SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES

K982521 · Leonhard Lang Co. · DRX · Oct 26, 1999 · Cardiovascular

Device Facts

• Record ID: K982521
• Device Name: SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
• Applicant: Leonhard Lang Co.
• Product Code: DRX · Cardiovascular
• Decision Date: Oct 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Skintact ECG electrodes are intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recordings. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

Device Story

Skintact ECG electrodes are disposable, non-sterile, self-adhesive sensors for ECG monitoring and diagnostic recording. Device consists of silver/silver chloride sensing element, stainless steel stud, and conductive gel on a carrier tape with pressure-sensitive medical-grade adhesive. Used in clinical settings by healthcare professionals to acquire electrical signals from patient skin for electrocardiographic procedures. Output is raw electrical signal transmitted to ECG monitoring equipment for physician interpretation. Benefits include reliable signal acquisition for patient surveillance and diagnosis.

Clinical Evidence

Bench testing only. Electrical performance verified against ANSI/AAMI EC12/1991 standards. Biocompatibility assessed per ISO 10993-1. Real-time shelf life studies conducted.

Technological Characteristics

Materials: silver/silver chloride sensing element, stainless steel stud, conductive gel, pressure-sensitive medical-grade adhesive. Form factor: disposable, self-adhesive electrode. Standards: ANSI/AAMI EC12/1991 (electrical performance, labeling, shelf life, packaging, safety), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recordings. For use on intact, uninjured skin only. Must be ordered by a physician.

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.

Predicate Devices

• Skintact AG Electrodes

Submission Summary (Full Text)

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OCT 26 1999

Summary ; 15. 510 (k)

长982521

Date:

Manufacturer :

Telephone: Fax :

Contact Person:

Device Trade Names:

Common Name:

Classification Name:

Regulatory Reference:

Predicate Device:

Description :

Intended Use:

October 29, 1997

Leonhard Lang GmbH Archenweg 56 A-6020 Innsbruck Austria

[phone] [phone]

Burrhus Lang, President

Skintact ECG Electrodes S&W ECG electrodes

Disposable ECG monitoring electrode

Electrocardiograph electrode

74 DRX

Skintact AG Electrodes

Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.

Skintact ECG electrodes are intended for use in general electrocardiographic procedures where ECG monitoring is

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## 1 1982521

Physical/Technical Comparison:

Performance Summary:

## Biocompatibility Testing:

Shelf Life:

deemed necessary and is ordered by a physician.

Skintact ECG electrodes are equivalent to the predicate device. Physical and technical characteristics, including, design, materials used, safety and efficacy characteristics and intended use of Skintact ECG electrodes and the predicate device are either identical or comparable.

The electrical performance of Skintact ECG electrodes meets the requirements of the voluntary standard ANSI/AAMI EC12/1991 "Disposable ECG Electrodes". In addition Skintact ECG electrodes meet the requirements of ANSI/AAMI EC12/1991 for labeling, shelf life, packaging and safety.

The biological safety of Skintact ECG electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The tests were selected on the basis of ISO 10993-1 "Biological Evaluation of Medical Devices - Partl: Guidance on selection of tests".

Data obtained in real time shelf life studies was reviewed and found to substantiate the claimed shelf life.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 26 1999

Leonhard Lang GmbH c/o Carole Stamp Third Party Official TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

K982521 Re: Skintact™ ECG Electrodes, S&W ECG Electrodes Regulatory Class: II (two) Product Code: DRX October 8, 1999 Dated: October 12, 1999 Received:

Dear Ms. Stamp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carole Stamp

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

VCAloteli

Witten, Ph.D., M.D. lia M. Actinq Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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10. Statement of Indications for Use

510(k) Number (if known):

Device Name: Skintact ECG electrodes

## Indications For Use:

Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recordings.

Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

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| Concurrence of CRRH, Office of Device Evaluation | |
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| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K183521 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |