(141 days)
The Heartport Cable Bulldog Clamp is intended for the temporary occlusion of a vessel, including the Internal Mammary Artery or vein grafts, and other clamping procedures. The Cable Bulldog Clamp may be introduced to surgical sites through a thoracic port or incision for use during endoscopic cardiac surgical procedures.
The Heartport Cable Bulldog Clamp combines the same functions as the individual predicate devices into a single device.
The provided text is a 510(k) summary for a medical device (Heartport™ Cable Bulldog Clamp). It does not contain information about acceptance criteria for an algorithm/AI study or details of a study that would prove a device meets such criteria. Therefore, I cannot generate the requested table and information.
The document focuses on:
- Device Information: Classification, trade name, common name, product code.
- Equivalent Devices: Listing predicate devices it is substantially equivalent to.
- Intended Use: Temporary occlusion of vessels during endoscopic cardiac surgical procedures.
- Comparison to Predicate Devices: Stating it combines functions of existing devices.
- Non-Clinical Test Results (Performance): It mentions in vitro testing for "clamping force" and states it was "equivalent to the predicate device tested and meets the anticipated clinical requirements." However, it does not provide specific acceptance criteria or detailed results.
- Non-Clinical Test Results (Biocompatibility): States materials are similar to predicates and have proven biocompatibility.
- Conclusion: Substantial equivalence.
This is a regulatory submission for a physical medical device, not an AI/algorithm-based device, and thus the requested AI-specific acceptance criteria and study details are not present.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).