(128 days)
k 021696
No
The summary describes a laser photocoagulation system using a solid-state laser. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies. The focus is on the laser technology and its application in ophthalmic procedures.
Yes
The device is used in ophthalmic surgical procedures for photocoagulation, iridotomy, and trabeculoplasty, which are therapeutic interventions.
No
This device is a photocoagulator used for surgical procedures like retinal and macular photocoagulation, iridotomy, and trabeculoplasty, which are treatments rather than diagnostic processes.
No
The device description explicitly states it is a "solid state laser (green laser beam)" and a "photocoagulation system," indicating it is a hardware device that emits a laser for surgical procedures. It also mentions connecting to a "Delivery Unit," further confirming its hardware nature.
Based on the provided information, the Nidek Green Laser Photocoagulator Model GYC-1000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ophthalmic surgical procedures, specifically photocoagulation of the retina and macula, iridotomy, and trabeculoplasty. These are therapeutic procedures performed directly on the patient's eye.
- Device Description: The device is a laser system used for surgical intervention. It delivers a laser beam to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a therapeutic medical device used for surgical treatment.
N/A
Intended Use / 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 codes (comma separated list FDA assigned to the subject device)
GEX
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
k 021696
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the logo for NIDEK. The logo features a stylized eye above the word "NIDEK" in bold, block letters. The eye is composed of curved lines forming the upper and lower lids, with a large, circular pupil in the center. The overall design is simple and modern.
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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Image /page/1/Picture/0 description: The image shows the Nidek logo. The logo consists of an eye symbol above the word "NIDEK" in bold, block letters. The eye symbol is stylized, featuring a large, circular pupil within an outlined eye shape.
34-14, Mastama, reishicho, Seragen, Aichi 443-0038, Japar.
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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
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.
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Image /page/2/Picture/0 description: The image shows the Nidek logo. The logo consists of a stylized eye above the word "NIDEK" in bold, sans-serif font. The eye is formed by a curved line representing the upper eyelid and a filled circle representing the pupil. The logo is black and white.
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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Image /page/3/Picture/12 description: The image shows the logo for NIDEK. The logo consists of an eye symbol above the word "NIDEK". The eye symbol is a stylized representation of an eye, with a large pupil and a curved upper eyelid. The word "NIDEK" is written in a bold, sans-serif font.
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:
್ಗಾ
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
6
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
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