K962346 · United States Endoscopy Group, Inc. · KNS · Aug 8, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K962346
Device Name
PAPILLOTOME
Applicant
United States Endoscopy Group, Inc.
Product Code
KNS · Gastroenterology, Urology
Decision Date
Aug 8, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.4300
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
Device Story
Papillotome used in endoscopic papillotomy and sphincterotomy procedures; operated by physicians in clinical settings. Device facilitates access and cutting of the papilla/sphincter. Performance based on predicate device specifications. Sterilized via EtO.
Clinical Evidence
No clinical data provided; bench testing only based on performance specifications.
Technological Characteristics
Materials certified to standards appropriate for use; sterilization via EtO; quality assurance based on MIL-STD-9858.
Indications for Use
Indicated for patients undergoing endoscopic papillotomy and sphincterotomy. Contraindications include 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, or other physician-determined contraindications.
Regulatory Classification
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.
Submission Summary (Full Text)
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## SECTION II
### 510(K) Summary of Safety & Effectiveness
The Summary of Safety and Effectiveness for the Papillotome 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
Hardick, Marcia and Beck, Marjorie (Editors), *Manual of 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.
