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 KL 02 liguid gel. Just like the QR liquid gel electrodes, KL 02 liquid gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KL 02 liquid 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 QR liquid gel conducting media.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Electrodes with KL 02 liquid gel, focusing on acceptance criteria and supporting studies:

Overview:

This 510(k) submission seeks to demonstrate substantial equivalence of the Skintact® ECG Electrodes with KL 02 liquid gel to a predicate device (Skintact® ECG Electrodes with QR liquid gel) that was previously cleared (K982521). The primary change is the type of liquid gel used. The testing focuses on proving that this change does not negatively impact the device's performance regarding biocompatibility, electrical properties, and clinical utility.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ANSI/AAMI EC 12:2000 standard for "Disposable ECG electrodes" and equivalence comparisons to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (from ANSI/AAMI EC 12:2000 & Equivalence)	Reported Device Performance (Skintact® ECG Electrodes with KL 02 liquid gel)	Pass/Fail
I. Biocompatibility	Cytotoxicity	No adverse results	Pass
	Skin Irritation	No adverse results	Pass
	Sensitization	No adverse results	Pass
II. Electrical Performance	AC Impedance (limits defined by ANSI/AAMI EC 12:2000)	Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate	Pass
	DC Offset Voltage (limits defined by ANSI/AAMI EC 12:2000)	Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate	Pass
	Defibrillation Overload Recovery (limits defined by ANSI/AAMI EC 12:2000)	Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate	Pass
	Combined Offset Instability and Internal Noise (limits defined by ANSI/AAMI EC 12:2000)	Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate	Pass
	Bias Current Tolerance (limits defined by ANSI/AAMI EC 12:2000)	Well inside the limits defined in ANSI/AAMI EC12-2000, similar to predicate	Pass
III. Shelf-Life	Electrical performance within ANSI/AAMI EC 12:2000 limits for 24 months	Electrical performance stayed within limits for 24 months (real-time aging)	Pass
IV. Clinical Equivalence	Equivalent ECG traces compared to predicate device	"KL 02 liquid gel performs the same" and "ECG traces... demonstrate that KL 02 liquid gel electrodes are equivalent to the QR liquid gel electrodes."	Pass
	No skin problems during 48-hour wear	"Did not cause any skin problems for the volunteers."	Pass
	No deterioration of electrical performance during 48-hour wear	"No deterioration of electrical performance"	Pass
	Gel did not dry out during 48-hour wear	"Gel did not dry out"	Pass
	No displacement during 48-hour wear	"Did not show any displacement"	Pass

Study Details:

Based on the provided text, the studies are primarily intended to demonstrate equivalence to a predicate device and adherence to industry standards, rather than proving novel clinical effectiveness.

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

Biocompatibility Testing: The specific sample sizes for cytotoxicity, skin irritation, and sensitization tests are not provided in the summary.
Electrical Performance Testing: The specific sample sizes for AC impedance, DC offset voltage, etc., are not provided. The testing "was used to define the requirements for Skintact ECG Electrodes with KL 02 liquid gel" and involved a "certification to conformance EC12:2000."
Shelf-Life Testing: "Real-time aging" was performed, and "retain samples" were tested. Specific sample sizes are not provided.
Clinical Data (Trace Testing & Wear Tests):
- Trace Testing: No specific sample size is mentioned for the "clinical trace testing per the FDA guidance." It states the gel was evaluated, implying direct comparison.
- Wear Tests: "Three wear test reports for Holter monitoring electrodes used for 48 hours were provided." This implies a small sample size, likely involving a few participants per report, but the exact number of individuals is not specified.
- Data Provenance: The manufacturer is Leonhard Lang GmbH, located in Austria. It is highly probable the data originated from Austria or a European location, given the company's geographical information. The studies appear to be prospective as they were specifically conducted for this submission (e.g., repeating clinical trace testing, real-time aging, wear tests).

