SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

K081371 · Leonhard Lang GmbH · MKJ · Sep 24, 2008 · Cardiovascular

Device Facts

• Record ID: K081371
• Device Name: SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
• Applicant: Leonhard Lang GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.

Device Story

Self-adhesive, single-use, non-sterile pediatric multifunction electrodes; interface between patient skin and external defibrillator/monitor. Input: electrical signals for monitoring or energy delivery for defibrillation/pacing/cardioversion. Output: electrical therapy delivery to patient. Used in clinical settings by healthcare professionals. Electrodes feature DH03 conductive gel; compatible with various defibrillator models (Zoll, Medtronic, Philips, Welch Allyn) delivering max 100 joules. Facilitates cardiac rhythm management and resuscitation; benefits patient via reliable electrical contact for therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993. Performance testing conducted per ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003.

Technological Characteristics

Self-adhesive, single-use, non-sterile electrodes. Features DH03 conductive gel. Designed for compatibility with external defibrillators (max 100J). Complies with ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. Biocompatible per ISO 10993.

Indications for Use

Indicated for pediatric patients < 8 years of age or < 25 kg (55 lbs) requiring 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

• Hewlett Packard Multifunction Pediatric Defibrillation Electrodes (K992977)
• Leonhard Lang Skintact® Multifunction Electrodes with DH02 Gel (K072233)

Submission Summary (Full Text)

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KOf1371

SEP 2 4 2008

Archenweg 56 6020 Innsbruck

Leonhard Lang GmbH

## 510(k) Summary

SUBMITTER

Submitted on behalf of:

Company Name: Address:

Austria Telephone: ++ 43 / 512 / 33 4 25 7 Fax: ++ 43 / 512 / 39 22 10 Registration Number: 8020045 Owner/Operator Number: 8020045

by:

Elaine Duncan, MS.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: [phone] Fax: [phone]

Contact Person: Date prepared: Trade Name:

Skintact® Pediatric Multifunction Electrodes with DH03 Gel (and as also to be offered for sale under various private label tradename) Common Name: Defibrillation Electrodes Classification Name: Dc-defibrillator, low-energy, (including paddles) Regulation: Defibrillators, Automatic, External, 21 CFR & 870.5310 Regulatory Class This device is Class III Device Panel and Product Code: 74 Cardiovascular, MKJ Reason for 510(k) Submission: new device

Elaine Duncan

May 12, 2008

Substantial Equivalence: Skintact® Pediatric Multifunction Electrodes with DH03 Gel are substantially equivalent to the stated predicate devices:

K992977 Hewlett Packard Multifunction Pediatric Defibrillation Electrodes

Leonhard Lang Skintact® Multifunction Electrodes with DH02 Gel available with different K072233 connectors compatible with different devices

Description of device: All Skintact® Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pediatric Multifunction Electrodes with DH03 Gel are composed of the same materials as the predicate device K073322 by Leonhard Lang except the modified DH03 Gel (made by Leonhard Lang).

Indications for use: Skintact® Pediatric Multifunction Elcctrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medironic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.

Basis for Equivalence - performance testing: Biocompatibility testing was conducted and passed ISO 10993 for intact skin. The performance data of Skintact® Pediatric Multifunction Electrodes with DH03 Gel and the predicate device (K072233) met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. The introduction of the Skintact® Pediatric Multifunction Electrodes (and as also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and the Skintact® Pediatric Multifunction Electrodes with DH03 Gel are substantially cquivalent to the predicate devices K992977 and K072233.

Traditional 510(k): Skintact® Pediatric Multifunction Electrodes with DH03 Gel

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the department's name. The department's name is arranged in a circular fashion around the caduceus. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Leonhard Lang, GmbH c/o Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082

Re: K081371

Trade/Device Name: Skintact® Pediatric Multifunction Electrodes with DH03 Gel Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ Dated: September 18, 2008 Received: September 22, 2008

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours.

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® Pediatric Multifunction Electrodes with DH03 Gel

Indications For Use:

Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators: Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) 11

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qmal

inn of Cardiovascular Devices

KORISTI 510(k) Number