(264 days)
Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a sterile surgical drape, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not contain any details about performance metrics, study designs, sample sizes, or ground truth establishment.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.