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 for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral 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. The Nalu System is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Disc, and Clinician Programmer and Remote Control.

AI/ML Overview

This document describes a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. The submission aims to establish substantial equivalence to a previously cleared predicate device (K183579), primarily focusing on an update to the device's Magnetic Resonance (MR) Conditional Labeling to include full body scans.

Based on the provided text, there is no acceptance criteria table or specific study performance data for a device meeting acceptance criteria in the traditional sense of an AI/ML model for diagnostic or predictive purposes. This document is a regulatory submission for a physical medical device (implantable neurostimulator) and its associated external components and software, not an AI/ML diagnostic software. The "performance" discussed here relates to the safety and functionality of the device itself, particularly its compatibility with MRI, rather than the accuracy of a diagnostic algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's "performance" as presented in the context of this 510(k) submission, specifically concerning the MRI compatibility, as this is the primary change necessitating the resubmission.

Summary of Acceptance Criteria and Device (MRI) Performance:

Since this is not an AI/ML diagnostic device, the "acceptance criteria" are not framed in terms of metrics like accuracy, sensitivity, or specificity. Instead, they are related to established safety standards for medical devices, particularly regarding MRI compatibility. The "device performance" refers to the results of testing performed to ensure these safety standards are met.

1. Table of Acceptance Criteria and Reported Device Performance (Focusing on MRI Compatibility):

Acceptance Criteria Category	Specific Criteria (Implicitly based on standards)	Reported Device Performance / Assessment
Magnetic Resonance (MR) Safety and Compatibility for Full Body Scans	Conformance to MR Conditional Labeling for full body scans.	Testing included in this submission demonstrates the safety and compatibility of the Nalu System for PNS in the Magnetic Resonance (MR) Environment for full body.
Magnetically Induced Displacement Force	Meet limits defined in ASTM F2052-15	Testing performed to standard.
Magnetically Induced Torque	Meet limits defined in ASTM F2213-17	Testing performed to standard.
MR Image Artifacts	Meet limits defined in ASTM F2119-2013	Testing performed to standard.
Safety of Active Implantable Medical Device in MRI	Conformance to ISO/TS 10974	Testing performed to standard.
General Device Safety and Performance	Conformance to ISO 14708 (Parts 1 & 3)	Testing performed to standard.
Design Controls	Adherence to 21 CFR 820.30	Nalu follows these procedures.
Risk Management	Adherence to ISO 14971	Nalu follows these procedures.
Quality Management System	Adherence to ISO 13485:2016	Nalu follows these procedures.
Biocompatibility	Demonstrated through testing.	Testing performed.
Sterilization	Demonstrated through testing.	Testing performed.
Human Factors and Usability	Demonstrated through testing.	Testing performed.
Functional Specification	Device meets user needs.	Validation and performance testing demonstrate this.
Substantial Equivalence	Identical indications for use, performance, and technological characteristics to predicate.	Stated as "identical" and "no differences that would impact safety or effectiveness." The only noted difference is the updated MR Conditional Labeling, which is supported by new testing.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: The document does not specify the sample sizes used for the engineering tests (e.g., number of devices tested for MRI compatibility, displacement, torque, or artifacts). These are typically bench tests on physical units, not clinical data sets.
Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based, non-clinical performance and bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable. This is not a study assessing the performance of a diagnostic algorithm where expert ground truth is established for medical images. The "ground truth" for this device's performance relies on engineering measurements and adherence to international and national standards (e.g., ISO, ASTM) for device safety and functionality.

4. Adjudication Method for the Test Set:

Not Applicable. As there are no human readers or diagnostic interpretations involved in the "test set" (which consists of physical device tests), no adjudication method is necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is typically done for diagnostic imaging devices or AI tools that assist human readers. This submission is for an implantable neurostimulation system, not a diagnostic imaging or AI assistance tool.

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

Not Applicable. There is no "algorithm only" performance being evaluated in this submission in the context of diagnostic AI. The device's functionality (e.g., electrical stimulation parameters) and safety (e.g., MRI compatibility) are evaluated.

