The Nidek Frequency Doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including but not limited to Retinal and Macular Photocoagulation; Iridotomy and Trabeculoplasty.

Device Description

The Nidek GYC-1500/2000 Solid State Photocoagulators are frequency doubled Nd: YAG lasers producing a characteristic 532 nanometer (nm) wavelength light as A 633nm helium-neon (HeNe) laser is used for the aiming beam treatment beam. source. The doubling process of the 1064nm wavelength results when the infrared beam goes through a special crystal, which is an optical dielectric that exhibits a non-The 532nm - Green - wavelength is produced by linear optical response. harmonic generation of the 1064nm laser beam. The laser treatment beam is delivered through the cornea to the target tissue by an optical delivery system which is mounted either on a slit lamp microscope or binocular indirect microscope. Tissue may also be treated inter-operatively by direct radiation from a fiber optic end-ocular probe or a optical deliver system mounted on an operating microscope. The beam may be further manipulated by accessory contact lenses or near contact "aspheric" lenses. An aiming beam is provided by the system to indicate the target tissue prior to the treatment exposure. The desired treatment parameters of power exposure duration, and spot size are selected as required. The location and operation of all controls and indicators is described in the Nidek Prima Frequency Doubled Nd:YAG Operator Manual. Treatments are always started with the lowest applicable exposure and the dosage is increased until the desired effect is obtained.

AI/ML Overview

This document is a 510(k) summary for the Nidek Models GYC-1500 and GYC-2000 Solid State Ophthalmic Laser Photocoagulator. This submission is an amendment to a previous 510(k) (K951079) to add two new indications: iridotomy and trabeculoplasty. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device description and software validation process.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain acceptance criteria in the traditional sense of numerical performance targets (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. This is a medical device submission for a laser photocoagulator, not an algorithm, and the "acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence. The "performance" is intrinsic to the device's function as a laser.

However, based on the context of the submission, the implicit "acceptance criteria" and "performance" are as follows:

Acceptance Criteria (Implied Regulatory)	Reported Device Performance
Safety: Device operates without undue risk to patients or users.	Not explicitly quantified with metrics, but implied by:
	- The device is a frequency-doubled Nd:YAG laser producing a 532 nm wavelength, similar to Argon lasers commonly used in ophthalmic surgery.
	- A 633nm HeNe laser is used for aiming, indicating tissue prior to treatment.
	- Treatments are always started with the lowest applicable exposure, with dosage increased until the desired effect is obtained, indicating user control and safety protocols.
	- "There are no significant changes or modifications from the predicate products that affects safety, effectiveness, or the intended use of the product." (Section 6)
Effectiveness: Device performs its intended clinical applications.	Not quantified with clinical outcomes data in this document, but established by:
	- Intended Use: "The Nidek Frequency Doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including but not limited to Retinal and Macular Photocoagulation; Iridotomy and Trabeculoplasty." (Section 4 and Indications For Use page)
	- Substantial Equivalence: Demonstrated through comparison to predicate devices (Ophthalas 532 by Alcon, Cerlas G by CeramOptec, Oculight GL by Iris, and previous Nidek GYC-1500/2000 K951079). The submission states the purpose is to add iridotomy and trabeculoplasty, implying the core functionality for other applications (retinal and macular photocoagulation) was previously established.
Software Validation: Software ensures reliable and safe operation.	Nidek has "implemented the software development process which is described and defined in the Software Development Procedure." This includes:
	- Hazard (risk) analysis and mitigation.
	- Design reviews at each phase (specifications, coding, module/integration testing).
	- Verification that specifications address design requirements.
	- Validation through module and integration testing, ensuring specifications and system requirements are met.
	- Engineering and Quality Assurance management review of documentation and reports to assure system specifications and requirements have been met. (Section 9)
Technical Specifications: (e.g., wavelength, power) consistent with intended use and predicate devices.	- Wavelength: 532 nanometer (nm) (green) for treatment, 633nm for aiming.
	- Power: GYC-1500 has max. power of 1.5W, GYC-2000 has max. power of 2.0W. These are the same models as previously cleared (K951079), with the current application adding indications, not changing core power specifications. (Section 3 and 5)

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

The document does not describe a "test set" in the context of an algorithm or AI model evaluation. This is a 510(k) submission for a physical medical device (laser). Therefore, there is no mention of a traditional "sample size" of patient data or data provenance (country of origin, retrospective/prospective) for algorithm testing.
The "test" described pertains to software validation which involves testing the software against its specifications and system requirements. This is internal software testing, not clinical data evaluation for device performance as a diagnostic or AI tool.

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

Not applicable. As described in point 2, there is no "test set" in the context of an algorithm requiring expert-established ground truth. The "ground truth" for this device's performance would be the physical properties of the laser and its effectiveness in specified surgical procedures, typically assessed through clinical studies (which are not detailed in this summary for the new indications, as the submission relies on substantial equivalence).

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

Not applicable. There is no "test set" for an algorithm requiring an adjudication method.

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 not an AI or CADe device. An MRMC study would not be relevant here.

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

Not applicable. This is not an algorithm.

