The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Description

Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty when a delivery unit such as the Endophotocoagulation Delivery Unit is connected.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be seen for novel devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this document because the regulatory pathway is different.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines "acceptance criteria" as demonstrating substantial equivalence to the predicate device (Nidek Green Laser Photocoagulator Model GYC-1000, K032085). The performance is shown by verifying and validating that the modified device:

Acceptance Criteria Category	Reported Device Performance
Intended Use	The proposed device shares the same indications for use as the predicate device: ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Technological Characteristics	The proposed device maintains the same technological characteristics and principle of operation as the predicate device. Minor differences in endophotocoagulation delivery units (addition of 23G and 25G probes, reduced fiber core diameter, changed cone angle, optional fixed protective filter) are justified as not raising new safety or efficacy concerns.
Functional Specifications & Performance Requirements	Verification and validation confirmed that the GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit meets its functional specifications and performance requirements. This is supported by bench testing.
Compliance with International Standards	The device complies with applicable international standards: IEC 60601-1, 60601-1-2, 60601-2-22, 60825-1, and ISO10993-1.
Safety and Efficacy	The modifications (added probe sizes, reduced fiber core diameter, changed cone angle, added protective filter) were reviewed and justified as not raising new issues of safety or efficacy compared to the predicate device.

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

Not applicable / Not Specified. This document uses a "Special 510(k)" pathway, which primarily relies on demonstrating that modifications do not significantly alter safety or effectiveness, often through engineering analysis and bench testing, rather than extensive clinical studies with human patient data. The "test set" in this context refers to the modifications and components themselves, rather than a clinical dataset.
The testing performed was "bench testing" (Page 3).

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

Not applicable / Not Specified. This information is typically relevant for studies involving human interpretation or performance assessment (e.g., of an AI algorithm). The current submission focuses on physical device characteristics and safety/efficacy of modifications.

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

Not applicable / Not Specified. Adjudication methods are used to establish ground truth in clinical studies, which is not the primary mechanism of demonstration in this 510(k).

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:

No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices or algorithms, not for a laser photocoagulator with modified delivery units.

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

Not applicable. This device is a physical medical instrument (laser photocoagulator), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.

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

The "ground truth" for this device's substantial equivalence determination is its predicate device (Nidek Green Laser Photocoagulator Model GYC-1000, K032085). The "truth" being established is that the modified device is as safe and effective as the predicate.
For the specific modifications, the "ground truth" comes from engineering analysis and bench testing to confirm that changes (e.g., fiber core diameter, cone angle) do not negatively impact safety or efficacy, and that the device meets its functional specifications and comply with relevant standards (IEC, ISO).

8. The sample size for the training set:

Not applicable / Not Specified. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary

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NIDEK CO., LTD.

4-14, Machoma, Uraishi-cho, Gamagori, Aichi 443-0038, Japan

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7.510(K) SUMMARY

This summary of the 510(k) premarket notification for the Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

OCT 3 1 2013

510(k) Notification K _131894

GENERAL INFORMATION

Applicant:

NIDEK CO., LTD. 34-14 Maehama, Hiroishi Gamagori, Aichi, 443-0038 Japan

Contact Person: Yoneji Mizuno Contact Title: Senior Manager, Regulatory Affairs Department Contact Phone Number: +81-533-67-8901 Contact Fax Number: +81-533-67-6628 E-mail: Yoneji_Mizuno@nidek.co.jp.

Date Prepared: June 20, 2013

Classification: 21 CFR § 878.4810, Class II

NIDEK CO., LTD. Special 510(k) GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 1 of 4

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Classification name:

Laser surgical instrument for use in general and plastic surgery and in dermatology

Product Code:

GEX

Trade Name:

GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe)

Generic/Common Name:

Powered laser surgical instrument

Predicate Device

Nidek Green Laser Photocoagulator Model GYC-1000 (K032085)

Indications for use

The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Product Description

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IDEK CO., LTD.

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Substantial Equivalence

The GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics.

The differences between the proposed and old Endophotocoagulation Delivery Units and justifications as to why these differences do not raise safety or efficacy concerns are as follows:

23G and 25G sterilized endopho probes were added to the proposed device and available as options. They have been FDA cleared (k 021696).
The fiber core diameter at the end of the probe tip was reduced to 300 um for 20G or 23G probe and 200 um for 25G probe from 400 um. The smaller fiber core diameter will result in increase in the power per unit size. As the probe is moved closer to the retina, the beam diameter becomes smaller. On the other hand, as the probe is moved away from the retina, the beam diameter becomes larger. In practice, the surgeon adjusts the beam diameter by moving the probe before emission of the laser. Therefore, the change in fiber core diameter raises no new issues of safety or efficacy.
Cone angle, the degree the laser beam that disperses from the aperture of the probe, was changed from 11º or less to 12.5º or less. The cone angle is dependent on the used fiber, rather than on the gauge of the endophoto probe. As the probe is moved away from the retina, the beam diameter becomes larger. On the other hand, as the probe is moved closer to the retina, the beam diameter becomes smaller. In practice, the surgeon adjusts the beam diameter by moving the probe before emission of the laser. Therefore, the change in cone angle because of the change of the probes raises no new issues of safety or efficacy.

NIDEK CO., LTD.

Special 510(k)

GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 3 of 4

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IDEK CO., LTD.

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Fixed protective filter was added to the proposed device and available as an option. The major specifications such as guard wavelength, and optical density for the added fixed protective filter are the same as those for the electrically-powered and manual protective filters except for operation principle, dimensions, mass and its cable length.
The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or the indication for use or (2) alter the fundamental scientific technology of the device. The proposed Endophotocoagulation Delivery Unit shares the same indications for use, the same technological characteristics and the same principle of operation as the old Endophotocoagulation Delivery Unit of the predicate device. Therefore, based on the similarities between the two devices, the proposed Endophotocoagulation Delivery Unit is substantially equivalent to the old Endophotocoagulation Delivery Unit covered by the cleared GYC-1000 (K032085) as the predicate device.

Testing in Support of Substantial Equivalence Determination

We have verified and validated that the GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) meets its functional specifications and performance requirements, and complies with applicable international standards (IEC 60601-1, 60601-1-2, 60601-2-22, 60825-1, ISO10993-1}.

As mentioned, all necessary bench testing was conducted on the modifications, the addition of the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) to support a determination of substantial equivalence to the predicate device.

Summary

The Nidek Green Laser Photocoagulator Model GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate device.

NIDEK CO., LTD. Special 510(k) GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 4 of 4

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October 31, 2013

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

NIDEK Corporation, LTD. Yoneji Mizuno Senior Manager, Regulatory Affairs 34-14 Maehama Hiroishi-cho Gamagori, Aichi China

Re: K131894

Trade/Device Name: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 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: September 6, 2013 Received: October 13. 2013

Dear Mizuno:

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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 mav 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

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Page 2 - Yoneji Mizuno

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Long H Chen -A

for MXM

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

Enclosure

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Indications for Use

510(k) Number:_ K131894

Device Name: Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe)

Indications For Use:

The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Neil R Ogden= 2013.10.31 110:40:28 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K131894

Page 1 of 1

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.