(57 days)
No
The description focuses on the optical and digital capture capabilities of the device, with no mention of AI, ML, or advanced image processing beyond basic visualization and recording. The performance studies listed are standard safety and compatibility tests, not AI/ML validation.
No
The device is indicated for non-invasive illumination, magnification, visualization, and recording of the anterior segment of the human eye, which are diagnostic and imaging functions, not therapeutic.
Yes
The device is indicated for "illumination, magnification, visualization and to record digital photographs and video of anterior segment...of the human eye and surrounding area." This functionality allows healthcare professionals to observe and understand the condition of the eye, which is a key component of diagnosing medical conditions. While it doesn't explicitly state "diagnosis," it provides the necessary visual information for a healthcare professional to make a diagnosis.
No
The device description clearly states it is a "digital hand-held slit lamp system" and describes physical components like an LED light source, high-resolution lens, CMOS Sensor, TFT-LCD screen, and ports (USB, Wi-Fi, Bluetooth, HDMI). It also mentions being a "Li-ion battery-powered optical device." The performance studies include tests for electrical safety, electromagnetic compatibility, and biocompatibility, which are relevant to hardware.
Based on the provided information, the MiiS Horus Eye Anterior Camera is not an IVD (In Vitro Diagnostic) 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.
- MiiS Horus Eye Function: The MiiS Horus Eye Anterior Camera is used for non-invasive illumination, magnification, visualization, and recording of images and video of the anterior segment of the human eye and surrounding area. It directly examines the human body, not specimens taken from it.
The device's function aligns with imaging and diagnostic tools used for direct examination of the body, not with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MiiS Horus Eye Anterior Camera 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.
Product codes
HJO, HKI
Device Description
MiiS Horus Eye Anterior Camera 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 Eye Anterior Camera 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 memory card, or via the USB, Wi-Fi and Bluetooth transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the HDMI output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos.
MiiS Horus Eye Anterior Camera includes two models. The first model consists of control unit DSC 300 and lens unit DEA 200. The second model consists of control unit DSC 300P and lens unit DEA 200P. Either auto or manual focus can be used in first model while only manual focus is used in the second model.
The control unit DSC 300 includes a cover glass while DSC 300P does not. The contact rim in lens unit DEA 200 is different from that in DEA 200P.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.
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
Nonclinical Tests:
- IEC 62304 for Software verification and validation testing.
- IEC/EN 60601-1:2005/2006+A1:2012/2013 for electrical safety.
- IEC/EN 60601-1-2:2014/2015 for electromagnetic compatibility.
- Bluetooth testing for compatibility and functionality.
- HDMI compliance test was conducted in compliance with HDMI 1.4b sink and source devices.
- ISO 14971:2007 and EN ISO 14971:2012 for risk management.
- ISO 15004-2:2007 for light hazards.
- ISO10993-5:2009 and ISO10993-10:2010 standards for biocompatibility.
Clinical Tests: No clinical studies were performed.
Optical Radiation Safety Assessment: The MiiS Horus Eye Anterior Camera 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 MiiS Horus Eye Anterior Camera is in compliance with the of Group 2 instrument requirements provided by the standard.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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January 14, 2020
Image /page/0/Picture/1 description: The image contains the text "Medimaging Integrated Solution Inc. (MiiS)". The text appears to be a company name or a product name. The text is written in a clear, legible font.
Yi-Ying Chen Regulatory Affairs 3F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, 30077 Cn
Re: K193188
Trade/Device Name: MiiS Horus Eye Anterior Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO, HKI Dated: November 18, 2019 Received: November 18, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193188
Device Name MiiS Horus Eye Anterior Camera
Indications for Use (Describe)
MilS Horus Eye Anterior Camera 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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Image /page/3/Picture/0 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 consists of concentric circles divided into quadrants, with alternating shades of gray and black. The word "MiiS" is written in a bold, sans-serif font and underlined with a blue line. The entire logo is enclosed in a rounded rectangle with a blue border.
Medimaging Integrated Solution Inc.
510(k) Summary
January 9, 2020 Prepared: Medimaging Integrated Solution Inc. (MiiS) Submitter/Owner's 3F , No.24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan Name/ Address 30077, R.O.C. Contact Person: Chen, Yi-Ying Telephone: Fax: +886-3-5798860 Ext: 1703 Email Address: +886-3-5798011 yimmy.chen@miis.com.tw
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Image /page/4/Picture/0 description: The image contains the logo for Medimaging Integrated Solution Inc. The logo consists of a circular graphic on the left, followed by the company name in a bold, sans-serif font. The text is black and the background is white, providing a clear contrast.
Image /page/4/Picture/1 description: The image is a logo with a circular target-like design at the top and the text "MiiS" at the bottom. The target consists of concentric rings alternating in shades of gray and white, divided into quadrants. The text "MiiS" is in blue, with a horizontal line underlining it. The entire logo is set against a white background with a rounded blue border.
Device Identification:
Trade/Device Name: MiiS Horus Eye Anterior Camera Common Name: Digital Eye Anterior Camera, Digital Ophthalmoscope, Slit lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO, HKI
Predicate Device:
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
Description of Device:
MiiS Horus Eye Anterior Camera 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 Eye Anterior Camera 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 memory card, or via the USB, Wi-Fi and Bluetooth transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the HDMI output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos.
MiiS Horus Eye Anterior Camera includes two models. The first model consists of control unit DSC 300 and lens unit DEA 200. The second model consists of control unit DSC 300P and lens unit DEA 200P. Either auto or manual focus can be used in first model while only manual focus is used in the second model.
The control unit DSC 300 includes a cover glass while DSC 300P does not. The contact rim in lens unit DEA 200 is different from that in DEA 200P.
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Image /page/5/Picture/0 description: The image is a logo with a circular target-like design at the top and the text "MiiS" in blue at the bottom. The target design consists of concentric circles divided into alternating black and white segments. The logo has a white background with a blue border.
Medimaging Integrated Solution Inc.
Indications for Use (IFU):
MiiS Horus Eye Anterior Camera 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
Below is a summary table comparing the IFUs and key technological characteristics between the subject and the predicate devices.
| Device | K193188 | K170470 | |
|---|---|---|---|
| Model name | MiiS Horus Scope DSC 300 | ||
| MiiS Horus+ Scope DEA 200 | MiiS Horus Scope DSC 300P | ||
| MiiS Horus Scope DEA 200P | MiiS Horus+ Scope DEA 200 | ||
| Intended use | MiiS Horus Eye Anterior Camera 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. | MiiS 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. | |||
| Slit Lamp | |||
| Slit length | 10 mm Fixed | 10 mm Fixed | |
| Slit Width | ≤0.2, 0.2, 0.5, 2, 5,10 mm | ≤0.2, 0.2, 0.5, 2, 5,10 mm | |
| Slit projection | |||
| angle | ± 45 degree (+/-5%) | ± 45 degree (+/-5%) | |
| Filter | Blue, Green | Blue, Green | |
| Working | |||
| distance | 80mm (+/- 5%) | 80mm (+/- 5%) | |
| The lens unit | Image: The lens unit with contact rim | Image: The lens unit with contact ring would be longer 2 mm than DEA 200 | Image: The lens unit with contact rim |
| Digital Camera | |||
| Focus | Auto & Manual Focus | Manual Focus | Auto & Manual Focus |
| Picture | |||
| Resolution | 2560X1920 pixels | 2560X1920 pixels | 2560X1920 pixels |
| Video | |||
| Resolution | 2560X1920 pixels | 2560X1920 pixels | 1280X960 pixels |
| Display | Display on the TFT-LCD or connect to and display on computer | Display on the TFT-LCD or connect to and display on | Display on the TFT-LCD or |
| connect to and display on | |||
| Image storage | Memory card and could be transfer to user's computer | Memory card and could be transfer to user's computer | Memory card and could be |
| transfer to user'scomputer | |||
| Interface | A. USB | ||
| B. HDMI | |||
| C. Wi-Fi | |||
| D. Bluetooth | A. USB | ||
| B. AV | |||
| The control | |||
| unit | Image: control unit with cover glass | Image: control unit without cover glass | Image: control unit with cover glass |
| Light Source | |||
| Type | White LED | White LED | White LED |
| Light Intensity | |||
| Adjustment | Six levels: 0B, 1B, 2B, 3B, 4B, 5B | Six levels: 0B, 1B, 2B, 3B, 4B, 5B | Six levels: 0B, 1B, 2B, 3B, 4B, |
| 5B | |||
| System | |||
| Power Source | Lithium-ion rechargeable battery | Lithium-ion rechargeable battery | Lithium-ion rechargeable |
| battery | |||
| The camera | |||
| system | Image: camera system | Image: camera system |
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Image /page/6/Picture/0 description: The image shows a logo with a circular target-like design at the top and the text "MiiS" at the bottom. The target design consists of concentric circles alternating in shades of gray and black, with a white circle in the center. The text "MiiS" is written in blue, with a line underneath it. The entire logo is enclosed in a rounded rectangular border.
Medimaging Integrated Solution Inc.
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Image /page/7/Picture/0 description: The image shows the text "Medimaging Integrated Solution Inc." The text is written in a clear, sans-serif font and is horizontally aligned. The text appears to be a company name, possibly for a medical imaging solutions provider.
Image /page/7/Picture/1 description: The image is a logo with a white background and a blue border. The logo features a circular target-like design with alternating black, white, and gray sections. Below the circular design, the text "MiiS" is written in blue, bold letters. The overall design is simple and clean, with a focus on the circular target and the text.
Substantial Equivalence Discussion
Similarities:
- MiiS Horus Eye Anterior Camera and the predicate device, MiiS Horus* Scope DEA 200 । (K170470), have the same intended use and same specifications in focusing capabilities, picture resolution, working distance, slit length, slit projection angle, light source, filters, image storage, display function, appearance, input voltage, power source, size and weight.
Differences:
- The primary differences between the subject and predicate devices are the electronic interfaces of the devices.
- The subject device (K193188) can be connected to a display screen or a computer . through the universal serial bus (USB), high-definition multimedia interface (HDMI), Wi-Fi, or Bluetooth while the predicate device (K170470) is through USB or audio-visual (AV) port.
- The subject device has higher video resolution (2560x1920 pixels) than that of the predicate device (1280x960 pixels).
Nonclinical Tests
The following tests have been performed in support of the substantial equivalence determination:
- IEC 62304 for Software verification and validation testing. -
- IEC/EN 60601-1:2005/2006+A1:2012/2013 for electrical safety. -
- IEC/EN 60601-1-2:2014/2015 for electromagnetic compatibility. -
- Bluetooth testing for compatibility and functionality. -
- HDMI compliance test was conducted in compliance with HDMI 1.4b sink and source devices.
- ISO 14971:2007 and EN ISO 14971:2012 for risk management. -
- -ISO 15004-2:2007 for light hazards.
- ISO10993-5:2009 and ISO10993-10:2010 standards for biocompatibility. The patient contacting parts are the holder of chin rest CR100 and the forehead stopper.
Clinical Tests
No clinical studies were performed.
Optical Radiation Safety Assessment
The MiiS Horus Eye Anterior Camera 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 MiiS Horus Eye Anterior Camera 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 Eye Anterior Camera to the predicate devices MiiS Horus+ Scope DEA 200 (K170470).