(295 days)
No.
The provided text describes a medical imaging device and its associated software for viewing and analyzing images. It details image acquisition, processing (opening, reviewing, analyzing, printing, co-registering), and clinical interpretation by licensed practitioners. There is no mention of AI, machine learning, or deep learning models being used within the device or its software for any function, especially interpretation or diagnosis. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an ophthalmoscope used for imaging the retina, indicated for viewing and analyzing retinal images, not for providing therapy or treatment.
Yes
The device is an ophthalmoscope that captures images of the retina using infrared and autofluorescence. These images are then reviewed, analyzed, and printed using dedicated software. The intended use of the device states it is "indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina," and the "clinical interpretation of the images acquired by OcuMet Beacon is restricted to licensed eye care practitioners," indicating its use in assessing the retina, which is a diagnostic activity. The description also mentions that the interpretation and use in clinical practice are "as an adjunctive modality for the clinician to optionally combine with other structural images, and functional studies," further supporting its role in diagnosis.
No
The OcuMet Beacon is clearly described as a scanning LED-based ophthalmoscope, a hardware device that captures images of the retina. While it uses dedicated software for image processing and viewing (Clinician Report Generator Software), the primary device is a physical instrument, not just software.
No.
The device is an ophthalmoscope for imaging the human retina; it does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent.
Product codes
MYC
Device Description
Ocumet Beacon is a scanning LED based ophthalmoscope which uses infrared and blue light to obtain confocal images of the retina. Multiple retinal fields can be captured using a programmable internal fixation target. The device integrates a tablet and is provided with an external power supply. The device works with a dedicated software application and operates as a standalone unit.
Ocumet Beacon offers two different acquisition modalities:
- black and white reflectance images of the retina obtained using infrared illumination;
- black and white fluorescence images of the retina obtained using blue illumination (peak at 458 nm) and a barrier filter to select only autofluorescent emission between 520 and 540 nm.
Clinician Report Generator Software is required to open, review, analyze, and print images obtained from Ocumet Beacon. The software runs on a standalone laptop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared (IR) and autofluorescence (AF) imaging
Anatomical Site
Human retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The clinical interpretation of the images acquired by Ocumet Beacon is restricted to licensed eye care practitioners. A device specific training is required for any operator to become able to use the system and certification training is available for operators who will be capturing images in a clinical trial. The interpretation and use in clinical practice is as an adjunctive modality for the clinician to optionally combine with other structural images, and functional studies.
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
The system has been tested and meets relevant standards for electrical safety, light hazard, biocompatibility and system verification and validation testing.
For electrical safety and EMI, the device complies with IEC 60601-1 and IEC 60601-1-2.
For light hazard, the device meets Group 1 light safety under ANSI+Z80.36-2016 and ISO 15004-2:2007.
The patient contact points meet all biocompatibility testing requirements.
The system was tested and passes system verification and validation testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
FDA 510(k) Clearance Letter - OcuMet Beacon (OCUB100)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 21, 2025
OcuSciences, Inc.
℅ Robert Bard
Regulatory Consultant/Attorney
HealthCare Technologies Consultants, LLC
111 S Lafayette St
No 506
South Lyon, Michigan 48178
Re: K241931
Trade/Device Name: OcuMet Beacon (OCUB100)
Regulation Number: 21 CFR 886.1570
Regulation Name: Ophthalmoscope
Regulatory Class: Class II
Product Code: MYC
Dated: March 18, 2025
Received: March 18, 2025
Dear Robert Bard:
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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K241931 - Robert Bard 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-
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K241931 - Robert Bard 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 PSC Publishing Services (301) 443-6740 EF
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): K241913
Device Name: OcuMet Beacon
Indications for Use (Describe)
OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent.
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.
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:
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Page 5
510(k) Summary – K241931
| Date of preparation: | April 18, 2025 |
|---|---|
| Proprietary Name(s): | OcuMet Beacon |
| Manufacturer: | Kurt Riegger |
| OcuSciences Inc. | |
| 2890 Carpenter Rd | |
| Suite 1800 | |
| Ann Arbor, M8108 | |
| Telephone: 734 623-9434 | |
| Email: | |
| Official Contact Person | Robert J Bard, JD, CQE, RAC |
| HealthCare Technologies Consultants, LLC | |
| 111 Lafayette | |
| South Lyon, MI 48178-9998 | |
| rbard@reglaw.net | |
| +734 330 5990 | |
| Classification Name | Ophthalmoscope, AC Powered |
| Ophthalmoscope, Laser, Scanning | |
| Product Code: | MYC |
| Regulation Number: | 886.1570 |
| Common Name: | Ophthalmoscope |
| Panel: | Ophthalmic |
| Class: | II |
| Indications for Use: | Ocumet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent. |
| Legally marketed device (Predicate) | Predicate: EIDON FA, EIDON, EIDON AF, EIDON UWFL (K211328) |
| Reference Device: Heidelberg Spectralis HRA (K201252 Spectralis HRA+OCT and variants) |
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Device description
Ocumet Beacon is a scanning LED based ophthalmoscope which uses infrared and blue light to obtain confocal images of the retina. Multiple retinal fields can be captured using a programmable internal fixation target. The device integrates a tablet and is provided with an external power supply. The device works with a dedicated software application and operates as a standalone unit.
