(16 days)
The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a device called "VTI 20 MHz Gated Doppler." This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt for evaluating a device's performance against acceptance criteria.
The document primarily focuses on:
- Confirming the FDA's review of the 510(k) submission.
- Stating that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements the manufacturer must comply with.
- Identifying the device's regulation number, regulation name, regulatory class, and product code.
- Providing an "Indications for Use Statement" which clarifies what the device is intended for (intraoperative and transcutaneous evaluation of blood flow).
Therefore, I cannot provide the requested table and information based on the given text. The information needed for such a description would typically be found in the 510(k) summary, clinical study reports, or validation reports that are part of a more comprehensive submission, not in the FDA's clearance letter itself.
§ 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).