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 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).

AI/ML Overview

The Nalu Neurostimulation System is a non-AI device, and the provided documentation is a 510(k) submission for substantial equivalence. Therefore, the questions related to AI/algorithm performance, ground truth, training sets, and expert adjudication are not applicable here.

The document discusses the Nalu Neurostimulation System, which is an implantable neurostimulation device for pain relief.

Here's the information extracted based on the provided text, focusing on the device's characteristics and the justification for substantial equivalence, which is the "study" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for substantial equivalence does not typically present a formal "acceptance criteria table" in the same way clinical trials for new devices might. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" in this context refers to the device's technical specifications and intended clinical outcomes, which are asserted to be equivalent to the predicate.

For the Nalu Neurostimulation System (Subject Device), the performance is demonstrated by its substantial equivalence to the predicate and reference devices (K183047, K183579, K191435). The key "acceptance criteria" here implicitly are that the device meets the same safety and effectiveness profiles as the predicate.

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a 510(k) premarket notification for substantial equivalence. The core of this "study" is a comparison to predicate and reference devices, along with performance testing.

Justification: The submission asserts that the subject device is substantially equivalent to the predicate (Nalu Neurostimulation System for SCS, K183047) and reference devices (Nalu Neurostimulation System for PNS, K183579 and K191435) because:
- They are identical with regard to indications for use, performance, and technological characteristics, except for the increased service life of the IPG and the re-usable nature of the Therapy Disc.
- "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."
- Risk analysis of the proposed changes (extended IPG service life, reusable Therapy disc) did not raise any questions of safety and effectiveness.
- Performance testing was conducted by Nalu Medical, Inc. to support the safety and performance, adhering to 21 CFR 820.30, ISO 14971, and ISO 13485:2016. The test results from the predicate device are considered applicable to the subject device for unchanged aspects.

2. Sample size used for the test set and the data provenance

The document does not specify a clinical "test set" in the traditional sense of a clinical trial with a defined patient sample size. This is a 510(k) submission based on substantial equivalence, not a new clinical efficacy study. The "test set" for performance is described as "a range of testing to gather data supporting the safety and performance," including:

No specific patient sample size is mentioned. The comparison is largely based on technical specifications and existing cleared devices.
Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing mentioned appears to be primarily bench testing and engineering validation (e.g., meeting standards like ISO 14971, ISO 13485) rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is not a study assessing diagnostic accuracy or involving human interpretation of data for ground truth establishment. It's a review of a neurostimulation device for chronic pain based on its technical features and equivalence to previously cleared devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not applicable to a 510(k) submission for a non-AI neurostimulation device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device does not involve AI or human "readers" assessing cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A. Ground truth in the context of diagnostic performance is not relevant here. The "ground truth" for this submission is established through adherence to standards, engineering validation, and comparison to the known safety and efficacy profile of predicate devices.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

N/A. This is not an AI/ML device that requires a training set.

Summary

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

K201618

Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92009 Phone: (760) 448-2360 Fax: (760) 448-2377 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 (PainRelief)
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, PeripheralNerve 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

Indications for Use

Spinal Cord Stimulation (SCS)

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)

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

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 NeurostimulationSystem (ReferenceDevices: K183579,K191435)	Nalu NeurostimulationSystem (Subject Device)	Analysis ofTechnologicalDifferences
Trade Name	Nalu NeurostimulationSystem	Nalu NeurostimulationSystem	Same
Manufacturer	Nalu Medical, Inc.	Nalu Medical, Inc.	Same
Intended Use	The NaluNeurostimulation systemis intended for thestimulation of theperipheral nerve fortreatment of chronic,intractable pain.	The NaluNeurostimulation systemis intended for thestimulation of theperipheral nerve fortreatment of chronic,intractable pain.	Same
Indications forUse	This system is indicatedfor pain management inadults who have severeintractable chronic painof peripheral nerveorigin, as the solemitigating agent, or as anadjunct to other modesof therapy used in amultidisciplinaryapproach. The system isnot intended to treatpain in the craniofacialregion.The trial devices aresolely used for trialstimulation (no longerthan 30 days) todetermine efficacy beforerecommendation for apermanent (long term)device.	This system is indicatedfor pain management inadults who have severeintractable chronic painof peripheral nerveorigin, as the solemitigating agent, or as anadjunct to other modesof therapy used in amultidisciplinaryapproach. The system isnot intended to treatpain in the craniofacialregion.The trial devices aresolely used for trialstimulation (no longerthan 30 days) todetermine efficacybefore recommendationfor a permanent (longterm) device.	Same
Clinicalapplication	Treatment of chronicperipheral nerve pain	Treatment of chronicperipheral nerve pain	Same
Prescription Use	Yes	Yes	Same
Intended User	Physician, Layperson	Physician, Layperson	Same
Device	Nalu NeurostimulationSystem (ReferenceDevices: K183579,K191435)	Nalu NeurostimulationSystem (Subject Device)	Analysis ofTechnologicalDifferences
Principle ofOperation	Stimulation of theperipheral nerve toprovide therapeutic relieffor chronic pain	Stimulation of theperipheral nerve toprovide therapeuticrelief for chronic pain	Same
Mode of Action	RF wireless transmissionof energy to deliverstimulation at stimulatorelectrodes	RF wireless transmissionof energy to deliverstimulation at stimulatorelectrodes	Same
ImplantNeurostimulator	Nalu IPG 27.7 mm x 9.3mm x 4.2 mm	Nalu IPG 27.7 mm x 9.3mm x 4.2 mm	Same
Lead	40 cm, 60 cm; Platinum-iridium 90:10;Multilumen tube	40 cm, 60 cm; Platinum-iridium 90:10;Multilumen tube	Same
	25 cm, 40 cm Platinum-iridium 90:10, Coiledwires	25 cm, 40 cm Platinum-iridium 90:10, Coiledwires
Externally worndevices	Trial Therapy Disc andTherapy Disc	Trial Therapy Disc andTherapy Disc	Same
Electronics	A printed circuit board(PCB) that generates RFpower with embeddedwaveform parametersettings and buttons forchanging parametersettings	A printed circuit board(PCB) that generates RFpower with embeddedwaveform parametersettings and buttons forchanging parametersettings	Same
ClinicianProgrammer	Software to communicateto Trial Therapy orTherapy Disc	Software tocommunicate to TrialTherapy or Therapy Disc	Same
Patient RemoteControl	Software to pair withTrial Therapy or TherapyDisc	Software to pair withTrial Therapy or TherapyDisc	Same
Human Factors	Integrated controls andindicators that allows theuser to turn the deviceon/off, increase ordecrease therapy levels,select from configuredtherapy profiles andmonitor device status	Integrated controls andindicators that allows theuser to turn the deviceon/off, increase ordecrease therapy levels,select from configuredtherapy profiles andmonitor device status	Same
ExternallyContactingMaterials	Hydrocolloid adhesiveapplied to skin	Hydrocolloid adhesiveapplied to skin	Same
Device	Nalu NeurostimulationSystem (ReferenceDevices: K183579,K191435)	Nalu NeurostimulationSystem (Subject Device)	Analysis ofTechnologicalDifferences
	Biocompatible PC ABShousing	Biocompatible PC ABShousing
	Textile material of belt	Textile material of belt
Labeling	Implantable PulseGenerator:The service life of theImplantable PulseGenerator is 10 years.	Implantable PulseGenerator:The service life of theImplantable PulseGenerator 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.

Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

Feature / Criterion	Predicate Device (K183047) Performance (for SCS) / Ref. Devices (K183579, K191435) Performance (for PNS)	Subject Device Performance (Nalu Neurostimulation System)	Technological Differences
Intended Use	Stimulation of spinal cord/peripheral nerve for chronic, intractable pain.	Stimulation of spinal cord/peripheral nerve for chronic, intractable pain.	Same
Indications for Use (SCS)	As sole or adjunct agent for chronic, intractable trunk/limb pain (unilateral/bilateral). Trial use < 30 days.	As sole or adjunct agent for chronic, intractable trunk/limb pain (unilateral/bilateral). Trial use < 30 days.	Same
Indications for Use (PNS)	Pain management in adults severe intractable chronic pain of peripheral nerve origin (not craniofacial). Trial use < 30 days.	Pain management in adults severe intractable chronic pain of peripheral nerve origin (not craniofacial). Trial use < 30 days.	Same
Clinical Application	Treatment of chronic, intractable pain of trunk/limbs (SCS); chronic peripheral nerve pain (PNS).	Treatment of chronic, intractable pain of trunk/limbs (SCS); chronic peripheral nerve pain (PNS).	Same
Principle of Operation	Stimulation of spinal/peripheral nerve to provide therapeutic relief for chronic, intractable pain.	Stimulation of spinal/peripheral nerve to provide therapeutic relief for chronic, intractable pain.	Same
Mode of Action	RF wireless transmission of energy to deliver stimulation at stimulator electrodes.	RF wireless transmission of energy to deliver stimulation at stimulator electrodes.	Same
Implant Neurostimulator (IPG)	Nalu IPG 27.7 mm x 9.3 mm x 4.2 mm dimensions.	Nalu IPG 27.7 mm x 9.3 mm x 4.2 mm dimensions.	Same
Leads	40 cm, 60 cm; Platinum-iridium 90:10; Multilumen tube (SCS/PNS). Additional 25 cm, 40 cm Coiled wires (PNS).	40 cm, 60 cm; Platinum-iridium 90:10; Multilumen tube (SCS/PNS). Additional 25 cm, 40 cm Coiled wires (PNS).	Same
Externally Worn Devices	Trial Therapy Disc and Therapy Disc.	Trial Therapy Disc and Therapy Disc.	Same
Electronics	PCB that generates RF power with embedded waveform parameter settings.	PCB that generates RF power with embedded waveform parameter settings.	Same
Clinician Programmer	Software to communicate to Trial Therapy or Therapy Disc.	Software to communicate to Trial Therapy or Therapy Disc.	Same
Patient Remote Control	Software to pair with Trial Therapy or Therapy Disc.	Software to pair with Trial Therapy or Therapy Disc.	Same
Human Factors	Integrated controls/indicators: on/off, increase/decrease therapy, select profiles, monitor status.	Integrated controls/indicators: on/off, increase/decrease therapy, select profiles, monitor status.	Same
Externally Contacting Materials	Hydrocolloid adhesive, Biocompatible PC ABS housing, Textile material of belt.	Hydrocolloid adhesive, Biocompatible PC ABS housing, Textile material of belt.	Same
Implantable Pulse Generator Service Life	10 years	18 years	New (Increased service life)
Therapy Disc (for SCS)	Single use	Re-usable	New (Changed from single use to reusable)
Therapy Disc (for PNS)	Single use	Re-usable	New (Changed from single use to reusable)