(62 days)
Multipurpose Drainage: Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Nephrostomy Drainage: Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Biliary Drainage: Catheters are intended for percutaneous drainage of the biliary tree.
The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.
The provided text describes a 510(k) summary for a Percutaneous Drainage Catheter by Navilyst Medical, focusing on its substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, study details proving device performance against those criteria, or information on AI/ML components.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study methodologies, or AI performance as the information is not present in the provided document.
The document states:
- H. Performance Data: "The proposed drainage catheters were tested and compared to predicate devices. Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use."
This broadly indicates that testing was performed to show safety, effectiveness, and substantial equivalence, including biocompatibility. However, it does not provide the specific performance metrics, acceptance criteria, or detailed study designs requested in your prompt.
To answer your specific questions, a more detailed study report or performance evaluation section would be required.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.