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U.S. Department of Health and Human Services

Product Classification

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Device adjunctive predictive cardiovascular indicator
Regulation Description Adjunctive predictive cardiovascular indicator.
Definition The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Physical State The device consists of software shipped on a patient monitor. It collects data from first- or third-party sensors attached to the patient.
Technical Method The device combines data collected from indwelling catheters to produce a single value that estimates the likelihood of a future adverse cardiovascular event.
Target Area The device target area is systemic due to the broad effects of hypotension during surgical procedures.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQAQ
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible