Skintact, various other tradenames

K142803 · Leonhard Lang GmbH · MKJ · Dec 2, 2014 · Cardiovascular

Device Facts

• Record ID: K142803
• Device Name: Skintact, various other tradenames
• Applicant: Leonhard Lang GmbH
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Skintact® Multifunction Electrodes are passive, single-use, non-sterile disposable accessories for defibrillators; applied to intact skin. Device consists of backing material, conductive layer, and conductive adhesive gel. Electrodes interface with various defibrillator models via specific connectors to deliver electrical therapy or monitor cardiac signals. No active electronics, software, or firmware. Used in clinical settings by healthcare professionals for emergency treatment of cardiac arrest patients. Output is the delivery of defibrillation/pacing energy or transmission of ECG signals to the host defibrillator. Benefits include facilitating life-saving cardiac interventions.

Clinical Evidence

Bench testing only. Performance testing conducted per IEC 60601-2-4:2010 (basic safety and essential performance of cardiac defibrillators). Biocompatibility testing performed for materials with direct skin contact confirmed materials are biocompatible.

Technological Characteristics

Hydrogel polymeric self-adhesive electrode pads. Consists of backing material, conductive layer, and conductive adhesive gel. Passive device; no active electronics. Dimensions modified for enhanced total area; active area equivalent to predicate. Non-sterile, single-use. Tested per IEC 60601-2-4:2010.

Indications for Use

Indicated for adults and children weighing >25 kg requiring external defibrillation, pacing, monitoring, or cardioversion. Contraindicated for patients weighing ≤25 kg.

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 (K072233)

Reference Devices

• 9131 Defibrillation Electrodes, Cardiac Science Corporation (K082090)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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

December 2, 2014

Leonhard Lang Gmbh % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K142803

> Trade/Device Name: Skintact® Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: October 2, 2014 Received: October 3, 2014

Dear Elaine 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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Melissa A. Torres -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K142803

Device Name Skintact® Multifunction Electrodes

#### Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 10(K) SUMMA

This 510(k) summary has been prepared in accordance with the requirements of 21CFR 807.92:

# SUBMITTER:

## Submitted on behalf of:

| Company Name:<br>Address: | Leonhard Lang GmbH<br>Archenweg 56<br>6020 Innsbruck<br>Austria |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person:<br>Telephone:<br>Fax: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082<br>715-549-6035<br>715-549-5380 |
| Date prepared: | November 26, 2014 |
| Device Identification: | |
| TRADE NAME: | Skintact® Multifunction Electrodes<br>(and also to be offered for sale under various<br>private label tradenames) |
| COMMON NAME:<br>CLASSIFICATION NAME:<br>PRO CODE:<br>Regulation No.:<br>Classification: | Defibrillation Electrodes<br>DC-defibrillator, low-energy, (including paddles)<br>MKJ<br>21CFR 870.5310<br>Class III |
| SUBSTANTIALLY EQUIVALENT TO: | |
| K072233 | Skintact® Multifunction Electrodes with DH02 Gel |

ト available with different connectors compatible with different devices, Leonhard Lang GmbH, decision date: 10/05/2007 K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008

#### INDICATIONS FOR USE:

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

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# 510(k) Summary-Continued

#### DESCRIPTION of the DEVICE:

Skintact® Multifunction Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin. Skintact® Multifunction Electrodes are accessories to defibrillators. Skintact® Multifunction Electrodes are passive devices and do not contain active electronics, software or firmware.

Skintact® Multifunction Electrodes consist of a backing material, conductive layer and conductive adhesive gel. The Multifunction Electrodes are applied on a release liner. This is the same composition like used for devices approved in existing K072233.

The shape of the electrodes has been slightly modified in comparison with K072233. The difference in shape of electrodes is an enhanced total area, but the active area is equivalent like approved in existing K072233.

Also this submission adds additional models of multifunction electrodes compatible with additional models of defibrillators.

An additional type of packaging is offered. This type of packaging is substantially equivalent to reference device approved in existing 510(k) K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008.

