(97 days)
The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.
The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.
Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.
The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.
Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.
This document, a 510(k) Premarket Notification for the Olympus Single Use Retrieval Basket V (K243807), details the device's substantial equivalence to a predicate device. However, it does not contain the specific information required to address your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human comparative effectiveness study.
The provided text focuses on the device's mechanical, material, and operational equivalence to a previously cleared device. It outlines:
- Device Description: Single-use retrieval baskets for stones in the biliary tract.
- Performance Data: Biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135), packaging validation (ISO 11607-1, ASTM F1980-21), and mechanical testing (Insertion/Withdrawal, Open/Close Basket, Dimensional verification, Grasping Basket Effective Test, Attachment/Detachment of Hook, Injecting Fluid, Strength of Junction).
- Conclusion: The device is substantially equivalent to the predicate based on these non-clinical tests.
Crucially, the document explicitly states:
- "Animal study data and clinical study data were not required to demonstrate substantial equivalence."
This indicates that a study involving human subjects or AI-assisted performance, which would typically contain the data you're requesting, was not part of this 510(k) submission. The acceptance criteria described are for the physical and material properties of the basket, not for diagnostic performance or human-AI interaction.
Therefore, I cannot provide the requested information from this document. The device in question is a medical instrument (a retrieval basket), not an AI/software as a medical device (SaMD) that would have diagnostic performance metrics, ground truth establishment, or multi-reader studies.
§ 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.