KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS

K962595 · KARL STORZ Endoscopy-America, Inc. · FFS · Sep 4, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962595
• Device Name: KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: Sep 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is designed to supply light for endoscopic diagnostic and surgical procedures.

Device Story

300W xenon light source; provides illumination for endoscopic diagnostic and surgical procedures. Features manual or automatic brightness control. Not intended for flash photography. Used in clinical settings by physicians/surgeons. Device supplies light via fiber optic cables to endoscopes to visualize internal anatomy; assists in surgical/diagnostic decision-making by providing necessary visibility.

Clinical Evidence

Bench testing only.

Technological Characteristics

300W xenon lamp; manual or automatic brightness control; non-flash application; electrical power source.

Indications for Use

Indicated for patients undergoing endoscopic diagnostic and surgical procedures requiring illumination.

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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STORZ
Karl Storz Endoscopy
SEP - 4 1996
K962595

# 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 documents are accurate and complete to the best of KSEA’s knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

## Contact:

Betty M. Johnson
Manager, Regulatory Affairs

## Device Identification:

**Common Name**
300W Xenon Light Source

**Trade Name**
Karl Storz Xenon 300 Light Source for Non-Flash Applications

## Indication:

This device is designed to supply light for endoscopic diagnostic and surgical procedures.

## Device Description:

This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.

## Substantial Equivalence:

The KSEA light source is substantially equivalent to the predicate device, since the basic features, design and intended uses are the same. The minor differences between the Xenon light source and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.

Signed: Betty M. Johnson
Manager, Regulatory Affairs

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