(13 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the ECG electrodes, with no mention of AI or ML for signal processing or interpretation.
No
The device is described as an ECG electrode used for monitoring and diagnosis, not for treating any condition. ECG monitoring is a diagnostic procedure.
Yes
The "Intended Use / Indications for Use" section explicitly states that the electrodes are for "ECG diagnosis recording," and the "Device Description" mentions they are for "diagnostic resting ECG."
No
The device description clearly outlines physical components (PET tape, carbon ink, Ag/AgCl ink, conductive gel) and describes testing related to material biocompatibility and electrical performance of these physical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician." This involves measuring electrical activity of the heart from the surface of the skin.
- Device Description: The device is an "ECG Tab Electrode" which is a physical component applied to the skin to acquire an electrical signal.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not analyze any bodily fluids or tissues. It is a sensor applied to the body surface.
Therefore, the Skintact® ECG electrodes described are considered a medical device used for physiological monitoring, but not an IVD.
N/A
Intended Use / 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."
Product codes
DRX
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"physician"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
"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."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
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 (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
3
510(k) Number (if known)
KO30509
Device Name:
Skintact® ECG Tab Electrodes
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.
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
OR
Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Signvascular Devices
510(k) Number_**_