(68 days)
The Advance Medical Designs Fluid Pouch is a body fluid drainage device. The Fluid Pouch is used for Hysteroscopy, Cystoscopy, Urology, and Brachytherapy procedures.
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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 for a surgical fluid pouch, which focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation.
§ 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.