VERMED A10021 RESTING EKG TAB ELECTRODE

K030073 · Vermont Medical, Inc. · DRX · Mar 28, 2003 · Cardiovascular

Device Facts

• Record ID: K030073
• Device Name: VERMED A10021 RESTING EKG TAB ELECTRODE
• Applicant: Vermont Medical, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures. This electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.

Device Story

Vermed A10021 is a single-use, disposable resting EKG electrode. Device applied to patient skin by clinician to acquire cardiac electrical signals for resting EKG evaluation. Electrodes facilitate signal conduction from patient to EKG monitoring equipment. Intended for infant, pediatric, and adult populations; maximum wear time 1 hour. After use, electrode is discarded. Device aids clinicians in obtaining diagnostic cardiac data for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, disposable resting EKG electrode. Designed for short-term (up to 1 hour) skin contact. Class II device (21 CFR 870.2360).

Indications for Use

Indicated for infant, pediatric, and adult patients undergoing resting EKG cardiac evaluation procedures. Maximum duration of use is 1 hour. Single-use disposable device.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Vermont Medical, Inc. c/o Mr. Marc Fillion Regulatory Compliance Manager Industrial Park Bellows Falls, Vermont 05101

Re: K030073

Trade Name: Vermed A10021 "Resting EKG Tab Electrode" Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: February 13, 2003 Received: February 28, 2003

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

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Page 2 - Mr. Marc Fillion

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); 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). You may obtain other general information on your responsibilities under the Act 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 vours,

K. Oahtlu
R. Zuber, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use Statement

510(k) K030073 Number (if known) Vermed A10021 "Resting EKG Electrodes" Device Name The Vermed A10021, is designed to be a single use disposable Indications electrode for resting EKG cardiac evaluation procedures. This for Use electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.

Kelle TM

510(k) Numbe

Prescription Use ✓