(90 days)
No
The description focuses on the laser technology and optical delivery system, with no mention of AI or ML capabilities.
Yes
The device is used for ophthalmic surgery, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty, which are medical treatments for diseases or injuries.
No
Explanation: The device is a laser used for ophthalmic surgical procedures (photocoagulation, iridotomy, trabeculoplasty), not for diagnosing conditions. It is a treatment device.
No
The device description clearly details a physical laser system with optical components, delivery systems, and controls, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nidek Frequency Doubled Nd: YAG Laser is a surgical laser used for ophthalmic procedures. It directly interacts with the patient's tissue (photocoagulation, iridotomy, trabeculoplasty) rather than analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "ophthalmic surgery" and lists specific surgical procedures.
- Device Description: The description details the laser technology and how it's delivered to the target tissue within the eye. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Model Ophthalas 532 by Alcon (K962592), Model Cerlas G by CeramOptec (K962948), Model Oculight GL by Iris (K960971)
Reference Device(s)
Models GYC-1500/2000 (K951079)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
-
- Device Name: Models GYC-1500 and GYC-2000 Solid state ophthalmic laser photocoagulator Ophthalmic Laser
-
- 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 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.
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.
-
- Device Labels:
Copies of advertising brochure, operator's manual with product label information are attached.
- Device Labels:
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
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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.
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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
2
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)
..