(89 days)
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No
The description focuses on the optical and mechanical components of a light source, with no mention of AI or ML technologies.
No
The device is described as a light source for illumination purposes for accessories like headlights and endoscopes, not for treating or diagnosing medical conditions.
No
The device description states it is a light source for illumination, and the intended use confirms it supplies illumination for accessories like headlights and endoscopes, which are tools used for viewing, not for diagnosis by themselves.
No
The device description clearly details hardware components such as a light source, turret, lamp module, shutter, lens, and filters, indicating it is a physical medical device, not software-only.
Based on the provided information, the Lumenon™ Xenon Light Source is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "supply adjustable high intensity illumination for accessories such as headlights and endoscopes." This describes a device used for visualization during medical procedures, not for examining specimens in vitro (outside the body).
- Device Description: The description focuses on the light source's technical specifications (xenon lamp, lenses, filters, intensity control) and its function in providing light for other medical devices. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or methods for analyzing biological samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions. The Lumenon™ Xenon Light Source does none of these things.
Therefore, the Lumenon™ Xenon Light Source is a medical device used for illumination during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lumenon™ Xenon Light Source is intended to supply adjustable high intensity illumination for accessories such as headlights and endoscopes.
Product codes (comma separated list FDA assigned to the subject device)
78 GCT
Device Description
The Lumenon™ Xenon Light Source is a fiberoptic illuminator for supplying high intensity illumination for accessories such as headlights and endoscopes. The device has a universal turret with four (4) receptacles to accept various light cables. It features a quick-change lamp module and two (2) lamp life indicators. The device incorporates a graduated shutter to attenuate the intensity of the light output, adjustable from 0 to 100 percent. The intensity control is adjusted by turning the attenuater knob located on the front panel The Lumenon™ Light Source utilizes a Plano Convex Lens for focusing light down to the diameter of the fiber optic cable. The 5600°K, light is produced by a Xenon Ceramic Short Arc Lamp. The visible output is 515 X 10(3) Candelas. The equivalent visible output in terms of Lux is 47,862 Lux. ORC coats the glass window of the xenon lamp in order to reduce UV output. The IR is reduced by a glass filter with an IR coating which blocks IR transmissions. UV output is 2.6 watts.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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Summary of Safety and Effectiveness
| Submitter Name and Address: | Walter Lorenz Surgical, Inc
1520 Tradeport Drive
Jacksonville, FL 32218-2480 |
|------------------------------|------------------------------------------------------------------------------------|
| Contact Person and Telephone | Trevor Byrd
(904) 741-9455 |
Device Name: Lumenon™ Xenon Light Source
Classification Name and Reference: Light Source, Endoscope, Xenon Arc
Intended Use: The Lumenon™ Xenon Light Source is intended to supply adjustable high intensity illumination for accessories such as headlights and endoscopes.
Detailed Device Description: The Lumenon™ Xenon Light Source is a fiberoptic illuminator for supplying high intensity illumination for accessories such as headlights and endoscopes. The device has a universal turret with four (4) receptacles to accept various light cables. It features a quick-change lamp module and two (2) lamp life indicators. The device incorporates a graduated shutter to attenuate the intensity of the light output, adjustable from 0 to 100 percent. The intensity control is adjusted by turning the attenuater knob located on the front panel The Lumenon™ Light Source utilizes a Plano Convex Lens for focusing light down to the diameter of the fiber optic cable. The 5600°K, light is produced by a Xenon Ceramic Short Arc Lamp. The visible output is 515 X 10(3) Candelas. The equivalent visible output in terms of Lux is 47,862 Lux. ORC coats the glass window of the xenon lamp in order to reduce UV output. The IR is reduced by a glass filter with an IR coating which blocks IR transmissions. UV output is 2.6 watts.
Potential Risks:
- The Lumenon™ Xenon Light Source must not be used in the presence of flammable . anesthetics or other flammable gases due to the danger of possible explosion.
- High energy radiated light guided through endoscopes or fiber optics may produce . high temperatures in front of the light outlet and at the tip of the instrument.
- Verify that the tip of the instrument is not in excess of 41° C prior to use. .
- This product should be used only with type BF endoscopic instruments which have ● been certified according to IEC 601-1 for medical equipment and IEC 601-2-18 for endoscopic equipment.
- The lamp produces high intensity visible and ultraviolet radiation that may cause burns . to skin or eyes.
- Adequate cooling is required for proper operation of the unit. .
- Grounding reliability is achieved only when connected to a "Hospital-use" or . "Hospital-grade" receptacle.
- Disconnect the power cord before attempting any service to the Lumenon™ Xenon . Light Source
- The lamp is filled with xenon gas at very high pressure. Do not subject the lamp to . mechanical forces or rough handling, explosion may result.
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Substantially Equivalent Device: The Lumenon™ Xenon Light Source is substantially equivalent to the Welch Allyn Xenon 300 Light Source, the Xenon Light Source Model LS 6035 and other legally marketed Xenon Light Sources in operational principles, and technological characteristics. Any difference between devices are minor and rise no new issues of safety and effectiveness.
ບບໍ່ປີ00002
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1999
Mr. Trevor Byrd Requlatory Assistant Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480
Dear Mr. Byrd:
Re: K992050 Lumenon Xenon Light Source Dated: August 18, 1999 Received: August 19, 1999 Regulatory Class: 11 21 CFR §876.1500/Procode: 78 GCT
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 (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 II (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 delermination 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 regult 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 diagnosic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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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510(k) Number (if known): K992050
Device Name: Lumenon Xenon Light Source
Indications For Use: The Lumenon Xenon Light Source is intended to supply adjustable high intensity illumination for accessories such as headlights and endoscopes.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use i (Per 21 FR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devig 510(k) Number