KOWA, FM-600, MODEL LSS50

{0}------------------------------------------------ # AUG 0 7 2009 owa Kowa Company. Ltd. ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHIHONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)3-5623-8063 FAX: +81-(0)3-5623-8060 # 510(k) Summarv K091039 Submitter information: Applicant: Kowa Company, Ltd. 4-14, Nihonbashi-honcho 3-Chome Chuo-ku, Tokyo, 103-8433 Japan Contact: Satohiko Takanashi, PE Date summary prepared: Aug. 4, 2009 #### Device identification: Device trade name: Regulation Number: Product code: Classification name: Regulatory Class: KOWA FM-600 21 CFR 886.1570 MYC Ophthalmoscope, Laser, Scanning Class II ## Identification of predicate devices: Kowa Company believes that this device is substantially equivalent to: Laser flare meter FM-500 manufactured by Kowa, 510(k)# K913852. Laser flare cell meter FC-1000 manufactured by Kowa, 501(k)# K880920. ## Device description: KOWA FM-600, here after refer to as FM-600, is a noninyasive flare photometry device that is able to assess anterior protein level quantitatively. FM-600 consists of three units, Measurement unit, Operating unit and Power supply unit. The measurement unit is contained optical system including Laser, photo receiver and CCD camera for observation. The operating unit is contained Observation monitor. Analyzer of detected photon intensity, printer for output and migratory mechanism of the units. The power supply unit is contained Power unit. ## Intended use: KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eve. ## Technical characteristics: Kowa FM-600 is a single-function device of laser flare measurement. Kowa FM-600 and the predicate devices have similar technological characteristics for flare measurement. The flare measurement volume in anterior chamber, measurement aperture and laser intensity at the patient eye are same characteristics of the predicate devices. {1}------------------------------------------------ The light sources of FM-600 are used a laser source for flare measurement and LED light for illumination to observe the measurement area. The laser light source wavelength is almost same to the predicate device. The light source for illumination is different type of the predicate device. To evaluate safety, tests based on optical hazard standards, ISO15004-2: 2007, IEC60825-1: 2007, and IEC60601-1: 1988 and related amendments, are performed and it is confirmed in equivalent level of safety to the predicate devices. According to ISO5725-1 and ISO5725-2. repeatability and reproducibility are evaluated. and are obtained 1.5% for repeatability and 4% for reproducibility in standard deviation. The results are shown in Table Al. Relation of flare value and using Bovine albumin solution, BSA, is shown in Figure A1. #### Precision: The precision is defined by standard deviation of measurement value built in calibrator of FM-600. This calibrator has a reflection ability of 80 photon counts per millisecond. The precision of FM-600 is less than 5% at 80 photon counts per millisecond. Image /page/1/Figure/6 description: The figure is a plot of flare value in PC/ms versus BSA concentration in mg/dL. The x-axis ranges from 0 to 10000, and the y-axis ranges from 0 to 500. The plot shows a linear relationship between flare value and BSA concentration up to approximately 4000 mg/dL, with the equation y = 0.126x + 4.720 and an R-squared value of 0.993. Beyond 4000 mg/dL, the flare value plateaus around 400 PC/ms. ## FIGURE A1. RELATION OF FLARE VALUE AND BSA CONCENTRATION In figure, solid line is a linearity regression line calculated by the data up to 2000mg/dL in concentration. Briefly conversion factor is 100mg/dL equal to 13 photon count/millisecond. Error bar indicates standard deviation. The standard deviation is estimated measurements taken on the same albumin sample using different three instruments, including repeatability (in PC/ms). Measurement is performed 10 repeating at one concentration of BSA Kowa Company, Ltd., KOWA FM-600 1 {2}------------------------------------------------ | BSA concentration<br>[mg/dL] | Mean flare values<br>[PC/ms] | Repeatability*<br>[PC/ms] | Reproducibility**<br>[PC/ms] | |------------------------------|------------------------------|---------------------------|------------------------------| | 2000 | 248.69 | 4.15 | 11.27 | | 