(88 days)
No
The summary describes a laser photocoagulation system with various delivery units and standard electrical and safety testing. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is indicated for "ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty," which are therapeutic interventions. Additionally, the performance studies section refers to "therapeutic" laser equipment.
No
The device is a photocoagulator, used for ophthalmic surgical procedures and treatment of conditions like retinal and macular photocoagulation, iridotomy, and trabeculoplasty. Its primary function is therapeutic (to coagulate tissue), not diagnostic.
No
The device description clearly outlines a physical laser system with various hardware components (diode laser, fiber-optic cable, delivery units, protective filter). The performance studies also include testing related to electrical safety and laser equipment standards, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ophthalmic surgical procedures, specifically retinal and macular photocoagulation, iridotomy, and trabeculoplasty. These are therapeutic procedures performed directly on the patient's eye.
- Device Description: The device is a laser photocoagulation system that emits a laser beam to treat tissue. This is a therapeutic device, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The device is clearly a therapeutic medical device used for surgical treatment, not for in vitro diagnostic testing.
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
HQF, GEX
Device Description
The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red 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).
The Model GYC-1000 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 or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.
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 eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:
- Endophotocoagulation Delivery Unit .
- NIDEK Slit-Lamp Delivery Unit
- ZEISS Slit-Lamp Attachable Delivery Unit ●
- HAAG Attachable Slit-Lamp Delivery Unit .
- Binocular Indirect Ophthalmoscope Delivery Unit .
- Combination Delivery Unit for Nidek Nd:YAG laser .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal, macular
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)
System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. The following testing was performed on the Nidek Green Laser Photocoagulator Model GYC-1000 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:
A. Electrical Safety Testing & Electromagnetic Compatibility
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.
B. Programmable Electrical Medical Systems
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.
C. Requirements For The Safety Of Diagnostic And Therapeutic Laser Equipment
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with IEC 60601-2-22, JIS T1204, and JIS C6802, and was found to meet all requirements of the standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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KO32087 510(k) SUMMARY NIDEK GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
SUBMITTER INFORMATION 1.
| A. | Company Name: | Nidek Incorporated |
|---|---|---|
| B. | Company Address: | 47651 Westinghouse Drive. |
| Fremont, CA 94539-7474 | ||
| C. | Company Phone: | (510) 353-7719 |
| Company Fax: | (510) 226-5750 | |
| D. | Contact Person: | Mr. Hiro Matsuzaki |
| Regulatory and QA Manager | ||
| Nidek Incorporated | ||
| E. | Date Summary Prepared: | October 1, 2003 |
2. DEVICE IDENTIFICATION
| A. | Classification Name: | Ophthalmic Laser, and Powered Surgical Laser
Instrument |
|----|-------------------------|------------------------------------------------------------|
| B. | Trade/Proprietary Name: | Nidek Green Laser Photocoagulator
Model GYC-1000 |
| C. | Device Classification: | Class II (per 21 CFR 886.4390 and 878.4810) |
| D. | Product Code: | HQF and GEX |
SUBSTANTIAL EQUIVALENCE 3.
The Nidek Green Laser Photocoagulator Model GYC-1000 is of comparable type and is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Nidek Laser Photocoagulator | |||
| Model GYC-1500/2000 | Nidek Co. Ltd. | ||
| Japan | K980547 | May 13, 1998 |
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The fundamental technical characteristics and device specifications of the Nidek Green Laser Photocoagulator Model GYC-1000 are the same as those of the predicate device. The Model GYC-1000 and the predicate device are frequency doubled solidstate lasers with a wavelength of 532 nm. The Model GYC-1000 and the predicate device use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, endoprobes, and Nd: Y AG lasers to deliver the laser beam. The Model GYC-1000 and the predicate device are indicated for use in macular and retinal photocoagulation, and glaucoma procedures such as iridotomy and trabeculoplasty.
4. DEVICE DESCRIPTION
The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red 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).
The Model GYC-1000 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 or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.
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
2
from a patient's eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:
- Endophotocoagulation Delivery Unit .
- NIDEK Slit-Lamp Delivery Unit
- ZEISS Slit-Lamp Attachable Delivery Unit ●
- HAAG Attachable Slit-Lamp Delivery Unit .
- Binocular Indirect Ophthalmoscope Delivery Unit .
- Combination Delivery Unit for Nidek Nd:YAG laser .
5. 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.
TECHNOLOGICAL CHARACTERISTICS 6.
A comparison of the technological characteristics of the Nidek Green Laser Photocoagulator Model GYC-1000 and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the Nidek Green Laser Photocoagulator Model GYC-1000 has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device. The differences between the Nidek Green Laser Photocoagulator Model GYC-1000 and the predicate device are insignificant and do not affect the safety or effectiveness of the device.
