(70 days)
This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.
The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria. Instead, it details a 510(k) premarket notification for a medical device (J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula).
The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The "Summary of Testing" section (Page 1) mentions:
- Biological qualification safety tests: Specifically, "Cytotoxicity Test" and "Intracutaneous Reactivity Test" were performed on materials used in the device.
- Acceptance: "These materials have met the testing requirements and were found to be acceptable for the intended use."
This indicates that biocompatibility was evaluated, and the materials met the necessary safety standards for their intended use. However, these are general material safety tests, not performance-based acceptance criteria for the device itself (e.g., accuracy, success rate of bone marrow acquisition, torque resistance, etc.). The document explicitly states the "subject device has the same Technological Characteristics as a legally marketed predicate device," implying that performance is assumed to be equivalent rather than independently proven against new, quantitative acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria or details about a study demonstrating performance in the way described in your request (e.g., sample size for test set, expert qualifications, MRMC study, etc.) because this information is not present in 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.