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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.

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