(23 days)
ECG Skintact 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 single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
All Skintact® ECG Tab Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Tab Electrodes with KH06D Gel are composed of the same materials as the predicate devices by Leonhard Lang except the modified gel.
Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Tab Electrodes with KH06D Gel, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993 for intact skin | Cleared and passed ISO 10993; materials confirmed biocompatible; change does not introduce new risks. |
| Electrical Performance: ANSI/AAMI EC12:2000/(R)2005 | Met specifications as established in the standard. Additionally, the predicate device (K030509) also met this standard. |
| Shelf Life: Tested in accelerated aging | Tested in the same manner as the predicate device (K030509). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for the test set.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing against established standards (biocompatibility, electrical performance, shelf life), it's highly likely this was prospective testing conducted by the manufacturer to verify compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For this specific device (ECG electrodes), the "ground truth" is typically established by objective measurements and standardized tests rather than expert interpretation of images or patient data. The provided documentation does not mention using experts to establish ground truth for the performance testing. Instead, the ground truth is defined by the requirements of the standards (ISO 10993, ANSI/AAMI EC12).
4. Adjudication Method for the Test Set
As the "ground truth" is based on objective measurements against industry standards, an adjudication method like "2+1" or "3+1" (which typically applies to human interpretation tasks) is not applicable here and is not mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (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. The device in question is a medical accessory (ECG electrode), and its performance is evaluated through technical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance assessments of the device itself (the ECG electrode). The biocompatibility, electrical performance, and shelf-life tests involve the device operating on its own or in a controlled environment, without a human-in-the-loop for its basic function.
7. The Type of Ground Truth Used
The ground truth used for the performance testing is based on objective technical standards and material properties:
- Biocompatibility: Conformance to ISO 10993 standards.
- Electrical Performance: Conformance to ANSI/AAMI EC12:2000/(R)2005 specifications.
- Shelf Life: Results of accelerated aging tests, compared to the predicate device's established shelf life.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI algorithms. As this device is an ECG electrode and not an AI/ML diagnostic tool, there is no training set in the conventional sense mentioned or implied for its development or testing.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, the question of how its ground truth was established is not applicable.
{0}------------------------------------------------
510(k) Summary
AUG 21 2009
| Company Name: | Leonhard Lang GmbH |
|---|---|
| Address: | Archenweg 56 |
| 6020 Innsbruck | |
| Austria | |
| Telephone: | ++ 43 / 512 / 33 4 25 7 |
| Fax: | ++ 43 / 512 / 39 22 10 |
| Registration Number: | 8020045 |
| Owner/Operator Number: | 8020045 |
| 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 | |
| Elaine Duncan | |
| 28, July 2009 |
Contact Person: Date prepared: Trade Name:
:
SUBMITTER
Submitted on behalf of:
Common Name: Classification Name: Regulation: Regulatory Class Device Panel and Product Code: Cardiovascular: 74 DRX Reason for 510(k) Submission:
-6032 -5380 Skintact® ECG Tab Electrodes with KH06D Gel (and as also to be offered for sale under various private label tradenames)
Disposable ECG Electrodes Electrocardiograph (ECG) Electrode Electrocardiographic electrode, 21 CFR 870.2360 This device is Class II change of material
Substantial Equivalence: Skintact® ECG Tab Electrodes with KH06D Gel are substantially equivalent to K030509 "Leonhard Lang Skintact" ECG Electrodes with KH06 Gel" and have same individual for use. The only change between the original Skintact® ECG Tab Electrodes with KH06 Gel and the Skintact® ECG Tab Electrodes with KH06D Gel is the modification of gel. No new technology is required for this change.
Description of device: All Skintact® ECG Tab Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Tab Electrodes with KH06D Gel are composed of the same materials as the predicate devices by Leonhard Lang except the modified gel.
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 physiciati. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact® ECG Electrodes are single-use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Basis for Equivalence - performance testing: Biocompatibility testing was cleared and passed ISO 10993 for intact skin. Biocompatibility testing confirms the materials are biocompatible and the change does not introduce new risks. According to the performance data, Leonhard Lang Skintact® ECG Tab Electrodes with KH06D Gel met specifications as established in the standard, ANSI/AAMI EC12:2000/(R)2005, as did the predicate device). The shelf life of Skintact® ECG Tab Electrodes with KH06D Gel was tested in accelerated aging in the same manner as the predicate device K030509. The introduction of the Skintacte ECG Tab Electrodes with KH06D Gel does not introduce new issues of safety or effectiveness and the Skintact® ECG Tab Electrodes with KH06D Gel are substantially equivalent to the predicate device.
37 OF 99
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right of the image. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 21 2009
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: K092291
Trade/Device Name: Leonhard Lang Skintact ECG Tab Electrode with KH06D Gel Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (Two) Product Code: DRX Dated: July 28, 2009 Received: July 29, 2009
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.
{2}------------------------------------------------
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 (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 yours.
M. A. Villebrun
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Skintact® ECG Tab Electrodes with KH06D Gel
Indications For Use:
ECG Skintact 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 single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hilleheusen
(Division Sign-Off)
Division of Cardiovascular Devices
1092291 510(k) Number
§ 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.