Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

Device Description

Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with KS 01 solid wet gel. Just like the OR liguid gel electrodes, KS 01 solid wet gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KS 01 solid wet gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using OR liguid gel conducting media.

AI/ML Overview

The provided text describes the acceptance criteria and the studies performed for the Skintact® ECG Electrodes with KS 01 solid wet gel.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity	No adverse results	Confirmed (no adverse results)
	Skin Irritation	No adverse results	Confirmed (no adverse results)
	Sensitization	No adverse results	Confirmed (no adverse results)
Electrical Performance	ANSI/AAMI EC 12:2000	Values within standard limits	All electrical tests (AC impedance, DC offset voltage, Defibrillation overload recovery, Combined offset instability and internal noise, Bias current tolerance) showed conformance to EC 12:2000.
Shelf-Life	Real-time aging (24 months)	Electrical performance within ANSI/AAMI EC 12:2000 limits	Electrical performance remained within limits for 24 months.
Clinical Performance	Clinical trace testing	ECG traces equivalent to predicate device	KS 01 solid wet gel electrodes perform the same as OR liquid gel electrodes; ECG traces demonstrate equivalence.
	Wear Test (48 hours)	Good performance without skin problems, no deterioration of electrical performance, no gel dry-out or displacement	Confirmed: good performance, no skin problems, no deterioration of electrical performance, no gel dry-out, no displacement.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated for specific tests.
- Biocompatibility tests: Implied N/A as these are material-level tests, likely conducted on samples of the material, not on human subjects.
- Electrical tests: Also implied N/A as these are device performance tests under laboratory conditions.
- Shelf-life tests: Implied N/A as these are laboratory aging tests.
- Clinical trace testing: Not explicitly stated.
- Wear test reports: "Three wear test reports" were provided, implying a small number of volunteers. The exact number of participants per report is not given.
Data Provenance: Not explicitly stated. However, the manufacturer is Leonhard Lang GmbH, located in Innsbruck, Austria, suggesting the studies were likely conducted in Austria or Europe.
Retrospective or Prospective: Not explicitly stated; however, clinical trace testing and wear tests are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

Clinical Trace Testing and Wear Tests: "A physician" reviewed the performance of the wear tests and examined for skin irritation. No specific qualifications (e.g., years of experience, specialty) for this physician are provided.
Other tests: Ground truth for electrical and biocompatibility tests is based on adherence to a recognized standard (ANSI/AAMI EC 12:2000) or laboratory protocols, not expert consensus in the form described for clinical data.

4. Adjudication Method

For wear tests: A single physician reviewed the performance and examined for skin irritation. This implies a "none" or "single expert" adjudication method without consensus or independent review processes mentioned.
For clinical trace testing: The comparison was made between the new and predicate electrodes, and it was "determined that the KS 01 solid wet gel performs the same." The method of this determination (e.g., visual inspection by an expert, quantitative comparison) is not elaborated, so no specific adjudication method is described beyond comparison.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study in this submission. The studies focus on demonstrating equivalence to a predicate device and adherence to a standard, not on comparing human reader performance with and without AI assistance. The device is an ECG electrode, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable. The device is an ECG electrode, which is a physical medical device for signal acquisition, not a software algorithm that performs diagnostics independently. Therefore, a "standalone algorithm performance" study as typically understood for AI/ML devices was not performed.

7. Type of Ground Truth Used

Biocompatibility: Laboratory test results conforming to established protocols (cytotoxicity, skin irritation, sensitization).
Electrical Performance: Measurements confirming adherence to ANSI/AAMI EC 12:2000 standard.
Shelf-Life: Real-time aging test results validating electrical performance against the standard over time.
Clinical Performance (Wear Tests): Physician review of clinical performance and skin condition, along with observation of electrical signal integrity, gel integrity, and adhesion.
Clinical Performance (Trace Comparison): Comparison of ECG traces between the new and predicate devices. The implicit ground truth here is the established performance of the predicate device.

8. Sample Size for the Training Set

This question is not applicable. The device is an ECG electrode, not an AI/ML model that requires a training set.

