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 Description

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.

AI/ML Overview

This document is a 510(k) summary for the Skintact® Multifunction Electrodes. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared devices. It is a submission to the FDA, not a study report, and therefore does not contain the detailed study information requested in the prompt.

Here's a breakdown of why the requested information cannot be fully provided from this document:

This is a 510(k) submission, not a study report. A 510(k) demonstrates substantial equivalence to a predicate device, often through a combination of comparisons to existing devices, design verification, and some performance testing. It is not generally a study designed to "prove" a device meets acceptance criteria in the same way a clinical trial or a formal comparative effectiveness study would.
The device is "passive" and an "accessory." The Skintact® Multifunction Electrodes are described as passive devices without active electronics, software, or firmware. This means the performance evaluation focuses on physical and electrical characteristics as an accessory, rather than complex algorithm performance.
Focus on Substantial Equivalence: The primary objective of this document is to establish substantial equivalence to predicate devices (K072233 and K082090). Therefore, the "acceptance criteria" discussed are largely related to meeting the performance characteristics of those predicates and relevant safety standards.

Despite these limitations, I can extract and infer some information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Stated)
Preamble/General: Device is safe and effective when used as intended.	"Testing has shown the devices perform as intended and are safe when used according to the instructions for use."
Biocompatibility: Materials with direct skin contact must be biocompatible and not introduce new risks.	"Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks."
Electrical and Adhesive Performance: Must meet relevant standards for functionality and ensure proper connection/adhesion.	"Electrical and adhesive performance testing" was conducted. "Results are within limits." (Limits are not specified in this document but would refer to relevant standards like IEC 60601-2-4).
Applicable Standards Compliance: Meet requirements of IEC 60601-2-4:2010 (Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators).	"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."
Indications for Use: Ability to function for external defibrillation, pacing, monitoring, and cardioversion on specified patient populations (adults and children weighing > 25kg).	The device is intended for these uses, and the submission argues its substantial equivalence to a predicate device with the same indications (with a modified weight criterion for children), implying it meets the necessary performance for these functions when used with compatible defibrillators. The "Substantial Equivalence Summary" states "Skintact® Multifunction Electrodes have the same indications for use as Skintact® Multifunction Electrodes with DH02 Gel..."
Material Composition and Design Principles: The core composition (backing, conductive layer, adhesive gel) should be similar to existing approved devices.	"This is the same composition like used for devices approved in existing K072233." The active area is equivalent to K072233, despite a slight modification in shape.
Packaging: New packaging types should be substantially equivalent to existing approved packaging.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. This document only states that "Performance testing was conducted" and "Biocompatibility testing has been performed." It does not provide details on the number of electrodes or test subjects used.
Data Provenance: Not specified. The submission is from Leonhard Lang GmbH, based in Innsbruck, Austria. The testing would likely have been conducted in a laboratory setting, but specifics are not provided. It is not mentioned whether it was retrospective or prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The testing described is for the physical and electrical performance and biocompatibility of a medical device accessory, not the interpretative accuracy of an AI or diagnostic tool. Ground truth in this context would be established by laboratory measurements against defined standards, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used when human interpretation or judgment is involved in establishing a ground truth (e.g., in reading medical images), which is not the case for the type of device testing described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a passive accessory (electrodes) for a defibrillator, not an AI-powered diagnostic or interpretive tool that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this question is not applicable. The device is a physical electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

Physical measurements against established engineering standards: For electrical impedance, adhesion strength, and physical dimensions.
Biocompatibility test results: Against ISO standards or other recognized guidelines for biological safety.
Functional tests with compatible defibrillators: To ensure proper signal transmission and energy delivery.

This is fundamentally different from a clinical ground truth for a diagnostic device.

8. The sample size for the training set

Not applicable. This device is a passive medical accessory, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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:Address:	Leonhard Lang GmbHArchenweg 566020 InnsbruckAustria
Telephone:Fax:	+43 512 334257+43 512 392210
Contact Person:Telephone:Fax:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082715-549-6035715-549-5380
Date prepared:	November 26, 2014
Device Identification:
TRADE NAME:	Skintact® Multifunction Electrodes(and also to be offered for sale under variousprivate label tradenames)
COMMON NAME:CLASSIFICATION NAME:PRO CODE:Regulation No.:Classification:	Defibrillation ElectrodesDC-defibrillator, low-energy, (including paddles)MKJ21CFR 870.5310Class 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:

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510(k) Summary-Continued

DESCRIPTION of the DEVICE:

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

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 Electrodeswith DH02 Gel available with differentconnectors compatible with differentdefibrillators	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,monitoring and cardioversion.	for external defibrillation, pacing,monitoring and cardioversion.
The device is non-sterileand single use only.	The device is non-sterileand 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
TechnicalCharacteristics/ Features	Emergency treatment of cardiac arrest patients
	for use on adultsand childrenover eight years old	for use on adultsand childrenweighing more than 25 kg
	for short term use (< 24 hours)
	disposable
	self-adhesive
	non-sterile
	sealed foil pouch
Packaging	--	additional packaging:Cable out-of-pouch,substantially equivalent toK082090
Testing	Biocompatibility testing
	Electrical and adhesive performance testing

Models of Skintact® Multifunction Electrodes:

Model	Compatible with device
DF20NDF20NC	Physio Control (Medtronic)
	Lifepak 9
	Lifepak 10
	Lifepak 12
	Lifepak 15
	Lifepak 20
	Lifepak 500
	Lifepak 1000
DF26NDF26NC	Philips Codemaster
	Codemaster XL
	Codemaster XL+
	Codemaster 100
DF27NDF27NC	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
DF28NDF28NC	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
DF59NDF59NC	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

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.