COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM

K971057 · Cogent Light Technologies, Inc. · GCT · Mar 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971057
• Device Name: COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
• Applicant: Cogent Light Technologies, Inc.
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.

Device Story

XLS Illuminator System provides high-intensity visible light for surgical visualization. Device consists of a control box housing a Xenon arc lamp and power supply; connects to proprietary single quartz fiberoptic cable or standard fiber bundles via adapter. Used in OR/clinical settings by surgeons/staff to illuminate surgical sites via endoscopes or headlamps. Safety features include lamp access interlock, forced-air cooling, internal thermal protection, and system timer limiting lamp use to 650 hours (below 1000-hour rating). Housing includes internal baffles to contain debris in event of non-passive lamp failure. Single fiber technology provides uniform illumination compared to traditional fiber bundles. Device benefits include consistent, uniform light output and reduced risk of lamp failure during procedures.

Clinical Evidence

No clinical data. Bench testing only. Safety and effectiveness supported by design specifications, thermal protection mechanisms, lamp life management, and comparative analysis of spectral output and illumination uniformity against predicate technology.

Technological Characteristics

Xenon arc lamp light source; forced-air cooling; internal thermal protection; safety interlock; system timer for lamp life management; internal baffles for debris containment. Proprietary single quartz fiberoptic cable or fiber bundle adapter. Standalone control box unit.

Indications for Use

Indicated for providing visible light for illumination of surgical headlights and rigid or flexible endoscopes in surgical procedures including arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.

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

• Cogent Light Technologies Illuminator System (K971057)

Submission Summary (Full Text)

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From: Keith Lowrey To: FDA Donald St. Pierre Date: 3/27/97 Time: 09:21:04 Page 1 of 2 MAR 28 1997 K971057

Cogent Light Technologies 510(k) Premarket Notification for the XLS Illuminator System
510(k) Number: K 971057

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS:

A. Safety:

The Cogent Light XLS Illuminator System is designed with a safety interlock on the lamp (XLF) access cover. If the cover is opened, the power to the illuminator will be interrupted. The instrument is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and fails to operate properly and the internal temperature of the illuminator exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the unit.

The lamp (XLF) with fixture and power source may fail passively (i.e., just not turn on, or just go out). Typically, lamp and power source defects do not result in lamps going out during a surgical case. It is more likely that a lamp cannot be turned on during preparation for a surgical case. The consequences is that this would cause an inconvenience and a time delay. However, it is expected to result in no adverse medical condition in the patient.

To minimize such inconveniences, the XLS Illuminator System contains a user replaceable lamp (XLF) and would encourage the operator to have a spare lamp available on site.

The lamp (XLF) may fail in a non-passive mode, resulting in an audible sound which may startle the user. Due to the inherent nature of all short arc Xenon lamps, including those found in the predicate device, it is impossible to guarantee against all such failures, although they are rare.

To minimize such events, the XLS system has incorporated several safety features into the product design. These safety features include:

(1) The lamp is never operated beyond its specified power range.

(2) The lamp is limited to 650 operating hours by a system timer. This limit is significantly below the safe rated life expectancy of the lamp (approximately 1000 hours) as stated by the lamp manufacturer.

(3) The housing of the system has interior structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure.

(4) The user replaceable Lamp Housing Module (XLF) would minimize the inconvenience.

B. Effectiveness:

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From: Keith Lowrey To: FDA Donald St. Pierre
Date: 3/27/97 Time: 09:22:08
Page 2 of 2
K971057

# Cogent Light Technologies 510(k) Premarket Notification for the XLS Illuminator System
510(k) Number: **K 971057**

All Xenon arc lamps produce light that is spectrally similar to sunlight. What is actually delivered to an endoscope, surgical headlight, or surgical instrument, is determined by optical coatings and the transmissive properties of the light delivery system (single or bundle fiber).

The XLS Illuminator uses a proprietary single fiberoptic cable. A single multimode fiber typically produces a uniform image at the output end independent of the intensity profile of the light on the input end. By contrast, fiber bundles produce non-uniform images because they consist of many fibers bonded together, producing spaces between the fibers and generally low light intensity at the very center. Any application involving direct illumination (e.g., surgical headlamp) requires preferably uniform illumination.

Fiber bundles have been the standard light delivery system in use. Liquid bundles are somewhat more transmissive, but substantially more expensive. Light delivered through a fiber bundle is attenuated more in the blue than the red,

producing a more yellow light than that from a liquid bundle. Cogent Light Technologies’ single quartz fiber, used as part of the subject device, as well as the predicate device, transmits white light uniformly throughout the visible spectrum.

## C. SUMMARY:

Cogent Light Technologies believes that the Cogent Light XLS Illuminator System is substantially equivalent in design, component materials, function, labeling, and intended use to the Cogent Light Technologies Illuminator System.

Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.

Both devices consist of a light source control box which houses a Xenon lamp, power supply, and connects to a proprietary fiberoptic cable. With a fiber bundle adapter, this illuminator can also be used with regular fiber bundle optic cables and headlamps.

510(k) Number: **K 971057**