(74 days)
The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.
The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.
The provided text is a 510(k) summary for a medical device (Datex AS/3™ Cardiac Output and SvO2 Module). It describes the device, its intended use, and its measurement techniques. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow for the completion of the requested table and study description.
Therefore, I cannot provide the requested information based on the input text. The 510(k) summary primarily focuses on the description and equivalence to previously cleared devices, not on the detailed clinical validation studies and their results.
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510(k) SUMMARY
K961063
15.03.96
MAY 31 1996
Datex-Engström Division Instrumentarium Corp. P.O. Box 446 FIN-00101 Helsinki Finland Tel: +358 0 39411 Fax: +358 0 1463310
Contact person: Rauno Ruoho
PRODUCT NAMES
| Device name: | AS/3TM Cardiac Output and SvO2 Module |
|---|---|
| Common name: | Cardiac Output and SvO2 Measurement Device |
DESCRIPTION OF THE DEVICE
The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.
The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.
The hardware of all parameter measurement is in the M-COPSv module. The software for all measurement algorithm is in the M-COPSv module. C.O. and REF measurements are based on the thermodilution technique. Sv02 is measured utilizing a spectrophotometric technique. C.O., REF and SvO2 measurement algorithm are licensed from Baxter Edwards. The hardware and software for cardiac output and invasive pressure measurements of the COPSv module is exactly same as in the COP module (File K922876).
§ 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).