## Substantial Equivalence Summary [21CFR 807.92(a) (6)]

Skintact® Multifunction Electrodes have the same indications for use as Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different devices approved in existing 510(k)s K072233. The indicated limitation of use on children is by age in K072233 but in this submission it is being changed to weight. Children may have variations in weight at the same age and weight is the more important characteristic for safe performance on children.

| Indications for Use | |
|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| K072233 | This submission |
| Skintact® Multifunction Electrodes<br>with DH02 Gel available with different<br>connectors compatible with different<br>defibrillators | Skintact® Multifunction Electrode |
| are for use on adults | are for use on adults |
| and children | and children |
| over eight years old | weighing more than 25 kg |
| for external defibrillation, pacing,<br>monitoring and cardioversion. | for external defibrillation, pacing,<br>monitoring and cardioversion. |
| The device is non-sterile<br>and single use only. | The device is non-sterile<br>and single use only. |

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Skintact® Multifunction Electrodes are substantially equivalent to predicate devices:

| Comparison | Skintact® Multifunction Electrodes | |
|--------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------|
| | K072233 | This submission |
| Description | Hydrogel polymeric self-adhesive electrode pads | |
| Technical<br>Characteristics<br>/ Features | Emergency treatment of cardiac arrest patients | |
| | for use on adults<br>and children<br>over eight years old | for use on adults<br>and children<br>weighing more than 25 kg |
| | for short term use (< 24 hours) | |
| | disposable | |
| | self-adhesive | |
| | non-sterile | |
| | sealed foil pouch | |
| Packaging | -- | additional packaging:<br>Cable out-of-pouch,<br>substantially equivalent to<br>K082090 |
| Testing | Biocompatibility testing | |
| | Electrical and adhesive performance testing | |

Models of Skintact® Multifunction Electrodes:

| Model | Compatible with device |
|-----------------|----------------------------|
| DF20N<br>DF20NC | Physio Control (Medtronic) |
| | Lifepak 9 |
| | Lifepak 10 |
| | Lifepak 12 |
| | Lifepak 15 |
| | Lifepak 20 |
| | Lifepak 500 |
| | Lifepak 1000 |
| DF26N<br>DF26NC | Philips Codemaster |
| | Codemaster XL |
| | Codemaster XL+ |
| | Codemaster 100 |
| DF27N<br>DF27NC | Philips Heartstart |
| | Heartstart FR2(+) |
| | Heartstream FR2 |
| | Heartstart FR3 |
| | Heartstart MRx |
| | Heartstart XL |
| | Heartstart XL+ |

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| Model | Compatible with device |
|-----------------|------------------------|
| | Zoll |
| | Zoll M, E & R Series |
| | Zoll PD 1200 |
| DF28N<br>DF28NC | Zoll PD 1400 |
| | Zoll PD 1600 |
| | Zoll PD 1700 |
| | Zoll PD 2000 |
| | Welch Allyn |
| | AED10 |
| DF29N | AED20 |
| DF29NC | PIC 30 |
| | PIC 40 |
| | വാ 50 |
| DF55N | GE |
| DF55NC | CardioServ |
| | Responder 3000 |
| | Zoll |
| DF59N<br>DF59NC | Zoll AED Plus |
| | Zoll AED Pro |
| | M Series |
| | E Series |
| | R Series |
| | X Series |
| DF82l | Cardiac Science |
| | Powerheart AED G3 |
| | Powerheart AED G3 pro |
| | Powerheart AED G3 plus |

#### SUMMARY of TESTING:

#### Performance Data:

Performance testing was conducted according standard IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, relevant clauses. Results are within limits.

#### Biocompatibility:

Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.

#### CONCLUSION:

The introduction of the Skintact® Multifunction Electrodes (and also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and the Skintact® Multifunction Electrodes are substantially equivalent to the predicate device. Testing has shown the devices perform as intended and are safe when used according to the instructions for use.

# Traditional 510(k): Skintact® Multifunction Electrodes