RetiCapture

K173474 · Ilooda Co,., Ltd. · HKI · Jul 27, 2018 · Ophthalmic

Device Facts

• Record ID: K173474
• Device Name: RetiCapture
• Applicant: Ilooda Co,., Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

Device Story

RetiCapture is a hand-held, portable digital ophthalmic camera used by clinicians to capture images and video of the human eye fundus. The device utilizes a 5-megapixel CMOS sensor and an integrated LED light source (white and infrared) for illumination, with additional LEDs for eye fixation. It features a 5-inch TFT-LCD display for real-time viewing. Captured image data is stored on a flash memory card and transferred to a PC via USB connection. Powered by a rechargeable Li-ion battery, the device allows clinicians to document ocular conditions. The output consists of digital photographs and video, which the healthcare provider reviews to assist in clinical assessment and decision-making regarding eye health.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included photobiological safety (IEC 62471:2006, ISO 15004-2), electromagnetic compatibility (EN 60601-1-2:2007), basic safety and performance (IEC 60601-1:2005), ophthalmic instrument standards (ISO 10940:2009), and software validation (IEC 62304:2006). Risk management was conducted per ISO 14971:2012.

Technological Characteristics

Hand-held ophthalmic camera; 5MP CMOS sensor; white and IR LED light source; 5" TFT-LCD display; rechargeable 3.7V Li-ion battery; USB connectivity; SD card storage. Standards: IEC 60601-1 (safety), EN 60601-1-2 (EMC), IEC 62471 (photobiological), ISO 15004-2 (light hazard), ISO 10940 (ophthalmic instruments), IEC 62304 (software).

Indications for Use

Indicated for recording digital photographs and video of the fundus of the human eye and surrounding area in patients requiring ophthalmic imaging.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• MiiS Horus Scope DEC 100 (K120982)

Submission Summary (Full Text)

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July 27, 2018

Ilooda Co., Ltd. % Mina Joo Assistant Manager BT Solutions. Inc. Unit 502, 148 Yeoksam-ro Gangnam-gu Seoul, 06249 Republic of Korea

Re: K173474

Trade/Device Name: RetiCapture Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: June 6, 2018 Received: June 8, 2018

Dear Mina Joo:

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 devicerelated 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Bradley S. Cunningham -A

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) K173474

Device Name RetiCapture

Indications for Use (Describe)

RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5. 510(k) Summary

# 1. General Information

| Applicant/Submitter: | ILOODA Co., Ltd. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 120, Jangan-ro, 458beon-gil, Jangan-gu<br>Suwon-Si, Gyeonggi-do, 16200<br>Republic of Korea<br>Tel) [phone]<br>Fax) [phone] |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul,<br>Republic of Korea<br>Tel) +82.2.538.9140<br>Email) [e-mail] |
| Preparation Date: | July-24-2018 |

# 2. Device Name and Code

| Device Trade Name: | RetiCapture |
|----------------------|-------------------|
| Common Name: | Ophthalmic Camera |
| Classification Name: | Ophthalmic camera |
| Product Code: | HKI |
| Regulation Number: | 886.1120 |
| Classification: | Class II |
| Review Panel: | Ophthalmic |

# 3. Predicate Devices

RetiCapture is substantially equivalent to the following devices

| Applicant | Device Name | 510(k) Number |
|----------------------------------------|--------------------------|---------------|
| Medimaging Integrated<br>Solution Inc. | MiiS Horus Scope DEC 100 | K120982 |

# Table 5 1 Predicate devices

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#### 4. Device Description

RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

#### 5. Indications / Intended Use

RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

#### 6. Technical Characteristics in Comparison to Predicate Devices

RetiCapture is substantially equivalent to the following legally marketed predicate devices

| | Predicate Device | Proposed Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K120982 | K173474 |
| Manufacturer | Medimaging Integrated Solution Inc. | ILOODA CO., LTD |
| Device Name | MiiS Horus Scope DEC 100 | RetiCapture |
| Clearance Date: | Sep 17,2012 | N/A |
| Classification / | Class II/21 CFR 886.1120 Ophthalmic | Class II/21 CFR 886.1120 Ophthalmic |
| Regulation | Camera | Camera |
| Product Code | HKI | HKI |
| Intended Use/<br>Indications for<br>Use | MiiS Horns Scope DEC 100 is a digital<br>hand-held eye-fundus camera used to<br>record digital photographs and video of<br>fundus of the human eye and<br>surrounding area | RetiCapture is a digital hand-<br>held(portable) eye-fundus camera used<br>to record digital photographs and video<br>of fundus of the human eye and<br>surrounding area |
| Intended for | Prescription Use | Prescription Use |
| Observation light<br>Source | white & IR LED | white & IR LED |
| Diopter | -20D ~ +20D | -20D ~ +20D |
| FOV (Field of<br>view) | 40° | 50° |
| Resolutions | 1920x1080 | 3072x1728 |
| Storage<br>media | SD CARD | SD CARD |
| Image data<br>format | JPEG (Still picture)<br>H.264(Video) | JPEG (Picture),<br>Full HD (Video) |
| LCD Display | 3.5" full color LCD | 5" full color TFT-LCD |
| Power | Rechargeable Li-ion battery<br>3.7V | Rechargeable Li-ion battery<br>3.7V |

#### 7. Performance Data

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# RetiCapture

#### 510(k) Summary

Non-clinical tests: Measurement of Photobiological safety of lamps and lamp systems were performed. Other performance, such as electromagnetic compliance, and etc, were tested using following consensus standards:

- Basic safety and essential performance of the RetiCapture is tested and evaluated according to IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR.2:2007 + A1:2012. All the results presented here demonstrated general requirements for basic safety and essential performance.
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to EN 60601-1-2:2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -Photobiological safety of lamps and lamp systems of medical devices is evaluated according to FDA-recognized consensus standard, IEC 62471:2006 (First Edition). All the results presented here demonstrated the Photobiological safety of lamps and lamp systems of the RetiCapture.
- Risk management was recorded by referring to ISO 14971:2012. -
- -Fundamental requirements and test methods for light hazard protection of RetiCapture is evaluated according to FDA-recognized consensus standard, ISO 15004-2 First Edition.
- -Extensive software testing and validation have been conducted to ensure that RetiCapture performs to acceptable level, repeatedly and reliably referring to consensus standard IEC 62304:2006 and ISO 14971:2012.
- -Ophthalmic instruments of RetiCapture were tested and evaluated according to FDArecognized consensus standard ISO 10940:2009.

## 8. Substantial Equivalence

The intended use of the RetiCapture is within the scope of the predicate device. RetiCapture, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses. Based upon the overall performance characteristics for the RetiCapture, ILOODA Co., Ltd., believes that no significant differences exist in usage of its underlying technological principles between RetiCapture and the cited predicate device.

## 9. Conclusions

On the basis of the information provided in this Summary, ILOODA Co., Ltd., believes that RetiCapture is substantially equivalent to legally commercialized predicate device for the purposes of this 510 (k) submission.