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K Number
K030073
Device Name
VERMED A10021 RESTING EKG TAB ELECTRODE
Manufacturer
VERMONT MEDICAL, INC.
Date Cleared
2003-03-28

(79 days)

Product Code
DRX
Regulation Number
870.2360
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device (Vermed A10021 "Resting EKG Tab Electrode"). This document does NOT contain information about acceptance criteria, device performance studies, or details regarding the development and validation of an AI algorithm.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory requirements but provides no technical details about how the device's performance was evaluated or what specific criteria it met.

Therefore, I cannot fulfill your request for the following reasons:

  1. Table of acceptance criteria and reported device performance: This information is not present in the document.
  2. Sample size and data provenance for the test set: Not available.
  3. Number and qualifications of experts for ground truth: Not available.
  4. Adjudication method for the test set: Not applicable as no such study is described.
  5. MRMC comparative effectiveness study: Not applicable, as this is a physical electrode, not an AI system.
  6. Standalone (algorithm only) performance: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How ground truth for the training set was established: Not applicable.

§ 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.