(463 days)
Not Found
Not Found
No
The summary describes standard ECG electrodes and their performance against a voluntary standard. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as ECG electrodes used for monitoring and diagnosis, not for treating a condition.
No
Explanation: The device is an ECG electrode, used for monitoring and recording ECG signals. While these recordings can be used for diagnosis, the electrode itself does not perform the diagnostic function.
No
The device description explicitly states that the device includes physical components such as a silver/silver chloride sensing element, a stainless steel stud, conductive gel, carrier tape, and adhesive, 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 clearly states the electrodes are for "general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician." This involves measuring electrical activity of the heart on the patient's body.
- Device Description: The description details components like a sensing element, stud, conductive gel, and adhesive for attachment to the skin. These are all external components used for signal acquisition from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological or pathological state. This description does not mention any such use or interaction with bodily specimens.
Therefore, Skintact ECG electrodes are medical devices used for in vivo (on the body) measurement, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Skintact ECG electrodes are intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Skintact AG Electrodes
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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.
3
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
4
- 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 |