(29 days)
Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for The use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed Precise™ Nitinol Stent Transhepatic Biliary System (6F) is as follows.
• 5 / 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy;
• Expanded stent diameters 8, 9, and 10 mm;
• Stent lengths: 20, 30, and 40 mm;
• Stent delivery system usable length 135 cm; and
• Guidewire lumen 0.018".
The provided text is a 510(k) summary for a medical device called "Precise™ Nitinol Stent Transhepatic Biliary System (6F)". This document focuses on demonstrating substantial equivalence to a predicate device through preclinical testing and does not contain information regarding clinical studies, acceptance criteria, or performance metrics in the way typically required for AI/ML device evaluations.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.
The document primarily covers:
- Device Name: Precise™ Nitinol Stent Transhepatic Biliary System (6F)
- Predicate Device: Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445)
- Classification: Class II
- Indications for Use: Palliation of malignant neoplasms in the biliary tree.
- Device Description: Stent delivery system profile, stent material, expanded stent diameters, stent lengths, usable length, and guidewire lumen.
- Biocompatibility: Stated that all materials are biocompatible.
- Substantial Equivalence: Stated that equivalence was confirmed through "pre-clinical testing."
There is no mention of:
- Acceptance criteria for device performance.
- Any clinical study or performance study on humans or with AI/ML components.
- Sample sizes for test sets or training sets.
- Data provenance, expert ground truth, adjudication methods, or MRMC studies.
- Ground truth types.
§ 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.