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

This question is not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

K024/264

JAN 1 6 2003

510(k) Summary

SUBMITTED ON BEHALF OF:

Trade Name:

Common Name:

	Company Name:Address:	Leonhard Lang GmbHArchenweg 566010 InnsbruckAustria
	Telephone:	++ 43 / 512 / 33 4 25 7
	Fax:	++ 43 / 512 / 39 22 10
by:	Elaine Duncan, MS.M.E., RAC
	President, Paladin Medical, Inc.
	PO Box 560
	Stillwater, MN 55082
	Telephone:	715-549-6035
	Fax:	715-549-5380
	CONTACT PERSON:	Elaine Duncan
	DATE PREPARED:	December 18, 2002
	Trade Name:	Skintact® ECG Electrode

Classification Name: Electrocardiograph (ECG) electrode SUBSTANTIALLY EQUIVALENT TO: Skintact® ECG Electrodes with KS 01 solid wet gel

Disposable ECG Electrodes

are substantially equivalent to the Skintact® ECG Electrodes with OR liguid gel (the manufacterer's predicate device cleared under K982521)

DESCRIPTION of the DEVICE: Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with KS 01 solid wet gel. Just like the OR liguid gel electrodes, KS 01 solid wet gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KS 01 solid wet gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH.

All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using OR liguid gel conducting media.

INDICATIONS FOR USE:

{1}------------------------------------------------

510(k) Summary-Continued

SUMMARY of TESTING:

Biocompatibility testing confirms the materials are biocompatible and the change does not introduce new risks. The following testing showed no adverse results: Cytotoxicity; Skin Irritation; Sensitization.

The ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" was used to define the requirements for Skintact ECG Electrodes with KS 01 solid wet gel. All electrical tests are according to ANSVAAMI EC 12:2000. A certification to conformance EC12:2000 with this standard has been provided. The testing conducted was: AC impedance; DC offset voltage: Defibrillation overload recovery; Combined offset instability and internal noise; Bias current tolerance.

The shelf life of the electrodes with KS 01 solid wet gel was tested in real-time aging.

Leonhard Lang has experience for about 20 years of using the current packaging and this ensures all requirements for the 24 months shelf-life of the electrodes. No differences were required for packaging of the solid wet gel electrodes compared to the predicate electrode.

The results of these tests confirm that the shelf-life of Leonhard Lang Skintact ECG Electrodes with KS 01 solid wet gel is well inside the limits defined in ANSI/AAMI EC12-2000, both for the first tests and for the tests with real-time aged electrodes. Thus the conclusion that the electrical performance of the KS 01 solid wet gel electrodes will stay within the limits during their shelf-life of 24 months. The comparison with the predicate device and the data from the KS 01 solid wet gel electrodes shows similar results. The difference is negligible in the limits defined in ANSI/AAMI EC12-2000. Therefore electrical performance of the predicate device and KS 01 solid wet gel electrodes is equivalent.

Clinical data: The potential effect of material change to the conducting signal was evaluated by repeating the clinical trace testing per the FDA guidance on the KS 01 solid wet gel electrodes and determined that the KS 01 solid wet gel performs the same. Comparing the ECG traces between KS 01 solid wet gel electrodes and QR liquid gel electrodes demonstrate that KS 01 solid wet gel electrodes are equivalent to the QR liquid gel electrodes. Three wear test reports for Holter monitoring electrodes used for 48 hours were provided. A physician reviewed the performance of the wear tests and examined for skin irritation. The tests confirm that the performance of electrodes is quite good and that wearing of the electrodes does not cause any skin problems for the volunteers. During a time of 48 hours there was no deterioration of electrical performance and the gel did not The electrodes were not replaced during this time and did not show any dry out. displacement; although the volunteers worked and participated in sports as usual demonstrating the adhesion was also very good. (No change to adhesive formulation was made.)

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2003

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

Re: K024264

Skintact® ECG Tab Electrodes with KS 01 solid wet gel Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: December 18, 2002 Received: December 23, 2002

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.

{3}------------------------------------------------

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

K. Garten

Rhona D. Zuckerman, M.D.

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known)

K024264/

Device Name:

Skintact® ECG Electrodes (with KS 01 gel)

Indications for Use:

Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.

(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over -The-Counter Use

(Optional Format 1-2-96)

K.Q. Carter

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K024264

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.