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.

Device Description

The Nalu Neurostimulation system is consisted of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, through the dura, to the desired location of the spinal cord site. The leads are implantable and designed to deliver electrical pulses to the spinal cord in the epidural space via an array of eight cylindrical electrodes at the distal end. The leads may be secured in place with the Nalu Lead Anchor. 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) is performed via standard SCS surgical tools and techniques, as described in (K183047).

AI/ML Overview

The provided text is a 510(k) Summary for the Nalu Neurostimulation System, which is an implanted spinal cord stimulator for pain relief. The document focuses on demonstrating substantial equivalence to a previously cleared device (K183047) and specifically addresses updated magnetic resonance imaging (MRI) conditional labeling for full-body scans.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) because it is a submission for a spinal cord stimulator, not an AI/imaging device with such metrics. Instead, the "acceptance criteria" here relate to demonstrating safety and effectiveness for a broader indication (full-body MRI scans) and substantial equivalence to the predicate device.

The reported device performance primarily focuses on the Magnetic Resonance (MR) Conditional Labeling. The previous predicate device (K183047) had MR Conditional Labeling only for local RF coils (head, foot/ankle, knee, or wrist). The current submission proposes an update to include full-body MR Conditional Labeling.

The acceptance criteria implicitly derive from the standards and guidance documents listed, ensuring that the device's behavior in an MRI environment (e.g., displacement force, magnetically induced torque, image artifacts) is safe and within established limits for full-body scans.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Intended Use & Indications	Substantially equivalent to predicate: "stimulation of the spinal cord for treatment of chronic, intractable pain" including full body pain.
Technological Characteristics	"All of the physical and therapeutic attributes... share the same technological characteristics and has no differences that would impact safety or effectiveness."
MRI Safety for Full Body	Nalu performed MRI testing on the standard horizontal MR bore system to support the safety of the RF body coil. Proposed an update to the MR Conditional Labeling with the full body scan.
Compliance with Standards	Device meets applicable standards and guidance documents, including ISO/TS 10974, ISO 14708, ASTM F2052-15, ASTM F2213-17, ASTM F2129-2013 (related to MRI safety).
Clinical Performance	Bench and non-clinical testing are sufficient; device is safe and effective as the predicate. Clinical performance data explicitly stated as not required.

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

The document does not specify a "test set" in the context of an imaging AI device with a dataset of patient images. The testing conducted was primarily nonclinical performance testing (bench testing) related to MRI safety and device functionality.

Sample Size: Not applicable in the typical sense of patient samples for an AI model. The testing involved physical devices or components. The number of hardware units tested for MRI compatibility is not specified.
Data Provenance: Not applicable in the geopolitical or retrospective/prospective sense. The data is generated from laboratory (bench) testing.

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

This information is not applicable to this 510(k) submission. Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluating medical images. This submission is for an implanted neurostimulation system, and the primary focus of the new data is on MRI compatibility for the physical device, not an interpretation of clinical findings by experts.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods are used to resolve discrepancies in expert ground truth labeling.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers provide interpretations, and the AI's impact on their performance is evaluated. This 510(k) is for a physical implantable device, and the new data concerns its safety in an MRI environment.

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

This concept is not applicable to this device. A spinal cord stimulator does not have an "algorithm-only" performance in the sense of an AI diagnostic tool. Its performance is its ability to deliver stimulation and its safety profile, which was assessed through bench testing.

7. The type of ground truth used

The "ground truth" for the nonclinical testing primarily refers to established engineering and medical device safety standards for:

MRI Compatibility: Defined by standards like ISO/TS 10974, ASTM F2052-15 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), and ASTM F2129-2013 (MR image artifacts). The "ground truth" is that the device must meet the safety limits defined by these standards when exposed to full-body MRI conditions.
Biocompatibility: Assessed to ensure the materials are safe for implantation.
Sterilization Validation: Ensures the device can be adequately sterilized.
Functional Specifications: The device must meet its intended operational parameters (e.g., stimulation delivery).

8. The sample size for the training set

This information is not applicable. The device is an implanted hardware system, not an AI model trained on a dataset.

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

This information is not applicable for the same reasons as point 8.

Summary

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November 9, 2020

Nalu Medical, Inc. Pauline Lieu, Ph.D. Regulatory Affairs Consultant 2320 Faraday Ave. Suite 100 Carlsbad, California 92009

Re: K202274

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 Dated: August 10, 2020 Received: August 11, 2020

Dear Dr. 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 probibitions 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 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

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801); medical device reporting (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 (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,

Pamela D. 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) K202274

Device Name

Nalu Neurostimulation System for SCS

Indications for Use (Describe)

For Spinal Cord Stimulation

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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510(k) Summary

K202274

1. 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: Aug. 10th, 2020

2. 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

3. Predicate Device:

Nalu Neurostimulation System for Spinal Cord Stimulation (K183047)

4. Device Description

The Nalu Neurostimulation system has been cleared by the FDA (K183047) for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or

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limbs including unilateral or bilateral pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 has been previously cleared by the FDA (K183047) with the magnetic resonance imaging (MRI) Conditional Labeling for the leads, anchor and implantable pulse generator which can be scanned safely with the local RF coils, including head, foot/ankle, knee, or wrist, as stated in the instructions for use. In this submission, Nalu performed MRI testing on the standard horizontal MR bore system to support the safety of the RF body coil. Nalu proposes an update to the MR Conditional Labeling with the full body scan as indicated in the proposed labeling update.

