(61 days)
The Daum NeuroCut NeuroBiopsyNeedle is designed for biopsy of the soft tissue in the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle.
Daum NeuroCut NeuroBiopsy Needle
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Daum NeuroCut NeuroBiopsy Needle). This type of document does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement in a study.
The letter primarily confirms that the device is substantially equivalent to a previously marketed device and can therefore be legally marketed. It details regulatory classifications, general controls, and responsibilities of the manufacturer.
Therefore, according to the provided input, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets those 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.