(59 days)
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, 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 is a 510(k) summary for the NMI PDC II percutaneous drainage catheter and related FDA correspondence. It discusses the device's description, intended use, technological characteristics, and a conclusion of substantial equivalence to predicate devices based on performance data. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria for device performance, the study used to prove it, sample sizes, ground truth establishment, or expert involvement.
The document only states, "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 is a general statement indicating that testing was performed, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance. (The document does not mention data being "provenced" in terms of country of origin or retrospective/prospective nature regarding clinical performance data for the device itself, only biocompatibility.)
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size. (This device is a physical catheter, not an AI or diagnostic imaging device where MRMC studies are typically performed).
- If a standalone (algorithm only) performance study was done. (Again, not applicable to a physical medical device like a catheter).
- The type of ground truth used.
- The sample size for the training set. (Not applicable as this is not an AI/algorithm-based device).
- How the ground truth for the training set was established. (Not applicable).
In summary, the provided text does not contain the granular detail about performance criteria, study design, statistical analysis, or expert involvement that you are asking for. The 510(k) submission process for this type of device (a medical catheter) focuses on demonstrating substantial equivalence to a predicate device through engineering tests (e.g., mechanical performance, biocompatibility) rather than clinical performance metrics typically associated with diagnostic algorithms or AI.
§ 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.