(20 days)
The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Any use for procedures other than those indicated in the instructions is not recommended.
The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure.
The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft.
The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.
Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (Bridge Occlusion Balloon). It discusses the device's indications for use, comparison to a predicate device, and the basis for its substantial equivalence.
However, it does not contain details about a study that proves the device meets specific acceptance criteria based on performance data. Specifically, the document states:
- "No preclinical or clinical data was needed to support this submission."
- "The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years."
This indicates that any "test data" referred to is related to shelf-life and packaging changes, not a performance study of the device itself with acceptance criteria for a new or modified functionality. There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request based on the provided text.
§ 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).