(30 days)
The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is intended for single use only.
The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.
The provided documents describe the Wilson-Cook Needle Knife Papillotome and its 510(k) submission. However, the information available is limited regarding acceptance criteria and a structured study proving the device meets these criteria. Medical device 510(k) submissions, especially from this era (1997), typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria as one might expect for a novel AI device today.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Established through a history of use in other similar medical devices for patient-contacting materials. |
| Sterility | Validated EO cycle, following AAMI Overkill Method to SAL 10-6. |
| Functional Performance | Functional testing conducted per approved protocol. All samples were deemed acceptable, with test specifications met. |
| Dimensional Specifications | Samples subjected to dimensional analysis; all deemed acceptable. |
| Visual Inspection | Samples subjected to visual inspection; all deemed acceptable. |
| Intended Use | Substantially equivalent to the predicate device for accessing the common bile duct when standard cannulation methods have been exhausted. |
Missing Information: Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N," "insertion force must be
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).