(4 days)
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No
The summary describes a light source for surgical illumination and makes no mention of AI or ML technology.
No
The device is intended for illumination during surgical procedures and endoscopy, not for treating a disease or condition.
No
The device is a light source for illumination during surgical procedures and endoscopy. It does not perform any diagnostic function.
No
The device description explicitly states it consists of a "light source control box which houses a Xenon lamp, power supply, and connects to a proprietary fiberoptic cable," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visible light for illumination during surgical procedures using headlights and endoscopes. This is a therapeutic/surgical support function, not a diagnostic one.
- Device Description: The device is a light source. It does not interact with biological samples (blood, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely illumination for visualization during surgery.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
The Cogent Light XLS Illuminator System consists 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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Cogent Light Technologies 510(k) Premarket Notification for the XLS Illuminator Syst 510(k) Number: K 971057
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS:
Safety: A.
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 (XLl) 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 XI.S. 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:
- The lamp is never operated beyond its specified power range. (1)
- The lamp is limited to 650 operating hours by a system timer. This limit is (2) 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.
- The user replaceable Lamp Housing Module (XLF) would minimize the (4) inconvenience.
B. Effectiveness:
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K97105
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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 hetween the fihers 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 Tcchnologics 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