(79 days)
Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.
Bone Marrow Biopsy and Aspiration Tray
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a "Bone Marrow Biopsy and Aspiration Tray," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, such as good manufacturing practices, labeling, and drug components within the kit, but it does not detail performance metrics or studies performed to prove the device meets specific acceptance criteria.
§ 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.