(27 days)
Not Found
No
The description focuses on acquiring and redisplaying information and providing secondary alarm annunciation, with no mention of AI or ML technologies.
No.
Explanation: The device is described as a monitoring system that provides secondary annunciation of alarms from primary medical devices. It is not intended to treat, mitigate, or cure any disease or condition.
No
The "Intended Use / Indications for Use" states, "The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care." Additionally, its primary function is "secondary annunciation of compatible primary medical device alarms" and to "redisplay it on a single monitor in a central location," not to diagnose a condition.
No
The device is described as a "PC based central monitoring station" which implies the inclusion of hardware (a PC) in addition to the software for acquiring and displaying information.
Based on the provided information, the FlexView™ Clinical Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "secondary annunciation of compatible primary medical device alarms" and to "acquire information from primary medical devices... and redisplay it on a single monitor". It's an accessory to existing medical devices and supplements, not replaces, current monitoring procedures.
- Device Description: The description reinforces its function as a "PC based central monitoring station used to acquire information from primary medical devices... and redisplay it". It focuses on data acquisition and display, not on analyzing biological samples or providing diagnostic information based on those samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of biological samples.
- Image processing, AI/ML, or specific anatomical sites, which are often associated with diagnostic devices.
The device's function is to consolidate and display data from other medical devices and provide secondary alarm notifications. This falls under the category of a medical device accessory for monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.
The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care.
The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.
The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.
Product codes
74 MSX
Device Description
The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.
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
"The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored."
"The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers."
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the modified FlexView™ Clinical Monitoring System described in this submission has been demonstrated through risk and verfication and validation testing. Test results demonstrated that the modified FlexView™ Clinical Monitoring System performance, functionality and safety characteristics are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0