1000 | 144.28 | 2.57 | 4.00 | | 500 | 77.49 | 1.51 | 2.73 | | 250 | 37.52 | 1.09 | 2.19 | | 125 | 18.97 | 0.80 | 1.07 | | 62.5 | 10.30 | 0.53 | 0.94 | | 31.3 | 5.03 | 0.29 | 0.65 | | 15.6 | 2.93 | 0.56 | 0.53 | | 0 (HBSS) | 0.96 | 0.33 | 0.32 | TABLE A1. Repeatability and reproducibility (according to ISO 5725-1 and 5725-2) at eight different prepared BSA concentrations measured 30 times using three (3) instruments and ten (10) replicate measurements per instrument. * Repeatability is an estimate of the standard deviation among measurements taken on the same albumin sample using the same instruments. ** Reproducibility is an estimate of the standard deviation among measurements taken on the same albumin sample using different instruments, including repeatability. ISO5725-1: 1994 Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions. ISO5725-2: 1994 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method. ## Substantial equivalency of performance Comparison with the predicate device is shown in Table A2. To evaluate performance equivalency, performance test using Bovine albumin solution as protein model in the anterior chamber is performed. From the studies of correlation and Bland-Altman plot of the flare value, KOWA FM-600 has good correlation and low valiance for the predicate device. It is concluded that KOWA FM-600 is substantially equivalent to the predicate devices. {3}------------------------------------------------ . | Table A2: Comparison with predicate devices | | | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed device | Predicate devices | | | Proprietary name | KOWA FM-600 | Laser Flare Meter<br>FM-500 | Laser Flare Cell Meter<br>FC-1000 | | 510(k) number | - | K91385 | K880920 | | Indications for use or Scope | KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye. | Quantitative measurement of protein concentration in the aqueous provides important information for evaluation anterior segment inflammation. | Quantitative measurement of protein concentration and cells in the aqueous provides important information for evaluation anterior segment inflammation. | | Functions | | | | | Slit lamp function | No | Yes | Yes | | Cell measurement | No | No | Yes | | Flare measurement | | Yes | | | Flare measurement function and principal parts | | | | | Laser source | 635nm Laser diode | 670nm Laser diode | 0.5mW 633nm Helium Neon Laser | | Laser scanning width | | 0.6 mm | | | Beam west diameter | | 20 μm | | | Laser light intensity at the subject eye | | Less than 0.05mW | | | Photo detector | | Photo multiplier tube | | | Measurement area | | 0.3 x 0.5 mm2 | | | Measurement time | 0.5 second | 0.5 second | 1.0 second | | Illumination light source | Infrared LED | 12V, 30W Halogen lamp | 6V, 30W Halogen lamp | | Observation method | Electrical image by CCD camera | Binocular microscope | Binocular microscope | | Fixation light source | | Visible LED | | Kowa Company, Ltd.. KOWA FM-600 . {4}------------------------------------------------ Image /page/4/Picture/0 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 an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002 KOWA Company, LTD., c/o Mr. Satohiko Takanashi Chief Analyst 4-14, Nihonbashihoncho 3-chome Chuo-ku, Tokyo Japan 103-8433 AUG 0 7 2009 Re: K091039 Trade/Device Name: KOWA FM-600 Model LSS50 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: MYC Dated: July 7, 2009 Received: July 9, 2009 Dear Mr. Takanashi: 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 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); 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. {5}------------------------------------------------ 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/CentersOffices/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/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/Resourcesfor You/Industry/default.htm. Sincerely yours. Kesia Alexander for Marvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if know): Ko91039 FM-600 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use: KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye. Prescription Use_ ﻧﮯ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF MEEDED) Concurrence of CDRH, Office of Device (Division Sign-Off) Division of Ophthalmie, Neurological and Ear, Nose and Throat Devices 510(k) Number K091039