(399 days)
Occlusion of small vessels as a compliment to bipolar coagulation.
These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
The provided text describes a 510(k) summary for the Sugita AVM Microclip, focusing on its design, intended use, and a summary of test data. However, it does not contain the level of detail regarding acceptance criteria and the comprehensive study methodology typically found in regulatory submissions for AI/ML-driven devices.
The information provided is more akin to validation testing for a medical device that does not involve algorithmic performance or human-AI interaction. Therefore, I cannot fully answer all aspects of your request as the input document does not contain the necessary information.
Based on the provided text, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Changes During Sterilization | Change in closing force |
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).