Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

K233801 · Boston Scientific Neuromodulation · GZB · Aug 23, 2024 · Neurology

Device Facts

• Record ID: K233801
• Device Name: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Aug 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SCS: Stimulation of the spinal cord for treatment of chronic, intractable pain. PNS: Stimulation of peripheral nerves for chronic, intractable pain.

Device Story

Nalu Neurostimulation System treats chronic, intractable pain via pulsed electrical current inhibiting pain signal transmission. System includes miniature implantable pulse generator (IPG) and leads (implanted in epidural space or peripheral nerves) powered by externally worn Therapy Disc (TD2) via 40.68 MHz RF transmission. Physician configures therapy parameters using Clinician Programmer app; patient manages stimulation levels/profiles via Remote Control app on mobile device (Android/iOS). TD2 features gesture controls for BLE bond renegotiation. System used in clinical/home settings. Output affects clinical decision-making by providing adjustable, patient-controlled neuromodulation to manage pain, potentially reducing reliance on other therapies.

Clinical Evidence

Bench testing only. Verification and validation testing included EMC (IEC 60601-1 series), packaging validation (ISTA 3A), biocompatibility (ISO 10993-1), software validation (IEC 62304), and formative/summative usability testing (IEC 62366-1). No clinical data.

Technological Characteristics

Implantable IPG/leads (unchanged). External TD2: PC ABS housing, hydrocolloid adhesive, RF power (40.68 MHz). Connectivity: Bluetooth Low Energy (BLE) and Wi-Fi for cloud data. Software: Android/iOS apps for clinician/patient control. Sterilization: Not applicable (externals).

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin or chronic, intractable pain of the trunk/limbs (including unilateral/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 (for SCS & PNS) (K221376)

Reference Devices

• Nalu Neurostimulation System for SCS (K202274)
• Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

August 23, 2024

Nalu Medical Inc. Chelsea Gutierrez Vice President, Regulatory/Quality 2320 Faraday Ave., Suite 100 Carlsbad, California 92008

Re: K233801

Trade/Device Name: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB, GZF Dated: August 16, 2024 Received: August 16, 2024

Dear Chelsea Gutierrez:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lauren E. Woodard -S

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices

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OHT5: Office of Neuromodulation 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) K233801

#### Device Name

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

# Indications for Use (Describe)

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.

#### 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 Nalu Neurostimulation System for PNS 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Submission Sponsor

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

Date Prepared: August 22, 2024

## Device Names and Classification

510(k) Number: K233801

| Primary Product Code | |
|---------------------------|------------------------------------------------------------------------|
| Trade/Proprietary Name | Nalu Neurostimulation System |
| Common/Usual Name | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Classification Regulation | 21 CFR 882.5880; Implanted spinal cord stimulator for pain relief |
| Product Code | GZB |
| Class | Class II |
| Review Panel | Neurology |
| Secondary Product Code | |
| Trade/Proprietary Name | Nalu Neurostimulation System |
| Common/Usual Name | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Classification Regulation | 21 CFR 882.5870; Implanted peripheral nerve stimulator for pain relief |
| Product Code | GZF |
| Class | Class II |
| Review Panel | Neurology |

## Predicate/Reference Devices

- Predicate Device: Nalu Neurostimulation System (for SCS & PNS) (K221376)
- Reference Device: Nalu Neurostimulation System for SCS (K202274)
- . Reference Device: Nalu Neurostimulation System for Peripheral Nerve Stimulation ( K183579)

## Device Description

The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on

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peripheral nerves or central nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use.

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

The Nalu System is comprised of the following components:

• Implantables (there are no proposed changes to these components as previously provided in K221376):

o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s).

o Leads – 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.

o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG.

- Externals, Non-Sterile:
o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission).

o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC).

• Software (subject of this submission):

o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.

Technological characteristics of the device under review (non-sterile externals including the Therapy Disc and Therapy Disc Charger and the associated software updates) are identical to

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that of the predicate device previously cleared under K221376, with the exception of minor electronics updates, updates to the user interfaces (which now include the use of gesture controls for BLE bond renegotiation), reduction of the size of the Therapy Disc (including updates to the wearable accessories to accommodate the new Therapy Disc size) and lastly, minor patient-contacting material updates. None of these technological differences in the device under review affect safety or efficacy of the Nalu System as they have been fully evaluated for equivalence through design Verification and Validation.

## Indications for Use

ટર:

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.

