The Nalu Neurostimulation 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 thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.

Device Description

The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.

AI/ML Overview

This 510(k) submission is for the Nalu Lead Blank, an accessory to the Nalu Neurostimulation System, not an AI device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to the provided text.

The document describes the device, its intended use, and establishes substantial equivalence to a predicate device (Nalu Neurostimulation System K183047) and a reference device (Stimwave Freedom 8 SCS System K170141).

The "studies" conducted are nonclinical performance tests, primarily bench testing, sterilization validation, and biocompatibility testing, along with human factors and usability testing (including a cadaver lab evaluation). Animal testing and clinical performance data were not considered necessary for this device's clearance.

Since this is not an AI/ML device, the following points of your request cannot be extracted from the provided text:

Table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.): Not applicable for a surgical accessory. The acceptance criteria relate to mechanical and biological safety, not diagnostic performance.
Sample size used for the test set and data provenance: While non-clinical tests were performed, the concept of a "test set" for AI evaluation isn't relevant here.
Number of experts used to establish ground truth: Not applicable. Ground truth for a surgical tool is its physical and biological performance attributes.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not a diagnostic AI device.
Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI sense. Ground truth here relates to engineering specifications and biological compatibility.
Sample size for the training set: Not applicable as there's no machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance / Performance Demonstration (based on provided text):

The Nalu Lead Blank underwent the following nonclinical performance testing to demonstrate its safety and effectiveness:

Bench Testing: Mechanical tests to show the device met target specifications over a range of operating and storage conditions.
Sterilization Validation: Ensures the device can be properly sterilized.
Biocompatibility Testing: Followed ISO 10993-1:2009 standards.
- Categorization: Implant tool for tissue/bone contact for a limited duration (≤ 24 hours).
- Tests Included: Cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity.
- Result: Biocompatibility was demonstrated.
Human Factors and Usability Testing: Performed on the device, including evaluation in a Surgical Validation cadaver lab.
Design Controls: Nalu followed 21 CFR 820.30, ISO 14971:2007, and ISO 13485:2016 for design control processes, ensuring proper planning, evaluation, and testing.

Conclusion stated by the sponsor: "The bench and non-clinical data support the safety of the device. The verification and validation demonstrated that the Nalu Lead Blank, which is part of the Nalu Neurostimulation System, performs as intended in the specified use conditions. The results do not raise new questions of safety and effectiveness."

The acceptance criteria for this device are implicitly tied to meeting the requirements of the standards and guidance documents listed (e.g., ISO 10993-1 for biocompatibility, mechanical test specifications, usability requirements), enabling the FDA to determine substantial equivalence to previously cleared predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows 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 11, 2019

Nalu Medical, Inc. Sunny Gill Senior Quality Assurance and Regulatory Affairs Specialist 2320 Faraday Avenue, Suite 100 Carlsbad, California 92008

Re: K190960

Trade/Device Name: Nalu Lead Blank (50cm) Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: April 11, 2019 Received: April 12, 2019

Dear Sunny Gill:

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.

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

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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 (OS) 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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190960

Device Name Nalu Lead Blank

Indications for Use (Describe)

The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5.1. Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Sunny Gill, Senior Quality Assurance and Regulatory Affairs Specialist

5.2. Date Prepared

July 11, 2019

Device Identification 5.3.

Trade/Proprietary Name: Nalu Lead Blank Common/Usual Name: Lead Blank Product Code: GZB Regulation number: 21 CFR 882.5880: Stimulator, spinal-cord, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology

5.4. Legally Marketed Predicate Device(s)

Nalu Neurostimulation System (K183047) by Nalu Medical, Inc.

5.5. Device Description

5.6. Indications for Use Statement

The Nalu Neurostimulation 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.

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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 Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.

The Indications for Use statement for the Nalu Lead Blank is identical to the predicate device. Both the subject and predicate devices have the same intended use, which is for the stimulation of the spinal cord for treatment of chronic, intractable pain.

5.7. Substantial Equivalence Discussion

The primary predicate for this submission is the Nalu Neurostimulation System that was most recently cleared in K183047. The Nalu System is intended for adult patients and contains a lead that has the same intended use as the lead blank. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank is used to create a path for the lead in the epidural space. With this submission, there is no change to the Nalu neurostimulator, leads, external components, or therapy.

