Nalu Neurostimulation System

K221376 · Boston Scientific Neuromodulation · GZB · Jun 10, 2022 · Neurology

Device Facts

• Record ID: K221376
• Device Name: Nalu Neurostimulation System
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Jun 10, 2022
• 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 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

Implantable neurostimulation system for chronic, intractable pain; delivers pulsed electrical current to spinal cord or peripheral nerves to inhibit pain signal transmission. Components: Implantable Pulse Generator (IPG), leads with 4 or 8 electrodes, Therapy Disc (battery/RF electronics), and remote programmer. Used in hospital/home settings by physicians (orthopedic, neurosurgeon, anesthesiologist) and patients. Clinician uses programmer to set stimulation parameters; patient uses remote to control therapy. System uses RF wireless transmission for power and control. Updated software allows optional model-based current steering to optimize stimulation delivery. Patient remains in feedback loop to determine therapy effectiveness.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench and non-clinical performance testing, including software/firmware validation.

Technological Characteristics

Active implantable neurostimulator; RF wireless power transmission (40.68 MHz). Leads with 4 or 8 cylindrical electrodes. Waveform: charge-balanced, delayed, asymmetrical biphasic; decaying exponential pulse shape. Connectivity: wireless communication between Therapy Disc, IPG, and remote programmer. Software: Moderate level of concern; supports manual and model-based current steering. Standards: ISO 14708-1/3, IEC 60601-1/1-2/1-11, EN ISO 14971.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin or chronic, intractable pain of the trunk/limbs (SCS). 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 (K203547)

Submission Summary (Full Text)

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June 10, 2022

Nalu Medical, Inc. Chelsea Gutierrez VP Regulatory and Quality 2320 Faraday Avenue, Suite 100 Carlsbad, California 92008

Re: K221376

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: May 12, 2022 Received: May 12, 2022

Dear Chelsea Gutierrez:

We have reviewed vour 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

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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-reporting-

combination-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,

Amber Ballard, PhD 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) K221376

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 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:flex; align-items:center;"> <span>☑</span> <span>Research that is Part 21 CFR 58 Subject to Bioresearch Monitoring Program</span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span>☐</span> <span>One Time Contracted (to Part 21 CFR 58) Study</span> </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 1. Submission Sponsor

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

#### 2. Date Prepared: June 10, 2022

#### 3. 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; Implanted spinal cord stimulator for pain relief |
| Product Code | GZB |
| Review Panel | Division of Neurology |

| Secondary Product Code | |
|---------------------------|------------------------------------------------------------------------|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Class | II |
| Classification Regulation | 21 CFR 882.5870; Implanted peripheral nerve stimulator for pain relief |
| Product Code | GZF |
| Review Panel | Division of Neurology |

#### 4. Predicate Device(s)

Nalu Neurostimulation System, K203547

For software differences between the Nalu Neuromodulation System and the predicate(s) (K203547), substantial equivalence to the predicate device is demonstrated.

#### 5. Device Description

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) 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

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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 (5) 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 (4) or eight (8) 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 (K203547).

#### 6. 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 Stimulator (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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#### 7. Comparison with the Predicate Device

| Table 1: Nalu Neuromodulation System for Spinal Cord Stimulation (SCS) | | | |
|------------------------------------------------------------------------|--|--|--|
|------------------------------------------------------------------------|--|--|--|