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 Nalu Neurostimulation System for PNS 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.

# Substantial Equivalence Comparison

This Traditional 510(k) premarket notification is for the proposed device, the Nalu Neurostimulation System (inclusive of both the SCS and PNS indications), which is a modification of the cleared Nalu Neurostimulation System (K221376). Nalu is proposing design modifications to the externally worn controller (i.e., Therapy Disc and Base Station), as well as software application updates (i.e., Clinician Programmer and Remote Control). The modifications outlined in this 510(k) do not raise different questions of safety or effectiveness as demonstrated by the completed testing provided within this submission. Based on the similarities between the cleared and modified devices, the proposed Nalu System is substantially equivalent to the cleared Nalu Neurostimulation System (K221376). Provided in Table 1 is a comparison of the cleared and modified devices which includes a rationale for substantial equivalence.

Of note, the implanted components, surgical tools, and therapy settings remain unchanged. The modifications made to the Nalu System described herein only impact the external control device referred to as the Therapy Disc and the Therapy Disc Base Station (charger) as well as the Clinician Programmer and Remote-Control Application Software.

Please also note that the second-generation Therapy Disc, Base Station Charger and accessories as well as the updated PC and RC software applications are to be used in both FDA cleared indications for use, Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS).

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| | Nalu Neurostimulation System for SCS & PNS<br>K233801 (Proposed Device) | Nalu Neurostimulation System for SCS & PNS<br>K221376 (Predicate Device) | Comparison |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Code<br>and<br>Classification | GZB, Class II<br>GZF, Class II | GZB, Class II<br>GZF, Class II | Same as predicate. |
| Regulation | SCS:<br>21 CFR §882.5880<br>PNS:<br>21 CFR §882.5870 | SCS:<br>21 CFR §882.5880<br>PNS:<br>21 CFR §882.5870 | Same as predicate. |
| Classification<br>Name | SCS:<br>Implanted spinal cord stimulator for pain<br>relief<br>PNS:<br>Implanted peripheral nerve stimulator for<br>pain relief | SCS:<br>Implanted spinal cord stimulator for pain<br>relief<br>PNS:<br>Implanted peripheral nerve stimulator for<br>pain relief | Same as predicate. |
| Intended Use | SCS:<br>Stimulation of the spinal cord for treatment<br>of chronic, intractable pain<br>PNS:<br>Stimulation of peripheral nerves for<br>chronic, intractable pain | SCS:<br>Stimulation of the spinal cord for<br>treatment of chronic, intractable pain<br>PNS:<br>Stimulation of peripheral nerves for<br>chronic, intractable pain | Same as predicate. |
| Indications for<br>Use | SCS:<br>This system is indicated as the sole<br>mitigating agent, or as an adjunct to other<br>modes of therapy used in a<br>multidisciplinary approach for chronic,<br>intractable pain of the trunk and/or limbs,<br>including unilateral or bilateral pain.<br>The trial devices are solely used for trial<br>stimulation (no longer than 30 days) to<br>determine efficacy before<br>recommendation for a permanent (long<br>term) device.<br>PNS:<br>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<br>an adjunct to other modes of therapy used<br>in a multidisciplinary approach. The Nalu<br>Neurostimulation System for PNS is not<br>intended to treat pain in the craniofacial<br>region.<br>The trial devices are solely used for trial<br>stimulation (no longer than 30 days) to<br>determine efficacy before<br>recommendation for a permanent (long<br>term) device. | SCS:<br>This system is indicated as the sole<br>mitigating agent, or as an adjunct to other<br>modes of therapy used in a<br>multidisciplinary approach for chronic,<br>intractable pain of the trunk and/or limbs,<br>including unilateral or bilateral pain.<br>The trial devices are solely used for trial<br>stimulation (no longer than 30 days) to<br>determine efficacy before<br>recommendation for a permanent (long<br>term) device.<br>PNS:<br>This system is indicated for pain<br>management in adults who have severe<br>intractable chronic pain of peripheral<br>nerve origin, as the sole mitigating agent,<br>or as an adjunct to other modes of<br>therapy used in a multidisciplinary<br>approach. The system is not intended to<br>treat pain in the craniofacial region.<br>The trial devices are solely used for trial<br>stimulation (no longer than 30 days) to<br>determine efficacy before<br>recommendation for a permanent (long<br>term) device. | Same as predicate. |
| Prescription<br>Use | Yes | Yes | Same as predicate. |
| Implant Site | SCS:<br>Lead: Epidural space<br>IPG: Subcutaneous, mid back<br>PNS: | SCS:<br>Lead: Epidural space<br>IPG: Subcutaneous, mid back<br>PNS: | Same as predicate. |