For areas where slight differences occur between the Nalu Lead Blank and the primary predicate (K183047), substantial equivalence to a reference device in this same product code is demonstrated. The Stimwave Freedom 8 SCS System cleared in K170141 is used as the reference device since the design of the lead blank and its sole purpose is more aligned with the guide wire used as part of the Stimwave Freedom 8 SCS System. This reference device was used as part of the predicate history to the primary predicate in this submission. The history of the predicates is summarized in Table 5-1.

Device	510(k)	Predicate(s) used forclearance
Stimwave Freedom 8 SCS System	K170141	K162161
Nalu Neurostimulator System(Primary Predicate)	K183047	K170141

Table 5-1: Predicate history of the proposed primary predicate

The following table compares the Nalu Lead Blank to the predicate device and the reference 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. Summary information on the Nalu device, predicate device and reference device are provided in Table 5-2 below:

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	Nalu Lead Blank(Subject Device)	NaluNeurostimulationSystem(Primary Predicate)	Stimwave Freedom8 SCS system(K170141)(Reference Device)	Analysis ofTechnologicalDifferences fromPrimaryPredicate
510(k)	K190960	K183047	K170141	NA
Product Code andclass	GZB, Class II	Same	Same	Same
Regulation number	21 CFR 882.5880	Same	Same	Same
Classification name	Implanted spinalcord stimulator forpain relief.	Same	Same	Same
Intended Use	Stimulation of spinalcord for chronic,intractable pain	Same	Same	Same
Indications for Use	This system isindicated as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain.The trial devices aresolely used for trialstimulation (nolonger than 30 days)to determineefficacy beforerecommendation fora permanent (longterm) device.The Nalu Lead Blankis an optionalaccessory intendedto be used as asurgical aide toinsert the NaluNeurostimulationSystem Leads.	This system isindicated as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain.The trial devices aresolely used for trialstimulation (nolonger than 30 days)to determineefficacy beforerecommendationfor a permanent(long term) device.	The Freedom SpinalCord Stimulator(SCS) System isintended as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or lower limbs,including unilateralor bilateral pain.The trial devices aresolely used for trialstimulation (nolonger than 30 days)to determineefficacy beforerecommendationfor a permanent(long term) device.	Same
Prescription Use?	Yes	Same	Same	Same
Anatomical site	Epidural space	Same	Same	Same
	Nalu Lead Blank(Subject Device)	NaluNeurostimulationSystem(Primary Predicate)	Stimwave Freedom8 SCS system(K170141)(Reference Device)	Analysis ofTechnologicalDifferences fromPrimaryPredicate
Environmental Use	Hospital, Home	Same	Same	Same
Intended Clinician	Orthopedic,Neurosurgeon,Anesthesiologist	Same	Same	Same
Intended User	Physician, Layperson	Same	Same	Same

Table 5-2: Substantial Equivalence Table – Primary predicate and Reference Device Summary

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Physical characteristics of the implantable components of the Nalu Lead Blank, the lead within the Nalu Neurostimulation System (primary predicate) and the guide wire within the Stimwave reference device are compared in Table 5-3 below.

	Nalu Lead Blank(Subject Device)	Lead within NaluNeurostimulationSystem(K183047)(Primary Predicate)	Guide wire withinthe StimwaveFreedom 8 SCSsystem(K170141)(Reference Device)	Analysis ofTechnologicalDifferences fromPrimary Predicate
DeviceFunction	Create a pathway inthe epidural spacefor the lead tofollow	The stimulatingportion of theneurostimulatorthat is inserted intothe epidural spaceand creates apathway through itsinsertion.	Create a pathway inthe epidural spacefor the lead tofollow	Optional devicemeant to enhancethe surgicalexperiencecompared to theprimary predicate.Same as referencedevice.
Construction	Flexible coiled wire	Flexible multilumenextrusion consistingof 8 (1x19) leadwires and 8 contacts	Flexible coiled wire	Optional devicemeant to enhancethe surgicalexperiencecompared to theprimary predicate.Same as referencedevice
Material	Stainless steel	Multilumenextrusion made of55D Pellethane; leadwires made of35NLT-DFT-28%AG(ETFECOATED); andcontacts made of(90/10) PT/IR	Stainless steel	Optional devicemeant to enhancethe surgicalexperiencecompared to theprimary predicate.Same as referencedevice
Duration ofUse	Surgical procedure	Duration of long-term implant (>30days)	Surgical procedure	Optional devicemeant to enhancethe surgical

