(57 days)
proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
The provided text is a clearance letter from the FDA for a medical device called "ProMedical Surgical Equipment Covers". It does not contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device submission would.
The document pertains to a Class II device (Surgical Drape and Drape Accessories) which is a physical product designed to provide a protective barrier for surgical equipment. The FDA clearance is based on "substantial equivalence" to legally marketed predicate devices, not on a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices that undergo rigorous performance evaluation studies, which is not the case for this type of surgical equipment cover.
§ 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.