BARD DIRECTOR GUIDEWIRE (000560)

K964780 · C.R. Bard, Inc. · OCY · Feb 26, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964780
• Device Name: BARD DIRECTOR GUIDEWIRE (000560)
• Applicant: C.R. Bard, Inc.
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: Feb 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

For use with devices having a .035" guidewire compatible lumen. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts.

Device Story

Bard Director Guidewire is a medical device used to facilitate the placement of endoscopic accessories within the GI tract and to assist in the cannulation of pancreatobiliary ducts. The device is operated by a physician during endoscopic procedures, typically performed under endoscopic and/or fluoroscopic visualization. The guidewire is advanced through a duodenoscope to the target anatomical location. Its design features a multi-segment core construction intended to provide kink resistance, torque control, and radiopacity, aiding the clinician in navigating complex ductal anatomy. By providing a stable track, the device enables the successful delivery of therapeutic or diagnostic accessories, potentially improving procedural efficiency and patient outcomes during GI interventions.

Clinical Evidence

Bench testing only. Performance was evaluated through comparative bench testing for stiffness, torque, and radiopacity against the Microvasive Geenen Endotorque and Wilson-Cook Tracer wire guides. Biocompatibility testing was performed to confirm the safety of the materials used in the device construction.

Technological Characteristics

Guidewire with three-segment core: proximal segment (Bisphenol A epoxy with fibers, polyethylene jacket), mid-section (PTFE-coated stainless steel), and distal section (nitinol tapered core, polyester weave, polyurethane, hydrophilic coating). Radiopaque. Designed for .035" lumen compatibility.

Indications for Use

Indicated for guiding endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts in patients requiring endoscopic procedures.

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

• Microvasive® Geenen Endotorque™ Guidewire (K942677/A)
• Wilson-Cook® Tracer™ Wire Guide (K910497)
• Davol® Laparoscopic Suction Irrigation Probe (K941334)

Submission Summary (Full Text)

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K964780/S1
p192
BARD

Bard Interventional Products Division
C.R. Bard, Inc.
129 Concord Road
P.O. Box 7031
Billerica, MA 01821-7031
508-663-8989
FEB 26 1997
BAARD

## 6.0 510(k) SUMMARY FOR THE BARD®DIRECTOR™ GUIDEWIRE

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

## 6.1 General Information

- Name and address of submitter:

Bard Interventional Products Division, C.R. Bard, Inc.
129 Concord Road, Building #3
Billerica, MA 01821-7031

- Contact:

Beth A. Rochette, R.A.C. Phone: [phone]
Regulatory Affairs Manager Fax: [phone]

- Date of Summary:

November 15, 1996

- Name of Device:

Trade Name: Bard® Director™ Guidewire
Common/Usual Name: Guidewire
Classification Name: Endoscope and accessory

- Predicate Device(s):

Microvasive® Geenen Endotorque™ Guidewire
Wilson-Cook® Tracer™ Wire Guide
Davol® Laparoscopic Suction Irrigation Probe

- Description and Intended Use of Device:

For use with devices having a .035" guidewire compatible lumen. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts.

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K964780
P292

## 6.2 Summary of Similarities and Differences

The Bard® Director™ Guidewire is substantially equivalent to the currently marketed Microvasive® Geenen Endotorque™ Guidewire (#K942677/A), the Wilson-Cook® Tracer™ Wire Guide (#K910497), and the Davol® Laparoscopic Suction Irrigation Probe (#K941334).

The indication statements are different, however, the Director guidewire has the same intended use as the Geenen Endotorque guidewire and the Tracer wire guide. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts. The general design and functionality of the Director guidewire is similar to these devices. All three of the guidewires are advanced through a duodenoscope (side viewing endoscope) under endoscopic and/or fluoroscopic visualization into the GI tract to the desired location. The major differences between the guidewires are:

The Director guidewire is constructed with three core segments that are bonded together. The proximal core is a Bisphenol A epoxy with fibers, covered with a polyethylene jacket, the mid section of the guidewire is a PTFE coated stainless steel, and the distal section is a nitinol tapered core covered with a polyester weave, polyurethane, and proprietary hydrophilic coating. Both the Geenen Endotorque guidewire and the Tracer wire guides have a single nitinol distal tapered core with a teflon jacket and a distal tip coating for lubricity.

Although the materials and construction are different; these materials are used in currently marketed devices. The Bisphenol A epoxy used in the proposed Director guidewire is the same material utilized with the Davol Laparoscopic Suction Irrigation Probe tip. The Davol Laparoscopic Suction Irrigation Probe is a nonconductive fiberglass probe intended for suction and irrigation of the operative site during electrosurgical laparoscopic procedures. PTFE and stainless steel are standard materials used in the manufacturing of guidewires. The jacket material covering the distal tapered nitinol core is different from the Geenen Endotorque and the Tracer wire guide, however, biocompatibility testing has confirmed the materials are safe for contacting mucosa and tissue.

The distal tapered core with the polyurethane coating provides a kink resistant, radiopaque, lubricious guidewire. Stiffness, torque, and radiopacity bench testing has confirmed the device is substantially equivalent to the Microvasive Geenen Endotorque™ guidewire and the Wilson-Cook Tracer™ wire guide.

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