MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005

K021537 · Vermont Medical, Inc. · GXY · Mar 3, 2003 · Neurology

Device Facts

• Record ID: K021537
• Device Name: MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
• Applicant: Vermont Medical, Inc.
• Product Code: GXY · Neurology
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 can be used for Sleep Studies, surface EMG, NCS and EP. The A10005 electrode is provided in a NON-STERILE format only, and should be used on the surface of the skin.

Device Story

Multipurpose Neuroplus Electrode (Model A10005) is a cutaneous electrode; functions as a passive sensor to detect electrical signals from skin surface; used for sleep studies, surface EMG, NCS, and EP; operated by clinicians in clinical settings; provides signal acquisition for diagnostic monitoring; non-sterile; facilitates muscle activity measurement for diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous electrode; non-sterile; surface-applied; passive sensing component for electrical signal acquisition.

Indications for Use

Indicated for patients requiring surface measurement of muscle activity for sleep studies, surface EMG, nerve conduction studies (NCS), and evoked potential (EP) testing.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 3 2003

Vermont Medical, Inc. Marc Fillion Regulatory Compliance Manager Industrial Park Bellows Falls, Vermont 05101-0556

Re: K021537

Trade/Device Name: Multipurpose Neuroplus Electrode, Model A10005 Regulation Number: 883.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: December 2, 2002 Received: December 3, 2002

Dear Mr. Fillion:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 -- Mr. Marc Fillion

(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(on Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE VERMED NEUROPLUS DEVICES PRODUCT NO. A10005

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 can be used for Sleep Studies, surface EMG, NCS and EP.

The A10005 electrode is provided in a NON-STERILE format only, and should be used on the surface of the skin.

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________