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| | Nidek Model GYC-1000 | Nidek GYC-1500/2000
K980547 (Predicate Device) |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Laser | Laser diode pumped,
frequency doubled Nd:YAG
solid state laser | Model GYC-1500: Arclamp
(Krypton) pumped, frequency
doubled Nd:YAG solid state laser
Model GYC-2000: Laser diode
pumped, frequency doubled
Nd:YAG solid state laser |
| Wavelength | 532 nm | 532 nm |
| Output | Continuous Wave | Continuous Wave |
| Power Output | 50 to 1700mW
(50 to 500mW in 10mW
increments,
500 to 1700mW in 50mW
increments) | 50 to 1500mW in 10mW
increments (Model I)
or
50 to 2000mW in 10mW
increments (Model II) |
| Exposure Time | 0.01 to 0.10 sec. in 0.01 sec.
increments
0.10 to 0.50 sec. in 0.05 sec.
increments
0.50 to 1.00 sec. in 0.10 sec.
increments
1.00 to 3.00 sec. in 1.00 sec.
increments | 0.02 to 3.00 sec. |
| Repetition Mode | Interval time 1.0 to 0.1 sec. in
0.1 sec. increments | 1.0, 0.6, 0.4 and 0.2 sec. |
| Cooling Method | Air cooled | Internal water cooling system |
| Microprocessor | Two CPU's: Master CPU for
controlling the device, and Sub
CPU for monitoring the
Master CPU | One CPU |
| Aiming Laser | | |
| Type | Diode Laser | Diode Laser |
| Wavelength | 635 nm (red) | 633 nm (red) |
| Output Type | Continuous Wave | Continuous Wave |
| Power Output | 0.2 to 0.4mW | 0.2 to 0.8mW |
| Accessories | | |
| Endophotocoagulation Delivery
Unit | Straight and angled probes,
which are single-use
disposable | Straight and angled probes, which
are single-use disposable |
| Slit Lamp Delivery Unit | Nidek SL-1600 Type | Nidek SL-1600 Type |
| Slit Lamp Adaptors | Zeiss Type
• | Zeiss Type
• |
| PREDICATE DEVICE COMPARISON TABLE | | |
| | Nidek Model GYC-1000 | Nidek GYC-1500/2000
K980547 (Predicate Device) |
| Binocular Indirect
Ophthalmoscope (B.I.O.)
Delivery Unit | Haag Streit Type Heine Omega 180 Type | Haag Streit Type Heine Omega 180 Type |
| Combination Delivery Unit | For use with Nidek Nd:YAG
lasers | For use with Nidek Nd:YAG
lasers |
| Spot Size at Target | 50 to 500 µm (parfocal) for Combination Unit and
Slit Lamp Units 180 to 520 µm for B.I.O. 400 µm for Endo probes | 50 to 500 µm (parfocal) for
Combination Unit and Slit
Lamp Units 180 to 520 µm for B.I.O. 400 µm for Endo probes |
| Operating Microscope Filters | Zeiss Möeller Wedel Topcon Wild | Zeiss Möeller Wedel Topcon Wild |
| Power Requirements | 90-264 VAC, 50/60 Hz,
200 VA | 100/120/230 VAC, 50/60 Hz,
1500 VA (continuous) |
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7. PERFORMANCE DATA
System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. The following testing was performed on the Nidek Green Laser Photocoagulator Model GYC-1000 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:
A. Electrical Safety Testing & Electromagnetic Compatibility
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.
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-
Programmable Electrical Medical Systems B.
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard. -
C. Requirements For The Safety Of Diagnostic And Therapeutic Laser Equipment
The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with IEC 60601-2-22, JIS T1204, and JIS C6802, and was found to meet all requirements of the standards.
8. CONCLUSIONS
Nidek Incorporated has demonstrated through its evaluation of the Nidek Green Laser Photocoagulator Model GYC-1000 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2003
Mr. Hiro Matsuzaki Regulatory and QA Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, CA 94539-7474
Re: K032085
Trade/Device Name: Nidek 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 dermatiology Regulatory Class: II Product Code: GEX Dated: July 1, 2003 Received: July 7, 2003
Dear Mr. Matsuzaki:
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 (OS) 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 - Mr. Hiro Matsuzaki
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 (301) 594-4659. 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,
Muriam 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: | K032085 (To Be Assigned By FDA) |
|---|---|
| Device Trade Name: | Nidek Green Laser Photocoagulator Model GYC-1000 |
| 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. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
Miriam C Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032085
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