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K Number
K961798
Device Name
CT 200 ELECTROCARDIOGRAPH
Manufacturer
MACQUARIE MEDICAL SYSTEMS
Date Cleared
1998-08-05

(818 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
K946205
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.

Device Description

The device is a battery-operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.

AI/ML Overview

The provided text is a 510(k) summary for the Macquarie CT 200 Portable Electrocardiograph. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Based on the content, the document is primarily focused on:

  • Device Identification: K961798, Macquarie CT 200 Portable Electrocardiograph.
  • Classification: Class II (74 DSP).
  • Intended Use: As a diagnostic device to receive, record, and produce a visual display of the electrical signal produced by the heart.
  • Technological Similarity: To other standard electrocardiographs producing multipage printouts and utilizing application software.
  • Regulatory Communication: FDA's letter granting market clearance based on substantial equivalence to predicate devices.

The text does not include sections typically found in a clinical study report or a performance validation document, such as:

  • Specific performance metrics (e.g., sensitivity, specificity, accuracy).
  • Details of a test set, its size, or its provenance.
  • Information about expert review, adjudication, or ground truth establishment.
  • Any mention of standalone algorithm performance or human-in-the-loop studies.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).