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| | | | 310(k) Summary K233801 |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peripheral nerves, excluding craniofacial<br>region. | Peripheral nerves, excluding craniofacial<br>region. | Peripheral nerves, excluding craniofacial region. |
| Environmental<br>Use | Hospital Use, Home | Hospital Use, Home | Same as predicate. |
| Intended<br>Clinician | Orthopedic, Neurosurgeon,<br>Anesthesiologist | Orthopedic, Neurosurgeon,<br>Anesthesiologist | Same as predicate. |
| Intended User | Physician, Layperson | Physician, Layperson | Same as predicate. |
| Mode of Action | Radiofrequency (RF) wireless<br>transmission of energy to produce<br>stimulation at stimulator electrodes. | Radiofrequency (RF) wireless<br>transmission of energy to produce<br>stimulation at stimulator electrodes. | Same as predicate. |
| Labeling | SCS:<br>MR Conditional Labeling for Head and<br>Extremities.<br>Full Body MR Conditional Labeling for<br>Full Body.<br>PNS:<br>MR Conditional Labeling for Head and<br>Extremities. | Not publicly available | SCS:<br>Same as reference<br>device K202274.<br>PNS:<br>Same as reference<br>device K183579. |
| External Device<br>Names | Therapy Disc (second generation), Base<br>Station Charger and Trial Therapy Disc | Therapy Disc and Trial Therapy Disc | Therapy Disc and<br>Therapy Disc Charger<br>(Base Station) have<br>updated design. Trial<br>Therapy Disc remains<br>unchanged. |
| Electronics | Updated folded printed circuit board<br>(PCB) design that generates RF power<br>with embedded waveform parameter<br>settings that can be changed as needed by<br>the user | A printed circuit board (PCB) that<br>generates RF power with embedded<br>waveform parameter settings and buttons<br>for changing parameter settings as<br>needed by the user | Functional output of<br>TD2 electronics<br>remains unchanged.<br>PCB changes were<br>evaluated through<br>usability and EMC<br>testing to confirm<br>there are no different<br>questions of safety or<br>effectiveness. |
| User Interface | Integrated indicators allow the user to<br>monitor device status. Therapy Disc can<br>be controlled through flip gesture. The<br>Remote Control allows the user to<br>stop/start stimulation, increase or decrease<br>therapy levels, and select from configured<br>therapy profiles. | Integrated controls and indicators that<br>allow the user to turn the device on/off,<br>increase or decrease therapy levels, select<br>from configured therapy profiles and<br>monitor device status. | Gesture controls on<br>Therapy Disc replace<br>buttons. Changes<br>were evaluated<br>through usability<br>testing to confirm<br>there are no different<br>questions of safety or<br>effectiveness. |
| Antenna<br>(Therapy Disc<br>Only) | Integrated antenna supporting 40.68 MHz<br>power and data transfer | Integrated antenna supporting 40.68<br>MHz power and data transfer. | Same as predicate. |
| Wearable<br>Garments and<br>Adhesive Clips<br>(Therapy Disc<br>Only) | Therapy Disc is positioned over Nalu IPG<br>via two options:<br>• Adhesive clip (hydrocolloid adhesive)<br>• Elastic Belt/Cuff<br>Wearable accessories design has been<br>updated to accommodate smaller footprint<br>TD2 device | Therapy Disc is positioned over Nalu<br>IPG via two options:<br>• Adhesive clip (hydrocolloid adhesive)<br>• Elastic Belt/Cuff | New adhesive clip<br>using same materials.<br>Updated Elastic<br>Belt/Cuff. Changes<br>were evaluated<br>through usability<br>testing to confirm<br>there are no different<br>questions of safety or<br>effectiveness. |
| Size/Weight | Disc: ~1.3 cm thick, ~6.2 cm diameter | Disc: ~1.5 cm thick, 7.5 cm diameter | Similar. The<br>size/weight |

