The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Device Description

The Nidek Multi Color Laser Photocoagulator Model MC-300 is a diode pumped solid state laser (DPSSL) ophthalmic photocoagulation system that produces three treatment beams: a 532 nm (green) wavelength, a 561 (yellow) wavelength, and a 659 (red) wavelength. The Model MC-300 uses the same wavelength for the aiming beam as the treatment beams, so that the operator can recognize the selected wavelength by the color of the aiming spot. The Model MC-300 splits the pumped laser beam into the aiming and treatment beams so that they can both be controlled separately. The multi-color laser beam is aligned with the respective aiming laser beam in the optical system inside the unit and gathers them in a fiber optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

AI/ML Overview

This document, a 510(k) summary for the Nidek Multi Color Laser Photocoagulator Model MC-300, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, it is a premarket notification for a medical device seeking clearance from the FDA based on substantial equivalence to previously cleared predicate devices. Therefore, it does not typically include a standalone performance study with acceptance criteria in the way a new, high-risk device might.

Here's what can be extracted and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance:

Not provided. This document does not specify quantitative acceptance criteria or report performance against such criteria. The approval is based on substantial equivalence, implying the device performs comparably to the predicate devices, rather than meeting specific performance metrics that are formally tested and reported here.

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

Not provided. No test set or data derived from human or animal subjects is described. The evidence provided is based on a comparison of technological characteristics to predicate devices.

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 test set or ground truth establishment is described for this type of submission.

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 a laser photocoagulator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness metrics are irrelevant.

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

Not applicable. This is a hardware device, not a standalone algorithm.

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

Not applicable. No new ground truth was established for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no training set in the context of AI development.

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

Not applicable. As above, no training set is relevant.

Summary of available information relevant to "Acceptance Criteria" implicitly based on Substantial Equivalence:

The document states:

"The Nidek Multi Color Laser Photocoagulator Model MC-300 has been designed and will be tested in accordance with applicable safety standards." (Section 7. PERFORMANCE DATA)
"System and component testing was completed based on product specifications and hazard effects determined from the risk analysis." (Section 7. PERFORMANCE DATA)
The conclusion is that the device "is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness." (Section 8. CONCLUSIONS)
The "Basis of Approval" by the FDA reviewer includes "Predicate Device (PD)" and "Bench Test Data (BTD)" along with "Specifications (SPECS)".

This implies that the "acceptance criteria" for the MC-300 were primarily:

Conformance to Applicable Safety Standards: (e.g., electrical safety, laser safety - though specific standards are not listed here).
Meeting Product Specifications: (e.g., wavelength, power range, pulse width, repetition rate as listed later in the document).
Demonstrating "Substantial Equivalence" to Predicate Devices: This means showing that its intended use, technological characteristics, and safety and effectiveness profile are similar to devices already cleared by the FDA (Nidek Laser Photocoagulator Model GYC-1000 and Lumenis Novus Varia Ophthalmic Laser & Delivery Devices).

Study Proving Device Meets Acceptance Criteria:

The "study" described is a bench test and comparison to predicate devices.

Bench Test Data (BTD): This is explicitly mentioned as a basis for approval. These tests would have verified the product specifications (e.g., accurate wavelength emission, power output within stated range, pulse duration, etc.) and adherence to safety standards. No specific details of these bench tests (e.g., number of units tested, specific tests performed, results) are provided in this summary, as is typical for a 510(k).
Comparison of Technological Characteristics: The document outlines that the MC-300 and predicate devices are all Diode Laser Pumped Solid State Lasers (DPSSL) and use similar delivery systems. It states, "The fundamental technical characteristics and device specifications of the Nidek Multi Color Laser Photocoagulator Model MC-300 are the same as those of the predicate devices." (Section 3. SUBSTANTIAL EQUIVALENCE). It further specifies the wavelengths (532 nm, 561 nm, 659 nm), power range (50-2000 mW), pulse width (0.02-3.00 sec), and repetition rate (0.2-1.0 sec), noting that the power output is comparable to a predicate device (Nidek GYC-2000, K980547).

In essence, the "proof" is the successful completion of internal system and component testing to product specifications and a detailed technical comparison, demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices.

Summary

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510(k) SUMMARY NIDEK GREEN LASER PHOTOCOAGULATOR MODEL MC-300

DEC 1 4 2004

SUBMITTER INFORMATION 1.

Nidek Incorporated Company Name: A.. Company Address: 47651 Westinghouse Drive. B. Fremont, CA 94539-7474 Company Phone: C. (510) 353-7722 (510) 226-5750 Company Fax: Hiro Matsuzaki Contact Person: D. Manager, Regulatory Affairs Nidek Incorporated Date Summary Prepared: September 30, 2004 E.

DEVICE IDENTIFICATION 2.

A.	Classification Name:	Ophthalmic Laser, and Powered Surgical LaserInstrument
B.	Trade/Proprietary Name:	Nidek Multi Color Laser Photocoagulator ModelMC-300
C.	Device Classification:	Class II (per 21 CFR 886.4390 and 878.4810)
D.	Product Code:	HQF and GEX

SUBSTANTIAL EQUIVALENCE 3.

