(90 days)
This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets the acceptance criteria. The document is a 510(k) summary for a "BMN 'I' Type Marrow Biopsy Needle," which is a premarket notification to the FDA. It includes:
- Applicant and contact information.
- Device name, common name, and classification.
- Indication for use.
- FDA's determination of substantial equivalence to a predicate device.
- Regulatory information regarding marketing, general controls, and compliance.
There is no mention of performance metrics, acceptance criteria, study design, results, or ground truth establishment. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study.
§ 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.