(143 days)
Not Found
No
The summary describes a conventional laser photocoagulator system with various delivery units and control mechanisms that are manually operated by the user. There is no mention of automated decision-making, image analysis, or adaptive algorithms that would indicate the presence of AI/ML. The performance studies focus on standard safety and performance testing for medical devices, not on the validation of AI/ML algorithms.
Yes
The device is described as a "laser photocoagulator" intended for "ophthalmic surgical procedures" such as "retinal and macular photocoagulation, iridotomy and trabeculoplasty," which directly refers to treating medical conditions.
No
The device is a laser photocoagulator intended for ophthalmic surgical procedures (treatment), not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a laser source, control box, and various delivery units (slit lamp, binocular indirect ophthalmoscope) that guide the laser beam. It is a physical system, not solely software.
Based on the provided information, the Yellow Laser Photocoagulator System YLC-500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The YLC-500 is a laser photocoagulator used in ophthalmic surgical procedures. It directly applies a laser beam to the patient's eye for treatment purposes (retinal and macular photocoagulation, iridotomy, and trabeculoplasty).
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. It is a therapeutic device used for surgical intervention.
Therefore, the YLC-500 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Yellow Laser Photocoagulator System YLC-500 (hereafter referred to as "YLC-500") is a laser photocoagulator for ophthalmology using the 577 nm optically-pumped semiconductor laser (yellow laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation systems, the YLC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 is a modified version of the GYC-500 as the primary predicate device and MC-500 Vixi which were the subjects of premarket notification numbers K152603 and K111493.
The YLC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.
To use the YLC-500, the operator sets laser emission conditions such as laser power output, spot size, and exposure time according to the condition of treatment site through the control box of the YLC-500 or operation part of the connected delivery unit. When using an (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the YLC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the operator aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a scanning manner when a scan (attachable) delivery unit is connected to the YLC-500.
Various types of the delivery units are available for the YLC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrative filer and so on for connection to the slit lamp owned by the user.
Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The YLC-500 connected with a scan (attachable) delivery unit is called "Yellow Scan Laser Photocoagulator YLC-500 Vixi".
Various slit lamp delivery units are available that allow for the adaptation of the YLC-500 to a slit lamp. An optical fiber cable is connected from the YLC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp delivery units are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, HAAG BQ900).
Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit is available.
The B.I.O. delivery unit enables photocoagulation using a vellow laser beam (577 mm) while observing the patient's eye with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The delivery unit (Heine Omega 500 type) connects to the YLC-500 main body via an optical fiber cable. The delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens, illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the distance among the operator, the patient, and 20 D condensing lens, which can be varied within a range of 300 to 700 mm. The treatment and aiming beam spot size can also be selected by changing working distance (with the 20D condensing lens).
The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eye
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)
All necessary bench testing was conducted on the Yellow Laser Photocoagulator System YLC-500 to support a determination of substantial equivalence to the predicate devices. The tests performed include:
- Ophthalmic Testing per ISO 15004-1, and ISO15004-2
- Slit Lamp Testing per ISO 10939
- Laser Product Safety Testing per IEC 60601-2-22 and IEC 60825-1
- Software Verification and Validation per AAMI/ANSI/IEC 62304 The software of this device was considered as a "Major" level of concern based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on: May 11, 2005.
- Usability Testing per IEC60601-1-6 and IEC 62366
- Electrical Safety Testing per IEC60601-1 and Electromagnetic Compatibility Testing per IEC60601-1-2.
The collective performance testing demonstrates that the YLC-500 does not raise any new questions of safety or effectiveness when compared to the predicate devices. The results of the performance testing demonstrate that the YLC-500 performs as intended and does not raise any new questions of safety or effectiveness.
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.
Not Found
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
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
Nidek Incorporated Toshio Murata Senior RA/QA Manager 47651 Westinghouse Drive Fremont, CA 94539
Re: K170302
Trade/Device Name: Yellow Laser Photocoagulator System YLC-500 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: May 31, 2017 Received: June 1, 2017
Dear Toshio Murata:
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 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.
1
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); 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170302
Device Name
YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500
Indications for Use (Describe)
The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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3
Image /page/3/Picture/0 description: The image shows the logo for NIDEK CO., LTD. The logo consists of a blue square with a white eye symbol and the word "NIDEK" in white letters. To the right of the logo is the company name "NIDEK CO., LTD." in black letters. Below the company name is the address: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan, as well as a description of the company as manufacturers, exporters, and importers of ophthalmic instruments.
