(104 days)
Not Found
No
The 510(k) summary describes a fundus camera for capturing images and saving them for examination by a specialist. There is no mention of automated analysis, image processing, AI, or ML. The clinical study focuses on image quality comparison, not the performance of an AI/ML algorithm.
No
The device is described as a fundus camera intended to capture images of the retina for examination by an ophthalmic specialist. It does not provide any therapy or treatment.
Yes
The device captures images for examination by an ophthalmic specialist to assess retinal pathology, which is a diagnostic activity.
No
The device description explicitly states it is a "handheld ophthalmic camera that combines a condensing lens with a built-in digital camera" and mentions hardware components like a flash memory card, USB interface, and rechargeable battery. This indicates it is a physical hardware device, not software only.
Based on the provided information, the Eyenez V200 fundus camera is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Eyenez V200 directly captures images of the retina within the eye, which is part of the living human body, not a specimen taken from it.
- The intended use is to capture images for examination by an ophthalmic specialist. This is a diagnostic imaging device used for visual assessment, not a test performed on a biological sample.
The device description and intended use clearly indicate it's an ophthalmic imaging device for capturing images of the retina in vivo.
N/A
Intended Use / Indications for Use
The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Eyenez Ophthalmic Camera is a handheld ophthalmic camera that combines a condensing lens with a built-in digital camera to capture a digital photograph of the retina and allow for the examination of the picture by an ophthalmic specialist. The Eyenez Ophthalmic Camera will allow users to capture images of the retina. Images may be saved to a flash memory card and also have connectivity towards PC using a USB interface. Device has a rechargeable battery.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic specialist (implied)
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)
A clinical study was performed, whereas retinal images taken with both the Eyenez Ophthalmic Camera and the predicate device- Optomed Smartscope M5 with EY3 and ES1 (K110986) (i.e. Volk Pictor Ret1) were compared and at least 90% equivalent in their ability to capture the presence or absence of retinal pathology. The clinical study enrolled a total of 34 subjects (19 diseased and 15 healthy); whom all met enrollment criteria. The diseased subjects included the following conditions: Macular Tear, Vitreous Macular Traction (VMT), Cystoid Macular Edema (without Atrophy), Ischemic Hemi-Retinal Vein Occlusion (HRVO), History of Retinal Laser Treatment, Non-Proliferative Diabetic Retinopathy (NPDR), Diabetic Macular Edema (DME), Quiescent proliferative diabetic retinopathy (QPDR), Epi-Retinal Membrane (ERM), Retinal Heme (Hemorrhage), Branch Retinal Vein Occlusion (BRVO), Dry Age-Related Macular Degeneration (AMD), Wet Age-Related Macular Degeneration (AMD), Lamellar Hole, Proliferative diabetic retinopathy (PDR), Neovascularization Elsewhere (NVE). The independent Ophthalmologist reviewing the retinal images concluded that the Eyenez OC Retina Camera images were comparable to the Volk Pictor OP on 33 patients (97%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4. 2016
Eyenez LLC % Mr. Glen Feye President Accurate Consultants Inc. 3234 Ibis Street San Diego. CA 92103
Re: K161727
Trade/Device Name: Eyenez Ophthalmic Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Opthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: August 22, 2016 Received: August 25, 2016
Dear Mr. Feye:
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 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 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 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 yours,
Kesia Alexander
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) K161727
Device Name
Eyenez Ophthalmic Camera, Model V200
Indications for Use (Describe)
The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.
