(255 days)
No
The 510(k) summary describes a simple electrode for electrical stimulation and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device itself is an electrode that interfaces with a transcutaneous electrical nerve stimulator, which is the therapeutic device. The electrode's function is to conduct electricity from the stimulator to the skin, not to provide therapy directly.
No
Explanation: The device is an electrode for transcutaneous electrical nerve stimulation, it does not diagnose conditions but rather provides an interface for therapy.
No
The device description explicitly states it is an "Electrode" which is a physical component, not software. The performance studies also mention "electrical and mechanical tests" which are relevant to hardware.
Based on the provided information, the ASCEND Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as a conductive interface between the skin and a transcutaneous electrical nerve stimulator. This is a device that interacts with the body externally for therapeutic purposes (nerve stimulation), not for examining specimens from the body to provide diagnostic information.
- Device Description: The description reinforces its function as an electrically conductive interface for external use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ASCEND Electrode does not fit this description.
N/A
Intended Use / Indications for Use
The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.
Product codes (comma separated list FDA assigned to the subject device)
GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them, creating a sense of unity and movement.
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
1
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: | 882.1320 |
| GXY | |
| Cutaneous 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
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.
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.