GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

K964061 · W. L. Gore & Associates, Inc. · LYK · Feb 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964061
• Device Name: GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: LYK · Gastroenterology, Urology
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.

Device Story

Kit combines three commercially available, FDA-cleared components: GORE EZE-Sit Valvulotome, angioscope, and irrigation system. Used by surgeons during in-situ bypass procedures to visualize and incise venous valves and identify tributaries. Device facilitates vein preparation; provides visual guidance via angioscope; mechanical incision via valvulotome; irrigation maintains clear field. No changes to individual component function; single Instructions for Use document provided for surgical convenience.

Clinical Evidence

No clinical data; bench testing only via reliance on previously cleared predicate components.

Technological Characteristics

Kit consists of three separate, previously cleared devices: valvulotome, angioscope, and irrigation system. No modifications to component design, materials, or energy sources. Connectivity and sterilization remain consistent with individual component clearances.

Indications for Use

Indicated for patients undergoing in-situ bypass procedures requiring venous valve incision and intravascular tributary identification.

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

• URESIL Valvulotome (K930011)
• CLARUS Angioscope (K900894)
• NEURONAVIGATIONAL Angioscope (K923996)

Reference Devices

• GORE Irrigation System

Submission Summary (Full Text)

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K 964061

FEB 20 1997

# PREMARKET NOTIFICATION SUMMARY

1. Applicant: W. L. Gore and Associates, Inc.
1505 N. Fourth St.
P.O. Box 3000
Flagstaff, Arizona 86003-3000
Phone: 800 - 528-1866
FAX: 520 - 527-0584

Contact: Dawn Lopez
Associate

2. Applicant Device: GORE EZE-Sit Angioscopic Valvulotome Kit

Common Name: Angioscopic valvulotome

Classification Name: Kit components have the following
classification names:

- Valvulotome
- Angioscope
- Intravascular administration set

3. Predicate Device:

For the purpose of determining substantial equivalence, GORE cites the following as predicate devices:

- URESIL Valvulotome (marketed under contract as the "GORE EZE-Sit Valvulotome") - K 930011
- CLARUS Angioscope - K 900894
- NEURONAVIGATIONAL Angioscope - K 923996

NOTE: One of these two, or any other FDA-cleared, commercially marketed, angioscopes will be used in the angioscopic valvulotome kit.

GORE Irrigation System - Premarket notification submitted to General Hospital/Personal Use Division; number and clearance documentation to be supplemented to this submission upon receipt.

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4. Applicant Device Description :

The angioscopic valvulotome kit, intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass, consists of commercially available components cleared under previous and/or separate 510k premarket notifications: the GORE EZE-Sit Valvulotome, an angioscope, and an irrigation system. All kit components will be used within their labeled and FDA-cleared indications; the only difference is that GORE will write a single Instructions for Use document to facilitate surgical use.

5. Intended Use : The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.

6. Technological Characteristics :

As all components of the GORE EZE-Sit Angioscopic Valvulotome will be used within their labeled and FDA-cleared indications, with the only difference being that GORE will write a single Instructions for Use document to facilitate surgical use, there are no changes in technological characteristics. The applicant GORE kit and the predicate devices have the same intended uses, the same classifications, are reviewed by the same panels and utilize the same technological characteristics to achieve equivalent clinical results. No new safety and effectiveness questions arise when using the angioscopic valvulotome kit as intended.