KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM

K063585 · KARL STORZ Endoscopy-America, Inc. · FDF · Jan 31, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063585
• Device Name: KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physican / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Video Lower G.I. Endoscope System is intended to provide optical visualization via a video woontoo and therapeutic access to the lower digestive tract.

Device Story

Flexible video endoscope system; utilizes distal-CCD chip technology for optical visualization. Inputs: optical images of lower digestive tract. Processing: image capture via distal CCD; transmission to Karl Storz Camera Control Processor; display on video monitor. Outputs: real-time visual feed of lower GI tract. Used in clinical settings by physicians/endoscopists for diagnostic examination and therapeutic procedures. Features include air/water insufflation, jet nozzle, suction, and biopsy channels for therapeutic access. Benefits: enables minimally invasive visualization and treatment of lower GI pathologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible endoscope with distal-CCD chip technology. Includes air/water insufflation, jet nozzle, suction, and biopsy channels. Connects to Karl Storz Camera Control Processor. Class II device (21 CFR 876.1500).

Indications for Use

Indicated for use by physicians/endoscopists for visual examination and therapeutic treatment of the lower digestive tract, including the anus, rectum, colon, and ileocecal valve.

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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JAN 3 1 2007

## 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 600 Corporate Pointe Drive Culver City, CA 90230 [phone]

Contact:

Susie Chen Director, Regulatory and Legal Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

Monika Campbell Senior Regulatory Submissions Specialist Telephone: [phone] Fax: [phone] Email: mcampbell @ksea.com

Device Identification:

Common Name: Video Lower G.I. Endoscope System

Trade Name: Karl Storz Video Lower G.I. Endoscope System

Indication: The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physican / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Video Lower G.I. Endoscope System is intended to provide optical visualization via a video woontoo and therapeutic access to the lower digestive tract.

144 ( =

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STORZ
KARL STORZ ENDOSCOPY

Device Description: The Karl Storz Video Lower G.I. Endoscope System includes flexible endoscopes with distal-CCD chip technology which connects to the Karl Storz Camera Control Processor treatment of the lower digestive tract. The flexible video endoscopes contain an image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Lower G.I. Endoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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 Pointe, 5th Floor CULVER CITY CA 90230-7600

JAN 3 1 2007

Re: K063585

Trade/Device Name: Karl Storz Video Lower G.I. Endoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FDF, FAM and KOG Dated: November 30, 2006 Received: December 1, 2006

### 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 max. 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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with additional 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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

#### K063585 510(k) Number (if known):

Device Name: Karl Storz Video Lower G.I. Endoscope System

Indications for Use: The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Karl Storz Video Lower G.I. Endoscope System is intended to provide optical visualization via a video monitor and therapeutic access to the lower digestive tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nancy C brogdon
(Division Sign-Off)

Division of Reproductive A and Radiological Devic 510(k) Number