| 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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3
Section 5
510k SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Establishment Registration Number (FEI): | 3012121402 |
|---|---|
| Address of Manufacturer: | Eyenez LLC |
| 2619 E. Colorado Blvd Ste 100 | |
| Pasadena , CA 91107 | |
| Contact Person: | Glen Feye |
| Accurate Consultants Inc. | |
| 3234 Ibis Street | |
| San Diego, CA 92103 | |
| Regulatory Consultant | |
| Office (619)-517-1762 | |
| Fax (619)-393-0582 | |
| glen@accuratefdaconsulting.com | |
| Date Prepared: | May 20, 2016 |
| Trade or Proprietary Name: | Eyenez Ophthalmic Camera |
| Common or Usual Name: | V200 Ophthalmic camera |
| Classification Name: | Camera, Ophthalmic, Ac-powered |
| (21 CFR 886.1120, Product Code HKI) | |
| Predicate Device Identification: | Optomed Smartscope M5 EY3 and M5 ES1 |
| (K110986)- (aka. Volk Pictor Ret1) |
Device Description:
The Eyenez Ophthalmic Camera is a handheld ophthalmic camera that combines a condensing lens with a built-in digital camera to capture a digital photograph of the retina and allow for the examination of the picture by an ophthalmic specialist. The Eyenez Ophthalmic Camera will allow users to capture images of the retina. Images may be saved to a flash memory card and also have connectivity towards PC using a USB interface. Device has a rechargeable battery.
Intended use and comparison to predicate devices:
The Eyenez V200 fundus camera is intended to be used to capture images of the retina of the eye.
4
Technological characteristics and comparison to predicate devices:
When The Evenez Ophthalmic Camera is compared to the predicate device- Optomed Smartscope M5 with EY3 and ES1 (K110986), it can be seen that both devices have similar indications for use, and multiple similar technological features. Similar features include:
- . Both devices store images to a flash memory card and have connectivity towards PC using a USB interface
- Both use rechargeable batteries
- Both devices use visible and infrared LED for illumination .
- Devices have similar method of operation from a user's point of view. Both have graphic user interface and keyboard that is used for making adjustments before and during examination and fundus image capture
- . Both store images in a JPEG format
- . Both have a picture angle of over 40 degrees
- Both have diopter compensation of at least -20D to +20D .
- . Optical Equivalency and Radiation Safety measures since both have met the IEC60601-1 and IEC 60601-1-2.
- . Both meet 15004-2:2007 standards for Group 1 instruments: ophthalmic instruments for which no potential light hazard exists.
Summary of clinical performance data:
A clinical study was performed, whereas retinal images taken with both the Eyenez Ophthalmic Camera and the predicate device- Optomed Smartscope M5 with EY3 and ES1 (K110986) (i.e. Volk Pictor Ret1) were compared and at least 90% equivalent in their ability to capture the presence or absence of retinal pathology. The clinical study enrolled a total of 34 subjects (19 diseased and 15 healthy); whom all met enrollment criteria. The diseased subjects included the following conditions: Macular Tear, Vitreous Macular Traction (VMT), Cystoid Macular Edema (without Atrophy), Ischemic Hemi-Retinal Vein Occlusion (HRVO), History of Retinal Laser Treatment, Non-Proliferative Diabetic Retinopathy (NPDR), Diabetic Macular Edema (DME), Quiescent proliferative diabetic retinopathy (QPDR), Epi-Retinal Membrane (ERM), Retinal Heme (Hemorrhage), Branch Retinal Vein Occlusion (BRVO), Dry Age-Related Macular Degeneration (AMD), Wet Age-Related Macular Degeneration (AMD), Lamellar Hole, Proliferative diabetic retinopathy (PDR), Neovascularization Elsewhere (NVE). The independent Ophthalmologist reviewing the retinal images concluded that the Eyenez OC Retina Camera images were comparable to the Volk Pictor OP on 33 patients (97%).
There are no major safety concerns.
5
Substantial Equivalence determination:
The data within this submission demonstrate that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S. Any difference in the technology when compared to the predicate has been satisfactorily addressed by conformance to FDA and Internationally recognized safety consensus standards, as well as the company's design requirements and system validation. The Eyenez LLC Ophthalmic Camera is been deemed substantially equivalent by the Sponsor and no new or different questions of safety and effectiveness have been raised. The Eyenez LLC Ophthalmic Camera is as safe and effective as an ophthalmic camera, which is identical to the identified predicate device.