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| Externally<br>Contacting<br>Materials | Biocompatible PC ABS housing.<br>Occasional contact to fingers (e.g., taking<br>disc in and out of adhesive clip or<br>wearable garment. Textile material of<br>belt/cuff may be worn over clothing.<br>Hydrocolloid adhesive applied to skin. | Biocompatible PC ABS housing.<br>Occasional contact to fingers (e.g., button<br>use). Textile material of belt/cuff may be<br>worn over clothing. Hydrocolloid<br>adhesive applied to skin. | modifications do not<br>raise different<br>questions of safety or<br>effectiveness.<br>Dimensional<br>verification confirms<br>that the device meets<br>its specifications.<br>Similar as predicate.<br>Biocompatible PC<br>ABS housing<br>materials for the<br>bottom housing have<br>not changed. The<br>patient contacting<br>materials of the TD2<br>top housing are<br>similar to the top<br>housing of the<br>predicate device, the<br>differences in the top<br>housing materials do<br>not raise different<br>questions of safety or<br>effectiveness. The<br>biological evaluation<br>of these materials<br>poses a very low<br>biocompatibility risk<br>because they have a<br>long history of safe<br>use in legally<br>marketed medical<br>devices that contact<br>intact skin. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Battery<br>Charging<br>Configuration | Electrically isolated cradle charger<br>compatible with Therapy Disc devices.<br>Software installed on a compatible<br>Android tablet. | Electrically isolated cradle charger<br>compatible with Therapy Disc devices.<br>Software installed on a compatible<br>Android tablet. | Same as predicate. |
| Purpose | Allows healthcare provider to set desired<br>therapy levels and device settings across<br>Therapy Disc, Trial Therapy Disc, and<br>Patient Remote-Control devices | Allows healthcare provider to set desired<br>therapy levels and device settings across<br>Therapy Disc, Trial Therapy Disc, and<br>Patient Remote-Control devices. | Same as predicate. |
| Communication | Secure Bluetooth to Therapy Disc, Trial<br>Therapy Disc, Patient Remote Control and<br>Clinician Programmer.<br>Clinician Programmer and Base Station<br>Charger (BSC) also upload/download<br>encrypted data using a secure connection<br>to a Nalu cloud service via a Wi-Fi access<br>point. | Secure Bluetooth to Therapy Disc, Trial<br>Therapy Disc, Patient Remote Control<br>and Clinician Programmer.<br>Device usage information is stored<br>offline on the Therapy Disc and can be<br>transferred to the Clinician Programmer<br>via BLE connection | Same methods of<br>communication.<br>Changes were<br>evaluated through<br>usability and Software<br>testing to confirm<br>there are no different<br>questions of safety or<br>effectiveness. |
| Patient Remote<br>Control | Software app installed on compatible<br>mobile device (Android/iOS) providing<br>wireless selection among preconfigured<br>options and status readout for paired<br>Therapy Disc devices | Software app installed on compatible<br>mobile device (Android/iOS) providing<br>wireless selection among preconfigured<br>options and status readout for paired<br>Therapy Disc devices. | Same as predicate. |

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| Table 2: Predicate and Subject Device Comparison with the Nalu Neurostimulation therapy delivery (SCS and PNS) | | |
|----------------------------------------------------------------------------------------------------------------|--|--|
| | | |

| Comparator | Nalu Neurostimulation System<br>(Subject Device, K233801) | Nalu Neurostimulation System<br>(Predicate Device, K221376) | Analysis of<br>Technological<br>Differences<br>from Predicate |
|----------------------------------|-----------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------|
| Pulse Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | Same as predicate |
| Pulse Width | 12 to 2000 μs | 12 to 2000 μs | Same as predicate |
| Current/<br>Voltage<br>Regulated | Current | Current | Same as predicate |
| Output Voltage<br>(300 Ohms) | 0 to 3.1 V | 0 to 3.1 V | Same as predicate |
| Output Voltage<br>(500 Ohms) | 0 to 5.1 V | 0 to 5.1 V | Same as predicate |
| Output Voltage<br>(800 Ohms) | 0 to 8.2 V | 0 to 8.2 V | Same as predicate |
| Output Current<br>(300 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current<br>(500 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current<br>(800 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Waveform | charge balanced (delayed) biphasic<br>asymmetrical | charge balanced (delayed) biphasic<br>asymmetrical | Same as<br>predicate |
| Pulse Shape | Decaying Exponential | Decaying Exponential | Same as predicate |

