The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Device Description

The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm. The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.

AI/ML Overview

The provided text is for a 510(k) summary for the LIO-500 device. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance.

Therefore, many of the requested categories related to acceptance criteria, device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, and AI performance metrics are not applicable to this type of regulatory submission.

The LIO-500 is described as a medical device (Laser Indirect Ophthalmoscope 500) intended for photocoagulating ocular tissue in the treatment of eye diseases. It is a delivery system for laser light, not a diagnostic device that processes images or data to provide a medical assessment.

Here's an analysis based on the information provided, explicitly stating what is not applicable:

1. Table of acceptance criteria and the reported device performance

Not Applicable. The 510(k) summary does not define specific performance acceptance criteria for the LIO-500 itself that would be evaluated in a clinical or non-clinical study for performance metrics like sensitivity, specificity, accuracy, etc. Its regulatory path is based on demonstrating substantial equivalence to a predicate device, which implies that it functions similarly and meets comparable safety and effectiveness standards, not necessarily new quantitative performance metrics.

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

Not Applicable. No test set or data provenance is mentioned as part of a performance study for the LIO-500 in this 510(k) summary. The submission states, "There are no clinical or non-clinical tests required to show substantial equivalence."

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 by experts for a test set is mentioned because no such performance study was conducted or required for this 510(k) submission.

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

Not Applicable. No adjudication method is mentioned as no performance study with a test set was conducted or required.

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. The LIO-500 is a laser delivery device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

Not Applicable. The LIO-500 is a hardware device for laser delivery and does not involve an algorithm or AI. Standalone performance for an algorithm is not applicable.

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

Not Applicable. No ground truth for a performance study is mentioned or relevant to this 510(k) submission.

8. The sample size for the training set

Not Applicable. The LIO-500 is a hardware device and does not involve AI or algorithms that require a training set.

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

Not Applicable. As no training set is involved, the establishment of its ground truth is not applicable.

Summary of the K113390 Submission:

The LIO-500 received 510(k) clearance based on its substantial equivalence to the predicate device, VISULAS 532S (K013402). The key statement from the provided text is: "The LIO-500 has the same technical characteristics as the VISULAS 532S. There are no clinical or non-clinical tests required to show substantial equivalence." This means that the FDA determined that the LIO-500 is as safe and effective as the predicate device based on its design, materials, and intended use, without requiring specific performance studies that measure metrics like sensitivity or specificity.

Summary

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LIO-500 510(k) Summary

Submitter:

113390

Regulatory Insight, Inc. 5401 S. Cottonwood Ct. Greenwood Village, Colorado 80121 Contact: Mr. Kevin Walls, RAC Telephone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

for

MERIDIAN AG Bierigutstrasse 7 CH-3608 Thun Switzerland Phone: +41 33 334 11 11 Fax: + 41 33 334 11 19 Homepage: www.meridian.ch Email address: info@meridian.ch

Device Name:

Trade Name: Laser Indirect Ophthalmoscope 500 (LIO-500) Common Name: Ophthalmic Surgical Laser Classification Name: Powered Laser Surgical Instrument

Predicate Device:

VISULAS 532S manufactured by CARL ZEISS, INC. and cleared under 510(k) # K013402

Device Description:

The LIO-500 can be used on a 532 nm laser such as the MERILAS 532a or any other ophthalmic laser with 532 nm.

The LIO-500 does not incorporate any contacts, displays or other user accessible functions. Its main purpose is the delivery of the laser light, generated by an ophthalmic treatment laser unit to the eye of the patient. For the observation of the treatment area the attached indirect ophthalmoscope (such as the Heine Omega 500 or the Keeler Vantage Plus / Keeler Vantage Plus LED) gets used.

Intended Uses:

The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye.

The laser energy is delivered via either transpupillary delivery or intraccular endoprobe delivery.

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Comparison to Predicate Device:

The LIO-500 has the same technical characteristics as the VISULAS 532S. There are no clinical or non-clinical tests required to show substantial equivalence.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The image is in black and white.

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

FEB 1 4 2012

Meridian AG % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 South Cottonwood Court Greenwood Village, Colorado 80121

Re: K113390 ·

Trade/Device Name: Lase Indirect Ophthalmoscope 500 (LIO-500) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 15, 2011 Received: November 16, 2011

Dear Mr. Walls:

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 misleading.

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.

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Page 2 - Mr. Kevin Walls, RAC

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark A. Mellman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name: Laser Indirect Ophthalmoscope 500 (LIO-500)

Indications for Use:

The Laser Indirect Ophthalmoscope 500 (LiO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye.

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113390

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.