(165 days)
The SmartGuide is intended for use in punctures of anatomical sites such as in organs, cysts, lymph nodes, and tissue spaces, for purposes of aspiration biopsy, drainage, injection, or fluid collection. SmartGuide can be used in punctures where non-penetrable anatomic obstacles (e.g. bone, spine) or vital structures (e.g. blood vessels, nerves) are to be avoided. The device is intended for use in environments such as CT and radiographic ultrasound.
The SmartGuide is a puncturing device capable of extending an inner cannula which deflects in a curved shape.
The provided text is a 510(k) summary for a medical device called "SmartGuide." This document describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based solely on the input text. The 510(k) summary focuses on regulatory submission requirements and substantiating claims of equivalence, not detailed performance studies or statistical analyses of device accuracy.
§ 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.