The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus EndoLED. It primarily discusses the device's substantial equivalence to a predicate device and non-clinical testing performed.

The document does NOT contain information about a study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting.

Instead, it focuses on:

Substantial Equivalence: The primary assertion is that the EndoLED is substantially equivalent to the predicate device (PLS Portable Light Source by OPTIM Inc., K091829) in terms of general design, function, and indications for use.
Non-Clinical Testing: Risk analysis, reprocessing validation, and software validation were carried out according to established standards (ISO-14971, FDA guidance for reprocessing, and FDA guidance for software in medical devices).
Compliance with Standards: The device applied standards such as ISO 14971, IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.

Therefore, many of the requested sections about a performance study, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be filled from the provided text because such a study is not described.

Here's a response based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Technological Characteristics (Comparison to predicate)	- Portable detachable light source for endoscopes.- Available in straight and angled versions.- Utilizes a rechargeable NiMH battery.- Offers 40 minutes of use at maximum power.- Features a low battery indicator.- Houses an integrated cooling element.	These are comparative characteristics, not explicit acceptance criteria with quantitative targets and outcomes. The "acceptance" is based on being substantially equivalent to the predicate, which also offers 40 minutes of use.
Risk Analysis	Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.	No specific risk acceptance criteria or outcomes are detailed. Implies risks are acceptable per ISO 14971.
Reprocessing Validation	Carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."	No specific reprocessing acceptance criteria or outcomes are detailed. Implies reprocessing is validated per FDA guidance.
Software Validation	Performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software is "Minor Level of Concern."	No specific software validation acceptance criteria or outcomes are detailed. Implies software is validated per FDA guidance and deemed low risk.
Electrical Safety & EMC	Applied standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.	Implies the device meets the safety and electromagnetic compatibility requirements of these standards.
Usability	Applied standards: IEC 62366 (Medical devices - Application of usability engineering to medical devices).	Implies the device meets usability requirements of this standard.

2. Sample size used for the test set and the data provenance:

Not applicable. The document describes non-clinical testing and a comparison to a predicate device, not a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set or ground truth establishment by experts for performance evaluation is described.

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

Not applicable. No test set or adjudication process is described.

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 device is an LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

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

Not applicable. This is a hardware device (light source); it does not have an "algorithm only" performance. The software is noted as a "Minor Level of Concern," indicating its function is likely related to device control rather than interpretation or diagnosis.

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

Not applicable. No clinical performance study requiring a specific type of ground truth is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the applied standards (e.g., ISO 14971, IEC 60601 series).

8. The sample size for the training set:

Not applicable. No machine learning or AI training set is mentioned or relevant for this device.

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

Not applicable. No machine learning or AI training set is mentioned or relevant for this device.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top appears to be a series of numbers, specifically "K 133311". Below this, the text reads "Page 1 of 2", with the "2" being circled. The handwriting is somewhat stylized, with distinct spacing between the characters.

JUL 30 2014

510(k) Summary of Safety and Effectiveness

1. General information

트

Applicant: Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg
Germany
l Official Correspondent:
Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 484-896-5405 Phone: FAX: 484-896-7128 Email: sheri.musqnung@olvmpus.com Establishment Registration No.: 2429304
에 Manufacturer: Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg / Germany

Fax:

피 Registration number: 9610773
r Contact person:

2. Device identification

할 Proprietary name:
루 Common name:
t Classification name:
요 Regulations Number:
. Regulatory class:
트 Product code:
트 Device panel:

Predicate devices

K091829 - PLS Portable Light Source by OPTIM Inc., Sturbridge/MA

4. Description of device

EndoLED LED Light Source LED Light Source 21 CFR 876.1500 Class II NTN Gastroenterology/Urology

Mr. Jan Schueller-lwersen Phone: +49-66966-2860

+49-66966-2134

Email: jan.schueller-iwersen@olympus-oste.eu

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Page 2 of ②
K133311

5. Indications of use

The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.

6. Comparison of Technological characteristics

The EndoLED shares virtually all specifications and design characteristics of the predicate device. The EndoLED and predicate device are portable detachable light sources for use with rigid and flexible endoscopes. The EndoLED is available in a straight and angled version and the predicate is available in a straight version. The EndoLED utilizes a rechargeable NiMH battery; whereas the predicate device utilizes a rechargeable Lithium lon battery. Both devices offer the users 40 minutes of use at maximum power. The EndoLED device also features a low battery indicator and houses an integrated cooling element.

7. Summary of non-clinical testing

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.

Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

The following standards have been applied to the EndoLED:

ISO 14971 IEC 62366 IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18

8 Conclusion

In summary, we believe the EndoLED is substantially equivalent with the predicate device with respect to the general design approach, function, and the indications for use. The EndoLED raises no new concerns of safety or efficacy when compared to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2014

Olympus Winter & Ibe GmbH Ms. Sheri L. Musgnung Regulatory Affairs & Quality Assurance 3500 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K133311

Trade/Device Name: Endol.ED Model number WA91500A and WA91502A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class; Class II Product Code: NTN Dated: July 1, 2014 Received: July 2. 2014

Dear Ms. Musgnung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not mislcading.

If your device is classified (see above) into cither 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sheri L. Musgnung

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133311

Device Name EndoLED Model number WA91500A and WA91502A

Indications for Use (Describe)

The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.28 14:20:53 -04'00'

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.