KARL STORZ DIRECT COUPLED CAMERA HEAD

K973252 · Karl Storz Imaging, Inc. · FET · Nov 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973252
• Device Name: KARL STORZ DIRECT COUPLED CAMERA HEAD
• Applicant: Karl Storz Imaging, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) video processor and the KSI Telecam SL with IPM (Image Processing Module) video processor. The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. An optional adapter allows DCC camera head attachment to non-DCC rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor.

Device Story

Color television camera head for endoscopic visualization; attaches to KST DCC rigid/flexible endoscopes via direct coupling or optional adapter; compatible with KSI Telecam SL and Telecam SL with IPM video processors. Features two programmable function buttons for accessory/port control and two focus buttons; light cable connects to rear; rotatable head for image orientation. Used in operating rooms by physicians; output displayed on standard OR video monitors to assist in surgical/diagnostic visualization.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Color television camera head; includes programmable function buttons and focus controls; direct coupling mechanism for endoscopes; compatible with existing KSI video processors; standard OR video monitor output.

Indications for Use

Indicated for use with Karl Storz Tuttlingen (KST) DCC endoscopic visioning systems for visualization during endoscopic procedures, including sinoscopy, colonoscopy, sigmoidoscopy, gastroscopy, bronchoscopy, laparoscopy, choledoscopy, ureteroscopy, hysteroscopy, and arthroscopy.

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

Submission Summary (Full Text)

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K973252
Nov.24,1997

## 510(k) Summary of Safety and Effectiveness

This summary of premarket notification safety and effectiveness information is being submitted in CEP This Sunninal y or premarker notheaton safety and offees Act (SMDA) of 1990 and 21 CFR 807.92.

| Application: | Karl Storz Imaging, Incorporated<br>175 Cremona Drive<br>Goleta, California 93117 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Terry Fernandez |
| Registration: | 2027009 |
| Device Name: | Proprietary Name -- Karl Storz Imaging Direct Coupled Camera Head<br>Common Name -- Color Television Camera Head<br>Classification Name -- Camera, Television, Endoscopic |
| Intended Use: | The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a<br>color, television camera head designed for attachment to a Karl Storz Tuttlingen<br>(KST) DCC endoscopic visioning system. The KSI DCC camera head is<br>compatible with the currently marketed KSI Telecam SL (Super Luxury) video<br>processor and the KSI Telecam SL with IPM (Image Processing Module) video<br>processor. |
| | The camera head is suitable for attachment to any KST DCC rigid or flexible<br>endoscope, including, but not limited to sinoscopes, colonoscopes,<br>sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes,<br>ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to<br>the endoscope by directly pressing the endoscope onto the front of the DCC<br>camera head until it locks into place. An optional adapter allows DCC camera<br>head attachment to non-DCC rigid and flexible endoscopes. The endoscopic<br>image can be displayed on any standard operating room video monitor. |
| Device Description: | The KSI DCC incorporates two programmable function buttons (to select an<br>accessory port(s) and to control the port output) and two focus buttons.<br>The light cable is connected directly to the back of the camera head. The camera<br>is designed to allow the user to directionally rotate the camera head to maintain<br>proper image orientation on the monitor. |

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Substantial Equivalence:

KSI believes that its proposed new device, the Direct Coupled Camera Head, is substantially equivalent to several other camera heads currently in commercial distribution including the camera head in the KŠI Tricam Color Endoscopic Television Camera System (K950862) and the camera head in the KSI Telecam Color Endoscopic Television Camera System (K883943). The proposed new KSI camera head is unique only in that it incorporates into one camera head variations of several features found in similar, earlier camera head models.

Signed: Terry Fernandez

Date: 08/27/97

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1997

Terry Fernandez Director, Regulatory and Standards Compliance Karl Storz Imaging, Inc. 175 Cremona Drive Goleta, California 93117

Re: K973252 Karl Stortz Direct Coupled Camera Head Dated: August 27, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78KOG and GCJ

Dear Mr. Fernandez:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing 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.

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: KSI DIRECT COUPLED CAMERA SYSTEM

Indication for Use:

The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head The Kall Storz maging (Kor) Diroce Couptlingen (KST) DCC endoscopic visioning system. The KST
designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visionin designed for attachinent to a hear its the currently marketed KSI Telecam SL (Super Luxury) and the KSI Telecam SL with IPM (Image Processing Module) video processors.

The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but I no valiford to sinoscopes, colonoscopes, sigmoidoscopes, gastroscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. The endoscopic image can be displayed on any standard operating room video monitor.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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510(k) Number _

L Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_________

Pobut D (Division Sign-Off)

and Radiological Devices

Division of Reproductive, Abdominal, ENT,

510(k) Number_1973252

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