(55 days)
No.
The device description mentions "Auto-alignment and auto-focus algorithms" but does not explicitly state these algorithms are based on AI models. The document also states "Mentions AI, DNN, or ML: Not Found".
No.
The device is intended for taking digital images of the human retina as an aid to clinicians in the evaluation and diagnosis of ocular health, not for treating any condition.
Yes.
The device is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health, which indicates a diagnostic purpose.
No
The device is a physical fundus camera with multiple internal imaging systems (illumination, imaging, observation), charge-coupled devices (CCDs), and a movable 3D platform, clearly indicating it is a hardware device, not software-only.
No.
The device is an imaging system used to capture digital images of the human retina. It does not perform tests on biological samples or provide information for diagnostic purposes based on in vitro examination.
N/A
Intended Use / Indications for Use
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Product codes
HKI
Device Description
The Resolve Fundus Camera is a fundus camera designed to perform fundus observation, automatic pupil tracking and focusing, automatic image capture, and image preservation. The Resolve Fundus Camera is used for non-mydriatic observation and capturing of retinal images. The fundus camera employes three internal imaging systems to operate: illumination system, imaging system and observation system. Auto-alignment and auto-focus algorithms are used to automatically find and capture desired images of the fundus.
The fundus camera features an internal, movable three-dimensional platform that allows for switching and precise positioning of the left and right eyes. The imaging process is done one eye at a time (left eye and then the right eye). The internal, moveable three-dimensional platform contains two types of cameras: a set of infrared cameras (one on each side) as well as one main camera.
The observation system is used to detect and track the patient's pupil. Next, the illumination system determines the precise location of the ocular fundus after the pupil is located by the observation system. The system precisely finds the relationship between the position of the ocular fundus at different diopters, and the lens of the main camera.
Once the location of the fundus is found, a charge-coupled device (CCD) automatically captures a still image of the fundus through the main camera. The autofocus system utilizes a beam splitter to split a beam of light into two fine beams, which then image the ocular fundus onto the CCD. When the focus is at its sharpest position, the split beams align horizontally. At this point, the LED white light illumination system, installed in the imaging module on the three-dimensional movable platform, emits uniform white light of appropriate intensity to illuminate the ocular fundus. The imaging system captures the fundus information onto the CCD, and the received signals are displayed in real-time on a liquid crystal display (LCD) through the control system. Doctors can visually assess the patient's ocular fundus on the LCD screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images
Anatomical Site
human retina, ocular fundus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, Medical personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
Performance testing shows that the Resolve™ Fundus Camera complies with relevant performance standards including electrical safety, electromagnetic compatibility, ocular light safety, and biocompatibility, and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 30, 2025
Optain Health, Inc.
℅ Maureen Oconnell
Regulatory Consultant
OConnell Regulatory Consultants, Inc.
44 Oak Street
Stoneham, Massachusetts 02180
Re: K250683
Trade/Device Name: Resolve Fundus Camera
Regulation Number: 21 CFR 886.1120
Regulation Name: Ophthalmic Camera
Regulatory Class: Class II
Product Code: HKI
Dated: March 6, 2025
Received: March 6, 2025
Dear Maureen Oconnell:
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 (the 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 available 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.
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K250683 - Maureen Oconnell Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250683 - Maureen Oconnell Page 3
assistance/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,
Elvin Y. Ng -S
Elvin Ng
Assistant 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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250683
Device Name: Resolve Fundus Camera
Indications for Use (Describe):
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Page 5
K250683 510(k) SUMMARY
Optain Health, Inc.
Resolve™ Fundus Camera
510(k) Owner
Optain Health, Inc.
373 Park Avenue South
New York, NY 10016
Contact: Emilia Gonzalez
Telephone: 330-703-7443
Date Prepared: April 28, 2025
Trade Name of Device
Resolve™ Fundus Camera
Common or Usual Name
Ophthalmic Camera
Classification Name
AC-powered Ophthalmic Camera
Product Codes:
HKI
Device Classification
Class II
21 C.F.R. §886.1120
Predicate Device(s)
Next Sight Srl Nexy cleared in K180306
Device Description
The Resolve Fundus Camera is a fundus camera designed to perform fundus observation, automatic pupil tracking and focusing, automatic image capture, and image preservation. The Resolve Fundus Camera is used for non-mydriatic observation and capturing of retinal images. The fundus camera employes three internal imaging systems to operate: illumination system, imaging system and observation system. Auto-alignment and auto-focus algorithms are used to automatically find and capture desired images of the fundus.
The fundus camera features an internal, movable three-dimensional platform that allows for switching and precise positioning of the left and right eyes. The imaging process is done one eye at a time (left eye and then the right eye). The internal, moveable three-dimensional platform
Page 6
contains two types of cameras: a set of infrared cameras (one on each side) as well as one main camera.
The observation system is used to detect and track the patient's pupil. Next, the illumination system determines the precise location of the ocular fundus after the pupil is located by the observation system. The system precisely finds the relationship between the position of the ocular fundus at different diopters, and the lens of the main camera.
Once the location of the fundus is found, a charge-coupled device (CCD) automatically captures a still image of the fundus through the main camera. The autofocus system utilizes a beam splitter to split a beam of light into two fine beams, which then image the ocular fundus onto the CCD. When the focus is at its sharpest position, the split beams align horizontally. At this point, the LED white light illumination system, installed in the imaging module on the three-dimensional movable platform, emits uniform white light of appropriate intensity to illuminate the ocular fundus. The imaging system captures the fundus information onto the CCD, and the received signals are displayed in real-time on a liquid crystal display (LCD) through the control system. Doctors can visually assess the patient's ocular fundus on the LCD screen.
