(29 days)
The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Not Found
This document is a 510(k) clearance letter from the FDA for the "VTI Intraoperative Doppler Systems." It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter focuses on the regulatory clearance process, general controls, and compliance with federal statutes. It does not include details about specific performance metrics, studies, or clinical trial results that would typically be used to demonstrate acceptance criteria.
Therefore, I cannot provide the requested information based on the text provided.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).