(105 days)
MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy
NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy
PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest
HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.
FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Medax Biopsy Systems III does not contain any information about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.
The document is a standard 510(k) clearance letter, which focuses on:
- Substantial equivalence to legally marketed predicate devices.
- Regulatory classifications and general controls.
- Indications for Use of the biopsy needles (e.g., for soft tissues, bone marrow aspiration).
Therefore, I cannot extract the information requested for point 1 through 9. The text simply confirms the clearance of medical biopsy devices and their intended uses, not a study involving AI or algorithm performance metrics.
§ 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.