IMAGE1 GI CCU MODEL 22203020-114

K111997 · KARL STORZ Endoscopy-America, Inc. · FET · Apr 6, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K111997
• Device Name: IMAGE1 GI CCU MODEL 22203020-114
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Apr 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

Device Story

Image1 GI CCU is a camera control unit (CCU) used with a videoscope and light source to provide optical visualization for GI endoscopy. Device processes video signals from endoscope for display on a monitor; enables image recording via USB storage or printer. Operated by physicians/endoscopists in clinical settings. Features include brightness, enhancement, white balance, zoom, and HD capability. Incorporates KARL STORZ Communication Bus (SCB) for system integration. Benefits include enhanced image quality for GI procedures and improved documentation capabilities.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Camera control unit (CCU) and keyboard. Features: brightness control, enhancement control, light source control, white balance, zoom, HD capability, and USB connectivity for storage/printing. Incorporates KARL STORZ Communication Bus (SCB).

Indications for Use

Indicated for use by physicians/endoscopists for optical visualization and image recording during diagnostic and therapeutic procedures of the upper and lower digestive tract.

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

• Image1 Video Imaging System (K003325)
• Fujinon EPX-4400HD Video Processor and Light Source (K102466)

Submission Summary (Full Text)

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K111997

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APR - 6 2012

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. 2151 E. Grand Ave El Segundo, CA 90245 [phone]

Contact:

Winkie Wong Associate Regulatory Affairs Specialist

Date of Preparation:

July 11, 2011

#### Device Identification:

Gastroscopes and Accessories, Flexible/Rigid Common Name:

Trade Name: (optional) Image1 GI CCU

Indications: The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

Device Description: The Image1 GI CCU consists of two components: the camera control unit and a keyboard. The Image1 GI CCU is used in conjunction of a videoscope and a light source, which transmit the video signals to camera control unit (image processor) to provide optical visualization via a video monitor.

Substantial Equivalence: The Image1 GI CCU is a modification of the already cleared Image1 Video Imaging System, previously known as KSI's New Camera Architecture (NCA) Video Imaging System (K003325). The underlying fundamental technology and intended use remains unchanged. All the changes were made to enhance image quality specifically for GI indication and to allow to print an image via the USB printer or store an image to a USB storage device for documentation purpose. Internal safety and performance testing are performed to ensure the safety and efficacy of the device.

The Image1 GI CCU is also substantially equivalent to Fujinon EPX-4400HD Video Processor and Light Source (K102466). Both devices consist of a video processor (CCU) and a keyboard. They also share the same indications for use and fundamental technologies, which offers external image storage capability and

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similar features such as: Brightness Control, Enhancement Control, Light Source Control, White Balance, Zoom and HD Capability. The differences between the subject and predicate devices are the subject device incorporates the KARL STORZ Communication Bus (SCB) system for ease of use.

Conclusion: The Image1 GI CCU is substantially equivalent to the identified predicate devices and the differences between the subject and the predicate devices do not raise any new issues of safety and efficacy.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

PR -6 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Winkie Wong Associate Regulatory Affairs Specialist KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

Re: K111997

Trade/Device Name: Image1 GI CCU Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: March 13, 2012 Received: March 14, 2012

### Dear Ms. Wong:

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 for association 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 r ou mayy are su provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of advisod that I Dri a labor that your device complies with other requirements of the Act that i DA hade a dotenminentistic is as administered by other Federal agencies. You must of any I cocraf statures and regulements, including, but not limited to: registration and listing Confight and and the Prev Store Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

K111997

510(k) Number (if known): Not yet assigned

### Device Name: Image1 GI CCU

Indication for use: The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

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

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)

Helent Lunn

Division' Sign-Off) sion of Reproductive, Gastro-Renal, and ological Device k) Numbe