SKINTACT ECG TAB ELECTRODE by LEONHARD LANG GMBH

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 Tab Electrodes (and also to be sold under various private label tradenames) with KH 06 gel. Skintact® ECG Tab Electrodes with KH 06 gel are self-adhesive, non-sterile, single use disposable electrodes for diagnostic resting ECG. ECG Tab electrodes are composed of a PET tape, carbon ink and Ag/AgCl ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten cards per pouch.

AI/ML Overview

Here's an analysis of the provided text regarding the Skintact® ECG Tab Electrodes, focusing on the acceptance criteria and the study proving conformance:

This document is a 510(k) premarket notification for an ECG electrode, which means it describes the device's substantial equivalence to a predicate device rather than presenting novel clinical study results for a new AI medical device. Therefore, much of the requested information regarding AI device development and testing (like MRMC studies, training set details, and highly detailed ground truth establishment) is not applicable to this submission.

However, I can extract the acceptance criteria for the performance of the ECG electrodes and the studies conducted to show they meet those criteria.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Confirmed by biocompatibility testing.
AC Impedance	Tested in accordance with ANSI/AAMI EC 12:2000.
DC Offset Voltage	Tested in accordance with ANSI/AAMI EC 12:2000.
Defibrillation Overload Recovery	Tested in accordance with ANSI/AAMI EC 12:2000.
Combined Offset Instability and Internal Noise	Tested in accordance with ANSI/AAMI EC 12:2000.
Bias Current Tolerance	Tested in accordance with ANSI/AAMI EC 12:2000.
Shelf Life (24 months)	Demonstrated by real-time aging and accelerated aging (3 months at 40°C). Manufacturer has 20 years of experience with current packaging.
Clinical ECG Signal Quality	Provides a reliable signal tracing of consistently high quality.

Study Details (as much as applicable to this type of device submission)

Sample Size used for the test set and the data provenance:
- Clinical Data: Three ECG tracings were made. The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified. Each tracing contained more than 10 seconds of data.
- Performance (ANSI/AAMI EC 12:2000) & Shelf Life Testing: The sample sizes for these tests are not explicitly stated in the provided text. These would typically involve a specific number of electrodes or batches tested according to the standard's protocols. The shelf-life testing involved "electrodes" in an incubator.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device (ECG electrode), "ground truth" isn't established by expert consensus in the typical sense of diagnostic imaging or clinical decisions.
- For the clinical data, the assessment of "reliable signal tracing of consistently high quality" would likely be a qualitative assessment by an expert familiar with ECG waveform interpretation, but the number and qualifications of such experts are not mentioned.
- For the technical performance tests (ANSI/AAMI EC 12:2000), the "ground truth" is adherence to the specified technical parameters of the standard, measured by calibrated equipment. Experts in electrophysiology or biomedical engineering would interpret these results, but they aren't establishing a diagnostic ground truth.
Adjudication method for the test set:
- Not applicable in the typical sense for this device. The technical tests are pass/fail against a standard. The clinical tracings would have a single "assessment" outcome for signal quality.
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. This is not an AI-powered diagnostic device; it is a passive ECG electrode. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device. The device's performance is inherently "standalone" in that its electrical characteristics are measured directly.
The type of ground truth used:
- For technical performance: Adherence to the technical specifications outlined in the ANSI/AAMI EC 12:2000 standard.
- For clinical data: Qualitative assessment of ECG signal quality.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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MAR 0 4 2003

510(k) Summary

Submitted on behalf of: Leonhard Lang GmbH Company Name: Address: Archenweg 56 Innsbruck 6010 Austria Telephone: ++ 43 / 512 / 33 4 25 7 ++ 43 / 512 / 39 22 10 Fax: Paladin Medical, Inc. by: PO Box 560 Stillwater, MN 55082 Telephone: 715-549-6035; fax: 715-549-5380 Contact person: Elaine Duncan Date prepared: February 13, 2003 Trade Name: Skintact® ECG Tab Electrode Common Name: Disposable ECG Electrodes Classification Name: Electrocardiograph (ECG) electrode

SUBSTANTIALLY EQUIVALENT TO: Skintact® ECG Tab Electrodes with KH 06 gel are substantially equivalent to the Skintact® ECG Tab Electrodes with LecTec LT 4900 gel (the manufacterer's predicate - K023920). The additional carbon ink layer added for performance, is substantially equivalent to the MSB electrode (now distributed as Nikotab) originally cleared under K944260.

DESCRIPTION of the DEVICE: Skintact® ECG Tab Electrodes (and also to be sold under various private label tradenames) with KH 06 gel. Skintact® ECG Tab Electrodes with KH 06 gel are self-adhesive, non-sterile, single use disposable electrodes for diagnostic resting ECG. ECG Tab electrodes are composed of a PET tape, carbon ink and Ag/AgCl ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten cards per pouch.

INDICATIONS FOR USE: 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. (No change to original indication for use.)

SUMMARY of TESTING: Biocompatibility testing confirms the materials are biocompatible and the change does not introduce new risks. Skintact ECG Tab Electrodes with KH 06 gel were tested in accordance with ANSI/AAMI EC 12:2000. A certification to conformance to 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. Shelf life of the tab electrodes with KH 06 gel was tested in real-time aging and in accelerated aging. For accelerated aging the electrodes were in an incubator for a time of 3 months with an increased temperature of 40°C. In accelerated shelf life testing the electrodes are subjected to a controlled environment in which one or more extrinsic factors (e.g., temperature, humidity, gas atmosphere, light) is maintained at a higher than normal level. 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 adhesive electrodes compared to the predicate electrode. For clinical data, three ECG tracings using KH 06 gel electrodes were made. Each tracing contains more than 10 seconds of data. The data demonstrate that ECG Tab electrodes with KH 06 gel provide a reliable signal tracing of consistently high quality.

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Image /page/1/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is listed as 9200 Corporate Boulevard in Rockville, MD. The zip code is 20850.

MAR 0 4 2003

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

Re: K030509

Trade Name: Skintact® ECG Tab Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: February 13, 2003 Received: February 19, 2003

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.

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Page 2 – Ms. Elaine Duncan, M.S.M.E., RAC

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 (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. 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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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)

KO30509

Device Name:

Skintact® ECG Tab Electrodes

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)

(Division Signvascular Devices

510(k) Number_**_

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.