(219 days)
This device is used for endoscopic removal of biliary stones and for contrast injection.
The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon.
The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.
The provided text describes a 510(k) premarket notification for a medical device called the "Howell D.A.S.H Extraction Balloon With Multiple Sizing." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for an AI/ML-driven device.
Therefore, the information required to answer the prompt for acceptance criteria and the study that proves the device meets the acceptance criteria (specifically for an AI/ML-driven device) is not present in the provided text.
The document details:
- Device Name: Howell D.A.S.H Extraction Balloon With Multiple Sizing
- Intended Use: Endoscopic removal of biliary stones and for contrast injection.
- Predicate Device: Tri-Ex Extraction Balloon with Multiple Sizing (K170292)
- Minor Design Changes made to the predicate device (reduced catheter length and diameter, new ink markings).
- Performance Data: States "Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness."
- Non-Clinical Testing: Functional Testing (Balloon Inflation, Distal Ink Marking Validation), Shelf Life Testing, Packaging Validation, and Biocompatibility testing.
- Design Control Procedures (21 CFR § 820.30) were followed, including Risk Analysis (DFMECA).
The listed tests (Functional, Shelf Life, Packaging, Biocompatibility) are standard for physical medical devices to ensure mechanical integrity, shelf-life stability, and material safety, not for evaluating the performance of an AI/ML algorithm. There is no mention of an algorithm, AI, machine learning, or any form of software that would require the specific types of clinical validation outlined in the prompt (e.g., MRMC studies, standalone algorithm performance, ground truth establishment methods for a test set, etc.).
In conclusion, based on the provided text, it is not possible to fill out the table or answer the questions related to AI/ML device acceptance criteria and study proving performance. The document is for a traditional physical medical device seeking 510(k) clearance based on substantial equivalence.
§ 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.