(249 days)
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe.
The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.
The provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is primarily a 510(k) premarket notification letter from the FDA, followed by an "Indications for Use" statement and a "Traditional 510(k) Summary".
This type of document outlines the regulatory approval process for a medical device and describes its general characteristics and intended use, but it does not typically detail specific performance acceptance criteria, the methodology of studies, or the results in a way that would allow filling out the requested table and answering all questions.
Specifically, the document states:
- "The following performance bench and in vivo (animal) testing were performed to support the substantial equivalence of COBRA-OS to the identified predicate."
- "Performance testing was also conducted in vivo (swine model). The COBRA-OS™ meets applicable design and performance requirements."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- The specific performance metrics, thresholds, or actual results from these tests.
- Details about the sample size (other than "swine model" for in vivo) or data provenance.
- Information about experts, adjudication methods, or MRMC studies.
- Information about training sets or how their ground truth was established.
Therefore, I cannot provide the requested information based on the given input.
§ 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).