(15 days)
THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES
Bone Marrow Biopsy Procedure Tray
This FDA 510(k) letter for the "Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray" does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets specific performance metrics.
Here's why and what information is missing:
- Substantial Equivalence (SE) vs. Performance Data: This letter grants "substantial equivalence." This means the FDA has determined the device is as safe and effective as a legally marketed predicate device, not that it has passed specific, quantitative performance acceptance criteria in a study. A 510(k) submission typically relies heavily on comparison to a predicate device, rather than extensive new clinical or performance studies demonstrating novel performance claims.
- Device Type: A bone marrow biopsy tray is a collection of instruments and materials used to obtain a sample. The performance of the tray itself isn't typically measured by statistical metrics like sensitivity or specificity, but rather by its ability to facilitate the procedure (e.g., sterility, strength of components, ease of use, ability to obtain an adequate sample). The diagnostic performance (e.g., accuracy of diagnosis) is related to the subsequent pathological examination of the sample, not the tray itself.
Therefore, I cannot provide the requested information because it is not present in the provided document. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with 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.