7. The Type of Ground Truth Used:

The "ground truth" for the device's safety and performance is established through adherence to recognized international and national consensus standards (e.g., ISO/TS 10974, ISO 14708, ASTM F2052-15, ASTM F2213-17, ASTM F2119-2013) and engineering verification and validation testing. It is not based on expert consensus on medical image interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. (See point 8).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

August 21, 2024

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

Re: K232415

Trade/Device Name: Nalu Neurostimulation Kit (Integrated 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40cm/60cm/ 60cm Trial/ Extension Lead Kits, Patient Kits and Miscellaneous Replacement Kits Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: April 24, 2024 Received: April 24, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lauren E. Woodard -S

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

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Enclosure

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Indications for Use

510(k) Number (if known) K232415

Device Name

Nalu Neurostimulation System for Peripheral Nerve Stimulation

Indications for Use (Describe)

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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Submission Sponsor

Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Chelsea Gutierrez, Vice President of Regulatory Affairs and Quality Assurance

Date Prepared: May 15, 2024

Device Names and Classification

Device Identification
510(k) Number	K232415
Trade/Proprietary Name	Nalu Neurostimulation System for Peripheral Nerve Stimulation
Common/Usual Name	Peripheral Nerve Stimulator
Product Code	GZF; Stimulator, peripheral nerve, implanted (Pain Relief)
Regulation Number	21 CFR§882.5870; Implanted peripheral nerve stimulator for pain relief
Class	Class II
Neurology	Neurology

Predicate/Reference Devices

Predicate Device: Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
. Reference Device: Nalu Neurostimulation System, 4 Contact PNS System (K191435)
Reference Device: Nalu Neurostimulation System for Spinal Cord Stimulation (K202274)

Device Description

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1.	Nalu ImplantablePulse Generator	The implantable pulse generator (IPG), also referred to as the ImplantableNeurostimulator (INS), provides electrical stimulation pulses that are transmittedthrough the leads to the desired peripheral nerve. The IPG is available in two differentimplant architectures: an "integrated" system with pre-attached leads and a "ported"system where leads may be attached, via connector ports. In addition, both of theseversions are available in single or dual lead configurations. The hermetic IPG housingincludes a ceramic enclosure and a feedthrough connected internally to a printedcircuit board assembly. Wires leaving the IPG are encapsulated in polyurethane and asilicone over mold forms the final biocompatible surface of the IPG for direct patienttissue contact.
2.	Leads	Leads are implantable and are designed to deliver electrical pulses to the peripheralnerve via an array of eight cylindrical electrodes at the distal end. Leads may beintegrated with or connected to the IPG. Both Trial and Permanent Implant leads areavailable for use. The leads use polyurethane insulation with Pt/Ir electrodes. The leadsmay be secured in place with the Nalu Lead Anchor.
3.	Surgical and TrialTools	Implantation of the Nalu IPG and lead components for Peripheral Nerve Stimulation(PNS) is performed via standard PNS surgical techniques. The desired implant locationis accessed via needle placement, followed by lead placement through an introducer.The leads are anchored and the IPG is placed in a subcutaneous pocket. Patientcontacting materials include medical grade stainless steel, thermoplastic elastomers,ABS, silicone, and Urethane.
4.	Externally wornTherapy Disc	Two types of Therapy Disc are available, which are also referred to as the External TrialStimulator (ETS) and the External Transmitter Module (ETM). One is to be used duringthe trial phase (Trial Therapy Disc or ETS), and one is to be used after permanent IPGimplantation (Therapy Disc or ETM). Both devices are worn by the patient using one ofthe Nalu-provided options. The Therapy Discs house a rechargeable lithium-ionbattery, and electronics including a microcontroller running software for therapycontrol, patient interaction and communication with Nalu's Clinician Programmer andRemote Control devices. The Therapy Disc used to power and command the implantdoes so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clipapplied to the skin or a belt/cuff worn over clothing.
5.	ClinicianProgrammer andRemote Control	A Clinician Programmer Application is provided to configure the Trial Therapy Disc andTherapy Disc devices during surgery and programming. A Patient Remote ControlApplication is available to provide the patient with a convenient secondary option tocontrol their system in addition to built-in controls on the Therapy Disc. The ClinicianProgramming Application runs on an Android tablet and communicates over a secureBluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. Theprogrammer is responsible for configuring the devices to deliver therapy according toclinician defined levels and patient preferences, and for managing patient and sessionrecords. The Patient Remote Control Application runs on iOS and Android platformsand offers basic control of the Trial Therapy Disc and Therapy Disc through a secureBluetooth Low Energy link. The controls include selecting between clinician-definedtherapy options (programs), turning stimulation on and off, and managing alerts.

