Digital Eye Anterior Camera

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 6, 2017 Medimaging Integrated Solution Inc. (miis) % Yi-Ying Chen Engineer 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, Taiwan 30076 (R.O.C.) Re: K170470 Trade/Device Name: Digital Eye Anterior Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO, HKI Dated: August 24, 2017 Received: August 29, 2017 Dear Yi-Ying Chen: 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 (DICE) 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. 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 (DICE) 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. # Bradley S. Cunningham -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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170470 Device Name MiiS Horus+ Scope DEA 200 Indications for Use (Describe) MilS Horus+ Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The text "MiiS" is written in blue below the target. K170470 # 510(k) Summary Prepared: October 1, 2017 | Submitter/Owner's<br>Name/ Address | Medimaging Integrated Solution Inc. (MiiS)<br>1F, No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan<br>30076 (R.O.C.) | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Hsu, Chih-Lu (COO) | | Telephone: Fax: | +886-3-5798860 Ext: 1110 | | Email Address: | +886-3-5798821<br>luu@miis.com.tw | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo with a circular design at the top and the word "MiiS" in blue at the bottom. The circular design consists of concentric rings divided into alternating black and white segments, resembling a target or a stylized eye. The word "MiiS" is written in a bold, sans-serif font, with a blue color that stands out against the white background. The entire logo is enclosed within a rounded square with a thin blue border. K170470 ## Device Identification: Trade/Device Name MiiS Horus Scope DEA 200 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO, HKI ## Predicate Device: - 1. K063640 Trade/Device Name: Kowa SL-15 Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO - 2. K120982 Trade/Device Name: MiiS Horus Scope DEC 100 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI ### Description of Device: MiiS Horus* Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus* Scope DEA 200 has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in SD memory card, or via the USB transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the AV output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos. Below includes a summary of the technical information used in the substantial equivalence comparison. It is more efficient and suitable for many different applications, such as electronic filing. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo for MiiS. The logo is a rounded square with a white background. Inside the square is a circular target-like design with alternating black and white sections. Below the target design, the text "MiiS" is written in blue, with a line underneath it. # Indications for Use: MiiS Horus+ Scope DEA 200 is a digital hand-held slit lamp system indicated for noninvasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. # Substantial Equivalence Summary Key technological seminaries and differences between the ICON and the predicates: | Device | K170470 | K063640<br>Predicate Device | K120982<br>Predicate Device | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model name | MiiS Horus+ Scope<br>DEA 200 | KOWA SL-15 | MiiS Horus Scope<br>DEC 100 | | Intended use | MiiS Horus+ Scope DEA 200 is<br>a digital hand-held slit lamp<br>system indicated for non-<br>invasive illumination,<br>magnification, visualization and<br>to record digital photographs<br>and video of anterior segment<br>(including cornea, anterior<br>chamber, and lens) of the<br>human eye and surrounding<br>area. | KOWA SL-15 is an ophthalmic<br>device indicated for<br>non-invasive illumination,<br>magnification and observation<br>of the human eye. It consists of<br>a hand-held, battery powered<br>slit-lamp biomicroscope with<br>viewing and illumination<br>optical systems and an<br>AC-powered stand. | MiiS Horns Scope DEC 100 is<br>a digital hand-held eye-fundus<br>camera used to record digital<br>photographs and video of<br>fundus of the human eye and<br>surrounding area. | | Slit Lamp | | | | | Slit selection | Turret-type switching | Turret-type switching | | | Slit length | 10 mm Fixed | 12 mm Fixed | | | Slit Width | $≤$ 0.2, 0.2, 0.5, 2, 5,<br>10 mm | 0.1, 0.2, 0.8 mm and<br>$ ⌀ $ 12mm spot | | | Slit projection<br>angle | $ \pm $ 45 degree (+/- 5%) | 60 degree for<br>Horizontal | | | Filter | Blue, Green | Blue | None | | Digital Camera | | | | | Picture/Video | Built-in | Supports electronic image<br>with the optional camera<br>connection adapter<br>(C-mount). | Built-in | | Image sensor | CMOS | CCD | CMOS | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo for Miis. The logo is a circular target with alternating black, white, and gray sections. The word "Miis" is written in blue, bold letters below the target. | Magnification | 10X / 16X | 10X / 16X | 0.25X | | | | | | | | | |----------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--| | Display | Display on the TFT-LCD or<br>connect to and display on<br>computer | Connect to and display on<br>the camera and computer<br>display. | Display on the TFT-LCD or<br>connect to and display on<br>computer | | | | | | | | | | Image storage | SD card and could be transfer<br>to user's computer | User's computer | SD card and could be transfer<br>to user's computer | | | | | | | | | | Light Source | | | | | | | | | | | | | Type | White LED | Halogen Lamp | White LED and Infrared LED | | | | | | | | | | Maximum<br>Output power | 2.9V, 1.0 W | 7.5V, 15 W | 2.9V, 1.0 W | | | | | | | | | | Light Intensity<br>Adjustment | Six selection: 0B, 1B, 2B, 3B,<br>4B, 5B<br>From 0 mw /cm2 to 19.12 mw/cm2 | Three selection: Full, 1/2 and<br>1/4 | Sixteen selection:<br>0B, 1B, 2B, 3B, 4B, 5B, 6B, 7B,<br>8B, 9B, 10B, 11B, 12B, 13B,<br>14B, 15B | | | | | | | | | | | | | White<br>LED Infrared<br>LED Cornea 338.21<br>mw/cm2 3.11<br>mw/cm2 Retina 3.88<br>mw/cm2 0.036<br>mw/cm2 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | External light | Background Light | None | None | | | | | | | | | | System | | | | | | | | | | | | | Power Source | Lithium-ion rechargeable<br>battery | Lithium-ion rechargeable<br>battery | Lithium-ion rechargeable<br>battery | | | | | | | | | | Appearance<br>Outline<br>Drawing | Image: microscope | Image: microscope | Image: microscope | | | | | | | | | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target design consists of concentric circles divided into alternating black and white quadrants. The word "MiiS" is in a bold, sans-serif font and is underlined with a blue line. The entire logo is set against a white background with a rounded blue border. ## Substantial Equivalence Discussion ### Similarities: - MiiS Horus scope DEA 200 and the primary predicate device, KOWA SL-15, have the i same intended use. DEA 200 has similar specifications to KOWA SL-15, such as the working distance, slit length, slit width, filters, light weight and magnification function. - Both MiiS Horus scope DEA 200 and secondary predicate device, MiiS Horus scope -DEC 100 are Medimaging Integrated Solution Inc. (MiiS)'s products. They have same concept of design for image sensor, display function and image storage. ### Differences: - The Major differences are the Changes in light sources and optical system. Optical radiation hazard evaluation was performed that these changes will not affect the device safety. ## Nonclinical and Clinical Tests In this submission, the nonclinical tests were conducted, such as software (S/W) and hardware (H/W), EMC, safety and light hazard. The results of this testing indicate that the MiiS Horus+ scope DEA 200 is equivalent to predicate device. No clinical studies were performed. ## Optical Performance The MiiS Horus Scope DEA 200 was tested according to 15004-2:2007 to determine acceptable light safety limits for both the illumination and background lights. The test results demonstrate the DEA 200 is in compliance with the of Group 2 instrument requirements provided by the standard. ## Conclusion Substantial equivalence comparison and bench performance tests support the conclusion of substantial equivalence of MiiS Horus* Scope DEA 200 to the predicate devices (KOWA SL-15 and MiiS Horus Scope DEC 100).