(90 days)
The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
The Endoscopic Light Source XL180/L3 uses a 180 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 6000 °K and the lamp life is approximately 500 hours.
The provided text describes a 510(k) premarket notification for an Endoscopic Light Source XL180/L3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics through clinical trials. Therefore, the information requested about acceptance criteria for device performance, sample sizes, expert ground truth adjudication, MRMC studies, and standalone algorithm performance is not applicable to this document.
The document focuses on the device's compliance with established industry standards as evidence of safety and effectiveness, rather than specific performance metrics against a clinical ground truth.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International Standard IEC 60601-1 (General requirements for safety of medical electrical equipment) | The Endoscopic Light Source XL180/L3 complies with IEC 60601-1. |
| Compliance with International Standard IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests) | The Endoscopic Light Source XL180/L3 complies with IEC 60601-1-2. |
| Conformity to Medical Device Directive 93/42/EEC (European directive for medical devices) | The Endoscopic Light Source XL180/L3 conforms to Medical Device Directive 93/42/EEC. |
| Meeting requirements of Underwriters Laboratories Standard UL2601-1 (Similar to IEC 60601-1, specific to North America) | The device will meet the requirements of UL2601-1. |
2. Sample size used for the test set and the data provenance: Not applicable. The "study" described is compliance testing against safety and electromagnetic compatibility standards, not a clinical performance study using a "test set" in the context of AI/diagnostic device evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence) is not relevant for this type of submission focused on safety and technical standards compliance.
4. Adjudication method 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: Not applicable. This is a light source, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: For the purposes of this submission, the "ground truth" is defined by the compliance requirements of the specified international and regional standards (IEC 60601-1, IEC 60601-1-2, MDD 93/42/EEC, UL2601-1). This is a technical and regulatory ground truth rather than a clinical one.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of light source device and its regulatory submission focus.
9. How the ground truth for the training set was established: Not applicable.
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K023 468
Pg 1 of 2
510(K) SUMMARY Endoscopic Light Source XL180/L3
JAN 1 4 2003
I. Submitter:
WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany
II. Device Names:
- Classification Name: 1.
-
- Common or Usual Name:
- Proprietary Name: 3.
Accessory to an Endoscope Endoscopic Light Source Endoscopic Light Source
XL180/L3
III. Classification:
Class II. The device is described in 21 C.F.R. § 876.1500. The product code for the device is GCT.
IV. Predicate Device:
- Endoscopic Light Source XL202/L3 (K020889) manufactured by ● WORLD OF MEDICINE Lemke GmbH
- Endoscopic Light Source XL300/L5 (K021717) manufactured by . WORLD OF MEDICINE Lemke GmbH
- Karl Storz Xenon Light Source Model 201320-20 (K934559) ● manufactured by Karl Storz Endoscopy Imanging, Inc.
V. Intended Use:
The Endoscopic Light Source XL180/L3 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:
The Endoscopic Light Source XL180/L3 uses a 180 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 6000 °K and the lamp life is approximately 500 hours.
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VII. Substantial Equivalence:
The Endoscopic Light Source XL180/L3 described in this notification is similar in design and technological characteristics to the Endoscopic Light Source XL202/L3 (K020889) and to the Endoscopic Light Source XL300/L5 (K021717) both manufactured by WORLD OF MEDICINE Lemke GmbH and the Karl Storz Xenon Light Source Model 201320-20 (K934559) manufactured by Karl Storz Endoscopy Imanging, Inc.
Both the Endoscopic Light Source XL180/L3 and the predicate devices are intended to provide illumination of body cavities, hollow organs and canals during endoscopic diagnostic and surgical procedures. In addition, both the Endoscopic Light Source XL180/L3 and the predicate device Endoscopic Light Source XL202/L3 (K020889) are designed to be used with a 180 W Xenon lamp.
The differences between the Endoscopic Light Source XL180/L3 and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the Endoscopic Light Source XL180/L3 is substantially equivalent to the predicate devices currently on the market.
VIII. Performance Data:
The Endoscopic Light Source XL180/L3 complies with the International Standard IEC 60601-1. IEC 60601-1-2 and conforms 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. Reads
Susanne Raab Official Correspondent
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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 features a stylized image of an eagle with three tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WORLD OF MEDICINE LEMKE GmbH c/o Ms. Susanne Raab Official Correspondent 91 Trowbridge Street CAMBRIDGE MA 02138
JAN 1 4 2003
Re: K023468
Trade/Device Name: Endoscopic Light Source XL 180/L3 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCT Dated: September 24, 2002 Received: October 16, 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 vour 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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):
DEVICE NAME:
Endoscopic Light Source XL180/L3
INDICATIONS FOR USE:
The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
David A. Ingram
Prescription Use . (Per 21 CFR 801.109)
§ 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.