(139 days)
BeneVision N12/N15/N17/N19/N22
The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), 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), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:
· C.O. monitoring and A-Fib are intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
· rSO2 monitoring is intended for use in individuals greater than 2.5kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- PAWP, PNP, and PNC are intended for adult and pediatric patients only;
- A-Fib is intended for adult patients only;
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.
The subject BeneVision N Series Patient Monitors includes six monitors:
- BeneVision N12 Patient Monitor
- BeneVision N15 Patient Monitor
- BeneVision N17 Patient Monitor ●
- . BeneVision N19 Patient Monitor
- . BeneVision N22 Patient Monitor
- BeneVision N1 Patient Monitor ●
Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.
The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."
Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).
Given the information in the document, here's a structured response:
Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates
The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.
However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:
| Metric | Acceptance Criteria (Inferred from regulatory standards and typical arrhythmia detector performance) | Reported Device Performance (Implicitly stated as "meets accuracy specifications" and "substantially equivalent") |
|---|---|---|
| Arrhythmia Detection Accuracy (Sensitivity/Specificity) | e.g., Sensitivity ≥ 90%, Specificity ≥ 95% for various arrhythmia types (e.g., asystole, bradycardia, tachycardia, PVCs) in applicable age groups (neonates) | Met (stated as "meets accuracy specification") |
| False Alarm Rate | e.g., False QRS detection rate |
§ 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.