BARD TIGER GUIDEWIRE MODEL 000540
Device Facts
| Record ID | K962178 |
|---|---|
| Device Name | BARD TIGER GUIDEWIRE MODEL 000540 |
| Applicant | C.R. Bard, Inc. |
| Product Code | OCY · Gastroenterology, Urology |
| Decision Date | Oct 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The Bard® Tiger™ guidewire is indicated for use with devices having a .035" guidewire compatible lumen. The Tiger guidewire is designed to guide and exchange endoscopic accessories into the G.I. Tract, including, but not limited to, the common bile, cystic, the right, and left hepatic and pancreatic ducts. It is not necessary to withdraw or remove the Tiger guidewire during sphincterotomy.
Device Story
Tiger guidewire facilitates guidance and exchange of endoscopic accessories within G.I. tract; used during procedures involving common bile, cystic, hepatic, and pancreatic ducts. Operated by physicians during endoscopic procedures under visualization or fluoroscopy. Device remains in place during sphincterotomy. Core composed of Bisphenol A Epoxy and fibers; jacket of polyethylene. Nonconductive design aids in procedural safety. Benefits include streamlined accessory exchange and selective cannulation of biliary ductal system.
Clinical Evidence
No clinical data; biocompatibility testing performed to confirm safety of core and jacket materials for mucosal and tissue contact.
Technological Characteristics
Core: Bisphenol A Epoxy and fibers (fiberglass). Jacket: Polyethylene. Nonconductive. Compatible with .035" lumen devices. Mechanical design for endoscopic guidance and exchange.
Indications for Use
Indicated for patients requiring endoscopic accessory guidance and exchange within the G.I. tract, including common bile, cystic, hepatic, and pancreatic ducts, using devices with a .035" lumen.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Predicate Devices
- Boston Scientific Zebra™ Exchange Guidewire (K931650)
- Flexmedics FlexFinder Guidewire (K923755)
- Davol Laparoscopic Suction Irrigation Probe (K941334)
Related Devices
- K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO · Flexmedics · Mar 15, 1999
- K072354 — GUIDEWIRE, MODEL G-V220-3527S AND OTHERS · Accellent, Inc. · Dec 7, 2007
- K021179 — DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A · Olympus Optical Co., Ltd. · Jul 5, 2002
- K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A · Terumo Corp. · May 22, 2009
- K964780 — BARD DIRECTOR GUIDEWIRE (000560) · C.R. Bard, Inc. · Feb 26, 1997
