OLYMPUS KD SERIES SPHINCTEROTOME

K955247 · Olympus America, Inc. · KNS · Apr 30, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955247
• Device Name: OLYMPUS KD SERIES SPHINCTEROTOME
• Applicant: Olympus America, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Apr 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater

Device Story

Endoscopic electrosurgical accessory for sphincterotomy of papilla of Vater; used in clinical settings by physicians. Device comprises proximal control handle, flexible catheter shaft, and distal knife wire. Handle connects to electrosurgical generator; slider mechanism tensions or positions knife wire for cutting tissue. Provides controlled electrosurgical incision during endoscopic procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrosurgical accessory; flexible catheter with steel knife wire. Manual control handle for wire tensioning/positioning. Connects to standard electrosurgical generators. Non-sterile/sterile (implied single-use or reusable per standard endoscopic accessory practices).

Indications for Use

Indicated for patients requiring endoscopic sphincterotomy of the papilla of Vater.

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.

Predicate Devices

• Olympus KD-1/2 pre-Amendment Diathermic Cutters
• Olympus PK Papillotomy Knives
• Olympus KD-6G Sphincterotomes

Submission Summary (Full Text)

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K955247

# 510(k) Summary for Olympus KD Series of Sphincterotome

APR 30 1996

| Device Name: | Olympus KD Sphincterotome |
| --- | --- |
| Common/Usual Name: | Sphincterotome |
| Classification Name: | Endoscope Electrosurgical Unit and Accessories
21 CFR 876.4300 |
| Predicate Devices: | Olympus KD-1/2 pre-Amendment Diathermic Cutters, Olympus PK Papillotomy Knives, and Olympus KD-6G Sphincterotomes |
| Contact Person: | Barry Sands
Olympus America, Inc.
Medical Instrument Division
2 Corporate Center Drive
Melville, NY 11747-3157
[phone] |
| Summary Preparation Date: | 6 October 1995 |
| Statement of Intended Use: | The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater |
| Device Description: | The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater. The KD sphincterotomes consist of three primary parts: a proximal end control handle, a flexible catheter-like tube, and a distal end knife wire. The catheter shaft contains a thin steel wire that exits the catheter shaft for a short length and then re-enters the shaft. The exposed wire is referred to as the knife wire. The knife wire may be either tensioned or pushed to position the wire for cutting. This is accomplished by maneuvering the control handle slider accordingly. The detachable control handle contains the electrical connections which permit the knife wire to be connected to an electrosurgical generator. |