KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM

K974391 · Karl Storz Imaging, Inc. · GCJ · Jan 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974391
• Device Name: KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
• Applicant: Karl Storz Imaging, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope. The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.

Device Story

Endovision XL is a color endoscopic television camera system. Input: optical images from rigid or flexible endoscopes via V-mount optical adapters (15mm, 20mm, 25mm). Processing: microprocessor-controlled automatic exposure adjustment for image brightness; 1/4" CCD-chip sensor. Output: video signal displayed on standard operating room monitors. Used in clinical/OR settings by physicians to visualize internal anatomy during endoscopic procedures. Benefits: provides smaller, lighter, more portable visualization compared to previous systems; assists in clinical decision-making by providing real-time visual feedback of surgical or diagnostic sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes a camera head with 1/4" CCD-chip and a video processor. Features V-mount thread for optical adapters (15mm, 20mm, 25mm). Processor weight: 1.77 lbs; camera weight: 0.6 lbs. Microprocessor-controlled automatic exposure. Connectivity via 10-foot cable to standard OR video monitors.

Indications for Use

Indicated for use with rigid or flexible endoscopes (e.g., sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes, arthroscopes) for visualization during endoscopic procedures. Prescription use only.

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

• KSI Tricam Color Endoscopic Television System (K950862)
• KSI Telecam Color Endoscopic Television System (K883943)

Submission Summary (Full Text)

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JAN 30 1998

# 510(k) Summary of Safety and Effectiveness

K974 391

This summary of premarket notification 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.

Application: Karl Storz Imaging, Incorporated
175 Cremona Drive
Goleta, California 93117

Contact: Mr. Terry Fernandez

Registration: 2027009

Device Name: Proprietary Name -- Karl Storz Imaging Endovision XL Endoscopic Camera System
Common Name -- Color Television Camera System
Classification Name -- Camera, Television, Endoscopic

Intended Use: The Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope.

The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.

Device Description: The Endovision XL is a state-of-the-art endoscopic camera. The head of the camera is equipped with a V-mount thread, allowing the head to couple to Karl Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm, are available with the system. These couplers allow easy attachment of the XL head to any standard endoscope. Microprocessor controlled automatic exposure adjusts image brightness. The image sensor is a 1/4" CCD-chip.

The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07 inches and 1.96 x 2.4 x 3.9 inches respectively.

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# Substantial Equivalence:

KSI believes that its proposed new device, the Endovision XL endoscopic camera system, is substantially equivalent to several other systems currently on the market including the KSI Tricam Color Endoscopic Television System (K950862) and the KSI Telecam Color Endoscopic Television System (K883943). The proposed new KSI Endovision XL is unique only in that it is a smaller, lighter, more portable camera system.

Signed: Terry Fernandez
Date: 1/26/98

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JAN 30 1998

Mr. Terry Fernandez
Director Regulatory & Standards Compliance
Karl Storz Imaging, Incorporated
175 Cremona Drive
Goleta, California 93117

Re: K974391
Trade Name: Karl Storz Endovision XL Endoscopic Camera System
Regulatory Class: II
Product Code: GCJ
Dated: November 20, 1997
Received: November 21, 1997

Dear Mr. Fernandez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Fernandez

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page ______ of ______

510(k) Number (if known): _________________________

Device Name: KSI ENDOVISION XL CAMERA SYSTEM

Indication for Use:

The Karl Storz Imaging (KSI) Endovision XL Camera System is a color, television camera system designed for attachment to endoscopic visioning systems.

The camera head is suitable for attachment to any rigid or flexible endoscope, including, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope with a V-mount adapter. The camera is connected to the video processor via cable. The endoscopic image can be displayed on any standard operating room video monitor.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


510(k) Number K974391

Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐

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