(63 days)
The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.
Worldwide Medical Technologies AspirCore
The provided text is a 510(k) premarket notification letter from the FDA regarding the Worldwide Medical Technologies AspirCore, a bone marrow aspiration/core needle. This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, ground truth establishment, or any details of a study that proves the device meets specific acceptance criteria.
The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to the "indications for use" but does not detail any performance metrics or studies to support those indications beyond substantial equivalence to existing devices.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.