(463 days)
This device is intended for aspiration biopsy in the biliary system.
The Howell Biliary Aspiration Needle is a sterile, single use device that consists of a luer slip handle with adjustment wheel, outer catheter sheath, needle catheter with needle, stylet and winged hub. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Howell Biliary Aspiration Needle is 200 cm long. The catheter is comprised of PTFE while the needle is stainless steel and the stylet is nitinol.
The provided text describes a medical device submission (K153763) for the "Howell Biliary Aspiration Needle". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the safety and effectiveness of a novel device through extensive clinical trials for a new intended use.
Therefore, the document does not contain the information necessary to describe acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML or diagnostic imaging device, as implied by the structure of the prompt.
Specifically, the document states:
- "Performance testing consisting of non-clinical bench testing demonstrates that the Howell Biliary Aspiration Needle met the performance requirements to fulfill the intended use of the device."
- "The device is substantially equivalent to the cleared predicate device."
This indicates that the performance evaluation was based on bench testing for equivalence, not a clinical study designed to establish diagnostic performance against a ground truth.
Because the prompt asks for details typically found in submissions for AI/ML or diagnostic devices (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), and this document describes a physical medical instrument (a biopsy needle), most of the requested information is not applicable or present.
Therefore, I cannot populate the table or answer the specific questions as requested, because the provided text is about a physical medical device (a needle) and its substantial equivalence application, not a diagnostic or AI device with performance metrics like accuracy, sensitivity, or specificity against a ground truth from patient data.
§ 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.