(28 days)
Not Found
No
The summary describes a conventional laser photocoagulator system with no mention of AI or ML features in the device description, intended use, or performance studies.
Yes
The device is used in ophthalmic surgical procedures for photocoagulation, iridotomy, and trabeculoplasty, which are therapeutic interventions.
No
The device is described as a "photocoagulator system" intended for "ophthalmic surgical procedures," which are therapeutic rather than diagnostic. The description focuses on treatment wavelengths, delivery units, and the purpose of the device for procedures like retinal and macular photocoagulation, iridotomy, and trabeculoplasty, all of which are interventions, not diagnostic assessments.
No
The device description explicitly lists hardware components such as diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.
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 using laser photocoagulation to treat conditions in the eye. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system designed to deliver light energy to tissue. It's a surgical tool, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Nidek Multicolor Laser Photocoagulator System MC-500 is a therapeutic medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Product codes
GEX, HQF
Device Description
The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.
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)
All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device.
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
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.
0
Nidek, Inc.
SECTION 6 510(k) SUMMARY (CONT.)
510(k) Notification K_ K ( ( 022 P
FEB 2 3 2011 :
GENERAL INFORMATION
Applicant:
Nidek Incorporated 47651 Westinghouse Drive Fremont, CA 94539-7474 U.S.A. Phone: 510-226-5700 Fax: 510-226-5750
Contact Person:
Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-400-0856 ext. 112 Fax: 408-400-0865 Email: kitc@experiengroup.com
Date Prepared: January 24, 2011
Classification:
21 CFR§878.4810 and §886.4390, Class II
Product Code: GEX, HQF
Trade Name: Nidek Multicolor Laser Photocoagulator System MC-500
Generic/Common Name:
Ophthalmic Laser Photocoagulator
Predicate Device
Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)
Intended Use
The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
1
SECTION 6 510(k) SUMMARY (CONT.)
Product Description
The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.
Substantial Equivalence
The MC-500 is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed MC-500 is substantially equivalent to the predicate device.
Testing in Support of Substantial Equivalence Determination
All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device.
Summary
The MC-500 is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Nidek Incorporated % Experien Group, LLC Kit Cariquitan 155-A Moffett Park Drive, Suite 210 Sunnyale, California 94089
FEB 2 3 2", 1
Re: K110228
Trade/Device Name: Nidek Multicolor Laser Photocoagulator System MC-500 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: January 24, 2011 Received: January 26, 2010
Dear Kit Cariquitan:
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
3
Page 2 - Kit Cariquitan
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); 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 go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Aty B. R. to
ken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NIDEK, INC.
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Nidek Multicolor Laser Photocoagulator System MC-500
Indications for Use:
The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N.L. the
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110228