(154 days)
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.
The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.
The provided text describes the regulatory clearance of the ALARA BMA Neuro Access Kit, focusing on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing. However, it does not include acceptance criteria, reported device performance, or details of a study that proves the device meets specific performance criteria.
Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided document. The document primarily focuses on regulatory approval based on comparison to existing legally marketed devices, rather than a detailed performance study against predefined acceptance criteria.
§ 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.