(519 days)
The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.
The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.
The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It states that "various testing which included bench, biocompatibility, and animal testing was performed on the Boomerang Wire System to ensure the product and the product materials were adequately test and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use. In addition, post market clinical data have been included to further support that the product meets or exceeds the performance requirements and is safe and effective for its intended use." However, it does not provide the specifics of these tests or the "post market clinical data."
Therefore, I cannot populate the table or answer the specific questions provided in the request based on the given information.
Missing Information:
- Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., success rates, complication rates, time to hemostasis, etc.).
- Reported Device Performance: Without acceptance criteria, the document does not report specific performance metrics that can be directly compared against criteria.
- Study Design Details: There are no details about the design of any clinical studies, including:
- Sample size for test set
- Data provenance
- Number of experts, their qualifications, or adjudication methods for ground truth
- MRMC study details or effect size
- Standalone performance
- Type of ground truth used
- Sample size for training set (if applicable for an AI device, which this is not)
- How ground truth for training set was established (if applicable)
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than detailing the results of performance studies against specific acceptance criteria.
§ 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).