(195 days)
Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms
Not Found
I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Ultrasound Systems Drape Kit." This document explains the FDA's decision regarding substantial equivalence and the regulatory classification of the device.
It does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.
§ 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.