XENON LIGHTSOURCE

K962365 · Dsp Worldwide · GCT · Jul 18, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962365
• Device Name: XENON LIGHTSOURCE
• Applicant: Dsp Worldwide
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.

Device Story

Fiberoptic illuminator for endoscopic surgery; provides light via fiber optic cables. Features: power switch/circuit breaker, light guide receptacle (compatible with ACMI, Storz, Olympus, Wolf adapters), lamp usage clock, manual light intensity control, intensity indicator, lamp access door, cooling fan. Used in OR/clinic by surgeons/endoscopists. Provides illumination to visualize internal anatomy during procedures; intensity adjusted manually by operator. Benefits: enables visualization for endoscopic intervention.

Clinical Evidence

Bench testing only.

Technological Characteristics

Xenon fiberoptic light source. Components: Xenon bulb, cooling fan, power supply, manual intensity control, lamp usage clock. Connectivity: fiber optic cable receptacles with adapters for ACMI, Storz, Olympus, and Wolf. Standalone device. No software/firmware.

Indications for Use

Indicated for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic surgical procedures in patients undergoing such procedures.

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

• Karl Storz Xenon Light Source

Submission Summary (Full Text)

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JUL 18 1996
K962365

DSP Worldwide Snowden-Pencer Xenon Lightsource
510(k) Summary
(per 21 CFR 807.92)

1. Date of Preparation
June 18, 1996

2. Sponsor/Applicant
DSP Worldwide
Snowden-Pencer
5175 South Royal Atlanta Drive
Tucker, GA 30084

DSP Worldwide
600 Airport Road
Fall River, MA 02720

3. Contact Name
Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance
DSP Worldwide
Telephone: [phone]

4. Device Name
Trade/Proprietary Name: Xenon Lightsource
Common/Usual Name: Xenon fiberoptic light source
Classification Name: Endoscopic accessory

5. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed:
Karl Storz Xenon Light Source

DSP Worldwide Snowden-Pencer - Xenon Lightsource 510(k) 6/18/96 Page D-1

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K962365

## 6. Device Description

The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.

## 7. Intended Use

The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.

## 8. Similarities in Technological Characteristics

The DSP Worldwide Snowden-Pencer Xenon Lightsource is substantially equivalent the Karl Storz Xenon Light Source and to other legally marketed xenon light sources in design characteristics, operational principles, and technological characteristics. Any difference between devices is minor and raises no new issues of safety and effectiveness.

DSP Worldwide Snowden-Pencer - Xenon Lightsource 510(k) 6/18/96 Page D-2