The Nidek Multi Color Laser Photocoagulator Model MC-300 is of comparable type and is substantially equivalent to the following predicate devices:

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K042785 p. 2 of 4

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Nidek Laser PhotocoagulatorModel GYC-1000	Nidek Co. Ltd.Japan	K032085	October 3,2003
Lumenis Novus VariaOphthalmic Laser &Delivery Devices	Lumenis, Inc.	K022181	October 1,2002

The fundamental technical characteristics and device specifications of the Nidek Multi Color Laser Photocoagulator Model MC-300 are the same as those of the predicate devices. The Model MC-300 and the predicate devices are all Diode Laser Pumped Solid State Lasers (DPSSL). The Model MC-300 and the predicate device use a variety of delivery systems, including slit lamps, to deliver the laser beam. The Model MC-300 and the predicate devices are indicated for use in surgical treatment of ocular pathology, including retinal photocoagulation, panretinal photocoagulation, intravitreal endophotocoagulation, iridotomy, iridectomy and trabeculoplasty.

4. DEVICE DESCRIPTION

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K042785 p. 3 of 4

optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

The Model MC-300 can be used to coagulate the target tissue efficiently and safely, and the system can be applied to transpupillary photocoagulation procedures using a slit-lamp.

A protective filter may be attached to each delivery unit in the observation optical path so that the operator's eye can be protected from the laser beam if it is reflected from a patient's eye or contact lens during laser emission. The Model MC-300 uses the following delivery units for use in a variety of ophthalmic procedures:

NIDEK Slit-Lamp Delivery Unit .
ZEISS Slit-Lamp Attachable Delivery Unit .
Binocular Indirect Ophthalmoscope Delivery Unit (Keeler All Pupil II Type) .

INTENDED USE ડાં

The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty

6. TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Nidek Multi Color Laser Photocoagulator Model MC-300 and the predicate devices has been performed, and the results of this comparison demonstrate that the Nidek Multi Color Laser Photocoagulator Model MC-300 has the same basic technological characteristics as the predicate devices and is equivalent to the marketed predicate devices. The

09/30/04

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differences between the Nidek Multi Color Laser Photocoagulator Model MC-300 and the predicate devices are insignificant and do not affect the safety or effectiveness of the device.

PERFORMANCE DATA 7.

The Nidek Multi Color Laser Photocoagulator Model MC-300 has been designed and will be tested in accordance with applicable safety standards. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis.

CONCLUSIONS 8.

Nidek Incorporated has demonstrated through its evaluation of the Nidek Multi Color Laser Photocoagulator Model MC-300 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.

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Name of Manufacturer: Nidek Co., LTD

Laser Model Name and Number: Nidek Multi Color Laser Photocoagulator Model MC-300

Laser Type: (Circle all that apply) Alexandrite, Argon, CO2, Copper-Vapor(Diode) Dye, Nd: YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other Coumped solid state

Indications in this application: Ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty

FDA Document Control Number: K042785

FDA Product Codes: 79GEX, 86HQF

Reviewer Computer Initials: ABC

Date of Clearance Letter: 12/3/04

Basis of Approval: (Circle all that apply) Predicate Device (PD) Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Cest Data (BTD), Historical Information (HI), Other __________________________________________________________________________________________________________________________

Description of Laser: The Nidek Multi Color Laser Photocoagulator Model MC-300 is an ophthalmic photocoagulation system that uses a diode pumped solid state laser beam with wavelengths of 532 nm (green), 561 nm (yellow) and 659 nm (red) for therapeutic treatment as well as the aiming beams. The system can be used in ophthalmic surgical procedures such as retinal and macular photocoagulation, iridotomy and laser trabeculoplasty. The system can be applied to transpupillary photocoagulation procedures using two types of slit-lamp delivery units. The Binocular Indirect Ophthalmoscope (B.I.O.) Delivery Unit allows the physician to perform laser photocoagulation while observing the fundus with the indirect ophthalmoscope.

Operation Modes: (Circle all that apply) CW Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other ________________________________________________________________________________________________________________

Wavelength in Nanometers: 532, 561 and 659

Power/Energy Range (Watts/Joules): 50-2000 mW *

Pulse Width: 0.02-3.00 sec

Repetition Rate: 0.2-1.0 sec in 0.1 sec increments

Delivery System: fiber optic

Comments: * A predicate device for the Nidek GYC-1000 (K030285) is the Nidek GYC-2000 (Model II) (K980547) with a power output of 50-2000 mW in 10 mW increments.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Nidek. Incorporated c/o Ms. Carol Patterson Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630

Re: K042785

Trade/Device Name: Nidek Multi Color Laser Photocoagulator Model MC-300 Regulation Number: 21 CFR 878.4810, 21 CFR 886.4390 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Ophthalmic laser Regulatory Class: II

Product Code: GEX, HQF Dated: September 30, 2004 Received: October 6, 2004

Dear Ms. Patterson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Carol Patterson

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number:	K042785(To Be Assigned By FDA)
Device Trade Name:	Nidek Multi Color Laser Photocoagulator Model MC-300
Indications For Use:	The Nidek Multi Color Laser Photocoagulator ModelMC-300 is indicated to be used in ophthalmic surgicalprocedures, including retinal and macular photocoagulationiridotomy and trabeculoplasty.

Prescription Use _ X (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 CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1_

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510(k) Number K042785

09/30/04

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.