(79 days)
Not Found
Not Found
No
The summary describes a disposable EKG electrode and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as an electrode for resting EKG cardiac evaluation procedures, which is a diagnostic tool, not a therapeutic one.
Yes
The device is described as an "electrode for resting EKG cardiac evaluation procedures," which are diagnostic in nature as they assess cardiac function.
No
The device is described as a "single use disposable electrode," which is a physical hardware component.
Based on the provided information, the Vermed A10021 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resting EKG cardiac evaluation procedures." This involves measuring electrical activity of the heart on the body, not analyzing samples outside the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
The Vermed A10021 is an external medical device used for diagnostic purposes, but it operates in vivo (on the living body) rather than in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures.
Product codes
DRX
Device Description
The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures. This electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.
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
infant, pediatric, and adult
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, with flowing lines above them. The profiles are arranged in a row, with each one slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Vermont Medical, Inc. c/o Mr. Marc Fillion Regulatory Compliance Manager Industrial Park Bellows Falls, Vermont 05101
Re: K030073
Trade Name: Vermed A10021 "Resting EKG Tab Electrode" Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: February 13, 2003 Received: February 28, 2003
Dear Mr. Fillion:
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.
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
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Page 2 - Mr. Marc Fillion
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 vours,
K. Oahtlu
R. Zuber, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use Statement
510(k) K030073 Number (if known) Vermed A10021 "Resting EKG Electrodes" Device Name The Vermed A10021, is designed to be a single use disposable Indications electrode for resting EKG cardiac evaluation procedures. This for Use electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.
Kelle TM
510(k) Numbe
Prescription Use ✓