(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.
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510(k) SUMMARY FOR THE TIGER™ GUIDEWIRE 6.0
As required under Section 12, part (a){i)(3A) of the Sale Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.
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8.1 General Information
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Name and address of submitter:
Bard Interventional Products Division, C.R. Bard, Inc. 129 Concord Road Billerica, MA 01821-7031 -
Contact:
Beth A. Rochette Regulatory Affairs Manager -
Date of Summary:
June 6, 1996 -
Name of Device
Bard® Tiger™ Guidewire -
Predicate Device(s):
Boston Scientific Zebra™ Exchange Guidewire. Flexmedics FlexFinder Guidewire, and Davol Laparoscopic Suction Irrigation Probe.
Description and Intended Use of Device:
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.
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6.2 Summary of Similarities and Differences
The Tiger™ quidewire is substantially equivalent to the currently marketed Boston Scientifc Zebra™ exchange quidewire (K931650) and the Flexmedics Corporation FlexFinder guidewire (K923755). The tapered core material is the same as the Davol Laparoscopic Suction Irrigation Probe (K941334), which received concurrence on June 14, 1994.
The general design, and functionality of the Tiger guidewire is similar to the Boston Scientific Zebra exchange guidewire and the broader GI indication of the Flexmedics Corporation FlexFinder guidewire. All three of the guidewires have similar principles of operation. The guidewires are used to guide and exchange endoscopic accessory devices through the biopsy channel of an endoscope into the GI tract and to aid in selective cannulation of the billary ductal system under endoscopic visualization or fluoroscopy. The major differences between the guidewires are:
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- 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.
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- 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 Bisphenol A Epoxy and fibers, commonly known as fiberglass, used in the proposed Tiger quidewire is the same material utilized with the Davol Laparoscopic Suction Irrigation Probe tip. The Davol Laparoscopic Suction imigation Probe is a nonconductive fiberglass probe intended for suction and irrigation of the operative site during electrosurgical laparoscopic procedures. The probe tip is advanced to the desired location through a laparoscopic cannula under endoscopic visualization. All three guidewires have a plastic jacket, however, the jacket material of the Tiger quidewire is a slightly different polymer than used in the Zebra exchange and FlexFinder guidewire. Biocompatibility testing has confirmed the material is safe for contacting mucosa and tissue. Both of these materials were chosen for their strength and nonconductive properties.
§ 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.