(189 days)
The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N Q), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.
MAGLIFE C is a multi-parameter patient monitor which has been designed for use in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations. The parameters that can be monitored are electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N D), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO).
The monitor consists of a line-powered console (with optional back-up battery) which is placed outside the magnet bore, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the Maglife C patient monitor, primarily focusing on demonstrating substantial equivalence to predicate devices based on non-clinical testing and compliance with various standards.
Therefore, I cannot provide the requested information in the format specified.
However, I can extract the available information regarding testing:
Key Takeaways from the document:
- Non-clinical tests were conducted to demonstrate compliance with a list of standards (ANSI/AAMI EC13-1992, EC12-1991, SP10, SP9, BP22-1994, BP23-1986, ES21-1993, and IEC 601-1).
- The device was evaluated for electrical testing based on the November 1993 Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Devices Branch).
- Tests in an MRI unit were performed to:
- Determine the maximum field strength the Maglife C can withstand without performance degradation.
- Verify sufficiently small ferrous material content to prevent movement due to magnetic attraction.
- Assess the effect of Maglife C on the homogeneity of the magnetic field (with a 1.5 Tesla MR unit, showing it could be placed as close as 60 cm from the magnet without visible image differences).
- Conclusion from non-clinical testing: "The testing of the Maglife C demonstrates that the performance is substantially equivalent to predicate devices cited above."
Since the document focuses on non-clinical testing and substantial equivalence, and does not describe clinical studies or specific quantitative acceptance criteria for device performance with corresponding results, it's impossible to fill out the table and answer most of the questions as requested.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.