(168 days)
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use.
Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional.
OTC: StopsBleeding™ OTC Topical Hemostat Powder and Foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are sterile, topical wound dressings comprised of plant based polysaccharides that accelerate the coagulation process to form a stable clot. The hemostatic particles contained in both the powder form and the foam form accomplish this by quickening the natural drying process at the wound site and by concentrating the vital nutrients (proteins and platelets etc.) that the body uses to naturally form a clot. When more of these nutrients are present at a wound site, the body is able to accelerate the cessation of bleeding and allow the healing process to more quickly and naturally occur on its own.
The provided document is a 510(k) summary for the CoAg Medical LLC's "Stops Bleeding Topical Hemostat Powder and Foam." This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information about acceptance criteria and the comprehensive study results (including specifics on test set size, expert panels, and MRMC studies) that you requested.
510(k) summaries are typically high-level documents demonstrating substantial equivalence rather than a full study report with detailed performance metrics against specific acceptance criteria. They generally don't include the granular data points such as the exact sample sizes of test sets, the number and qualifications of experts for ground truth establishment, or clinical study designs like MRMC studies with effect sizes, unless those were pivotal for establishing equivalence in a novel way.
The document mentions "Bench Testing" and "Performance Testing" with conclusions of substantial equivalence, but it doesn't provide the raw data or detailed methodologies of these tests.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer your specific questions about study design elements like sample sizes, expert qualifications, adjudication methods, or MRMC study results based solely on the provided text.
What the document does provide regarding performance and testing is limited to:
- Performance Testing: "Comparative water holding capability bench testing and bleeding cessation testing in a porcine animal model demonstrated that the StopsBleeding™ Topical Hemostat Powder and Foam performed substantially equivalent to the primary predicate devices."
This broadly states what was tested and the outcome (substantially equivalent), but not the acceptance criteria for that equivalence in a quantifiable manner, nor the detailed data.
To provide the information you requested, a full clinical study report or a more detailed submission document to the FDA would be necessary.
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