(463 days)
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 recordings. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Skintact ECG Electrodes:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Voluntary Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12/1991 for Electrical Performance | Meets requirements |
| ANSI/AAMI EC12/1991 for Labeling | Meets requirements |
| ANSI/AAMI EC12/1991 for Shelf Life | Meets requirements |
| ANSI/AAMI EC12/1991 for Packaging | Meets requirements |
| ANSI/AAMI EC12/1991 for Safety | Meets requirements |
| ISO 10993-1 for Biocompatibility (material selection) | Appropriate levels of biocompatibility demonstrated |
| Shelf Life substantiation | Data obtained in real-time shelf life studies substantiate claimed shelf life |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective or prospective) for the electrical performance, biocompatibility, or shelf-life studies. It only mentions that the studies were performed and that the device met the requirements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies referenced are technical performance tests against a voluntary standard, not studies requiring expert interpretation of diagnostic output to establish ground truth in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of performance testing against a voluntary standard for electrical characteristics and biocompatibility, an adjudication method in the context of expert consensus on ground truth is not applicable here.
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 device is an ECG electrode, a consumable medical device, not an AI-powered diagnostic tool that would typically involve human readers interpreting output with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Skintact ECG Electrodes. This is a hardware medical device (an electrode), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established by voluntary standards (ANSI/AAMI EC12/1991 for electrical performance, labeling, shelf life, packaging, and safety) and international standards (ISO 10993-1 for biocompatibility). For shelf life, it was based on real-time shelf-life studies. In essence, the ground truth was defined by the specified technical and biological requirements of these standards.
8. Sample Size for the Training Set
This information is not applicable. The Skintact ECG Electrodes are a hardware device, not a machine learning model, and therefore do not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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OCT 26 1999
Summary ; 15. 510 (k)
长982521
Date:
Manufacturer :
Telephone: Fax :
Contact Person:
Device Trade Names:
Common Name:
Classification Name:
Regulatory Reference:
Predicate Device:
Description :
Intended Use:
October 29, 1997
Leonhard Lang GmbH Archenweg 56 A-6020 Innsbruck Austria
+43 512 33425-7 +43 512 392210
Burrhus Lang, President
Skintact ECG Electrodes S&W ECG electrodes
Disposable ECG monitoring electrode
Electrocardiograph electrode
74 DRX
Skintact AG Electrodes
Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.
Skintact ECG electrodes are intended for use in general electrocardiographic procedures where ECG monitoring is
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1 1982521
Physical/Technical Comparison:
Performance Summary:
Biocompatibility Testing:
Shelf Life:
deemed necessary and is ordered by a physician.
Skintact ECG electrodes are equivalent to the predicate device. Physical and technical characteristics, including, design, materials used, safety and efficacy characteristics and intended use of Skintact ECG electrodes and the predicate device are either identical or comparable.
The electrical performance of Skintact ECG electrodes meets the requirements of the voluntary standard ANSI/AAMI EC12/1991 "Disposable ECG Electrodes". In addition Skintact ECG electrodes meet the requirements of ANSI/AAMI EC12/1991 for labeling, shelf life, packaging and safety.
The biological safety of Skintact ECG electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The tests were selected on the basis of ISO 10993-1 "Biological Evaluation of Medical Devices - Partl: Guidance on selection of tests".
Data obtained in real time shelf life studies was reviewed and found to substantiate the claimed shelf life.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and torso.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1999
Leonhard Lang GmbH c/o Carole Stamp Third Party Official TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
K982521 Re: Skintact™ ECG Electrodes, S&W ECG Electrodes Regulatory Class: II (two) Product Code: DRX October 8, 1999 Dated: October 12, 1999 Received:
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Carole Stamp
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
VCAloteli
Witten, Ph.D., M.D. lia M. Actinq Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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- Statement of Indications for Use
510(k) Number (if known):
Device Name: Skintact ECG 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 recordings.
Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
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| Concurrence of CRRH, Office of Device Evaluation | |
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| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K183521 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
§ 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.