(260 days)
The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.
The PBN Dilator is comprised of tubing that is either a hard or soft polyethylene and a hub that is made of polyxymethylene. The dilators will be provided in the following French sizes of 4 through 30 Fr., and in lengths from 20 to 35 cm.
The provided text describes a 510(k) summary for the "PBN Dilators" and an FDA letter confirming substantial equivalence. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. This document is a regulatory submission for a physical medical device (dilators) and not a software-driven device requiring performance studies based on algorithms or human reading.
Therefore, I cannot extract the requested information. The document focuses on:
- Device Description: Polyethylene tubing dilators with a polyoxymethylene hub, available in Fr sizes 4-30 and lengths 20-35 cm.
- Intended Use: Introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.
- Substantial Equivalence: Claimed against Cook Urological, Inc.'s AQ Hydrophilic Dilator (K961904).
- Regulatory Clearance: FDA's confirmation of substantial equivalence for marketing.
None of the points in your request (1-9) are addressed in the provided text as they pertain to performance studies typically required for diagnostic or AI-powered devices.
§ 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.