(91 days)
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.
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.
This document does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
The provided text is a 510(k) summary for the Bard® Director™ Guidewire. It focuses on demonstrating substantial equivalence to predicate devices, primarily through:
- Description of the device and its intended use.
- Comparison of materials and construction with predicate devices.
- Discussion of biocompatibility testing.
- Bench testing for properties like stiffness, torque, and radiopacity to show substantial equivalence to predicate guidewires.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about training sets.
- Information on experts, adjudication methods, or ground truth establishment.
- Details of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fulfill your request for this specific information based on the provided text. This 510(k) summary is focused on regulatory clearance based on substantial equivalence rather than detailed performance study results against specific acceptance criteria.
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K9647800/S1
BATISTI
Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989
1192
FEB 26 1997
510(k) SUMMARY FOR THE BARDODIRECTOR™ GUIDEWIRE 6.0
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: (508) 663-8989 Regulatory Affairs Manager Fax: (508) 670-9827
Date of Summary:
November 15, 1996
Name of Device:
Bard® Director™ Guidewire Trade Name: 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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Summary of Similarities and Differences 6.2
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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.