(117 days)
The Biosensor Frequency Domain Heart Rate Variability (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques. The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician's discretion.
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The provided text is a 510(k) clearance letter and an "Indications For Use" statement for the "BIOSENSOR HOLTER MONITOR SYSTEM." It does not contain any information regarding acceptance criteria, reported device performance, sample sizes for testing, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth used, or training set specifics.
The letter from the FDA (MAR - 4 1998) confirms that the Biosensor Holter Monitor System (K974192) has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. The "Indications For Use" section describes the function of the device's Frequency Domain Heart Rate Variability (FD HRV) analysis option as an aid to other clinical diagnostic techniques for quantifying and graphically displaying heart rate changes. It also includes precautions and notes that validation data for FD HRV will be made available upon request.
Therefore, I cannot provide the requested information based on the given input.
§ 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).