Aesculap's Xenon Light Source 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 contain 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, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.

Device Description

The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:
Design: Light Source in stainless steel / aluminum housing
Dimensions: 305mm x 305mm x 82mm
Weight: 6.5kg
Lamp: 180W Xenon
Circuit: Transistorized
Voltage: 100 - 240V
AC Power Freq.: 50 - 60 HZ

AI/ML Overview

The provided text is a 510(k) summary for the "Aesculap Xenon Light Source". It describes the device, its intended use, and states its compliance with certain performance standards. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.

Instead, the document focuses on:

Substantial Equivalence: The primary "study" mentioned here is a comparison to legally marketed predicate devices (EG&G Electro-Optics, Lutex, Karl Storz, Wolf) to establish substantial equivalence in features and function. This is a regulatory pathway, not a performance study in the sense of accuracy metrics.
Safety Standards Compliance: The document states that the device complies with recognized safety standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1). This is about electrical safety and electromagnetic compatibility, not clinical performance or diagnostic accuracy.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the text, and where information is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in terms of clinical outcomes or diagnostic accuracy. Acceptance is based on substantial equivalence to predicate devices and compliance with safety standards.	Substantial equivalence to predicate devices (EG&G Electro-Optics K980044, Lutex K890716, Karl Storz K934559, Wolf K952696). Compliance with IEC 60601-1, IEC 60601-1-2, and UL 2601-1 safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable. No performance study involving a test set of data is described. The "test" here refers to meeting safety standards and demonstrating substantial equivalence.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a diagnostic or performance test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a light source, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a light source, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's regulatory clearance is its adherence to specified safety standards and its functional similarity to existing predicate devices.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

Not applicable.

Summary

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FEB 1 1999

Image /page/0/Picture/1 description: The image shows the logo for AESCULAP. On the left side of the logo is a symbol of a staff with a snake wrapped around it, enclosed in a circle. To the right of the symbol is the word "AESCULAP" in bold, uppercase letters.

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Aesculap Xenon Light Source

November 17, 1998

Submitted by:

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden (650) 624-5072 Phone: FAX: (650) 589-3007

Product: Aesculap Xenon Light Source Common Name: Xenon Light Source

Intended Use

Device Description

The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:

Design:	Light Source in stainless steel / aluminum housing
Dimensions:	305mm x 305mm x 82mm
Weight:	6.5kg
Lamp:	180W Xenon
Circuit:	Transistorized
Voltage:	100 - 240V
AC Power Freq.:	50 - 60 HZ

AN EQUAL OPPORTUNITY EMPLOYER

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Performance Standards

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Xenon Light Source complies with the following standards which appear on the FDA List of Recognized Consensus Standards:

International Electrotechnical Commission; Medical IEC 60601-1 Electrical Equipment, Part 1: General Requirements for Safetv.
IEC 60601-1-2 International Electrotechnical Commission; Medical Electrical Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.

In addition, the Xenon Light Source meets the requirements of the following Underwriters Laboratories standard.

Underwriters laboratories; medical electrical equipment, UL 2601-1 general requirements for safety.

Sterilization

The Xenon Light Source control unit is not intended for use in the sterile field. The Fiber Optic Cable provided with the Xenon Light Source is provided nonsterile and must be sterilized prior to use. The cable may be sterilized by steam sterilization.

Substantial Equivalence

Aesculap's Xenon Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044)

Lutex (K890716) Karl Storz (K934559) Wolf (K952696)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine, but in this case, it is a modern interpretation of the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Ms. Mary Ellen Holden Senior Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7028

Re: K984124 Trade Name: Aesculap Xenon Light Source Regulatory Class: II Product Code: FSS Dated: November 17, 1998 Received: November 18, 1998

Dear Ms. Holden:

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 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 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 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 regulation may result 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.

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Page 2 -- Ms. Mary Ellen Holden

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 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,

Stup Rhodes

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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INDICATION FOR USE STATEMENT

×984124

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Aesculap Xenon Light Source

Indication for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices	K984124
Prescription Use X (Per 21 CFR 801.109)	OR Over-The-Counter Use

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.