Table 5-3: Predicate and Reference Device comparison with the Nalu Lead Blank

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	Nalu Lead Blank(Subject Device)	Lead within NaluNeurostimulationSystem(K183047)(Primary Predicate)	Guide wire withinthe StimwaveFreedom 8 SCSsystem(K170141)(Reference Device)	Analysis ofTechnologicalDifferences fromPrimary Predicate
	Implant tool, limited(≤24 hrs)	Implant tool, limited(≤24 hrs)		experiencecompared to theprimary predicate.Same as referencedevice
Length	50 cm	40 cm, 60 cm	Unpublished	Differences do notaffect safety andeffectiveness ofintended use
Diameter	1.30 mm	1.30 mm	Unpublished	Differences do notaffect safety andeffectiveness ofintended use
Packaging	Tyvek and Mylarpouch	Tyvek and Mylarpouch	Unpublished	Same
SterilizationType	Ethylene Oxide	Same sterilizationsite and cycle	Ethylene Oxide	Same

All of the physical and therapeutic attributes for the Nalu Lead Blank are within or equivalent to the parameters seen in the predicate and reference devices. There are no significant differences in these characteristics that would raise new questions of safety or effectiveness. The information above supports the conclusion that the Nalu Lead Blank has the same intended use as the predicate and reference devices.

5.8. Nonclinical Performance Testing

Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Lead Blank for its intended use. Nalu followed the Design Controls section of 21 CFR 820.30, ISO 14971:2007, and ISO 13485:2016. These procedures ensured that all designs were appropriately planned, defined, evaluated, transferred to production, and ongoing changes are reviewed for impact on safety and effectiveness and appropriately evaluated and tested. The Nalu Lead Blank 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 was also performed on the device. Validation and performance testing demonstrate that the device acceptably meets user needs as reflected in the product requirements.

5.8.1 Applicable Standards and Guidance Documents
The testing for the Nalu Lead Blank includes the following test standards and guidance:

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Standard Number	Title
ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process
ISO 11070:2014	Sterile single-use intravascular introducers, dilators andguidewires
ISO 11135-1:2014	Sterilization of health-care products -- Ethylene oxide --Requirements for the development, validation and routinecontrol of a sterilization process for medical devices
ISO 11607-1:2006/Amd1:2014 and -2:2006/Amd1:2014	Packaging for terminally sterilized medical devices -- Part 1:Requirements for materials, sterile barrier systems andpackaging systems, Part 2: Validation requirements forforming, sealing and assembly processes
EN ISO 14971:2012	Medical devices -- Application of risk management tomedical devices
ISO 14971:2007
IEC 62366-1:2015	Medical Devices – Part 1: Application of usabilityengineering to medical devices
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devicesissued February 3, 2016

Table 5-4: Standards and Guidance Documents

5.8.2 Biocompatibility testing

The biocompatibility testing followed the International Standard ISO 10993-1: 2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," as well as Guidance for Industry and Food and Drug Administration Staff Document entitled "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued on: June 16, 2016.

Biocompatibility testing was based upon the categorization of the bodycontacting component and duration of the Nalu Lead Blank. The category was based upon the following classification, per the FDA guidance:

. implant tool for tissue/bone contact for a limited duration (≤ 24 hours)
Testing included: cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity. Biocompatibility was demonstrated.

5.8.3 Animal Testing

Animal Testing was not a necessary part of the verification and validation testing for the Nalu Lead Blank. Instead, usability of the Nalu Lead Blank was evaluated in a Surgical Validation cadaver lab.

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5.8.4 Summary of Nonclinical Performance Testing
Verification testing of the Nalu Lead Blank included mechanical tests to show that the device met its target specifications over a range of operating and storage conditions. Validation, performance, and usability testing demonstrated that the device met user needs as reflected in the functional specification.

5.9. Clinical Performance Data

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

5.10. Conclusions

The bench and non-clinical data support the safety of the device. The verification and validation demonstrated that the Nalu Lead Blank, which is part of the Nalu Neurostimulation System, performs as intended in the specified use conditions. The results do not raise new 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).