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| Maximum phase<br>charge (300<br>Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
|--------------------------------------------|---------------|---------------|----------------------|
| Maximum phase<br>charge (500<br>Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum<br>phase charge<br>(800 Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum<br>charge density<br>(300<br>Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximum<br>charge density<br>(500 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximum<br>charge density<br>(800 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as<br>predicate |
| Maximum<br>current<br>density (300<br>Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximum<br>current<br>density (500<br>Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximum<br>current<br>density (800<br>Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Net Charge | 0 µC | 0 µC | Same as predicate |
| Average Phase<br>Power (300<br>Ohms) | 0.031 W/phase | 0.031 W/phase | Same as predicate |
| Average Phase | 0.052 W/phase | 0.052 W/phase | Same as predicate |

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| Power (500<br>Ohms) | | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Average Phase<br>Power (800<br>Ohms) | 0.083 W/phase | 0.083 W/phase | Same as predicate. |
| Average Phase<br>Power density<br>(300 Ohms) | 0.25 W/cm²/phase | 0.25 W/cm²/phase | Same as<br>predicate. |
| Average Phase<br>Power density<br>(500 Ohms) | 0.51 W/cm²/phase | 0.51 W/cm²/phase | Same as predicate. |
| Average Phase<br>Power density<br>(800 Ohms) | 0.55 W/cm²/phase | 0.55 W/cm²/phase | Same as predicate. |
| Pulse Delivery<br>Mode | Continuous | Continuous | Same as predicate. |
| Current Path<br>options | Bipolar | Bipolar | Same as predicate. |
| Program Cycle | Cycle through programs | Cycle through programs | Same as predicate. |
| Pulse Pattern | Fine tuning of pulse patterns<br>(On/Off; If On, spans from 12 μs to 1000 μs) | Fine tuning of pulse patterns<br>(On/Off; If On, spans from 12 μs to<br>1000 μs) | Same as predicate. |
| Dosage Time | Allows for stimulation to be applied in<br>periodic doses (On/Off; If On, spans<br>from 1 ms to 1000 ms, If Off, spans<br>from 1 ms to 2000 ms) | Allows for stimulation to be<br>applied in periodic doses (On/Off;<br>If On, spans from 1 ms to 1000<br>ms, If Off, spans from 1 ms to<br>2000 ms) | Same as predicate |
| Daily Therapy<br>Time | Limits the number of hours in a day that<br>stimulation may be used<br>(Seconds to hours) | Limits the number of hours in a day<br>that stimulation may be used<br>(Seconds to hours) | Same as predicate. |
| Transmit<br>Frequency | 40.68 MHz | 40.68 MHz | Same as predicate |

# Technological Comparison

The Nalu Neurostimulation System has the same intended use and Indications for Use as the predicate device (K221376). Of note, the implanted components, surgical tools, and therapy settings remain unchanged. The modifications made to the Nalu Neurostimulation System described herein only impact the external control device referred to as the Therapy Disc and the Therapy Disc Base Station (charger) as well as the Clinician Programmer and Remote

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Control Application software. The differences between the Nalu Neurostimulation System and the predicate device (K221376) do not raise any different questions of safety or effectiveness as confirmed through non-clinical testing.

# Non-Clinical and/or Clinical Test Summary & Conclusions

The testing performed for the Nalu Neurostimulation System was developed in accordance with Nalu Medical, Inc. (Nalu)'s Quality System, including Design Control and Risk Management, per ISO 14971: 2019-12. Design Controls apply to all medical devices manufactured by Nalu in accordance with ISO 13485:2016 Medical devices - Quality management systems -Requirements for regulatory purposes, 21 CFR Part 820.

The testing performed consisted of the following:

• Verification and Validation Testing for second-generation Therapy Disc (TD2) System, including the following:

- . EMC testing in accordance with 60601-1 Edition 3.2 2020-08, 60601-1-2 Edition 4.0 2014-02, 60601-1-2 Edition 4.1 2020-09, 60601-1-6 Edition 3.2 2020-07, 60601-1-11 Edition 2.1 2020-07
- Packaging Validation in accordance with ISTA 3A 2018
- Biocompatibility testing in accordance with ISO 10993-1:2018
- Software testing in accordance with IEC 62304 Edition 1.1 2015-06, Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff published on June 14, 2023, and General Principles of Software Validation, Guidance for Industry and FDA Staff published on January 11, 2002.
- . Formative & Summative Usability Testing for TD2 System, in accordance with 62366-1 Edition 1.1 2020-06

No clinical testing was performed.

Testing demonstrated that the Nalu Neurostimulation System has been verified to perform in accordance with its product specifications, in support of its intended use.