The Nalu System has been previously cleared (K183579) by the FDA 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

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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.

Indications for Use

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

The Indications for Use for the predicate device and subject device are identical. Any differences in the specifications or performance between the devices do not raise any different questions of safety or effectiveness, as demonstrated by performance testing. Thus, the subject device is substantially equivalent to the predicate device.

Testing results included in this submission support the full body MR Conditional Labeling proposed in the instructions for use. There are no other significant differences from the predicate device in these characteristics that would raise different questions of safety or effectiveness.

The following tables compare the Nalu System to the predicate device with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Please refer to Table 1 for Substantial Equivalence Table – General and Implanted Components, Table 2 for Substantial Equivalence Table – External Components and Table 3 for Substantial Equivalence Table - Clinician Programmer and Remote Control.

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Table 1: Substantial Equivalence Table - General and Implanted Components
---------------------------------------------------------------------------	--	--	--

Device	Nalu Neurostimulation System for PeripheralNerve Stimulation (Subject Device)	Nalu Neurostimulation System for PeripheralNerve Stimulation(Predicate Device)	Analysis ofTechnologicalDifferences
510(k)	K232415	K183579	Different.
Product Code andClass	GZF, Class II	GZF, Class II	Same aspredicate.
Regulation Number	21 CFR §882.5870	21 CFR §882.5870	Same aspredicate.
Classification Name	Implanted peripheral nerve stimulator for painrelief.	Implanted peripheral nerve stimulator for painrelief.	Same aspredicate.
Intended Use	Stimulation of peripheral nerves for chronic,intractable pain	Stimulation of peripheral nerves for chronic,intractable pain	Same aspredicate.
Indications for Use	This system is indicated for pain management inadults who have severe intractable chronic pain ofperipheral nerve origin, as the sole mitigatingagent, or as an adjunct to other modes of therapyused in a multidisciplinary approach. The system isnot intended to treat pain in the craniofacialregion.The trial devices are solely used for trialstimulation (no longer than 30 days) to determineefficacy before recommendation for a permanent(long term) device.	This system is indicated for pain management inadults who have severe intractable chronic painof peripheral nerve origin, as the sole mitigatingagent, or as an adjunct to other modes oftherapy used in a multidisciplinary approach.The system is not intended to treat pain in thecraniofacial region.The trial devices are solely used for trial stimulation(no longer than 30 days) to determine efficacybefore recommendation for a permanent (longterm) device.	Same aspredicate.
Prescription Use	Yes	Yes	Same aspredicate.
Implant Site	Peripheral nerves, excluding craniofacial region	Peripheral nerves, excluding craniofacial region	Same aspredicate.
Environmental Use	Hospital, Home	Hospital, Home	Same aspredicate.
Intended Clinician	Orthopedic, Neurosurgeon, Anesthesiologist	Orthopedic, Neurosurgeon, Anesthesiologist	Same aspredicate.
Intended User	Physician, Layperson	Physician, Layperson	Same aspredicate.
Mode of Action	Radiofrequency (RF) wireless transmission ofenergy to produce stimulation at stimulatorelectrodes.	Radiofrequency (RF) wireless transmission ofenergy to produce stimulation at stimulatorelectrodes.	Same aspredicate.
Labeling	MR Conditional Labeling for Head and ExtremitiesFull BodyMR Conditional Labeling for Full Body	MR Conditional Labeling for Head and ExtremitiesFull BodyDo not use RF transmit body coil	Different thanpredicate.Testing included inthis submissiondemonstrates thesafety andcompatibility of the

