(260 days)
No
The summary describes a standard digital fundus camera for image and video capture, storage, and transfer. There is no mention of any analytical or interpretive functions that would typically involve AI/ML. The performance studies focus on safety and basic device functionality, not algorithmic performance.
No
The device is a camera used to record digital photographs and video of the fundus of the human eye, which is a diagnostic function, not a therapeutic one.
No
The device is described as an eye-fundus camera used to record digital photographs and video of the fundus. While it captures data that may be used for diagnosis, the device itself is an imaging tool, not one that performs diagnostic analysis or interpretation.
No
The device description explicitly details hardware components such as an LED light source, CMOS sensor, flash memory card, USB connection, and rechargeable battery, and the performance studies include testing of hardware aspects like photobiological safety and electromagnetic compliance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- RetiCapture's Function: RetiCapture is an imaging device that captures digital photographs and video of the fundus of the human eye. It is used to visualize the internal structures of the eye in vivo (within the living body).
- No Sample Analysis: The description does not mention any analysis of biological samples. The device's function is purely for capturing images of a part of the body.
Therefore, RetiCapture falls under the category of an ophthalmic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
HKI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus 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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.
0
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | ILOODA Co., Ltd. |
|---|---|
| Address: | 120, Jangan-ro, 458beon-gil, Jangan-gu |
| Suwon-Si, Gyeonggi-do, 16200 | |
| Republic of Korea | |
| Tel) +82-31-278-4660 | |
| Fax) +82-31-278-4661 | |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul, |
| Republic of Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| 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 | ||
| Solution Inc. | MiiS Horus Scope DEC 100 | K120982 |
Table 5 1 Predicate devices
4
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/ | ||
| Indications for | ||
| Use | MiiS Horns Scope DEC 100 is a digital | |
| hand-held eye-fundus camera used to | ||
| record digital photographs and video of | ||
| fundus of the human eye and | ||
| surrounding area | 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 | ||
| Intended for | Prescription Use | Prescription Use |
| Observation light | ||
| Source | white & IR LED | white & IR LED |
| Diopter | -20D ~ +20D | -20D ~ +20D |
| FOV (Field of | ||
| view) | 40° | 50° |
| Resolutions | 1920x1080 | 3072x1728 |
| Storage | ||
| media | SD CARD | SD CARD |
| Image data | ||
| format | JPEG (Still picture) | |
| H.264(Video) | JPEG (Picture), | |
| Full HD (Video) | ||
| LCD Display | 3.5" full color LCD | 5" full color TFT-LCD |
| Power | Rechargeable Li-ion battery | |
| 3.7V | Rechargeable Li-ion battery | |
| 3.7V |
7. Performance Data
5
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.