(32 days)
The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the needle in order to flush the injection site for better visualization.
The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the order to flush the injection site for better needle in visualization.
This document is a 510(k) summary for a Coaxial Needle and does not contain the acceptance criteria or a study demonstrating the device meets those criteria.
The provided text focuses on:
- Product Description: How the Coaxial Needle is used (endoscopic injection for bleeding control or polyp lifting) and its components (irrigation tube/syringe attachment).
- Contraindications: Uncooperative patient and severe coagulopathy.
- Manufacturing and Quality Assurance: Mentions U.S.E.'s adherence to performance specifications, Quality Systems Regulations, and MIL-STD-9858.
- Sterilization: EtO sterilization is used.
- Bibliography: Lists general references related to gastroenterologic procedures.
- FDA 510(k) Clearance Letter: Confirms the device's substantial equivalence to predicate devices and clearance to market.
- Indications for Use Statement: Reiterates the intended uses of the device.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because it is not present in the provided text.
To answer your questions, the document would need to include information such as:
- Specific performance metrics (e.g., needle sharpness measurements, flow rates, durability tests).
- Quantifiable targets for these metrics (the acceptance criteria).
- Details of a study (e.g., experimental design, methodology, results) that evaluated the device against these metrics.
§ 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.