KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM

K062918 · KARL STORZ Endoscopy-America, Inc. · FBO · Jan 17, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K062918
• Device Name: KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FBO · Gastroenterology, Urology
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

Device Story

Flexible video-urethro-cystoscope system; used for visual examination and therapeutic access during urological endoscopic procedures. System comprises video-urethro-cystoscope, Karl Storz CCU (Camera Control Unit), and light source. Physician operates device to obtain optical visualization on video monitor; provides therapeutic access for interventions. Used in clinical settings by urologists. Benefits include direct visualization of urinary tract for diagnostic and therapeutic purposes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarities to existing devices.

Technological Characteristics

Flexible endoscope; utilizes Karl Storz CCU and light source for visualization. Body contact materials consistent with existing Karl Storz devices with established biocompatibility history. System is intended for professional use in urological procedures.

Indications for Use

Indicated for physicians performing visual examination and treatment of urological endoscopic procedures. No specific patient population, age, or gender restrictions provided.

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.

Submission Summary (Full Text)

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K062918

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] | JAN 1 7 200 |
|------------------------|---------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Monika Campbell<br>Senior Regulatory Affairs Specialist | |
| Device Identification: | Common Name: Video-Urethro-Cystoscope System<br>Trade Name: Karl Storz Flexible Video-Urethro<br>-Cystoscope System | |

Indication: The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

Device Description: The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.

The Karl Storz Video-Urethro-Cystoscope System is substantially Substantial Equivalence: equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Video-Urethro-Cystoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signature: *Mhinda Campbell*

Monika Campbell Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Susie Chen Director, Regulatory and Legal Affairs Karl Storz Endoscopy-America, Inc. 600 Corporate Point, 5th Floor CULVER CITY CA 90230

JAN 1 7 2007

Re: K062918

> Trade/Device Name: Video Urethro-Cystoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: January 3, 2007 Received: January 5, 2007

Dear Ms. Chen:

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 (Premarket Approval), 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.

Image /page/1/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a circular border with text and stars.

Protesting and Promoting Public Health

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

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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## Indication for Use

510(k) Number (if known):

Device Name: Karl Storz Flexible Video-Urethro-Cystoscope System

Indications for Use: The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE!D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.Subpart D) AND/OR Over-The-Counter Use:
(21 CFR 801 Subpart C)

(21 CFR 801 Subpart C)

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Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K62918