The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

Device Description

The ASCEND Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a user's skin. It is intended to be disposable and for single person use. It is provided non-sterile.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a Class II medical device, the ASCEND Electrode. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that establishes acceptance criteria and proves the device meets them in the way a clinical trial or performance study would for a more complex device.

Based on the provided text, the following information can be extracted, but with significant limitations due to the nature of the document being a substantial equivalence submission for an electrode:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria for the ASCEND Electrode's performance. Instead, it states:
"Verification and performance testing demonstrated that the electrode met user needs as reflected in the functional specification." and "The ASCEND Electrode has the same technological characteristics as the predicate SENSUS Electrode that was validated with electrical and mechanical tests to show that the electrode met its target specifications over a range of operating and storage conditions."

However, no specific performance metrics or their acceptable ranges are listed. The focus is on demonstrating that it performs similarly to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "electrical and mechanical tests" and "verification and performance testing" but does not specify the sample size used for these tests. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). Given that it's a 510(k) for an electrode, these tests would typically be laboratory-based rather than involving human subjects for performance evaluation in the way a clinical study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the information provided. For an electrode, "ground truth" would typically relate to objective physical or electrical measurements, not expert interpretation of diagnostic images or clinical outcomes.

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

This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, which is not the case for the described testing of an electrode's physical properties.

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

This is not applicable. The device is an electrode, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable as the device is an electrode, not an algorithm.

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

For the non-clinical testing mentioned, the "ground truth" would be established through objective electrical and mechanical standards and specifications (e.g., conductivity measurements, adhesive strength tests, impedance measurements, biocompatibility standards). The document references "functional specification" directly.

8. The sample size for the training set

This is not applicable as the device is an electrode and does not involve machine learning or a "training set."

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

This is not applicable as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2014

NeuroMetrix, Inc. Mr. Rainer Maas Director of QA/RA 62 Fourth Ave. Waltham, MA 02451

Re: K140586

Trade/Device Name: ASCEND Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 18, 2014 Received: August 19, 2014

Dear Mr. Maas:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140586

Device Name ASCEND Electrode

Indications for Use (Describe)

The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary for ASCEND Electrode

SPONSOR

NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451 USA

Contact Person:	Rainer Maas
Telephone:	(781) 314-2781
Date Prepared:	March 6, 2014

DEVICE NAME

Proprietary Name:	ASCEND Electrode
Common/Usual Name:	Transcutaneous Electrical Nerve Stimulator Electrode
Classification Name:	882.1320GXYCutaneous Electrode

PREDICATE DEVICE

NeuroMetrix SENSUS Electrode (K121816)

INTENDED USE

The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

DEVICE DESCRIPTION

COMPARISON TO PREDICATE

The ASCEND Electrode has identical indications for use and technological characteristics as the cleared SENSUS Electrode (K121816). The only difference is that the ASCEND Electrode is labeled for overthe-counter use while SENSUS Electrode is labeled for prescription use. Many cutaneous electrodes intended for use with transcutaneous electrical nerve stimulators have been cleared by the FDA for overthe-counter use, e.g., the Axelgaard ValuTrode Neurostimulation Electrodes (K130987). Because the ASCEND Electrode has the same intended use and fundamental technology as these other electrodes, it is substantially equivalent to them.

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GUIDANCE DOCUMENT

The recommendations of the FDA's "Draft Guidance for Industry and Staff: Class II Special Controls Guidance Document: Cutaneous Electrode (April 5, 2010)" were taken into account in preparing this 510(k) submission. The draft guidance addresses requirements for cutaneous electrodes which are defined as "an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation." This definition includes electrodes intended for use with transcutaneous electrical nerve stimulators. NeuroMetrix believes that the ASCEND Electrode complies with the special controls as outlined in the draft guidance, thereby providing additional assurance of safe and effective use of the ASCEND Electrode.

NON-CLINICAL TESTING

The ASCEND Electrode has the same technological characteristics as the predicate SENSUS Electrode that was validated with electrical and mechanical tests to show that the electrode met its target specifications over a range of operating and storage conditions. Verification and performance testing demonstrated that the electrode met user needs as reflected in the functional specification.

The ASCEND Electrode conforms to the following voluntary standards:

· ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing.

CLINICAL TESTING

NeuroMetrix determined clinical testing was not required.

CONCLUSION

The ASCEND Electrode is substantially equivalent to the predicate SENSUS Electrode.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).