SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

K103186 · Leonhard Lang GmbH · MKJ · Feb 8, 2011 · Cardiovascular

Device Facts

• Record ID: K103186
• Device Name: SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
• Applicant: Leonhard Lang GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non - sterile and single use only.

Device Story

Self-adhesive, non-sterile, single-use disposable electrodes; used for defibrillation, pacing, cardioversion, and monitoring. Feature "radiotransparent" design allowing electrodes to remain on patient during imaging procedures. Used in clinical settings; operated by healthcare professionals. Device interfaces with external defibrillator/monitor units to deliver electrical therapy or acquire cardiac signals. Radiotransparency facilitates patient movement through hospital departments without electrode removal.

Clinical Evidence

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

Technological Characteristics

Self-adhesive, single-use, radiotransparent electrodes. Compliant with ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. Biocompatible per ISO 10993.

Indications for Use

Indicated for adults and children >8 years old or >25 kg 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

• Leonhard Lang Skintact Multifunction Electrodes with DH02 Gel (K072233)
• PadPro 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes (K014209)

Submission Summary (Full Text)

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# SECTION 5

FEB 8 2011

## 510(K) SUMMARY

#### SUBMITTER

| Submitted on behalf of: | 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 |
| | Registration Number: | 8020045 |
| | Owner/Operator Number: | 8020045 |
| | by: | Elaine Duncan, MS.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 |
| | | Telephone: [phone]<br>Fax: [phone] |
| Contact Person: | Elaine Duncan (see address above) | |
| Date prepared: | October 28, 2010 | |
| Trade Name: | Skintact Radiotransparent Multifunction Electrodes<br>(and also to be offered for sale under various private label tradenames) | |
| 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, MLN | |

Reason for 510(k) Submission: additional feature "radiotransparent"

Substantial Eguivalence: Skintact Radiotransparent Multifunction Electrodes are substantially equivalent to the stated predicate devices:

Leonhard Lang Skintact Multifunction Electrodes with DH02 Gel K072233

available with different connectors compatible with different devices

PadPro 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes K014209

Description of device: All Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. Multifunction electrodes can be used for defibrillation, pacing, cardioversion and monitoring. These multifunction electrodes have the additional feature "radiotransparent" which allows these electrodes to stay on the patient when moving through different departments.

Indications for use: Skintact Radiotransparent Multifunction Electrodes are for use on adults and children over 8 years old or weighing more than 25 kg in external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Basis for Equivalence - performance testing: Biocompatibility testing was conducted and passed ISO 10993 for intact skin. The performance data of Skintact Radiotransparent Multifunction Electrodes and predicate device (K072233) met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. The introduction of Skintact Radiotransparent Multifunction Electrodes (and also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and Skintact Radiotransparent Multifunction Electrodes are substantially equivalent to the predicate devices K072233 and K014209.

Traditional 510(k): Skintact Radiotransparent Multifunction Electrodes

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 8 2011

Paladin Medical®, Inc. c/o Ms. Elaine Duncan President P.O. Box 560 Stillwater, MN 55082-0560

Re: K103186

Skintact® Radiotransparent Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Defibrillators, Automatic, External Regulatory Class: Class III Product Code: MKJ Dated: January 18, 2011 Received: January 20, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

. . . . .

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### Page 2 – Ms. Elaine Duncan

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

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Page 3-Ms. Elaine Duncan

#### Indications for Use

510(k) Number: K103186

Device Name: Skintact® Radiotransparent Multifunction Electrodes

Indications For Use: Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non - sterile and single use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. W.

(Division Sinn off) Division of Caralovascular Devices

510(k) Number K03186