SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS

K072233 · Leonhard Lang GmbH · MKJ · Oct 5, 2007 · Cardiovascular

Device Facts

• Record ID: K072233
• Device Name: SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
• Applicant: Leonhard Lang GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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 consist of foam backing, laminated metallic substrate, and conductive DH02 gel; designed for external defibrillation, pacing, monitoring, and cardioversion. Device interfaces with various defibrillators via specific connectors. Used in clinical settings by healthcare professionals. Electrodes are non-sterile, single-use, and packaged in aluminized, water-vapor-proof pouches. Functionality relies on conductive gel to transmit electrical energy between defibrillator and patient skin. Benefits include compatibility with multiple defibrillator systems for emergency cardiac care.

Clinical Evidence

Bench testing only. Performance and safety testing conducted per ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. Biocompatibility testing (skin irritation and sensitization) performed; cytotoxicity data from previous submission (K041883) utilized.

Technological Characteristics

Materials: foam backing, laminated metallic substrate, conductive DH02 gel. Connectivity: various connectors for defibrillator compatibility. Packaging: water-vapor-proof, heat-sealed, non-transparent, aluminized pouches. Standards: ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003. Single-use, non-sterile.

Indications for Use

Indicated for adults and children over eight years old requiring external defibrillation, pacing, monitoring, or 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

• Skintact® Multifunction electrodes with DH02 Gel (K041883)

Submission Summary (Full Text)

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KO72233

# 510(k) Summary

| SUBMITTED ON BEHALF OF:<br>OCT 5 2007 | Company Name: | Leonhard Lang GmbH |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | Address: | Archenweg 56<br>6020 Innsbruck<br>Austria |
| | Telephone: | ++ 43 / 512 / 33 4 25 7 |
| | Fax: | ++ 43 / 512 / 39 22 10 |
| | By: | Elaine Duncan, MS.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 |
| | Telephone: | 715-549-6035 |
| | Fax: | 715-549-5380 |
| CONTACT PERSON:<br>DATE PREPARED: | Elaine Duncan<br>August 8, 2007 | |
| Trade Name: | Skintact® Multifunction Electrodes<br>with DH02 gel available with different connectors compatible with<br>different defibrillators | |
| Common Name:<br>Classification Name: | Defibrillation Electrodes<br>DC-defibrillator, low-energy, (including paddles) | |

#### Substantially equivalent to Predicate Device

Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are equivalent to Skintact® Multifunction electrodes with DH02 Gel (cleared in existing 510(k) K041883) There are no changes to the materials used in the construction. Test results are provided which show that this change does not introduce any new issues of safety and performance.

#### Device description

Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators (and as also to be offered for sale under various private label tradenames) consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH02 [all materials cleared in existing 510(k) K041883]. Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proof, heatsealed, non-transparent, aluminized pouches, non-sterile and single-use.

#### Indications for use

Skintact Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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.

#### Comparison of Characteristics

There are no technological or material differences between the The Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators and the predicate device.

#### Data Used in Determination of Substantial Equivalence

Special 510(k): Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators

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# 510(k) Summary-Continued

Bench testing demonstrated that the performance of the Skintact® Multifunction Electrodes with DH02 Gel available with different compatible with different defibrillators meets is specifications.

#### Summary of Testing

### Performance Testing:

Skintact Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators met the same requirements as those of the predicate. Performance and safety tests were conducted according to ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003 and were conducted by SGS (All test reports are available for access at: Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria).

All Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proofed, heat-sealed, non-transparent. aluminized pouches. Leonhard Lang has met requirements for 30 months shelf-life.

#### Biocompatibility testing:

All materials were cleared in 510(k) K041883: Results of updated testing for skin irritation and sensitization testing are included. (Cytoxicity tests were not repeated since previous submission. )

#### Conclusion

Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators does not introduce new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of overlapping human profiles, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 2007

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

Re: K072233

Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 6, 2007 Received: September 10, 2007

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 (sec 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 - Ms. Elain Duncan

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 (OS) 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/industry/support/index.html.

Sincerely vours.

Briminista for

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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510(k) Number (if known)

# Device Name: Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators

# Indications for Use:

Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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.

ಸ Prescription Use

OR

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Please Do Not Write Below This Line-Continue On Another Page If Necded) Concurrence of CDRH, Office of Device Evaluation (ODE)

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