(427 days)
The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
The provided text describes a 510(k) premarket notification for a Disposable Blood Pressure Transducer (DBPT). It does not contain information related to the acceptance criteria or study results for AI/ML-based devices. The discussion of non-clinical testing refers to traditional medical device testing standards (biocompatibility, product performance, safety) and a predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT)), which are typical for non-AI medical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided text. The document is for a traditional medical device, not an AI/ML-driven one.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).