TEL +81-533-67-6611
FAX +81-533-67-6610
URL
510(K) SUMMARY
GENERAL INFORMATION
Submission K170302 Applicant: NIDEK CO., LTD. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Phone: +81-533-67-8901 Fax: +81-533-67-6628
Contact Person:
Toshio Murata Senior RA/QA Manager NIDEK INCORPORATED 47651 Westinghouse Drive Fremont, CA 94539 U.S.A. Phone: 510-353-7789 FAX: 510-226-5750
Date Prepared: January 30, 2017
DEVICE INFORMATION
Trade Name:
Yellow Laser Photocoagulator System YLC-500
4
Generic/Common Name:
Ophthalmic laser
Classification:
21 CFR §886.4390, Class II
Product Code:
HQF
PREDICATE DEVICE(S)
- · GREEN LASER PHOTOCOAGULATOR MODEL GYC-500 (K152603) (as the primary predicate device with indications for use and technological characteristics that are most similar to the YLC-500)
- MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 Vixi (K111493)
The GYC-500 is chosen as the primary predicate device because it has the similar indications for use as and technological characteristics to the YLC-500. The hardware and software structures are similar between the YLC-500 and GYC-500 although the YLC-500 emits the treatment laser of a different wavelength with the different power output range from the GYC-500.
The MC-500 Vixi is also necessary and appropriate to support substantial equivalence in wavelength of and power output range of the treatment laser to the YLC-500.
INDICATIONS FOR USE
The Yellow Laser Photocoagulator System YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
The Yellow Laser Photocoagulator System YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500
PRODUCT DESCRIPTION
NIDEK CO., LTD K170302
YLC-500 510(k) 2 of 11
5
The Yellow Laser Photocoagulator System YLC-500 (hereafter referred to as "YLC-500") is a laser photocoagulator for ophthalmology using the 577 nm optically-pumped semiconductor laser (yellow laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation systems, the YLC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 is a modified version of the GYC-500 as the primary predicate device and MC-500 Vixi which were the subjects of premarket notification numbers K152603 and K111493.
The YLC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.
To use the YLC-500, the operator sets laser emission conditions such as laser power output, spot size, and exposure time according to the condition of treatment site through the control box of the YLC-500 or operation part of the connected delivery unit. When using an (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the YLC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the operator aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a scanning manner when a scan (attachable) delivery unit is connected to the YLC-500.
Various types of the delivery units are available for the YLC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrative filer and so on for connection to the slit lamp owned by the user.
NIDEK CO., LTD K170302
YLC-500 510(k) 3 of 11
6
Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The YLC-500 connected with a scan (attachable) delivery unit is called "Yellow Scan Laser Photocoagulator YLC-500 Vixi".
Various slit lamp delivery units are available that allow for the adaptation of the YLC-500 to a slit lamp. An optical fiber cable is connected from the YLC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp delivery units are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, HAAG BQ900).
Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit is available.
The B.I.O. delivery unit enables photocoagulation using a vellow laser beam (577 mm) while observing the patient's eye with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The delivery unit (Heine Omega 500 type) connects to the YLC-500 main body via an optical fiber cable. The delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens, illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the distance among the operator, the patient, and 20 D condensing lens, which can be varied within a range of 300 to 700 mm. The treatment and aiming beam spot size can also be selected by changing working distance (with the 20D condensing lens).
NIDEK CO., LTD K170302
YLC-500 510(k) 4 of 11
7
The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.
Comparison of technological characteristics with predicate devices
The YLC-500 and the predicate devices are all laser photocoagulators that are intended for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 and MC-500 Vixi emit a continuous optically-pumped semiconductor laser of 577 nm, whereas the MC-500 Vixi emits the lasers of 532 nm and that of 647 nm as well. The YLC-500's main body, control box and expansion box have three CPUs that are identical to the GYC-500 to respectively control the main body, control box and expansion box. The YLC-500 uses the expansion box controlling the scan function in common with the GYC-500 that was previously cleared in 510(k) No.152603. The YLC-500 uses the same cooling method as the predicate devices.
With regard to the specifications for the laser beams emitted from the YLC-500, the range of power output of the treatment laser is the same as that of 577 nm treatment laser of the MC-500 Vixi. The range of the exposure time, and the specifications for the aiming beam including the range of aiming beam power output available with the YLC-500 are the same as those of the GYC-500.
