(289 days)
The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate(HR)), respiration rate(RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation(SvO2/ScvO2), carbon dioxide (CO2), Oxygen(O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) are the developed new series based on the technical platform of the BeneView T Series patient monitors. The new series, much more compact and flexible with the appearance changes, are the sub-configuration models of the BeneView T Series patient monitors by adding some parameters monitoring functions, such as continuous cardiac output (CCO) and mixed /central venous oxygen saturation (SvO2/ScvO2) monitoring.
And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.
The provided text is a 510(k) summary for the Mindray Passport M Series Patient Monitors. It describes the device, its intended use, and its classification, and states that it complies with recognized safety, performance, and electromagnetic compatibility standards. However, it does not include specific acceptance criteria or an explicit study describing how the device meets those criteria.
The "Test Summary" section states: "The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors: Requirements specification review, Hardware and Software testing, Code design and code reviews, Environmental EMC testing, Safety testing, Performance testing, Hardware and Software validation."
While this indicates that performance testing and validation were conducted, it does not provide details on the specific acceptance criteria, the methodology of the studies, or the reported device performance against those criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies from the provided text.
To answer your request, a more detailed performance study report would be needed.
§ 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.