The EG&G Xenon 300mx is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other lighted tools that contain fiber optic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, borncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures.

The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.

Device Description

EG&G Optoelectronics has engineered the Xenon 300mx to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon Lamp with focusing optics, a variable light attenuator, a selector for four standard fiber optic cable sizes, and a forced air cooling system.

AI/ML Overview

This document is a 510(k) summary for a Xenon Light Source (Xenon 300mx). The core of this document is a claim of substantial equivalence to predicate devices, rather than a detailed study proving performance against defined acceptance criteria.

As such, no comprehensive study proving the device meets acceptance criteria is present in the provided text. The document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

However, based on the information provided, we can infer some details and present what is available:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Since no explicit "acceptance criteria" are provided as a formal table, we can infer them from the "Effectiveness" statement and the claim of substantial equivalence. The primary acceptance criterion appears to be achieving a certain light output sufficient for intended use, and being comparable to predicate devices.

Acceptance Criterion (Inferred from "Effectiveness" and Equivalence Claim)	Reported Device Performance (from "Effectiveness")
Light Output (Intensity): Sufficient for all known endoscopic illumination tasks.	Up to 800 lumens of white light at the output of a seven-foot-long, 5.0 mm diameter fiber bundle. This level is stated as "sufficient for all presently known endoscopic illumination tasks."
Temperature Control: Maintain temperature of the fiber bundle termination.	Internal forced air cooled turret design provides "greater control over the light delivered... [and] also serves to maintain temperature control of the bundle termination."
Functional Equivalence: Similar intended use, design, and function to predicate devices (Karl Storz Xenon 300, BFW MID 3000, Applied Fiberoptics Brite Lite III).	The device "is substantially equivalent to several medical illuminator systems presently on the market, while incorporating certain design improvements." All cited equivalent systems use 300W xenon lamps and have similar sub-systems.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. No formal "test set" or clinical study data is presented for direct evaluation of the device's performance against detailed acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
Data Provenance: Not applicable. The "performance data" mentioned (for the lamp and power supply, and a database search for adverse effects of marketed devices) is not described in detail regarding its origin or nature (retrospective/prospective, country of origin).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There's no "test set" and thus no ground truth established by experts for that purpose. The determination of "sufficiency" for light output (800 lumens for endoscopic tasks) is a generalized statement, not attributed to a specific expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set where adjudication would be necessary is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC study. It pertains to a light source, not an AI or diagnostic device that typically undergoes such studies for human-in-the-loop performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Not applicable in the typical sense for medical device performance (e.g., pathology, outcomes data). The "ground truth" for this submission revolves around the functional characteristics (light output, temperature control) of the device being comparable to those of legally marketed predicate devices and adequate for its intended use. The "effectiveness" statement implicitly defines this ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary

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3 1998 APR

510(k) Summary of Safety and Effectiveness: 13.0

December 22, 1997

Xenon Light Source 1. Device Submitted:

Xenon 300mx 2. Proprietary Name:

Common Usual Name: Xenon Fiber optic Light Source for Medical Procedures

Predicate Device: 4.

Xenon 300mx manufactured and marketed by EG&G Optoelectronics Division is substantially equivalent to the Karl Storz Cold Light Fountain Xenon 300 manufactured by Karl Storz Endoscopy-America, Inc., Culver City, CA , the Maxenon, manufactured by BFW, Lexington KY and the Brite Lite III manufactured by Applied Fiberoptics Sturbridge, MA.

Device Description: 5.

6. Intended Use:

7. Technological characteristic Similarities:

The EG&G Xenon 300mx is similar in intended use, design and function to the Karl Storz Xenon 300. BFW MID 3000 and and Applied Fiberoptics Brite Lite III.

8. Performance Data:

No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). However, performance data are given for the lamp and power supply in Attachment 4. A data base search has been performed to evaluate any adverse effects of devices which are currently marketed. The results are shown in Attachment 5.

Effectiveness : The EG&G Xenon 300mx medical illuminator provides up to 800 lumens ல் of white light at the output of a seven foot long, 5.0 mm diameter fiber bundle. This level of light output is sufficient for all presently known endoscopic illumination tasks. The internal forced air cooled turret design in addition to providing greater control over the light delivered to the four different types of fiber bundles, also serves to maintain temperature control of the bundle termination.

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14.0 Summary:

EG&G Inc. submits that this system is substantially equivalent to several medical illuminator systems presently on the market, while incorporating certain design improvements. All xenon Fiber optic bundle illuminators generate high intensity white light. All of the equivalent systems cited use 300 watt xenon lamps with provision for front panel control of the light level. In addition, all of the equivalent systems are composed of the same basic collection of sub-systems (EMI filtering, AC to DC Conversion, Current Regulation, Lamp Ignitor, Lamp Module, Light Attenuator, and Fiber Bundle Interface).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 APR

Mr. Anthony Statuto Manager, Quality Assurance EG&G Electro-Optics 35 Congress Street Salem, Massachusetts 01970

Re: K980044 Trade Name: Xenon 300mx Regulatory Class: II Product Code: FSS December 22, 1997 Dated: Received: January 6, 1998

Dear Mr. Statuto:

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 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.

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Page 2 - Mr. Statuto

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

Attachment #6

K980044 510(k) NUMBER (IF KNOWN) :

XENON 300 MX DEVICE NAME:

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sige-Offm
Division of General Restorative Devices K980044
51Ollel Number

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.