(137 days)
The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
Not Found
The provided text is a clearance letter from the FDA for the Syvek Patch™ (K972914) dated December 22, 1997. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. The letter simply grants market clearance based on substantial equivalence, implying that the detailed studies proving performance against specific criteria would have been part of the 510(k) submission, but those details are not present in the provided content.
Therefore, I cannot provide the requested information.
§ 880.5240 Medical adhesive tape and adhesive bandage.
(a)
Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.