Ocumet Beacon offers two different acquisition modalities:
- black and white reflectance images of the retina obtained using infrared illumination;
- black and white fluorescence images of the retina obtained using blue illumination (peak at 458 nm) and a barrier filter to select only autofluorescent emission between 520 and 540 nm.
Clinician Report Generator Software is required to open, review, analyze, and print images obtained from Ocumet Beacon. The software runs on a standalone laptop.
The total light exposure is qualified as Group 1 under ANSI Z80.36-2016
Clinician Report Generator Software is required to open, review, analyze and print a co-registered version of both the infrared and visible wavelength images obtained from Ocumet Beacon. The software runs on a standalone Windows 10 or 11 based laptop computer.
The clinical interpretation of the images acquired by Ocumet Beacon is restricted to licensed eye care practitioners. A device specific training is required for any operator to become able to use the system and certification training is available for operators who will be capturing images in a clinical trial. The interpretation and use in clinical practice is as an adjunctive modality for the clinician to optionally combine with other structural images, and functional studies.
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1.1 The device
The Predicate and Reference Device
This submission includes a Predicate and Reference Device
a) EIDON FA/AF (K211328) is the Predicate
The CenterVue EIDON AF is a confocal scanning ophthalmoscope indicated for color, infrared and autofluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.
CenterVue EIDON is a scanning ophthalmoscope which uses white light to obtain color images of the retina, infrared light to obtain infrared-reflectance images of the retina, and blue light to obtain autofluorescence and fluorescence images.
The CenterVue EIDON is part of a family of devices, which includes three models: EIDON FA, EIDON AF, and EIDON. EIDON is the base model, which features the following imaging modalities: infrared reflectance, color and red-free. EIDON AF adds autofluorescence imaging to the base model.
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b) SPECTRALIS HRA+OCT is the reference device. The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions.
The Spectralis and the Beacon have similar features in their autofluorescence. The Spectralis has the BluePeak™ autofluorescence, a non-invasive scanning laser fundus imaging modality. the Ocumet Beacon has a non-invasive confocal scanning LED autofluorescence modality.
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Substantial Equivalence Table for Ocumet Beacon and Predicate
| Parameter | EIDON FA/AF (K211328) Primary Predicate | Ocumet Beacon AF version 1.6 (K241931) | Comments |
|---|---|---|---|
| Indicated Use | The Centervue EIDON is intended for taking digital images of a human retina with or without the use of a mydriatic agent. | Ocumet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent. | Similar |
| Device type | Confocal scanning LED based ophthalmoscope | Confocal scanning LED based ophthalmoscope | Same |
| Field of View | 60° (H) x 55° (V) captured in a single exposure | ||
| 80° (H) x 75° (V) captured in a single exposure, with Ultra Widefield Lens | IR 60° (H) x 21.5° (V) | ||
| AF 17° (H) x 21.5° (V) | Similar | ||
| Ocumet has reduced field of view: Entire field can be viewed in multiple acquisitions | |||
| Modalities | Color, red-free, IR reflectance, autofluorescence (AF), fluorescein angiography (FA) Blue LED | Infrared (IR) | |
| Autofluorescence (AF) Blue LED | Similar without Color fundus, red-free and FA modality | ||
| Autofluorescence (AF) image from the Beacon output is black-and-white in gray scale and can be enhanced with color-coded images. | |||
| Imaging Modality- IR | Line Scanning IR 850 nm | Line Scanning IR 850 nm | Same |
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| Parameter | EIDON FA/AF (K211328) Primary Predicate | Ocumet Beacon AF version 1.6 (K241931) | Comments |
|---|---|---|---|
| Imaging Modality- autofluorescence | Line Scanning excitation LED 440-475 nm and detection greater than 500 nm | Line Scanning excitation LED plus filter 460-475 nm and detection filter 520-540 nm | Similar excitation with Blue LED but narrower filtering in detection wavelengths for Ocumet. |
