(50 days)
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
The provided document is a 510(k) clearance letter from the FDA for a device called "Daum NeuroGate Trocar". This document only states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given context. The document is a regulatory approval, not a scientific study report.
§ 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.