(74 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard physiological measurements.
No.
The device is a monitoring module that measures physiological parameters (cardiac output, right ventricular ejection fraction, mixed venous oxygen saturation, and invasive pressure), not actively treating a condition.
Yes
The device provides measurements of physiological parameters (cardiac output, right ventricular ejection fraction, mixed venous oxygen saturation, and invasive measurements) used to monitor the patient's condition, which is a characteristic function of a diagnostic device.
No
The device is described as a "module" that is a "part of the modular anesthesia monitoring system AS/3™" and provides measurements like cardiac output. This description strongly suggests a hardware component that integrates with a larger system, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as being used in a monitor to measure physiological parameters (cardiac output, ejection fraction, mixed venous oxygen saturation, and invasive measurements) of the patient. This is direct physiological monitoring, not testing of samples in vitro (outside the body).
- Device Description: The description confirms it's a module for a monitoring system that provides measurements of the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is for real-time physiological monitoring of a patient.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesia department, in intensive care department
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the word "Datex" in white letters against a black background. The background is a rounded rectangle shape. The font is bold and sans-serif. The word is centered in the rectangle.
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).