(143 days)
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.
Chito-Seal is a topical bandage intended to promote hemostasis when in contact with a bleeding wound.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary and approval letters for a device called "Chito-Seal™". While it describes the device, its intended use, and states that "Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of Chito-Seal", it does not provide specific details about acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information.
The document focuses on demonstrating substantial equivalence to a predicate device (Marine Polymer Technologies SyvekPatch® (K984177)) rather than detailing the results of a specific clinical performance study with acceptance criteria.
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