(15 days)
The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Not Found
I am sorry, but the provided text from the FDA letter about the "ClosureFAST™ Intravascular Catheter" (K082890) does not contain the specific details required to answer your request regarding acceptance criteria and a study proving device performance.
The document is a 510(k) clearance letter, which primarily states that the device has been found substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, product code, and indications for use. However, it does not include information about:
- Acceptance criteria or reported device performance metrics.
- Details of any specific study (sample size, data provenance, ground truth, expert qualifications, adjudication methods).
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
- Training set details for any AI/algorithm (which isn't applicable here as this is a catheter, not an AI device).
Therefore, I cannot generate the requested table and study details based on the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.