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

Not applicable to "ground truth" for an algorithm. For a physical device like a laser, the "truth" is established by its physical specifications (power, wavelength), its established mechanism of action in ophthalmic surgery, and the prior regulatory clearances of similar devices for similar indications. The addition of "iridotomy and trabeculoplasty" relies on the substantial equivalence to predicate devices that are already cleared for these procedures, implying historical clinical evidence supports their efficacy and safety.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the NIDEK Incorporated logo. The logo consists of a stylized eye on the left and the text "NIDEK Incorporated" on the right. The eye is a simple, black and white design with a large pupil. The text is in a simple, sans-serif font.

47651 Westinghouse Drive Fremont, California 94539

X 1510) 226-5750

MAY | 3 1998

K980Σ47

ובסוגוסטונים

는공

510(k) SUMMARY

This is a 510(k) Summary in accordance with CFR 807.92.

Submitter: 1.
Nidek Inc. for Nidek Co., Ltd., 34-14 Maehama Hiroishicho Gamagori, 443

Correspondent: Ken Kato, VP (510)226-5700 Phone: Fax: (510)226-5750

1. Device Name: Models GYC-1500 and GYC-2000 Solid state ophthalmic laser photocoagulator Ophthalmic Laser
1. Predicate Devices:

Model Ophthalas 532 by Alcon (K962592)

Model Cerlas G by CeramOptec (K962948)

Model Oculight GL by Iris (K960971)

Models GYC-1500/2000 (K951079) - The purpose of this application is to add two indications of: iridotomy and trabeculoplasty, to the current 510(k). GYC-1500 has max. power of 1.5W and 2000 of 2.0W.

Intended Use: র্বা
The Nidek Frequency Doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including but not limited to Retinal and Macular Photocoagulation; Iridotomy

{1}------------------------------------------------

and Trabeculoplasty.

5. Device Description:

The doubling process of the 1064nm wavelength results when the infrared beam goes through a special crystal, which is an optical dielectric that exhibits a non-The 532nm - Green - wavelength is produced by linear optical response. harmonic generation of the 1064nm laser beam.

The laser treatment beam is delivered through the cornea to the target tissue by an optical delivery system which is mounted either on a slit lamp microscope or binocular indirect microscope. Tissue may also be treated inter-operatively by direct radiation from a fiber optic end-ocular probe or a optical deliver system mounted on an operating microscope. The beam may be further manipulated by accessory contact lenses or near contact "aspheric" lenses. An aiming beam is provided by the system to indicate the target tissue prior to the treatment exposure.

The desired treatment parameters of power exposure duration, and spot size are selected as required. The location and operation of all controls and indicators is described in the Nidek Prima Frequency Doubled Nd:YAG Operator Manual. Treatments are always started with the lowest applicable exposure and the dosage is increased until the desired effect is obtained.

ર્જ Significant Changes/Modifications from Predicate Device:

There are no significant changes or modifications from the predicate products that affects safety, effectiveness, or the intended use of the product.

1. Device Labels:
  Copies of advertising brochure, operator's manual with product label information are attached.

8. Comparative Information:

Comparison table is attached to show the similarities and differences of the GYC

{2}------------------------------------------------

to the predicate devices.

9. Software Validation & Verification:

As the part of its quality system controls, Nidek has implemented the software development process which is described and defined in the Software Development Procedure. Changes on software are made in accordance with the Design Change Standard Procedure. These procedures address the requirements for software specification, design change control, and design verification and validation. At each phase, design reviews are conducted to ensure that policies and procedures are being followed and that requirements are being met.

During the development phase, overall design requirements (specifications) and software specification are developed. Based on the system requirements and software specifications, a hazard (risk) analysis is conducted and, where necessary, methods of mitigation defined. At the design review, reviewers verify that specification effectively address design requirements.

During the coding phase, the software specifications are translated, with the aid of appropriate software tools, into source, object and executable code. At the design review, reviewers, using procedures such as code walk through, verify that code address elements defined in the specifications.

During the module and integration testing phase, software emulation and prototyping tools are utilized to test module and larger sections of code. After module testing, the software is integrated with the target system and validation This testing ensures that specifications and system testing conducted. requirements have been met.

approval/release review, Engineering and Quality Assurance During the management verifies that required documentation is present and approved. The verification and validation reports are reviewed to assure that system specifications and requirements have been met.

These established policies and procedures ensure that current and future software development projects, including changes, will be verified and validated against appropriate software and system requirements and specifications.

{3}------------------------------------------------

Signed: Ken Kato, VP

(

Date: FEB 11 1998

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1998

Mr. Ken Kato ·Vice President Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539

Re: K980547 Nidek Prima Model GYC-1500/2000 Solid State Trade Name: Photocoagulator Requlatory Class: II Product Code: GEX February 11, 1998 Dated: February 12, 1998 Received:

Dear Mr. Kato:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{5}------------------------------------------------

Page 2 - Mr. Kato

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

of _ I l Page

510(k) Number (if known): _ K980547

Device Name:

GYC-1500/2000

Indications For Use:

(Pcr 21 CFR 801.109)

The Nidek Prima Frequency doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including Retinal and Macular Photocoagulation; Iridotomy and Trabeculoplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices	K980847
510(k) Number

Prescription Use	X
OR	Over-The-Counter Use

(Optional Format 1-2-96)

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.