| Light Safety | EIDON with software version 4.0 and Ultra Widefield Lens fulfills the requirements for a group 2 determination according to ANSI Z80-36, i.e., ophthalmic instruments with potential light hazard. | Group 1 according to ANSI+Z80.36-2016 and ISO 15004-2:2007 | Same |
| Electrical Safety EMC | Electrical safety and electromagnetic compatibility | ||
| The device complies with IEC 60601-1 and IEC 60601-1-2 | Electrical safety and electromagnetic compatibility | ||
| The device complies with IEC 60601-1 and IEC 60601-1-2 | Same | ||
| Blue light source | Blue LED | Blue LED | Similar with slightly longer blue excitation wavelength peak near 465nm Ocumet |
Reference Device
| Parameter | Heidelberg Spectralis HRA (K201252 Spectralis HRA+OCT and variants) | OcuMet Beacon version 1.6 | Summary |
|---|---|---|---|
| Indicated Use | The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, | Ocumet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent. | Similar in autofluorescence however the Ocumet does not have OCT, fundus photography, |
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| Parameter | Heidelberg Spectralis HRA (K201252 Spectralis HRA+OCT and variants) | OcuMet Beacon version 1.6 | Summary |
|---|---|---|---|
| fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects. | fluorescein angiography, indocyanine green angiography; | ||
| Electrical Safety EMC | The SPECTRALIS HRA+OCT has been tested according to IEC 60601-1 and IEC 60601-1-2 and was found to meet all requirements. | Electrical safety and electromagnetic compatibility | |
| The device complies with IEC 60601-1 and IEC 60601-1-2 | Same standards | ||
| Blue Light Source | Blue Laser excitation at 488 nm | Blue LED with filter to create a 460-475 nm excitation | Similar |
| Laser is a single nm width light source and LED with filter provides a |
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| Parameter | Heidelberg Spectralis HRA (K201252 Spectralis HRA+OCT and variants) | OcuMet Beacon version 1.6 | Summary |
|---|---|---|---|
| similarly narrow excitation light source. | |||
| Modalities | Color, red-free, IR reflectance, autofluorescence (AF), fluorescein angiography (FA) | Infrared (IR), Autofluorescence (AF) | Similar without Color fundus, red-free and FA images |
| Device type | Ophthalmoscope, Laser, Scanning | ||
| ProCode: MYC | |||
| The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). | |||
| The system is a laser product of Class 1 according to 21 CFR §1040.10 and complies with IEC 60825-1. | Confocal scanning LED based ophthalmoscope | ||
| ProCode: MYC | Similar except light sources are minimally different as a laser vs LED with filter. |
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Dimensional Characteristics Comparison
| Parameter | EIDON FA (K211328) | Heidelberg Spectralis HRA w BluePeak (K201252 Spectralis HRA+OCT and variants) | OcuMet Beacon version 1.6 | Summary |
|---|---|---|---|---|
| Dimensions | 620 x 590 x 360 mm | 486 x 870 x 874 mm | 620 x 590 x 360 mm | Similar |
| Weight | 25 Kg | 36 Kg | 25 Kg | Similar |
| Voltage | 12 VDC | 100-240 V | 12 VDC | Similar except power sources are different as a laser vs LED |
| Power consumption | 60 W | 140 VA | 60 W | Similar except power sources are different as a laser vs LED |
Performance Testing
The system has been tested and meets relevant standards for electrical safety, light hazard, biocompatibility and system verification and validation testing.
For electrical safety and EMI, the device complies with IEC 60601-1 and IEC 60601-1-2.
For light hazard, the device meets Group 1 light safety under ANSI+Z80.36-2016 and ISO 15004-2:2007.
The patient contact points meet all biocompatibility testing requirements.
The system was tested and passes system verification and validation testing.
Conclusion
The Ocumet Beacon is a device modification to the FDA cleared EIDON AF predicate device. The Ocumet Beacon has the same Indications for Use and the same technology as the cleared EIDON AF predicate device. Based on the Performance Testing and Comparison with the Predicate, the Ocumet Beacon is substantially equivalent to the EIDON AF and has the autofluorescence performance comparable to the Reference Device.
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In summary, OcuSciences' Ocumet Beacon has the same technical features and safety profile as the EIDON AF and poses no new safety risks. Therefore the Ocumet Beacon, is substantially equivalent to the predicate device and meets the current standards. Based on the comparison of the predicate and reference device the Ocumet Beacon is substantially equivalent.