(90 days)
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
Not Found
The provided document is a 510(k) summary for a medical device called the "Jamshidi Bone Marrow Biopsy Needle." It pertains to the regulatory clearance of a device, not a study evaluating its performance against specific acceptance criteria. This type of document is about demonstrating substantial equivalence to a predicate device for market approval, rather than reporting on a clinical or technical study.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it does not contain details about a performance study with such metrics.
The document primarily provides:
- Applicant Information: H.S. Hospital Service S.p.A.
- Contact Person: Mr. Lucio Improta
- Device Name: Jamshidi Bone Marrow Biopsy Needle
- Intended Use: For drawing osteomedullary substance and/or for explantation of bone marrow.
- Regulatory Information: Classification, product codes, and the FDA's clearance letter.
The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already legally marketed. This process often involves showing that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does not typically require the detailed performance study data against pre-defined acceptance criteria as would be found in a clinical trial report or a scientific publication.
§ 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.