(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.
§ 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.