(145 days)
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.
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. The Tiger guidewire core material is a composite of Bisphenol A Epoxy and fibers, while the Zebra exchange and FlexFinder guidewires are constructed of Nitinol. The Tiger guidewire jacket material is polyethylene, while the Zebra exchange and FlexFinder quidewires are constructed out of the following plastics: Fluropolymer, Urethane, and polyester.
The provided 510(k) summary for the TIGER™ GUIDEWIRE 6.0 does not contain information on acceptance criteria, device performance, or any studies with the specified details. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use.
Therefore, I cannot provide the requested information in the table format or answer the subsequent questions based solely on the given input.
The document discusses:
- Intended Use: Guiding and exchanging endoscopic accessories into the G.I. Tract.
- Predicate Devices: Boston Scientific Zebra™ Exchange Guidewire, Flexmedics FlexFinder Guidewire, and Davol Laparoscopic Suction Irrigation Probe.
- Similarities and Differences: Primarily material composition of the core and jacket. The TIGER™ guidewire uses Bisphenol A Epoxy and fibers for the core and polyethylene for the jacket, while predicate devices use Nitinol and other plastics.
There is no mention of:
- Acceptance criteria or device performance numbers.
- Sample sizes for test sets, data provenance, or training sets.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
§ 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.