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510(k) Data Aggregation
K Number
K231586Device Name
Endophys Blood Pressure Monitor model BPM-30
Manufacturer
Endophys Technologies LLC
Date Cleared
2023-11-03
(156 days)
Product Code
DSK
Regulation Number
870.1110Why did this record match?
Applicant Name (Manufacturer) :
Endophys Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endophys Blood Pressure Monitor Model BPM-30 is intended to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys PSS3 Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access. The Endophys Blood Pressure Monitor Model BPM-30 monitor is additionally intended for use in transport situations within hospital environments.
Device Description
The Endophys BPM-30 Blood Pressure Monitor is an electronic device that provides compatibility between a physiological fiber optic blood pressure sensor (transducer) and conventional invasive arterial blood pressure inputs to a standard physiological patient monitor. The device converts the optical transducer data to electrical signals that are interpreted by a conventional patient monitor and/or are displayed directly on the BPM-30. The BPM-30 accurately emulates a fluidic arterial blood pressure transducer and supplies electrical signals to its output that are indistinguishable from a conventional fluidic blood pressure transducer.
The BPM-30 is implemented as a self-contained unit that has a fiber optic transducer connection as an input source and communicates with a patient monitor as its output. The BPM acts to directly emulate the electrical interface characteristics of conventional fluidic blood pressure transducers (that patient monitors are compatible with) while providing much more precise blood pressure data derived from a fiber optic transducer placed within an artery. Electrically emulating a conventional fluidic transducer uniquely allows a fiber optic pressure sensor to be used with a wide variety of existing physiological patient monitors without modification of those monitors. Systolic, diastolic, and mean blood pressure values are also displayed directly on the BPM-30 every four seconds.
The BPM-30 is powered by a standard AC power adapter. The BPM-30 also has an internal battery supply that will automatically recharge and maintain operation during brief (up to 30 minutes) power interruptions. The BPM-30 is used outside of the sterile environment and has standard alerts and alarms.
The BPM-30 has an operating pressure range of -30 to 300 mmHg with an accuracy of ±1 mmHg plus ±1% of reading for pressures ≤ 50 mmHg and within ±3% of reading for pressures ≥ 50 mmHg
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