(87 days)
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study results related to the Manan™ VS Access Needle/Set. The document is a 510(k) summary for a medical device cleared in 1998, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against specific acceptance criteria.
The 510(k) summary states the following about the device:
- Device Name: Manan™ VS Access Needle/Set
- Intended Use: For the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
- Substantial Equivalence: To the Manan Medical Products V.S. Access Needle/Set (K963767).
To address your request, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical file that outlines the device's performance characteristics and how they were evaluated against specific acceptance criteria.
§ 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.