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510(k) Data Aggregation
(307 days)
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
The provided document is a 510(k) premarket notification for the SoftSeal-C device, specifically outlining its substantial equivalence to predicate devices for minor topical bleeding wounds. It does not contain information about the acceptance criteria or results from a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text. The document primarily focuses on regulatory approval based on substantial equivalence rather than presenting detailed study results for acceptance criteria.
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(55 days)
SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.
SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6.
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 (SoftSeal-STF topical hemostasis pad). While it mentions the device's intended use and technological characteristics, it does not include any details about acceptance criteria or a specific study proving the device meets said criteria.
The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against predefined acceptance criteria.
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