Indications for Use
The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Substantial Equivalence
Optain Health believes that the Resove Fundus Camera described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Next Sight srl Nexy cleared in K180306. The intended use of the Resolve Fundus Camera is the same as the intended use of the predicate device which is to take digital images of the human retina. Both devices are prescription devices for use by trained healthcare providers. The Resolve Fundus Camera has the same technological characteristics as the predicate device. Both devices are fundus camera used for taking images of the retina. Both cameras are tabletop cameras with auto alignment and auto focus. Technical specifications of the two devices are similar and they comply with the relevant recognized consensus standards. Therefore, the Resolve Fundus Camera is substantially equivalent to the predicate device.
Resolve Fundus Camera Substantial Equivalence Table
| Manufacturer | Optain Health | Next Sight | Comparison |
|---|---|---|---|
| Model | Resolve Fundus Camera | Nexy | - |
| 510 (K) Number | K250683 | K180306 | - |
| Intended Use | To take digital images of the human retina | To take digital images of the human retina | Substantially equivalent |
| Indications for Use | The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina | Nexy device is an automatic eye-fundus camera intended for taking digital images of a human | Substantially equivalent |
Page 7
| Manufacturer | Optain Health | Next Sight | Comparison |
|---|---|---|---|
| Model | Resolve Fundus Camera | Nexy | - |
| with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in evaluation and diagnosis of ocular health. | retina without the use of a mydriatic agent. | ||
| Clearance Type | Prescription | Prescription | Substantially equivalent |
| Product Code | HKI | HKI | Substantially equivalent |
| Classification | II | II | Substantially equivalent |
| Device Type | Fundus non-mydriatic camera | Fundus non-mydriatic camera | Substantially equivalent |
| Form Factor | Tabletop camera | Tabletop camera | Substantially equivalent |
| User | Medical personnel | Medical personnel | Substantially equivalent |
| Alignment | Auto | Auto | Sustantially equivalent |
| Focusing | Auto | Auto | Substantially equivalent |
| Field of view | 50 degrees | 45 degrees | Substantially equivalent: the slightly larger field of view in the subject device does not impact substantial equivalence |
| Minimum pupil size | 3.0 mm | 3.8 mm | Substantially equivalent: the ability to take fundus images with a smaller pupil size does not impact substantial equivalence |
| Image sensor | CMOS | CMOS | Substantially equivalent |
| Sensor size | 15 megapixel | 2.1 megapixel | Substantially equivalent: the bigger sensor size does not impact substantial equivalence |
| Light source | LEDs | LEDs | Substantially equivalent: both light sources were tested ANSI Z80.36 |
| Type of fixation light | White and continuous (during exam time) | Green and continuous (during exam time) | Substantially equivalent: both light sources were tested per ANSI Z80.36 |
| Focus on retina-type of light | IR, LEDs and continuous source (during the focusing time) | IR, LEDs and continuous source (during the focusing time) | Substantially equivalent |
| Type of flash | Natural white LED | White LEDs in the visible range and pulsed (duration less than 50 ms) with annular shape on the cornea | Substantially equivalent |
| Exposure conditions | In accordance with flash duration time | In accordance with flash duration time | Substantially equivalent |
| Light feature | Polarized | Polarized | Substantially equivalent |
Page 8
| Manufacturer | Optain Health | Next Sight | Comparison |
|---|---|---|---|
| Model | Resolve Fundus Camera | Nexy | - |
| Diopter adjustment | +20 D/-20 D | +15 D/-15 D | Substantiall equivalent |
| Fixation target | Internal OLED screen | Internal LEDs | Substantially equivalent: both light sources were tested per ANSI Z80.36 |
| Display | 5" full touch LCD mounted on camera unit | 10.4" tablet separate from camera unit | Substantially equivalent: both devices have a screen that allows the user to interact with the camera |
| DICOM Compliant | Yes | Yes | Substantially equivalent |
| Data Connectivity | WiFi | WiFi and Bluetooth | Substantially equivalent |
| Power supply | Rechargeable lithium battery and AC/DC | AC/DC | Substantially equivalent |
Standards Compliance
| Electrical safety | Per IEC 60601-1 | Per IEC 60601-1 | Substantially equivalent |
| EMC | Per IEC 60601-1-2 | Per IEC 60601-1-2 | Substantially equivalent |
| Biocompatibility | Per ISO 10993-1 for surface device, intact skin, limited duration | Per ISO 10993-1 for surface device, intact skin, limited duration | Substantially equivalent |
| Camera performance | ISO 10940, ISO 15004-2, ISO 15004-1 | ISO 10940, ISO 15004-2, ISO 15004-1 | Substantially equivalent |
Performance Data
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
- AAMI ANSI ES60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- ANSI Z80.36-2021 American National Standard for Ophthalmics-Light hazard protection for ophthalmic instruments
- ISO 10993-1: 2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process
- ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021 Biological evaluation of medical devices-Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Tests for irritation
- ISO 10940 Second edition Ophthalmic instruments-Fundus cameras
Page 9
- ISO 15004-1 Second edition Ophthalmic instruments-Fundamental requirements and test methods-Part 1: General requirements applicable to all ophthalmic instruments
- NEMA PS 3.1-3.20 2021e Digital and communications in medicine (DICOM) Set
- IEC 62133-2 Edition 1.0 2017 Secondary cells and batteries containing alkaline or other non-acid electrolysis-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications-Part 2: Lithium systems.
Additionally, software verification and validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Basic documentation set.
Conclusion
Performance testing shows that the Resolve™ Fundus Camera complies with relevant performance standards including electrical safety, electromagnetic compatibility, ocular light safety, and biocompatibility, and is substantially equivalent to the predicate device.