(51 days)
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
This document is a 510(k) summary for a medical device called "Papillotome." It describes the intended use, contraindications, potential complications, and manufacturing overview of the device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.
Therefore, I cannot provide the requested information based on the provided text. The document is solely focused on the regulatory submission for a physical medical device and lacks any data or details pertaining to an AI/ML study.
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AUG - 8 1996
SECTION II 510(K) Summary of Safety & Effectiveness
Summary of Safety and Effectiveness for the Papillotome The reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
Contraindications for Papillotomy and Sphincterotomy Procedure
- Coagulopathy .
- Acute pancreatitis (relative) -
- Allergy to contrast medium (relative) .
- Long stricture of the distal common bile duct .
- Presence of an extremely large stone .
- Inability to properly position sphinctertome .
- Other contraindications as determined by physician .
Complications that May Occur
- Bleeding •
- Perforation and impaction of stone or basket may occur as . immediate complications
- Torrential and late bleeding are rare .
- The occurrence of pancreatitis .
Manufacturing Overview
U.S.E. manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.
U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
Sterility Testing
The Papillotome is sterilized using Eto.
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Bibliography
- Manual of (Editors), Hardick, Marcia and Beck , Marjorie Gastrointestinal Procedures, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989.
Ravenscroft, M.M. and Swan, C.H.J. Gastrointestinal Endoscopy and Related Procedures. Baltimore: Williams & Wilkins, 1984.
Berci, George Endoscopy. New York: Appleton-Century-Crofts, 1976.
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§ 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).