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

Biocompatibility/Electrical Performance/Shelf-Life: These tests typically use validated laboratory methods and standards (ANSI/AAMI EC 12:2000) for determining "ground truth." Expert review would be part of the lab's quality assurance, but no specific external experts are mentioned for establishing the objective pass/fail criteria.
Clinical Data (Wear Tests): "A physician reviewed the performance of the wear tests and examined for skin irritation."
- Number of Experts: One physician is explicitly mentioned.
- Qualifications: "Physician." No further specific qualifications (e.g., years of experience, specialty) are provided in the summary.

4. Adjudication Method for the Test Set:

Biocompatibility/Electrical Performance/Shelf-Life: Not applicable in the context of standard human-read adjudication. These are objective measurements against defined technical standards.
Clinical Data (Wear Tests): A single "physician reviewed the performance." There is no explicit multi-reader adjudication method (like 2+1, 3+1) described for the clinical wear tests or the trace comparisons. The "clinical trace testing" simply states the KL 02 gel "performs the same" as the QR gel, implying a direct comparison without detailing an adjudication process.

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

No, an MRMC comparative effectiveness study was NOT done. The studies focused on demonstrating equivalence of the device (specifically the new gel) to a predicate device and adherence to technical standards. There is no mention of human readers and their improvement with or without AI assistance. This device is an electrode, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was NOT done. This device is an ECG electrode, which is a hardware component for collecting physiological signals, not a software algorithm.

7. Type of Ground Truth Used:

Biocompatibility: Ground truth is established by standardized, validated laboratory protocols for cytotoxicity, irritation, and sensitization (e.g., ISO 10993 series, though not explicitly cited here, implied by "biocompatibility testing").
Electrical Performance: Ground truth is defined by the objective limits and testing methodologies specified in the ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" standard.
Shelf-Life: Ground truth is the adherence to the electrical performance limits defined by ANSI/AAMI EC 12:2000 over time, as measured through real-time aging.
Clinical Data (Trace Testing & Wear Tests):
- Trace Equivalence: The "ground truth" for trace equivalence is likely a visual or quantitative comparison by experts of the generated ECG waveforms from the new gel electrodes versus the predicate gel electrodes, judged to be "the same" or "equivalent."
- Skin Irritation/Performance: The "ground truth" for skin irritation and overall electrode performance (adhesion, gel drying, electrical performance during wear) is the physician's review and observation for the wear tests.

8. Sample Size for the Training Set:

Not applicable. This submission describes a medical device (ECG electrode), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As stated above, there is no training set for an AI model.

Summary

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K024247

510(k) Summary

JAN 1 6 2003

SUBMITTED ON BEHALF OF:

Company Name:	Leonhard Lang GmbH
Address:	Archenweg 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
Common Name:	Disposable ECG Electrodes
Classification Name:	Electrocardiograph (ECG) electrode

SUBSTANTIALLY EQUIVALENT TO: Skintact® ECG Electrodes with KL 02 liquid gel are substantially equivalent to the Skintact® ECG Electrodes with QR liquid gel (the manufacter'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 KL 02 liguid gel. Just like the QR liquid gel electrodes, KL 02 liquid gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KL 02 liquid 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 QR liquid gel conducting media.

INDICATIONS FOR USE:

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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 KL 02 liquid gel. All electrical tests are according to ANSI/AAMI 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 KL 02 liquid 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 KL 02 liquid gel electrodes compared to the predicate electrodes.

The results of these tests confirm that the shelf-life of Leonhard Lang Skintact ECG Electrodes with KL 02 liquid gel is well inside the limits defined in ANSVAAMI EC12-2000, both for the first test and the retain samples with real-time aged electrodes. Thus the conclusion that the electrical performance of the KL 02 liquid 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 KL 02 liquid 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 KL 02 liquid 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 KL 02 liquid gel and determined that the KL 02 liquid gel performs the same. Comparing the ECG traces between KL 02 liquid gel electrodes and QR liquid gel electrodes demonstrate that KL 02 liquid 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 dry out.

The electrodes were not replaced during this time and did not show any 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.)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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: K024247

Skintact® ECG Tab Electrodes with KL 02 liquid 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. Iisting 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.

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Page 2 -- Ms. Elaine 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 (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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Ndether

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® ECG Electrodes (with KL02 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

Over -The-Counter Use

(Optional Format 1-2-96)

N. Deaton

510(k) Number K024247

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.