(78 days)
The BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "BMC Radio Frequency Perforation Generator."
This letter grants market clearance based on substantial equivalence to a previously marketed device, not on specific acceptance criteria and performance data as might be found in a clinical trial report or a detailed justification for performance claims.
The document primarily states:
- The device name: BMC Radio Frequency Perforation Generator
- The FDA regulation number and name the device falls under.
- The FDA's determination of substantial equivalence.
- Indications for Use: "The BMC Radio Frequency Perforation Generator... is indicated for use in general surgical procedures to cut and coagulate soft tissue."
Therefore, I cannot extract the requested information about acceptance criteria, detailed study parameters, or performance results from this document.
§ 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.