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Substantial Equivalence Table - General and Implanted Components Nalu Neurostimulation System for Peripheral Analysis of Nalu Neurostimulation System for Peripheral Nerve Stimulation Device Technological Nerve Stimulation (Subject Device) Differences (Predicate Device) Nalu System for PNS in the Magnetic Resonance (MR) Environment for full body. IPG Dimensions Lead = 1.30 mm diameter Lead = 1.30 mm diameter Same as predicate. IPG = 28 x 11 x 4.9 mm IPG = 28 x 11 x 4.9 mm Housing Material Silicone and Pellethane 2363-55D Silicone and Pellethane 2363-55D Same as predicate. Implant Site Peripheral nerves, excluding craniofacial region Peripheral nerves, excluding craniofacial region Same as predicate. Same as Electrical Embedded receiver, flexible circuit board Embedded receiver, flexible circuit board Components predicate. Power Delivery Coupled receiver radio frequency transmission Coupled receiver radio frequency transmission Same as predicate. Lead Same as Electrode Material Platinum-iridium 90:10 Platinum-iridium 90:10 predicate. Insulation Body Pellethane 2363-55D Pellethane 2363-55D Same as Material predicate. Cable Features Multilumen tube Multilumen tube Same as predicate. Lead Length 40 cm, 60 cm 40 cm, 60 cm Same as predicate. Diameter 1.30 mm 1.30 mm Same as predicate. Electrode Array 52 mm 52 mm Same as Length predicate. No. of Electrodes 8 8 Same as (per lead) predicate. Individual Electrode 3.0 mm 3.0 mm Same as Length predicate. Electrode Spacing 4.0 mm 4.0 mm Same as predicate. 12.25 mm² Electrode Surface 12.25 mm² Same as Area predicate.

Table 1: Substantial Equivalence Table - General and Implanted Components

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Substantial Equivalence Table - General and Implanted Components
Device	Nalu Neurostimulation System for PeripheralNerve Stimulation (Subject Device)	Nalu Neurostimulation System for PeripheralNerve Stimulation(Predicate Device)	Analysis ofTechnologicalDifferences
Lead Extension	Lead extension available	Lead extension available	Same aspredicate.
Lead Anchor	Molded silicone anchor with Ti locking mechanism	Molded silicone anchor with Ti locking mechanism	Same aspredicate.
Configurations	Integrated and with Ports	Integrated and with Ports	Same aspredicate.
Sterilization	Ethylene Oxide	Ethylene Oxide	Same aspredicate.

Table 2: Substantial Equivalence Table – External Components

Substantial Equivalence Table - External Components
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Name	Therapy Disc and Trial Therapy Disc	Therapy Disc and Trial Therapy Disc	Same aspredicate.
Electronics	A printed circuit board (PCB) that generates RFpower with embedded waveform parametersettings and buttons for changing parametersettings as needed by the user	A printed circuit board (PCB) that generates RFpower with embedded waveform parametersettings and buttons for changing parametersettings as needed by the user	Same aspredicate.
User Interface	Integrated controls and indicators that allows theuser to turn the device on/off, increase ordecrease therapy levels, select from configuredtherapy profiles and monitor device status	Integrated controls and indicators that allows theuser to turn the device on/off, increase or decreasetherapy levels, select from configured therapyprofiles and monitor device status	Same aspredicate.
Antenna(Therapy Disc only)	Integrated antenna supporting 40.68 MHz powerand data transfer.	Integrated antenna supporting 40.68 MHz powerand data transfer.	Same aspredicate.
Wearing(Therapy Disc only)	Therapy Disc is positioned over Nalu IPG via twooptions:• Adhesive clip (hydrocolloid adhesive)• Elastic Belt/Cuff	Therapy Disc is positioned over Nalu IPG via twooptions:• Adhesive clip (hydrocolloid adhesive)• Elastic Belt/Cuff	Same aspredicate.
Size/Weight	Disc: ~1. 5 cm thick, 7. 5 cm diameterWeight: ~0.08 kg	Disc: ~1. 5 cm thick, 7. 5 cm diameterWeight: ~0.08 kg	Same aspredicate.
ExternallycontactingMaterials	Biocompatible PC ABS housing.Occasional contact to fingers (e.g., button use).Textile material of belt/cuff may be worn overclothing.Hydrocolloid adhesive applied to skin.	Biocompatible PC ABS housing.Occasional contact to fingers (e.g., button use).Textile material of belt/cuff may be worn overclothing.Hydrocolloid adhesive applied to skin.	Same aspredicate.

