(65 days)
The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire is provided in two shaft flexibility's; regular shaft and stiff shaft. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure. The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness. The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).
This document does not contain an acceptance criteria table or a study description of the FlexFinder® Guidewire. The provided text is a summary of safety and effectiveness for a medical device (guidewire) and details its description, intended use, and technological characteristics, as well as a general statement about non-clinical test summaries. It states that the guidewires meet specifications for electrosurgical devices and materials, but it does not provide specific acceptance criteria values or detailed study information.
§ 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.