<br>for a permanent (long<br>term) device. | Same |
| Clinical<br>application | Treatment of chronic,<br>intractable pain of the<br>trunk and/or limbs,<br>including unilateral or<br>bilateral pain | Treatment of chronic,<br>intractable pain of the<br>trunk and/or limbs,<br>including unilateral or<br>bilateral pain | Same |
| Prescription Use | Yes | Yes | Same |
| Intended User | Physician, Layperson | Physician, Layperson | Same |
| Principle of<br>Operation | Stimulation of the spinal<br>cord to provide<br>therapeutic relief for | Stimulation of the spinal<br>cord to provide<br>therapeutic relief for | Same |
| | chronic, intractable pain<br>of the trunk and/or limbs<br>including unilateral or<br>bilateral pain | chronic, intractable pain<br>of the trunk and/or limbs<br>including unilateral or<br>bilateral pain | |
| Mode of Action | RF wireless transmission<br>of energy to deliver<br>stimulation at stimulator<br>electrodes | RF wireless transmission<br>of energy to deliver<br>stimulation at stimulator<br>electrodes | Same |
| Implant<br>Neurostimulator | Nalu IPG 27.7 mm x 9.3<br>mm x 4.2 mm | Nalu IPG 27.7 mm x 9.3<br>mm x 4.2 mm | Same |
| Lead | 40 cm, 60 cm; Platinum-<br>iridium 90:10;<br>Multilumen tube | 40 cm, 60 cm; Platinum-<br>iridium 90:10; Multilumen<br>tube | Same |
| Externally worn<br>devices | Trial Therapy Disc and<br>Therapy Disc | Trial Therapy Disc and<br>Therapy Disc | Same |
| Electronics | A printed circuit board<br>(PCB) that generates RF<br>power with embedded<br>waveform parameter<br>settings and buttons for<br>changing parameter<br>settings | A printed circuit board<br>(PCB) that generates RF<br>power with embedded<br>waveform parameter<br>settings and buttons for<br>changing parameter<br>settings | Same |
| Clinician<br>Programmer | Software to communicate<br>to Trial Therapy or<br>Therapy Disc | Software to communicate<br>to Trial Therapy or<br>Therapy Disc | Same |
| Patient Remote<br>Control | Software to pair with<br>Trial Therapy or Therapy<br>Disc | Software to pair with Trial<br>Therapy or Therapy Disc | Same |
| Human Factors | Integrated controls and<br>indicators that allows the<br>user to turn the device<br>on/off, increase or<br>decrease therapy levels,<br>select from configured<br>therapy profiles and<br>monitor device status | Integrated controls and<br>indicators that allows the<br>user to turn the device<br>on/off, increase or<br>decrease therapy levels,<br>select from configured<br>therapy profiles and<br>monitor device status | Same |
| Externally<br>Contacting<br>Materials | Hydrocolloid adhesive<br>applied to skin | Hydrocolloid adhesive<br>applied to skin | Same |
| | Biocompatible PC ABS<br>housing | Biocompatible PC ABS<br>housing | |
| | Textile material of belt | Textile material of belt | |
| Labeling | Implantable Pulse<br>Generator:<br>The service life of the<br>Implantable Pulse<br>Generator is 10 | Implantable Pulse<br>Generator:<br>The service life of the<br>Implantable Pulse<br>Generator is 18 | New |

### Nalu Neurostimulation System for Spinal Cord Stimulation (SCS)

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| | Therapy Disc: Single use | Therapy Disc: Re-usable | | |
|--|--------------------------|-------------------------|--|--|
|--|--------------------------|-------------------------|--|--|

