(166 days)
The Sterile endoscope biopsy sampling need to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope.
Sterile endoscope biopsy sampling needle, Model: DT-EN-W7 is mainly composed of needle head, PEEK outer tube assembly, and handle. Sizes are available in 18 - 22 gauge needles. The length of the needles range is between 0 and 80 mm. The needle is used by advancing the entire device to the site of soft tissue sampling through endoscopic channel aperture. The needle is advanced with gentle but firm pressure. Once the needle is in position, stab hard into the tissue and connect the external end of needle tube with aspirator in negative pressure. Retreat the needle head into tube, and get the needle out of the endoscope through the channel. The sample can then be expelled from the stylet notch.
The provided text describes a 510(k) premarket notification for a medical device called "Sterile Endoscope Biopsy Sampling Needle". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets explicit acceptance criteria through a standalone study in the way an AI/ML device would be assessed.
Therefore, many of the specific questions about acceptance criteria for an AI/ML device are not directly applicable or answerable from this document. However, I can extract the relevant performance data summaries and the non-clinical testing conducted to establish substantial equivalence, which serves a similar purpose in the context of this device type.
Here’s a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
The document defines "Technological characteristics" which act as acceptance criteria for the device, and then reports that performance bench testing was successfully completed for these. However, exact numerical "reported device performance" values against each criterion are not provided in this summary, only that they met the requirements.
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance |
|---|---|
| Smoothness and leakproofness | Successfully completed |
| Details: Needle head moves freely and smoothly in outer tube. Tip stays in outer tube after retraction. Pull rod fixed apace when operating aspirator and turning it. No air leakage except air passageway. | Meets all requirements |
| Joint strength | Successfully completed |
| Details: Connection of outer tube and handle ≥15N; connection of needle head and handle ≥15N. | Meets all requirements |
| Puncture force | Successfully completed |
| Details: Needle tip sharp with maximum puncture force ≤ 8 N. | Meets all requirements |
| Stiffness and resistance to breakage | Successfully completed |
| Details: Good stiffness with span 15mm ±0.1mm, load 10N ±0.1N, deflection value ≤ 0.50mm. Not broken in the same plane at 20 degrees by two-way repeated bending for 20 times with span 17.5mm ±0.1 mm. | Meets all requirements |
| Reducing substance | Successfully completed |
| Details: KMnO4 solution consumption volume of test liquid |
§ 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.