The YLC-500 is connected to one (or two when the dual type is used) of various types of delivery units to deliver the treatment laser beam to the patient's eve. The connected (scan/attachable) slit lamp delivery units are the same between the YLC-500 and GYC-500 except for the cutoff wavelength as discussed in "Justification that differences do not affect safety and effectiveness" of Table 12.1 "Substantial equivalence comparison table for YLC-500 and the predicate devices". The cutoff wavelength of the protective filter is the same between the (scan/attachable) slit lamp delivery units for the YLC-500 and those for the MC-500 Vixi. All the (scan/attachable) delivery units have the same intended use, principles of operation and technological characteristics as the delivery units connectable to the predicate devices, and also, the laser output emitted from these delivery units was tested and found to comply with IEC60601-2-22 and IEC 60825-1.
NIDEK CO., LTD K170302
YLC-500 510(k) 5 of 11
8
The YLC-500 also provides the operator with the option of performing procedures by delivering the laser beam in either a single spot or in patterns as the predicate devices do. Specifically, the YLC-500 and MC-500Vixi allow the operator to deliver a single spot laser or patterned scanning laser of 577 nm when connected to a scan (attachable) slit lamp delivery unit, whereas the MC-500 Vixi delivers a single spot or patterned scanning laser in three different wavelengths (i.e., green, yellow, and red) as well. The scan patterns available with the YLC-500 are the same as those with the GYC-500. CPU-controlled scanning mirrors create the various scan patterns consistently by moving the scanning mirrors and by deflecting the laser beam. The movable range of the scanning mirrors and the way the mirrors are driven, and control circuit are the same between the YLC-500 and predicate devices.
Comparison of technological characteristics with predicate devices is provided in Table 1:
| Product | Yellow Laser Photo-coagulator YLC-500 | Multicolor Scan Laser Photocoagulator MC-500 Vixi | Green Laser Photo-coagulator GYC-500 |
|---|---|---|---|
| Manufacturer | NIDEK | NIDEK | NIDEK |
| 510(k) number | — | K111493 | K152603 |
| 510(k) clearance date | — | 07/27/2011 | 05/02/2016 |
| Regulation medical specialty | Ophthalmic | ← | ← |
| Review panel | Ophthalmic | ← | ← |
| Product code | HQF | ← | ← |
| Regulation number | 21 CFR 886.4390 | ← | ← |
| Regulation description | Ophthalmic laser | ← | ← |
| Classification | II | ← | ← |
| Indications for use | The Yellow Laser Photocoagulator System YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation iridotomy and | The NIDEK Multicolor Scan Laser Photocoagulator MC-500 Vixi is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iri- | The NIDEK Green Laser Photocoagulator GYC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation iridotomy and |
| Product | Yellow Laser Photo- | ||
| coagulator System | |||
| YLC-500 | Multicolor Scan Laser | ||
| Photocoagulator | |||
| MC-500 Vixi | Green Laser Photo- | ||
| coagulator GYC-500 | |||
| trabeculoplasty. | |||
| The Yellow Laser Photo- | |||
| tocoagulator System | |||
| YLC-500 is intended to | |||
| work in conjunction | |||
| with the following de- | |||
| livery units in oph- | |||
| thalmic photocoagula- | |||
| tion procedures: NIDEK | |||
| SL-1800, SL-1600, | |||
| ZEISS SL 130, HAAG | |||
| BQ900, HEINE OMEGA | |||
| 500 | dotomy and trabeculo- | ||
| plasty. | trabeculoplasty. | ||
| Application | Ophthalmology | ← | ← |
| Technical | |||
| specifications | |||
| Treatment la- | |||
| ser | |||
| Laser type | Optically-pumped | ||
| semiconductor laser | 532 nm: Diode-pumped | ||
| solid-state laser, | |||
| 577 nm: Optical- | |||
| ly-pumped semicon- | |||
