KARL STORZ AUTOCLAVABLE CAMERA HEAD

K994090 · Karl Storz Imaging, Inc. · FET · Feb 4, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994090
• Device Name: KARL STORZ AUTOCLAVABLE CAMERA HEAD
• Applicant: Karl Storz Imaging, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.

Device Story

The Karl Storz Autoclavable Camera Head is a color television camera designed for endoscopic visualization. It couples to rigid or flexible endoscopes to capture internal anatomical images. The device transmits signals to a compatible Karl Storz Camera Control Unit (CCU), which processes the input for display on standard operating room video monitors. Key features include a hermetically sealed housing and a magnetic switch for hand-held camera control, enabling the device to withstand pressurized steam sterilization (autoclaving). It is operated by physicians or clinical staff during endoscopic procedures to facilitate diagnosis or surgical intervention. The device provides real-time visual feedback to the surgeon, aiding in clinical decision-making and procedural guidance.

Clinical Evidence

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

Technological Characteristics

Color television camera head; single or triple CCD (charge coupled device) sensor; hermetically sealed housing; magnetic switch for controls; compatible with standard KSI CCUs; designed for pressurized steam sterilization (autoclaving).

Indications for Use

Indicated for use with rigid or flexible endoscopes (e.g., sinoscopes, colonoscopes, bronchoscopes, laparoscopes, arthroscopes) for visualization during endoscopic procedures. No specific age or gender restrictions; intended for use by clinicians in operating room settings.

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 single chip camera head (K883943)
• KSI three chip camera head (K950862)
• M.P. Video Autoclaveable Medicam 900 Digicon Camera (K942358)

Submission Summary (Full Text)

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K994090

## 510(k) Summary of Safety and Effectiveness

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<br>175 Cremona Drive<br>Goleta, California 93117 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---------|
| Contact: | Mr. Terry Fernandez | | |
| Registration: | 2027009 | | |
| Device Name: | Proprietary Name -- Karl Storz Autoclavable Camera Head<br>Common Name -- Color Television Camera Head<br>Classification Name -- Camera, Television, Endoscopic | | |
| Intended Use: | The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television<br>camera. suitable for use with any rigid or flexible endoscope, including, but not<br>limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes,<br>gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes<br>and arthroscopes. The camera head is coupled to the endoscope. The camera<br>head may be used with any current, compatible KSI camera control unit<br>(CCU). The endoscopic image can then be displayed on any standard operating<br>room video monitor. | | |
| Device Description: | The new autoclavable camera heads are identical to previous single chip and<br>three chip models with the exception that these units are hermetically sealed<br>and use a magnetic switch for operating the integral hand-held camera controls. | | |
| Substantial Equivalence: | KSI Autoclavable Camera Heads are substantially equivalent to previously<br>reviewed KSI single CCD (charge coupled device) and triple CCD camera<br>heads and, in pressurized steam sterilization capability, to M.P. Video<br>Autoclaveable Camera Heads. KSI's proposed new camera heads and their<br>indications for use are based upon KSI's premarket notification numbers,<br>K883943 (single chip) and K950862 (three chip), and its autoclavability based<br>upon M.P. Video's "Autoclaveable Medicam 900 Digicon Camera",<br>premarket notification number K942358. | | |
| Signed: | <br>Terry Fernandez | Date: | 1/31/00 |
| 1/31/00 | | | |

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**DEPARTMENT OF E**

4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K994090

KSI Autoclavable Camera Head Dated: December 2, 1999 Received: December 3, 1999 Regulatory Class: Il 21 CFR §876.1500/Procode: 78 KOG

Dear Mr. Fernandez:

1 B

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 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 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/dsma/dsmamain.html".

Sincerely yours,

CART David S. Schulte, M.D.

CAPT Daniel G. Schultz, M.D. Acting 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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| 000<br>1 | | C<br>( | |
|----------|------------------------------------------|--------|--|
| | Market<br>of the consumer of the first a | | |

510(k) Number (if known):

Device Name: KSI AUTOCLAVABLE CAMERA HEAD

Indication for Use:

The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.

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

0000021

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

510(k) Number

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K994090 |
|---------------|---------|
|---------------|---------|