| Device | Nalu<br>Neuromodulation System (Subject Device, K221376) | Nalu<br>Neuromodulation System (Predicate Device, K203547) | Analysis of Technological Differences |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K221376 | K203547 | N/A |
| Product Code and Class | GZB and GZF, Class II | GZB and GZF, Class II | Same |
| Regulation Number | 21 CFR 882.5880 (GZB)<br>21 CFR 882.5870 (GZF) | 21 CFR 882.5880 (GZB)<br>21 CFR 882.5870 (GZF) | Same |
| Classification Name | Implanted spinal cord stimulator for pain relief. (GZB)<br>Implanted peripheral nerve stimulator for pain relief. (GZF) | Implanted spinal cord stimulator for pain relief. (GZB)<br>Implanted peripheral nerve stimulator for pain relief. (GZF) | Same |
| Trade Name | Nalu<br>Neuromodulation System | Nalu<br>Neurostimulation System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu<br>Neuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).<br>Stimulation of peripheral nerves for chronic, intractable pain (GZF). | The Nalu<br>Neuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).<br>Stimulation of peripheral nerves for chronic, intractable pain (GZF). | Same |
| Indications for Use | For Spinal Cord Stimulation-<br>This system is indicated as the | For Spinal Cord Stimulation-<br>This system is indicated as the | Same |
| Device | Nalu<br>Neuromodulation<br>System (Subject<br>Device, K221376) | Nalu<br>Neuromodulation<br>System (Predicate<br>Device, K203547) | Analysis of<br>Technological<br>Differences |
| | 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, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no<br>longer than 30<br>days) to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long- term) device.<br>For Peripheral<br>Nerve Stimulation-<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, or<br>as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach. The<br>system is not<br>intended to treat<br>pain in the<br>craniofacial region.<br>The trial devices are | 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, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no<br>longer than 30<br>days) to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long- term) device.<br>For Peripheral<br>Nerve Stimulation-<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, or<br>as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach. The<br>system is not<br>intended to treat<br>pain in the<br>craniofacial region.<br>The trial devices are | |
| Device | Nalu<br>Neuromodulation<br>System (Subject<br>Device, K221376) | Nalu<br>Neuromodulation<br>System (Predicate<br>Device, K203547) | Analysis of<br>Technological<br>Differences |
| | stimulation (no<br>longer than 30 day)<br>to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term) device. | stimulation (no<br>longer than 30 day)<br>to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term) device. | |
| Clinical application | Treatment of<br>chronic, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain. | Treatment of<br>chronic, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain. | Same |
| Prescription Use | Yes | Yes | Same |
| Environmental Use | Hospital, Home | Hospital, Home | Same |
| Intended Clinician | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Same |
| Intended User | Physician,<br>Layperson | Physician,<br>Layperson | Same |
| Implant site, leads | Epidural space (SCS)<br>or peripheral nerve<br>areas (PNS) | Epidural space (SCS)<br>or peripheral nerve<br>areas (PNS) | Same |
| Principle of<br>Operation | Stimulation of the<br>spinal cord to<br>provide therapeutic<br>relief for chronic,<br>intractable pain of<br>the trunk and/or<br>limbs including<br>unilateral or<br>bilateral pain. | Stimulation of the<br>spinal cord to<br>provide therapeutic<br>relief for chronic,<br>intractable pain of<br>the trunk and/or<br>limbs including<br>unilateral or<br>bilateral pain. | Same |
| Mode of Action | RF wireless<br>transmission of<br>energy to deliver<br>stimulation at<br>stimulator<br>electrodes. | RF wireless<br>transmission of<br>energy to deliver<br>stimulation at<br>stimulator<br>electrodes. | Same |
| Software Level of<br>Concern | Moderate | Moderate | Same |
| Clinician<br>Programmer | Software to<br>communicate to | Not publicly<br>available | The differences<br>do not impact the<br>safety and |
| Device | Nalu<br>Neuromodulation<br>System (Subject<br>Device, K221376) | Nalu<br>Neuromodulation<br>System (Predicate<br>Device, K203547) | Analysis of<br>Technological<br>Differences |
| | Trial Therapy or<br>Therapy Disc<br><br>Manual control of<br>current for selected<br>electrodes and<br>optional model<br>based allocation. | | effectiveness of<br>the device. The<br>safety parameters<br>(charge per phase,<br>charge density<br>and current<br>density) remain<br>unchanged. The<br>updated software<br>allows the<br>clinician to<br>optionally use a<br>mode to set the<br>current values on<br>up to 4 electrodes<br>based on a model.<br>The safety limits<br>continue to be<br>applied as before.<br>The new method<br>is an option that<br>may allow<br>programming to<br>go faster when<br>causing the<br>current steering<br>stimulation mode.<br>As with all<br>programming in<br>neurostimulation<br>the patient<br>remains in the<br>feedback loop and<br>determines the<br>effectiveness of<br>the therapy. |
| Patient Remote<br>Control | Software to pair<br>with Trial Therapy<br>or Therapy Disc<br><br>SW update to<br>reflect changes on<br>the Clinician<br>Programmer and | Not publicly<br>available | - |
| Device | Nalu<br>Neuromodulation<br>System (Subject<br>Device, K221376) | Nalu<br>Neuromodulation<br>System (Predicate<br>Device, K203547)…