COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH

K072521 · Cook Urological, Inc. · FFS · Nov 20, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072521
• Device Name: COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
• Applicant: Cook Urological, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

Device Story

Device consists of fiber optic bundle and deflecting access sheath; used for direct visualization of body cavities/organs during urological/laparoscopic procedures. Fiber optic bundle transmits images from distal lens to proximal eyepiece/video adapter; connects to external light source. Flexor sheath provides access/protection for bundle; features dual lumen design—one for bundle, one for instrumentation; includes handle-actuated tip deflection (up to 180°). Used in clinical settings by physicians; assembled system functions like flexible endoscope. Provides visualization and access for surgical instruments; benefits patient by enabling minimally invasive diagnostic/therapeutic procedures. Fiber optic bundle is reusable (up to 10 uses, liquid sterilization); sheath is single-use.

Clinical Evidence

Bench testing only. Biocompatibility and bench performance testing conducted by manufacturer and independent laboratory per recognized standards. All test results were acceptable.

Technological Characteristics

Fiber optic bundle: 2.8 French, 115/150cm lengths, plastic sleeve, distal lens, proximal eyepiece/video adapter. Flexor sheath: 15 French OD, 45/75cm lengths, dual lumen (8.85F and 3.15F), hydrophilic coating, handle-actuated deflection (up to 180°). Energy: external light source. Sterilization: liquid immersion for bundle; single-use sterile for sheath.

Indications for Use

Indicated for patients undergoing cystoscopic, nephroscopic, laparoscopic, or ureteroscopic procedures requiring direct visualization of body cavities or organs and/or passage of endoscopic instrumentation.

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

• Karl Storz Fiberscope (K925128/B)
• Flexible Fiber Optic Bundle (K922826)
• Flexor DL Ureteral Access Sheath (K043418)
• Forte' Plus Deflecting Renal Access Sheath (K030642)

Submission Summary (Full Text)

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K072521

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# 510(k) SUMMARY

## Submitted by:

Cindy Foote Requlatory Affairs Specialist Cook Urological, Incorporated 1100 West Morgan Street Spencer. IN 47460 812-829-4891 x7281 August 31, 2007

**NOV 20 2007**

Device: Trade Name:

Proposed Classification:

Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath (Final Trade Name is not yet determined)

Endoscope, Fiber Optic Laparoscope, General and Plastic Surgery Sheath, for Endoscope

21 CFR Part 876.1500

Product Codes and Class:

78GDB. Class II 78GCJ. Class II 78FED. Class II

#### Predicate Devices:

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are similar with respect to indications for use and technology to existing predicate devices in commercial distribution, Specifically, The Cook® Fiber Optic Bundle is similar to the Karl Storz Fiberscope (K925128/B) manufactured by Karl Storz Endoscope and the Flexible Fiber Optic Bundle(K922826) manufactured by Optimed Technologies, Incorporated. The Deflecting Flexor Access Sheath is similar to the Flexor DL Ureteral Access Sheath (K043418) manufactured by Cook Urological, Incorporated and the Forte' Plus Deflecting Renal Access Sheath (K030642) manufactured by Applied Medical.

## Device Description:

The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2,8

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French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion.

The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°.

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.

### Substantial Equivalence:

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are comparable with respect to intended use to the available predicate device description and meet the requirements for 510(k) substantial equivalence.

## Test Data:

Biocompatibility and bench performance testing was performed to demonstrate the safety and performance of the Cook® Fiber Optic bundle and the Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath when used together. Testing was performed by Cook Urological, Incorporated and an independent laboratory in accordance with recognized standards. All test results were acceptable.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2007

Ms. Cindy Foote Regulatory Affairs Specialist COOK UROLOGICAL INC. 1100 West Morgan Street SPENCER IN 47460

Re: K072521

Trade/Device Name: Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FED, FFS, FAJ, FGA, GCJ and FGB Dated: September 6, 2007 Received: September 7, 2007

Dear Ms. Foote:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

N 0725 21

510(k) Number (if known):

Device Name:

Indications for Use:

Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath

The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.

Prescription Use?_____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Pemen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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