The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

Device Description

The Endoscopic Light Source XL300/L5 uses a 300 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 5600 °K and the lamp life is approximately 500 hours.

AI/ML Overview

The provided text describes a 510(k) summary for the Endoscopic Light Source XL300/L5. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for an AI/ML device.

Here's an analysis based on the provided text, highlighting the absence of information typically requested for AI/ML device studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined by Manufacturer or Regulatory Body)	Reported Device Performance
Compliance with International Standard IEC 60601-1	Will comply
Compliance with International Standard IEC 60601-1-2	Will comply
Conformity to Medical Device Directive 93/42/EEC	Will conform
Compliance with Underwriters Laboratories Standard UL2601-1	Will meet requirements
Intended Use (illumination with fiber optic endoscopes)	Met (similar to predicate)
Design and Technological Characteristics (300 W Xenon lamp)	Met (similar to predicate)

Explanation: The "acceptance criteria" for this device are primarily regulatory and safety standards, and performance is evaluated based on its similarity to a legally marketed predicate device. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be typical for an AI/ML diagnostic device.

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

This information is not applicable/not provided in the document. The submission is a 510(k) summary for an endoscopic light source, which is a hardware device. It does not involve a "test set" of patient data for AI model evaluation. The demonstration of substantial equivalence is based on technical specifications and compliance with standards.

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

This information is not applicable/not provided. As there is no "test set" of patient data, there's no need for experts to establish ground truth for an AI model.

4. Adjudication Method for the Test Set

This information is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This information is not applicable/not provided. MRMC studies are relevant for evaluating the impact of AI assistance on human readers, which is not the subject of this 510(k) submission for a light source.

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

This information is not applicable/not provided. This device is a hardware component (a light source), not an AI algorithm.

7. The type of ground truth used.

This information is not applicable/not provided.

8. The sample size for the training set.

This information is not applicable/not provided.

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

This information is not applicable/not provided.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described in the document is a demonstration of substantial equivalence to a predicate device and a commitment to comply with relevant safety and performance standards.

Predicate Device: Karl Storz Xenon 300 Light Source for Non-Flash Applications (K962595).
Methodology: The manufacturer states that the Endoscopic Light Source XL300/L5 is "similar in design and technological characteristics" to the predicate device. Both devices are intended to provide illumination for endoscopic procedures using a 300W Xenon lamp. The manufacturer asserts that the "differences... are minor and raise no new questions of safety and effectiveness."
Performance Data: The device "will comply" with international safety standards (IEC 60601-1, IEC 60601-1-2), will "conform" to the Medical Device Directive 93/42/EEC, and "will meet the requirements" of UL2601-1. This indicates adherence to established electrical, electromagnetic compatibility, and medical device safety standards.
Conclusion: The FDA reviewed the 510(k) submission and determined that the device is substantially equivalent to the legally marketed predicate device, allowing it to proceed to market. This determination is based on the provided technical specifications, intended use, and commitment to compliance with recognized standards, not on a clinical performance study with patient data or an AI algorithm evaluation.

Summary

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K02/7/7

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510(K) SUMMARY Endoscopic Light Source XL300/L5

I. Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany

II. Device Names:

Classification Name: 1.
Common or Usual Name: 2.
Proprietary Name: 3.

Accessory to an Endoscope Endoscopic Light Source Endoscopic Light Source XL300/L5

III. Classification:

Class II. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCT.

IV. Predicate Device:

Karl Storz Xenon 300 Light Source for Non-Flash Applications . (K962595) manufactured by Karl Storz Endoscopy-America, Inc.

V. Intended Use:

The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

VI. Device Description:

VII. Substantial Equivalence:

The Endoscopic Light Source XL300/L5 described in this notification is similar in design and technological characteristics to the Karl Storz Xenon 300 Light Source for Non-Flash Applications (K962595) manufactured by Karl Storz Endoscopy-America, Inc.

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Koz1717

pg. 2 of 2

510(K) SUMMARY Page -2-1-2-

Both the Endoscopic Light Source XL300/L5 and the predicate device is intended to provide illumination of body cavities, hollow organs and canals during endoscopic diagnostic and surgical procedures. In addition, both devices are designed to be used with a 300 W Xenon lamp.

The differences between the Endoscopic Light Source XL300/L5 and predicate device are minor and raise no new questions of safety and effectiveness. Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the Endoscopic Light Source XL300/L5 is substantially equivalent to the predicate device currently on the market.

VIII. Performance Data:

The Endoscopic Light Source XL300/L5 will comply with the International Standard IEC 60601-1, IEC 60601-1-2 and will conform to the Medical Device Directive 93/42/EEC. In addition, the device will meet the requirements of the Underwriters Laboratories Standard UL2601-1.

Signed:

S. Roal

Susanne Raab Official Correspondent

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2002

WORLD OF MEDICINE LEMKE GmbH c/o Ms. Susanne Raab Official Correspondent 91 Trowbridge Street CAMBRIDGE MA 02138

Re: K021717

Trade/Device Name: Endoscopic Light Source XL300/L5 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCT Dated: May 11, 2002 Received: May 23, 2002

Dear Ms. Raab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

APPLICANT:

WORLD OF MEDICINE Lemke GmbH

510(K) NUMBER (if known):

021717

DEVICE NAME:

Endoscopic Light Source XL300/L5

INDICATIONS FOR USE:

The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

Regulation Number and Section

§ 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.