| ductor laser, 647 nm: | |||
| Diode laser | Diode-pumped | ||
| solid-state laser | |||
| Wavelength | 577 nm | 532 nm | |
| 577 nm | |||
| 647 nm | 532 nm | ||
| Laser mode | Continuous wave | ← | ← |
| Power output | 50 to 1500 mW | ||
| (50 to 500 mW in in- | |||
| crements of 10mW, | |||
| 500 to 1500 mW in | |||
| increments of 50mW) | |||
| 50 to 1500 mW (Scan | |||
| Mode) | 532 nm: 50 to 1700 | ||
| mW, 50 to 1500 mW | |||
| (Scan Mode) | |||
| 577nm: 50 to 1500 mW | |||
| 647nm: 50 to 800 mW | 50 to 1700 mW | ||
| (50 to 500 mW in in- | |||
| crements of 10mW, | |||
| 500 to 1700 mW in | |||
| increments of 50mW) | |||
| 50 to 1500 mW (Scan | |||
| Mode) | |||
| Exposure time | Single spot: | ||
| 0.01 to 3.00 sec. | |||
| Scan Mode: | |||
| 0.01 to 0.05 sec. | |||
| Auto M Mode | |||
| 0.01 to 3.00 sec | Single spot: | ||
| 0.01 to 1.00 sec, 2.00 | |||
| sec. and 3.00 sec. | |||
| Scan Mode: | |||
| Pattern: 0.01 to 0.03 | |||
| sec., | |||
| Auto M Mode | |||
| Single spot: 0.01 to | |||
| 1.00 sec., 2.00 sec. and | Single spot: | ||
| 0.01 to 1.00, 2.00, | |||
| 3.00 sec | |||
| 0.01 to 0.10 sec: 0.01 | |||
| increments | |||
| 0.10 to 0.50 sec: 0.05 | |||
| increments | |||
| 0.50 to 1.00 sec: 0.1 | |||
| increments | |||
| Product | Yellow Laser Photo- | ||
| coagulator | |||
| YLC-500 | Multicolor Scan Laser | ||
| Photocoagulator | |||
| MC-500 Vixi | Green Laser Photo- | ||
| coagulator GYC-500 | |||
| 3.00 sec. | Scan Mode | ||
| Pattern: 0.01 to 0.05 | |||
| sec. | |||
| Auto M Mode | |||
| Single spot: 0.01 to | |||
| 1.00 sec., 2.00 sec. | |||
| and 3.00 sec. | |||
| Interval time | 0.05 to 1.0 sec | 0.05 to 1.0 sec. in 0.05 | |
| increments | 0.05 to 1.0 sec. in 0.05 | ||
| increments | |||
| Cooling Method | Air cooled | ← | ← |
| Aiming beam | |||
| Type | Laser diode | ← | ← |
| Wavelength | 635 nm | 670 nm | 635 nm |
| Laser mode | Continuous wave | ← | ← |
| Power output | $0.3\pm0.1$ mW | 0.4 to 0.8 mW | 0.2 to 0.4 mW |
| Delivery units | |||
| Slit Lamp De- | |||
| livery Unit | • NIDEK SL-1800 | • NIDEK SL-1800 | • NIDEK SL-1800 |
| Attachable slit | |||
| lamp delivery | |||
| unit | • For ZEISS SL-130 | ||
| • For NIDEK | |||
| SL-1800/SL-1600 | • For ZEISS 30SL/M | ||
| • For NIDEK SL-1800 | • For ZEISS 30SL/M, | ||
| • For ZEISS SL130, | |||
| • For NIDEK | |||
| SL-1800/SL-1600 | |||
| • For HAAG 900BM | |||
| /900BQ | |||
| Scan slit lamp | |||
| delivery unit | • NIDEK SL-1800 | • NIDEK SL-1800 | • NIDEK SL-1800 |
| Scan attachable | |||
| slit lamp deliv- | |||
| ery unit | • For NIDEK | ||
| SL-1800/1600 | |||
| • For Zeiss SL 130 | |||
| • For HAAG BQ900 | • For Zeiss 30SL/M, | ||
| • For NIDEL SL-1800, | |||
| • For Zeiss SL 130 | • For ZEISS 30SL/M, | ||
| • For NIDEK | |||
| SL-1800/SL-1600 | |||
| • For ZEISS SL130, | |||
| • For HAAG 900BQ | |||
| Binocular Indi- | |||
| rect Ophthal- | |||
| moscope (B.I.O.) | |||
| delivery unit | HEINE OMEGA 500 | HEINE OMEGA 500 | HEINE OMEGA 500, |
| KEELER All Pupil II | |||
| Scan patterns | Single, Square (2×2, | ||
| 3x3, 4x4, 5×5), Equal | |||
| Space (2v2, 3v3, 4v4, | |||
| 5v5) *1, Line, Triangle, | |||
| Curve, Circle, Arc (3/4 | |||
| circle, 2/4 circle, 1/4 | Single spot, Squire | ||
| (2×2, 3×3, 4×4, 5×5) | |||
| Circle, Arc, Triple Arc, | |||
| Macula Grid, Triangle, | |||
| Line, and Curve | Single spot, Squire | ||
| (2×2, 3×3, 4×4, 5×5), | |||
| Equal space (2v2, 3v3, | |||
| 4v4, 5v5), Line, Trian- | |||
| gle, Curve, Circle, Arc | |||
| (3/4 circle, 1/2 circle | |||
| Product | Yellow Laser Photo-coagulator System YLC-500 | Multicolor Scan Laser Photocoagulator MC-500 Vixi | Green Laser Photo-coagulator GYC-500 |
| circle), Triple Arc, Arcade Grid, Rectangle, Triple Curve | 1/4 circle), Triple Arc, Arcade Grid (Arcade Grid, Arcade Grid 1, Arcade Grid 2), Rectangle, Triple Curve | ||
