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K Number
K031174
Device Name
BODY SIGNAL ECG ELECTRODE
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2003-07-10

(87 days)

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

Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.

Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding an ECG electrode. It does not contain any information about a study or performance metrics that would allow for the description of acceptance criteria or a study proving its conformance.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test and training sets, or data provenance.
  • Number of experts, their qualifications, or adjudication methods for ground truth.
  • Information on MRMC comparative effectiveness studies or standalone AI performance.
  • Type of ground truth used.
  • How ground truth was established for any training set.

The document is a regulatory approval notice, confirming that the "Body Signal ECG Electrode" is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance and the classification of the device.

§ 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.