(25 days)
RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
The modification to the SCC-100 device are as follows:
- Attachment of upper and lower plates: Modified RapidFlap device has a grooved post connection between the upper and lower plates.
- The material: Modified RapidFlap device is manufactured from titanium 6 Al 4 V alloy.
- Sterility: Modified RapidFlap device will be marketed sterile.
- Drawings for necessary instrumentation changes for application of modified device is included in Attachment I.
The provided text is a 510(k) summary for the RapidFlap Cranial Clamp, a medical device. It describes the device, its intended use, modifications from a predicate device, and potential risks. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on the regulatory aspects of device modification and substantial equivalence, not on performance studies or acceptance criteria.
To answer your questions, I would need a different type of document, such as a clinical study report, a verification and validation report, or a performance testing summary.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).