#### Nalu Neurostimulation System for Peripheral Nerve Stimulation

| Device | Nalu Neurostimulation<br>System (Reference<br>Devices: K183579,<br>K191435) | Nalu Neurostimulation<br>System (Subject Device) | Analysis of<br>Technological<br>Differences |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | Nalu Neurostimulation<br>System | Nalu Neurostimulation<br>System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu<br>Neurostimulation system<br>is intended for the<br>stimulation of the<br>peripheral nerve for<br>treatment of chronic,<br>intractable pain. | The Nalu<br>Neurostimulation system<br>is intended for the<br>stimulation of the<br>peripheral nerve for<br>treatment of chronic,<br>intractable pain. | Same |
| Indications for<br>Use | This system is indicated<br>for pain management in<br>adults who have severe<br>intractable chronic pain<br>of peripheral nerve<br>origin, as the sole<br>mitigating agent, or as an<br>adjunct to other modes<br>of therapy used in a<br>multidisciplinary<br>approach. The system is<br>not intended to treat<br>pain in the craniofacial<br>region.<br>The trial devices are<br>solely used for trial<br>stimulation (no longer<br>than 30 days) to<br>determine efficacy before<br>recommendation for a<br>permanent (long term)<br>device. | This system is indicated<br>for pain management in<br>adults who have severe<br>intractable chronic pain<br>of peripheral nerve<br>origin, as the sole<br>mitigating agent, or as an<br>adjunct to other modes<br>of therapy used in a<br>multidisciplinary<br>approach. The system is<br>not intended to treat<br>pain in the craniofacial<br>region.<br>The trial devices are<br>solely used for trial<br>stimulation (no longer<br>than 30 days) to<br>determine efficacy<br>before recommendation<br>for a permanent (long<br>term) device. | Same |
| Clinical<br>application | Treatment of chronic<br>peripheral nerve pain | Treatment of chronic<br>peripheral nerve pain | Same |
| Prescription Use | Yes | Yes | Same |
| Intended User | Physician, Layperson | Physician, Layperson | Same |
| Device | Nalu Neurostimulation<br>System (Reference<br>Devices: K183579,<br>K191435) | Nalu Neurostimulation<br>System (Subject Device) | Analysis of<br>Technological<br>Differences |
| Principle of<br>Operation | Stimulation of the<br>peripheral nerve to<br>provide therapeutic relief<br>for chronic pain | Stimulation of the<br>peripheral nerve to<br>provide therapeutic<br>relief for chronic pain | Same |
| Mode of Action | RF wireless transmission<br>of energy to deliver<br>stimulation at stimulator<br>electrodes | RF wireless transmission<br>of energy to deliver<br>stimulation at stimulator<br>electrodes | Same |
| Implant<br>Neurostimulator | Nalu IPG 27.7 mm x 9.3<br>mm x 4.2 mm | Nalu IPG 27.7 mm x 9.3<br>mm x 4.2 mm | Same |
| Lead | 40 cm, 60 cm; Platinum-<br>iridium 90:10;<br>Multilumen tube | 40 cm, 60 cm; Platinum-<br>iridium 90:10;<br>Multilumen tube | Same |
| | 25 cm, 40 cm Platinum-<br>iridium 90:10, Coiled<br>wires | 25 cm, 40 cm Platinum-<br>iridium 90:10, Coiled<br>wires | |
| Externally worn<br>devices | Trial Therapy Disc and<br>Therapy Disc | Trial Therapy Disc and<br>Therapy Disc | Same |
| Electronics | A printed circuit board<br>(PCB) that generates RF<br>power with embedded<br>waveform parameter<br>settings and buttons for<br>changing parameter<br>settings | A printed circuit board<br>(PCB) that generates RF<br>power with embedded<br>waveform parameter<br>settings and buttons for<br>changing parameter<br>settings | Same |
| Clinician<br>Programmer | Software to communicate<br>to Trial Therapy or<br>Therapy Disc | Software to<br>communicate to Trial<br>Therapy or Therapy Disc | Same |
| Patient Remote<br>Control | Software to pair with<br>Trial Therapy or Therapy<br>Disc | Software to pair with<br>Trial Therapy or Therapy<br>Disc | Same |
| Human Factors | Integrated controls and<br>indicators that allows the<br>user to turn the device<br>on/off, increase or<br>decrease therapy levels,<br>select from configured<br>therapy profiles and<br>monitor device status | Integrated controls and<br>indicators that allows the<br>user to turn the device<br>on/off, increase or<br>decrease therapy levels,<br>select from configured<br>therapy profiles and<br>monitor device status | Same |
| Externally<br>Contacting<br>Materials | Hydrocolloid adhesive<br>applied to skin | Hydrocolloid adhesive<br>applied to skin | Same |
| Device | Nalu Neurostimulation<br>System (Reference<br>Devices: K183579,<br>K191435) | Nalu Neurostimulation<br>System (Subject Device) | Analysis of<br>Technological<br>Differences |
| | Biocompatible PC ABS<br>housing | Biocompatible PC ABS<br>housing | |
| | Textile material of belt | Textile material of belt | |
| Labeling | Implantable Pulse<br>Generator:<br>The service life of the<br>Implantable Pulse<br>Generator is 10 years. | Implantable Pulse<br>Generator:<br>The service life of the<br>Implantable Pulse<br>Generator is 18 years | New |
| | Therapy Disc: Single use | Therapy Disc: Re-usable | |

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## Technological Characteristics

All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate devices share the same technological characteristics and have no differences that would impact safety or effectiveness.

# Summary of Performance Testing

Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Neurostimulation System prior to use. Nalu follows the Design Controls section of 21 CFR 820.30, ISO 14971, and ISO 13485:2016. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. Validation and performance testing demonstrate that the device meets user needs as reflected in the functional specification. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. All relevant testing for the proposed labeling changes were submitted and cleared in the previous submissions (K183047, K183579, and K191435). Therefore, test results from the predicate device remain applicable to the subject device of this 510(k).

## Conclusion

The subject device of this 510(k) is substantially equivalent to the predicate devices as they are identical with regard to indications for use, performance and the technological characteristics. Risk analysis of the proposed changes did not raise any questions of safety and effectiveness.