| Spot size | Slit lamp delivery unit: | ||
| 50 to 990 μm | |||
| Scan slit lamp delivery unit: 50 to 500 μm, | |||
| 100 to 500 μm in scan mode | |||
| B.I.O. delivery: | |||
| 212 to 664 μm | Slit lamp delivery unit: | ||
| 50 to 1000 μm, | |||
| Scan slit lamp delivery unit: | |||
| 50 to 500 μm in single mode, 100 to 500 μm in scan mode | |||
| B.I.O. delivery: | |||
| HEINE OMEGA 500 | |||
| 212 to 664 μm, | |||
| Combination delivery: | |||
| 50 to 500 μm | Slit lamp delivery unit: | ||
| 50 to 1000 μm | |||
| Scan slit lamp delivery: | |||
| 50 to 500 μm in single mode, 100 to 500 μm in scan mode | |||
| B.I.O. delivery | |||
| HEINE OMEGA500: | |||
| 212 to 664 μm | |||
| KEELER AP II: 185 to | |||
| 556 μm | |||
| Combination delivery: | |||
| 50 to 500 μm | |||
| Guard wavelength of protective filter | 577 nm | 532 nm, 577 nm, 647 nm | 532 nm |
| Electrical requirements | |||
| Voltage | 100 to 240 VAC ±10% | ||
| 50/60 Hz ±1 Hz | 100 to 240 VAC ±10% | ||
| 50/60 Hz | 100 to 240 VAC | ||
| 50/60 Hz | |||
| Power consumption | 250 VA | 400 VA or less | 250 VA |
| Physical characteristics | |||
| Dimension | 237 (W) × 318 (D) × 90 (H) mm (excluding protrusions) | 670 × 480 × 300 mm | 237 (W)× 318 (D) × 90 (H) mm |
| Weight | 5.6 kg | 35 kg | 6.2 kg (excluding the control box) |
Table 1 Substantial equivalence comparison table for YLC-500 and the predicate devices
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SUBSTANTIAL EQUIVALENCE
The YLC-500 is substantially equivalent to the predicate devices, Green Laser Photocoagulator Model GYC-500 as the primary predicate device, and Multicolor Scan Laser Photocoagulator MC-500 Vixi. They are all laser photocoagulators that are intended for use in ophthalmic
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surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty..
The YLC-500 is similar in technological characteristics, performance, principles of operation and has similar indications for use as the predicate devices. Any differences in technological characteristics between the proposed device and the predicate devices do not raise any new issues of safety or effectiveness. Thus, the YLC-500 is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the Yellow Laser Photocoagulator System YLC-500 to support a determination of substantial equivalence to the predicate devices. The tests performed include:
- Ophthalmic Testing per ISO 15004-1, and ISO15004-2
- Slit Lamp Testing per ISO 10939
- Laser Product Safety Testing per IEC 60601-2-22 and IEC 60825-1
- Software Verification and Validation per AAMI/ANSI/IEC 62304 The software of this device was considered as a "Major" level of concern based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on: May 11, 2005.
- Usability Testing per IEC60601-1-6 and IEC 62366
- Electrical Safety Testing per IEC60601-1 and Electromagnetic Compatibility Testing per IEC60601-1-2.
The collective performance testing demonstrates that the YLC-500 does not raise any new questions of safety or effectiveness when compared to the predicate devices. The results of the performance testing demonstrate that the YLC-500 performs as intended and does not raise any new questions of safety or effectiveness.
CONCLUSION
In summary, NIDEK CO., LTD. is of the opinion that the Yellow Laser Photocoagulator System YLC-500 does not introduce any new potential safety risks, is as effective and performs as well as the predicate devices, and concludes that the YLC-500 is substantially equivalent to the predicate devices.
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SUMMARY
The Yellow Laser Photocoagulator System YLC-500 is substantially equivalent to the predicate devices.
NIDEK CO., LTD K170302