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510(k) Data Aggregation
(212 days)
Corsano Health B.V.
The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.
The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.
The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.
The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):
- Pulse rate
- Oxygen saturation
- Temperature
- Movement
The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):
- Respiration rate.
The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:
- Non-invasive blood pressure
- Lung function & spirometry
- Weight
The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.
The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor.
The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.
The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.
Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.
The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).
The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.
The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
The Corsano CardioWatch 287-2 System's acceptance criteria and studies are detailed below, primarily focusing on Pulse Rate, SpO2, Respiration Rate, and Skin Temperature.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Feature | Acceptance Criteria (Proposed Device) | Reported Device Performance (Proposed Device) | Predicate Device Performance | Comment in Document |
|---|---|---|---|---|
| Pulse Rate Measurement Range | 25 BPM to 250 BPM | 25 BPM to 250 BPM | 30 BPM to 240 BPM | Similar range; no impact safety & effectiveness as validation has been made through bench & clinical testing. |
| Pulse Rate Accuracy | 3 BPM ARMS | 3 BPM ARMS | 3 BPM ARMS | Identical, both comply with ISO 80601-2-61. |
| SpO2 Measurement Range | 70% to 100% | 70% to 100% | 70% to 100% | Identical |
| SpO2 Measurement Resolution | 1% | 1% | 1% | Identical |
| SpO2 Accuracy |
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