5. 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.

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6. Comparison with the Predicate Device:

Table 1. Nalu Neurostimulation System for Spinal Cord Stimulation (SCS)

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	Textile material of belt	Textile material of belt
Labeling	MR Conditional Labelingfor Head and Extremities	MR Conditional Labelingfor Head and Extremities	Same
	Full BodyDo not use RF transmitbody coil	Full bodyMR Conditional Labelingfor Full Body	Different butdoes not raisedifferentquestions ofsafety andeffectiveness

7. Technological Characteristics

All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate device (K183047) share the same technological characteristics and has no differences that would impact safety or effectiveness.

8. Summary of nonclinical 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. These procedures ensure that all designs are appropriately evaluated and tested. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. Bench testing includes design verification and validation, sterilization validation, and biocompatibility testing. Human factors and usability testing were performed on the device. 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. Therefore, test results from the predicate device (K183047) except for the updated Magnetic Resonance testing remain applicable to the subject device of this 510(k).

Table 2. Applicable Standards and Guidance Documents

The testing for the labeling changes proposed for the Nalu Neurostimulation System includes the following test standards and guidance:

Standard Number	Title
ISO/TS 10974	Assessment of the safety of magnetic resonance imaging forpatients with an active implantable medical device
ISO 14708	Implant for surgery – Active implantable medical devices – Part1 and Part 3, General requirements and Implantableneurostimulator

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ASTM F2052-15	Standard Test Method for Measurement of MagneticallyInduced Displacement Force on Medical Devices in theMagnetic Resonance Environment
ASTM F2213-17	Standard Test Method for Measurement of MagneticallyInduced Torque on Medical Devices in the Magnetic ResonanceEnvironment
ASTM F2129-2013	Standard Test Method for Evaluation of MR Image Artifactsfrom Passive Implants

9. Clinical performance data

Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is safe and effective as the predicate device.

10. Conclusions

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. Nalu performed testing to support the full body MR scan and the proposed changes in the instructions for use to ensure the safety and effectiveness of the device.

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).

Device	Nalu NeurostimulationSystem (PredicateDevice: K183047)	Nalu NeurostimulationSystem (SubjectDevice)	Analysis ofTechnologicalDifferences
Trade Name	Nalu NeurostimulationSystem	Nalu NeurostimulationSystem	Same
Manufacturer	Nalu Medical, Inc.	Nalu Medical, Inc.	Same
Intended Use	The NaluNeurostimulationsystem is intended forthe stimulation of thespinal cord fortreatment of chronic,intractable pain.	The NaluNeurostimulationsystem is intended forthe stimulation of thespinal cord fortreatment of chronic,intractable pain.	Same
Indications forUse	This system is indicatedas the sole mitigatingagent, or as an adjunctto other modes oftherapy used in amultidisciplinaryapproach for chronic,intractable pain of thetrunk and/or limbs,including unilateral orbilateral pain.The trial devices aresolely used for trialstimulation (no longerthan 30 days) todetermine efficacybefore recommendationfor a permanent (longterm) device.	This system is indicatedas the sole mitigatingagent, or as an adjunctto other modes oftherapy used in amultidisciplinaryapproach for chronic,intractable pain of thetrunk and/or limbs,including unilateral orbilateral pain.The trial devices aresolely used for trialstimulation (no longerthan 30 days) todetermine efficacybefore recommendationfor a permanent (longterm) device.	Same
Clinicalapplication	Treatment of chronic,intractable pain of thetrunk and/or limbs,including unilateral orbilateral pain	Treatment of chronic,intractable pain of thetrunk and/or limbs,including unilateral orbilateral pain	Same
PrescriptionUse	Yes	Yes	Same
Intended User	Physician, Layperson	Physician, Layperson	Same
Principle ofOperation	Stimulation of the spinalcord to providetherapeutic relief forchronic, intractable painof the trunk and/orlimbs includingunilateral or bilateralpain	Stimulation of the spinalcord to providetherapeutic relief forchronic, intractable painof the trunk and/orlimbs includingunilateral or bilateralpain	Same
Mode ofAction	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
Externallyworn devices	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 tocommunicate to TrialTherapy or Therapy Disc	Software tocommunicate to TrialTherapy or Therapy Disc	Same
PatientRemoteControl	Software to pair withTrial Therapy or TherapyDisc	Software to pair withTrial Therapy or TherapyDisc	Same
HumanFactors	Integrated controls andindicators that allowsthe user to turn thedevice on/off, increaseor decrease therapylevels, select fromconfigured therapyprofiles and monitordevice status	Integrated controls andindicators that allowsthe user to turn thedevice on/off, increaseor decrease therapylevels, select fromconfigured therapy	Same
ExternallyContactingMaterials	Clip adhesives applied toskinBiocompatible PC ABShousing	Clip adhesives applied toskinBiocompatible PC ABShousing	Same