The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Description

The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.

AI/ML Overview

The provided text describes a 510(k) summary for the Nidek Multicolor Laser Photocoagulator System MC-500. This summary focuses on establishing substantial equivalence to a predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300, K042785) through bench testing.

Based on the provided information, here's a breakdown regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or provide a table of performance metrics. The assessment relies on a qualitative determination of "substantial equivalence" to a predicate device.

Acceptance Criteria	Reported Device Performance
Not specified	"All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device."

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

No specific "test set" in terms of patient data or clinical samples is mentioned. The testing conducted was "bench testing." Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable as it was not a clinical study.

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

As no clinical test set was used, there were no experts involved in establishing ground truth for such a set based on the provided information. The evaluation was focused on technical performance and equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or mentioned. The submission is based on bench testing to establish substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable, as this device is a laser photocoagulator system, not an AI algorithm. Its performance is evaluated based on its technical specifications and functional equivalence.

7. Type of Ground Truth Used:

The "ground truth" for the substantial equivalence determination was the performance and characteristics of the predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300). The MC-500's performance was compared to the established performance of the legally marketed predicate device through bench testing.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device (laser system), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

In summary, the provided document details a 510(k) submission for a medical device (a laser photocoagulator system) where substantial equivalence was demonstrated through bench testing against a predicate device. It does not involve AI, clinical efficacy studies with patient data, or expert-adjudicated ground truth as would be relevant for an AI/ML medical device.

Summary

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Nidek, Inc.

SECTION 6 510(k) SUMMARY (CONT.)

510(k) Notification K_ K ( ( 022 P

FEB 2 3 2011 :

GENERAL INFORMATION

Applicant:

Nidek Incorporated 47651 Westinghouse Drive Fremont, CA 94539-7474 U.S.A. Phone: 510-226-5700 Fax: 510-226-5750

Contact Person:

Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-400-0856 ext. 112 Fax: 408-400-0865 Email: kitc@experiengroup.com

Date Prepared: January 24, 2011

Classification:

21 CFR§878.4810 and §886.4390, Class II

Product Code: GEX, HQF

Trade Name: Nidek Multicolor Laser Photocoagulator System MC-500

Generic/Common Name:

Ophthalmic Laser Photocoagulator

Predicate Device

Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)

Intended Use

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

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SECTION 6 510(k) SUMMARY (CONT.)

Product Description

Substantial Equivalence

The MC-500 is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed MC-500 is substantially equivalent to the predicate device.

Testing in Support of Substantial Equivalence Determination

All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device.

Summary

The MC-500 is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Nidek Incorporated % Experien Group, LLC Kit Cariquitan 155-A Moffett Park Drive, Suite 210 Sunnyale, California 94089

FEB 2 3 2", 1

Re: K110228

Trade/Device Name: Nidek Multicolor Laser Photocoagulator System MC-500 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: January 24, 2011 Received: January 26, 2010

Dear Kit Cariquitan:

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.

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

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Page 2 - Kit Cariquitan

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/CentersOfTices/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/ReportalProblem/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 vours.

Aty B. R. to
ken

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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NIDEK, INC.

SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Nidek Multicolor Laser Photocoagulator System MC-500

Indications for Use:

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

N.L. the
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110228

Regulation Number and Section

§ 886.4690 Ophthalmic photocoagulator.

(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.