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K Number
K974546
Device Name
BIOSENSOR HOLTER MONITOR SYSTEM
Manufacturer
BIOSENSOR CORP.
Date Cleared
1998-03-04

(90 days)

Product Code
DQK
Regulation Number
870.1425
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Hotter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below, (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Reingquist I, Year Book Medical Publishers, 1981.)

  1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

  2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

  3. Evaluation of patients for ST segment changes.

  4. Evaluation of patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

  5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.

  6. Clinical and epidemiological research studies.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Biosensor Holter Monitor System, which declares the device substantially equivalent to a predicate device.

While it mentions the intended use of the device, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods for ground truth, or types of ground truth used in any specific study.
  • Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • Training set details.

This type of information would typically be found in a separate clinical study report or a more detailed section of the 510(k) submission, not in the clearance letter itself.

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).