FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

Q: Who is the manufacturer of FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING?

Flexmedics filed the 510(k) submission for FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING (K964955).

Q: What is the FDA product code for FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING?

OCY. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K964955 · Flexmedics · OCY · Feb 14, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K964955
Device Name	FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
Applicant	Flexmedics
Product Code	OCY · Gastroenterology, Urology
Decision Date	Feb 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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.

Device Story

Nitinol core wire guidewire; PTFE-coated; kink-resistant; tapered distal tip; regular or stiff shaft options; available with visual ink bands for endoscopic movement detection. Used in biliary procedures to guide/exchange endoscopic accessories and electrosurgical devices. Provides electrical insulation for wire-guided electrosurgical procedures. Operated by physicians in clinical settings. Disposable, single-procedure use.

Clinical Evidence

Bench testing only. Verified material integrity, dimensions, biocompatibility, and electrical insulation performance per AAMI HF 18 standards. Results met all product specifications.

Technological Characteristics

Nitinol core wire; PTFE coating; 0.035" diameter; 260-450 cm length. Insulation meets AAMI HF 18 standard for high-frequency therapeutic devices. Sterilized, single-use disposable.

Indications for Use

Indicated for selective cannulation of biliary ducts (common bile, cystic, pancreatic, hepatic) to guide and exchange endoscopic accessories and electrosurgical devices during biliary procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Wilson-Cook Medical, Inc. Protector Plus Guidewire (K910597)
Boston Scientific Corporation Zebra Guidewire (K931650)
FlexMedics Corporation, Inc. FlexFinder Guidewire (K942074)

Related Devices

K011759 — RADIUS NEXT GENERATION GUIDEWIRE · Radius Medical Technologies, Inc. · Aug 23, 2001
K153264 — EasyPass Guidewire · Medi-Globe Corporation · May 19, 2016
K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A · Terumo Corp. · May 22, 2009
K081708 — TAXI ENDOSCOPIC GUIDEWIRE · Lake Region Mfg., Inc. · Aug 26, 2008
K023603 — ENDO-GLIDE GUIDEWIRE · Endo-Therapeutics, Inc. · Feb 19, 2003

Submission Summary (Full Text)

{0} FEB 13 1997 K 964955 P1072 # FLEXMEDICS CORPORATION ## SUMMARY OF SAFETY AND EFFECTIVENESS FlexMedics Corporation, FlexFinder® Guidewire ### A. General Provisions Submitter’s Name: FlexMedics Corporation Submitter’s Address: 12400 Whitewater Drive Minnetonka, Minnesota 55343 Contact Person: Pam L. Schaub Regulatory Affairs Manager Classification Name: Gastrointestinal guidewire (Endoscope) 21 CFR Part 876.1500 and (Electrosurgical) 21 CFR Part 876.4300. Common or Usual Name: Guidewire Proprietary Name: FlexFinder® guidewire ### B. Name of Predicate Devices Wilson-Cook Medical, Inc. Protector Plus Guidewire K910597 Boston Scientific Corporation Zebra Guidewire K931650 FlexMedics Corporation, Inc. FlexFinder Guidewire K942074 ### C. Device Description 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. {1} FlexMedics Corporation Premarket Notification FlexFinder® Guidewire K964955 P2072 The guidewires are packaged, sterilized, and labeled and intended for one procedure use only (disposable). ## D. Intended Use 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. ## E. Summary of Technological Characteristics The FlexFinder® Guidewire uses common biocompatible materials which are identical to those of currently marketed Gastrointestinal guidewires manufactured by FlexMedics Corporation in K942074, Boston Scientific Corporation in K931650, Wilson-Cook Medical, Inc. in K910497. ## F. Non-Clinical Test Summary The guidewires have been verified as meeting specifications for electrosurgical devices providing insulation from the electrosurgical current; material integrity; dimensions; and, material biocompatibility. The results of functional testing were analyzed against product specifications and currently marketed devices. The test results demonstrate that the product meets requirements and is acceptable for its intended use.