SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21

K041883 · Leonhard Lang GmbH · MKJ · Sep 7, 2004 · Cardiovascular

Device Facts

• Record ID: K041883
• Device Name: SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
• Applicant: Leonhard Lang GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Skintact® Multifunction Electrodes are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single-use only.

Device Story

Skintact Multifunction Electrodes are self-adhesive, single-use, non-sterile disposable electrodes; used for external defibrillation, pacing, monitoring, and cardioversion. Device consists of foam backing, laminated metallic substrate, and conductive adhesive gel (DH 02). Electrodes are applied to patient skin; interface with monophasic and biphasic defibrillators to deliver electrical therapy or acquire ECG signals. Used by clinicians in clinical settings. Benefits include reliable electrical contact for life-saving cardiac interventions. Packaged in pairs with color-coded cabling in aluminized, heat-sealed pouches.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Performance testing conducted per internationally recognized standards for defibrillation electrodes, confirming compliance with specifications for active gel area (min 82 cm²) and total area (min 164 cm²). Accelerated aging studies confirmed 24-month shelf-life.

Technological Characteristics

Foam backing; laminated metallic substrate; conductive adhesive gel (DH 02). Self-adhesive, single-use, non-sterile. Dimensions meet standard requirements for adult/pediatric (>8 years) defibrillation and pacing. Compatible with monophasic and biphasic defibrillators.

Indications for Use

Indicated for adults and children over 8 years for external defibrillation, pacing, monitoring, and cardioversion.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Predicate Devices

• Philips HeartStart Defibrillation Pads (model DP2) (K955628)

Submission Summary (Full Text)

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## 510(k) Summary

| Date Summary Prepared: | July 9, 2004 | |
|-------------------------------|-----------------------------------------------|-----------------------------------------------------------------|
| Submitter's name and address: | Company Name:<br>Address: | Leonhard Lang GmbH<br>Archenweg 56<br>6020 Innsbruck<br>Austria |
| | Telephone: | ++ 43 / 512 / 33 4 25 7 |
| | Fax: | ++ 43 / 512 / 39 22 10 |
| Contact Person: | Elaine Duncan, MS.M.E., RAC | |
| | President, Paladin Medical, Inc. | |
| | | PO Box 560 |
| | Stillwater, MN 55082 | |
| | Telephone: | 715-549-6035 |
| | Fax: | 715-549-5380 |
| Device Name | | |
| Proprietary Name: | Skintact® Multifunction Electrodes | |
| Common Name: | Defibrillation Electrodes | |
| Classification Name: | Electrocardiograph (multifunction) electrodes | |

Substantially Equivalent to: The Skintact® Multifunction Electrodes are substantially equivalent to the Philips HeartStart Defibrillation Pads (model DP2). Philips Medical Systems, formerly Heartstream, cleared the HeartStart Defibrillation Pads (model DP2) under K955628, a bundled submission including defibrillator and accessories.

Device Description: Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable clectrodes. Skintact® Multifunction Electrodes consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH 02. Several shapes and sizes are offered, in accordance with standards. Skintact® Multifunction Electrodes are packaged in pairs with color-coded cabling within watervapor-proof, heat-sealed, non-transparent, aluminized pouches.

Indication for Usc: The Skintact Multifunction Electrodes are for use on adults and children over 8 years for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Summary of Comparison and Testing to Demonstrate Equivalence: Biocompatibility tests in accordance with ISO 10993 have been performed on the hydrogel. The testing confirms that the gel is biocompatible and does not introduce any risks. Testing to evaluate the performance of the Skintacte Multifunction Electrodes in accordance with internationally recognized standards demonstrated that the performance of the Skintact Multifunction Electrodes meet specifications and are suitable for use with the monophasic and biphasic defibrillators. Skintact Multifunction Electrodes are packaged in the same packaging used by Leonhard Lang GmbH in many previously approved products with demonstrated 24 month shelf-life. In addition, the Skintact Multifunction Electrodes were tested in accelerated aging. confirming the shelf-life of 24 months for DH02 gel and materials. Skintact Multifunction Electrodes used for adult defibrillation (and children over 8 years) and pacing have a minimum active (gel) area of 82 cm² and the total area of the two electrodes is at least 164 cm2, thus meeting the standard requirements. Other comparisons demonstrated that the Skintact Multifunction Electrodes do not introduce new risks and are substantially equivalent to the legally marketed predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2004

Paladin Medical, Inc. c/o Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, MN 55082-0560

Re: K041883

Trade name: Skintact® Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 09, 2004 Received: July 12, 2004

Dear Ms. Duncan:

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.

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## Page 2 -- Elaine Duncan, M.S.M.E., RAC

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); 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 yours,

Neil RP Ogden

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

510(k) Number (if known):

Device Name: Skintact® Multifunction Electrodes

## Indications For Use:

The Skintact® Multifunction Electrodes are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single-use only.

Prescription Use __ V__ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Neil R.P.Ogden |
|--|----------------|
|--|----------------|

| | for B02 |
|--|---------|
|--|---------|

| vision Sign-Off) | |
|---------------------------------|--|
| ision of Cardiovascular Devices | |

| (k) Number | K041883 |
|------------|---------|
|------------|---------|

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