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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA for a device named "MiiS Horus+ Scope DEA 200". This document focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance, or human-in-the-loop studies as typically found in clinical validation reports for AI/CAD devices.

Therefore, the following information CANNOT be extracted from the document:

A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, AUC targets) for detecting conditions, nor does it provide performance metrics against such criteria.
Sample size used for the test set and the data provenance: No information on a test set, its size, or origin is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not describe any expert-established ground truth or the qualifications of such experts.
Adjudication method for the test set: No test set means no adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document explicitly states, "No clinical studies were performed." This implies no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described in the document is a digital hand-held slit lamp system, a hardware device for imaging and recording. It is not an AI algorithm, so a standalone algorithm performance study is not applicable.
The type of ground truth used: Not applicable as there's no mention of a test set or performance evaluation against any ground truth.
The sample size for the training set: The device is a hardware imaging system, not an AI model, so there is no concept of a "training set" in the context of this document.
How the ground truth for the training set was established: Not applicable.

What the document does describe is a technical comparison of the "MiiS Horus+ Scope DEA 200" with two predicate devices (KOWA SL-15 and MiiS Horus Scope DEC 100) to demonstrate "substantial equivalence" based on similar intended use, technological characteristics, and safety evaluations (e.g., EMC, electrical safety, and optical radiation hazard assessment according to ISO 15004-2:2007). The document concludes that "bench performance tests support the conclusion of substantial equivalence."

In summary, this document is a regulatory submission for a medical imaging device (a digital hand-held slit lamp) and not an AI/CAD algorithm. Therefore, it does not contain the information requested about acceptance criteria, device performance, or clinical validation studies typically associated with AI systems.

Summary

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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.

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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

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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)
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 contains a single, large, uppercase letter 'K' in a simple, sans-serif font. The letter is black and stands out against a white background. The letter is centered in the image and takes up most of the space. The image is simple and clear.

Image /page/3/Picture/1 description: The image contains the logo for MiiS. The logo is a circular target with alternating black and white rings. The text "MiiS" is written in blue below the target.

K170470

510(k) Summary

Prepared: October 1, 2017

Submitter/Owner'sName/ Address	Medimaging Integrated Solution Inc. (MiiS)1F, No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan30076 (R.O.C.)
Contact Person:	Hsu, Chih-Lu (COO)
Telephone: Fax:	+886-3-5798860 Ext: 1110
Email Address:	+886-3-5798821luu@miis.com.tw

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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
1. 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:

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.

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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	K063640Predicate Device	K120982Predicate Device
Model name	MiiS Horus+ ScopeDEA 200	KOWA SL-15	MiiS Horus ScopeDEC 100
Intended use	MiiS Horus+ Scope DEA 200 isa digital hand-held slit lampsystem indicated for non-invasive illumination,magnification, visualization andto record digital photographsand video of anterior segment(including cornea, anteriorchamber, and lens) of thehuman eye and surroundingarea.	KOWA SL-15 is an ophthalmicdevice indicated fornon-invasive illumination,magnification and observationof the human eye. It consists ofa hand-held, battery poweredslit-lamp biomicroscope withviewing and illuminationoptical systems and anAC-powered stand.	MiiS Horns Scope DEC 100 isa digital hand-held eye-funduscamera used to record digitalphotographs and video offundus of the human eye andsurrounding 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, 5,10 mm	0.1, 0.2, 0.8 mm and$ ⌀ $ 12mm spot
Slit projectionangle	$ \pm $ 45 degree (+/- 5%)	60 degree forHorizontal
Filter	Blue, Green	Blue	None
Digital Camera
Picture/Video	Built-in	Supports electronic imagewith the optional cameraconnection adapter(C-mount).	Built-in
Image sensor	CMOS	CCD	CMOS

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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 orconnect to and display oncomputer	Connect to and display onthe camera and computerdisplay.	Display on the TFT-LCD orconnect to and display oncomputer
Image storage	SD card and could be transferto user's computer	User's computer	SD card and could be transferto user's computer
Light Source
Type	White LED	Halogen Lamp	White LED and Infrared LED
MaximumOutput power	2.9V, 1.0 W	7.5V, 15 W	2.9V, 1.0 W
Light IntensityAdjustment	Six selection: 0B, 1B, 2B, 3B,4B, 5BFrom 0 mw /cm2 to 19.12 mw/cm2	Three selection: Full, 1/2 and1/4	Sixteen selection:0B, 1B, 2B, 3B, 4B, 5B, 6B, 7B,8B, 9B, 10B, 11B, 12B, 13B,14B, 15B
			WhiteLED InfraredLED Cornea 338.21mw/cm2 3.11mw/cm2 Retina 3.88mw/cm2 0.036mw/cm2


External light	Background Light	None	None
System
Power Source	Lithium-ion rechargeablebattery	Lithium-ion rechargeablebattery	Lithium-ion rechargeablebattery
AppearanceOutlineDrawing	Image: microscope	Image: microscope	Image: microscope

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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).

Regulation Number and Section

§ 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.