(88 days)
The Daum NeuroPuncture Needle is designed for use in open and percutaneous sur cal pr of the brain i.e., punctures, biopsies and instillation of substrates. The Doum NeuroPunchia Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.
Daum NeuroPuncture Needle
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance,
or details about any studies conducted (sample size, experts, adjudication, MRMC, standalone performance, training set details).
The document is a US FDA 510(k) clearance letter for the Daum NeuroPuncture Needle, indicating that the device has been
found substantially equivalent to a predicate device. It defines the device's indications for use but does not contain
the kind of detailed study results you are asking for.
§ 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.