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Table 2: Substantial Equivalence Table – External Components

Substantial Equivalence Table - External Components
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Battery Charging	Electrically isolated cradle charger	Electrically isolated cradle charger	Same aspredicate.

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Table 3: Substantial Equivalence Table – Clinician Programmer and Remote Control

Substantial Equivalence Table - Clinician Programmer and Remote Control
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Clinician Programmer
Configuration	Software installed on a compatible Android tablet.	Software installed on a compatible Android tablet.	Same aspredicate.
Purpose	Allows healthcare provider to set desired therapylevels and device settings across Therapy Disc,Trial Therapy Disc, and Patient Remote Controldevices.	Allows healthcare provider to set desired therapylevels and device settings across Therapy Disc, TrialTherapy Disc, and Patient Remote Control devices.	Same aspredicate.
Communication	Secure Bluetooth to Therapy Disc, Trial TherapyDisc, and Patient Remote Control.	Secure Bluetooth to Therapy Disc, Trial TherapyDisc, and Patient Remote Control.	Same aspredicate.
Patient Remote Control
Patient RemoteControl	Software app installed on compatible mobiledevice (Android/iOS) providing wireless selectionamong preconfigured options and status readoutfor paired Therapy Disc and Trial Therapy Discdevices.	Software app installed on compatible mobile device(Android/iOS) providing wireless selection amongpreconfigured options and status readout forpaired Therapy Disc and Trial Therapy Disc devices.	Same aspredicate.

