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 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.

AI/ML Overview

This 510(k) summary describes a device that is essentially identical to a previously cleared predicate device, with no significant differences in materials or design. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device meeting the same standards and specifications as the predicate device, demonstrated through bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate device standards)	Reported Device Performance
Meets performance and safety requirements of ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003	"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..."
Materials cleared in existing 510(k) K041883	"All materials were cleared in 510(k) K041883"
Demonstrates acceptable skin irritation and sensitization	"Results of updated testing for skin irritation and sensitization testing are included." (Implies results were acceptable, as the device was cleared)
Maintain performance over a 30-month shelf-life	"Leonhard Lang has met requirements for 30 months shelf-life."
Device performance does not introduce new issues of safety or effectiveness	"Bench testing demonstrated that the performance of the Skintact® Multifunction Electrodes with DH02 Gel available with different compatible with different defibrillators meets is specifications." and "Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators does not introduce new issues of safety or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Performance and safety tests were conducted," but not the specific number of units tested.
Data Provenance: The tests were conducted by SGS, an independent third-party testing organization, presumably in Austria where Leonhard Lang GmbH is located. This is a prospective test for this specific device, demonstrating its performance against established standards, rather than analyzing existing datasets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The "ground truth" for this device's performance is defined by adherence to recognized international standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003) for defibrillation electrodes, not by expert consensus on clinical findings. The "experts" are likely the engineers and technicians at SGS who performed the tests according to these standards. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation). For bench testing against objective standards, the "adjudication" is whether the test results fall within the specified acceptance criteria of the standards.

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 type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. This submission is for a medical electrode.

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

No, this is not applicable. This device is a physical electrode, not a software algorithm. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering and safety standards (ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003).

8. The Sample Size for the Training Set

This document describes a medical device, not a machine learning model. Therefore, there is no training set in the context of artificial intelligence/machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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KO72233

510(k) Summary

SUBMITTED ON BEHALF OF:OCT 5 2007	Company Name:	Leonhard Lang GmbH
	Address:	Archenweg 566020 InnsbruckAustria
	Telephone:	++ 43 / 512 / 33 4 25 7
	Fax:	++ 43 / 512 / 39 22 10
	By:	Elaine Duncan, MS.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
	Telephone:	715-549-6035
	Fax:	715-549-5380
CONTACT PERSON:DATE PREPARED:	Elaine DuncanAugust 8, 2007
Trade Name:	Skintact® Multifunction Electrodeswith DH02 gel available with different connectors compatible withdifferent defibrillators
Common Name:Classification Name:	Defibrillation ElectrodesDC-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

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

ಸ Prescription Use

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)

Blymmlepon

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.