Table 4: Substantial Equivalence Table – Therapy

Substantial Equivalence Table - Therapy
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Pulse Frequency	2 Hz to 1500 Hz	2 Hz to 1500 Hz	Same aspredicate.
Pulse Width	12 to 2000 $μ$ s	12 to 1000 $μ$ s	No impact totherapy.Programmingchanges weremade as part ofthe softwareupdate (clearedunder K203547).
Current/VoltageRegulated	Current	Current	Same aspredicate.
Output Voltage(300 Ohms)	0 to 3.1 V	0 to 3.1 V	Same aspredicate.
Output Voltage(500 Ohms)	0 to 5.1 V	0 to 5.1 V	Same aspredicate.
Substantial Equivalence Table - Therapy
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Output Voltage(800 Ohms)	0 to 8.2 V	0 to 8.2 V	Same aspredicate.
Output Current(300 Ohms)	0 to 10.2 mA	0 to 10.2 mA	Same aspredicate.
Output Current(500 Ohms)	0 to 10.2 mA	0 to 10.2 mA	Same aspredicate.
Output Current(800 Ohms)	0 to 10.2 mA	0 to 10.2 mA	Same aspredicate.
Waveform	charge balanced (delayed) biphasic asymmetrical	charge balanced (delayed) biphasic asymmetrical	Same aspredicate.
Pulse Shape	Decaying Exponential	Decaying Exponential	Same aspredicate.
Maximum phasecharge (300 Ohms)	10.2 µC/pulse	10.2 µC/pulse	Same aspredicate.
Maximum phasecharge (500 Ohms)	10.2 µC/pulse	10.2 µC/pulse	Same aspredicate.
Maximum phasecharge (800 Ohms)	10.2 µC/pulse	10.2 µC/pulse	Same aspredicate.
Maximum chargedensity (300 Ohm)	83.3 µC/cm²	83.3 µC/cm²	Same aspredicate.
Maximum chargedensity (500 Ohm)	83.3 µC/cm²	83.3 µC/cm²	Same aspredicate.
Maximum chargedensity (800 Ohm)	83.3 µC/cm²	83.3 µC/cm²	Same aspredicate.
Maximum currentdensity (300 Ohm)	83.3 mA/cm²	83.3 mA/cm²	Same aspredicate.
Maximum currentdensity (500 Ohm)	83.3 mA/cm²	83.3 mA/cm²	Same aspredicate.
Maximum currentdensity (800 Ohm)	83.3 mA/cm²	83.3 mA/cm²	Same aspredicate.
Net Charge	0 µC	0 µC	Same aspredicate.
Average PhasePower (300 Ohms)	0.031 W/phase	0.031 W/phase	Same aspredicate.
Average PhasePower (500 Ohms)	0.052 W/phase	0.052 W/phase	Same aspredicate.
Average PhasePower (800 Ohms)	0.083 W/phase	0.083 W/phase	Same aspredicate.
Average Phase	0.25 W/cm²/phase	0.25 W/cm²/phase	Same as
Substantial Equivalence Table - Therapy
Device	Nalu Neurostimulation System (Subject Device)	Nalu Neurostimulation System for PNS(Predicate Device)	Analysis ofTechnologicalDifferences
Power density (300Ohms)			predicate.
Average PhasePower density (500Ohms)	0.51 W/cm2/phase	0.51 W/cm2/phase	Same aspredicate.
Average PhasePower density (800Ohms)	0.55 W/cm2/phase	0.55 W/cm2/phase	Same aspredicate.
Pulse DeliveryMode	Continuous	Continuous	Same aspredicate.
Current Pathoptions	Bipolar	Bipolar	Same aspredicate.
Program Cycle	Cycle through programs	Cycle through programs	Same aspredicate.
Pulse Pattern(advancedprogramming)	Fine tuning of pulse patterns (On/Off; If On, spansfrom 12 μs to 1000 μs)	Fine tuning of pulse patterns (On/Off; If On, spansfrom 12 μs to 1000 μs)	Same aspredicate.
Dosage Time(advancedprogramming)	Allows for stimulation to be applied in periodicdoses (On/Off; If On, spans from 1 ms to 25 ms)	Allows for stimulation to be applied in periodicdoses (On/Off; If On, spans from 1 ms to 25 ms)	Same aspredicate.
Daily Therapy Time	Limits the number of hours in a day thatstimulation may be used (Seconds to hours)	Limits the number of hours in a day that stimulationmay be used (Seconds to hours)	Same aspredicate.
Transmit Frequency	40.68 MHz	40.68 MHz	Same aspredicate.

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Technological Characteristics

The subject device and the predicate device (K183579) share the same technological characteristics with regard to physical and therapeutic attributes. There are no differences that would impact safety or effectiveness.

Summary of Non-Clinical Performance Testing

Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu 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 Nalu System is designed and tested to ensure that it meets all applicable standards and guidance documents. Bench testing includes design verification and validation, sterilization, 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 (K183579) except for the updated Magnetic Resonance testing remain applicable to the subject device of this 510(k).

The testing for the labeling changes proposed for the Nalu System includes the following test standards.

Standard Number	Title
ISO/TS 10974	Assessment of the safety of magnetic resonance imaging for patients with an activeimplantable medical device
ISO 14708	Implant for surgery – Active implantable medical devices – Part 1 and Part 3, Generalrequirements and Implantable neurostimulator
ASTM F2052-15	Standard Test Method for Measurement of Magnetically Induced Displacement Force onMedical Devices in the Magnetic Resonance Environment
ASTM F2213-17	Standard Test Method for Measurement of Magnetically Induced Torque on MedicalDevices in the Magnetic Resonance Environment
ASTM F2119-2013	Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

Table 5. Applicable Standards

Clinical Performance Data

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

Conclusion

The subject device of this 510(k) is substantially equivalent to the predicate device 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 were made to ensure the safety and effectiveness of the device.

Regulation Number and Section

§ 882.5870 Implanted peripheral nerve stimulator for pain relief.

(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).