(109 days)
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
The Verily Numetric Retinal Camera has the following acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resolving power (center) | ≥ 60 line pairs/mm at the center of the field | Pass |
| Resolving power (mid field) | ≥ 40 line pairs/mm at the mid field (r/2) | Pass |
| Resolving power (periphery) | ≥ 25 line pairs/mm at the periphery of the field (r) | Pass |
| Field of view | 45 degrees | Pass |
| Pixel pitch tolerance | < 7% | Pass |
| Alignment illumination | The alignment illumination is done via Near Infrared (NIR) LEDs during eye tracking. The intensity of the NIR LEDs is controlled by SW. | Pass |
| Flash illumination | The flash illumination is done via white LEDs during the image capture. The intensities and durations of the white LEDs are controlled by SW. | Pass |
| Range of focus | -20D to +20D (no compensating lens) | Pass |
| Minimum pupil size | 3.0mm | Pass |
| Alignment | Interactive alignment using 3D tracking. | Pass |
| Image quality | The gradability of images captured by VNRC is comparable to the predicated device on the same population. | Pass |
2. Sample Size and Data Provenance for Test Set
The document mentions that non-clinical performance testing for the Verily Numetric Retinal Camera includes analysis using raw data collected via a retrospective clinical study. It also states that the "gradability of images captured by VNRC is comparable to the predicated device on the same population."
However, the specific sample size used for the test set is not explicitly stated in the provided text. The country of origin of the data is also not specified.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only mentions that the images are "intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health" and that "the gradability of images captured by VNRC is comparable to the predicated device on the same population." This implies clinical evaluation but lacks details on the expert panel.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text in the typical sense of measuring human reader improvement with AI assistance. The document compares the performance of the device itself (Verily Numetric Retinal Camera) to a predicate device (NFC-700) regarding image quality and technical specifications. It notes that "the gradability of images captured by VNRC is comparable to the predicated device on the same population," implying a comparison of image utility for human readers, but no effect size on human reader improvement with AI assistance is provided as the device is a camera, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The Verily Numetric Retinal Camera is a hardware device (ophthalmic camera) that captures images, not a standalone AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI-based diagnostic software was not conducted or described. The focus is on the camera's ability to produce high-quality, gradable images.
7. Type of Ground Truth Used (for Test Set)
The document primarily refers to evaluating "image quality" and "gradability." While not explicitly stated as "expert consensus ground truth," the comparison of "gradability of images captured by VNRC... comparable to the predicated device on the same population" strongly implies that human expert evaluation of image quality was used as a form of ground truth for assessing the usability of the images for clinical purposes. There is no mention of pathology or outcomes data being used as ground truth for effectiveness.
8. Sample Size for the Training Set
The document does not provide a sample size for a training set. This is expected as the device is a camera, not an AI algorithm that typically requires a training set.
9. How Ground Truth for Training Set Was Established
As the device is a camera and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" does not directly apply in the context of this submission. The camera's performance is evaluated against technical specifications and a comparison to a predicate device.
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December 9, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Verily Life Sciences, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242508
Trade/Device Name: Verily Numetric Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 13, 2024 Received: November 13, 2024
Dear Prithul Bom:
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.
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"
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(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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
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Sincerely,
Elvin Y. Ng -S 2024.12.09
17:29:55 -05'00'
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
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Indications for Use
Submission Number (if known)
Device Name
Verily Numetric Retinal Camera
Indications for Use (Describe)
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation 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)
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510(k) Summary K242508
This summary of Traditional 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CPR 807.92.
| Date Prepared | December 9, 2024 |
|---|---|
| Submitter | Verily Life Sciences, LLC |
| Official Contact | Pooja Shah, Regulatory Affairs Specialist269 E Grand Avenue, South San Francisco, California, 94080Email: shahpoo@verily.com |
| Proprietary Name | Verily Numetric Retinal Camera |
| Common Name | Ophthalmic Camera |
| Classification | Class II Medical DeviceRegulation Number: 21 CPR 886.1120Product Code: HKI |
| Predicate Device | K182199,NFC-700 Non-Mydriatic Auto Fundus CameraRegulation Number: 21 CPR 886.1120 |
Indications for Use
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
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Device Description
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
Safety
All safety-related parameters of Verily Numetric Retinal Camera, such as light hazard protection, material biocompatibility, and IEC-60601 compliance, have been tested and conform to industry standards. The Verily Numetric Retinal Camera has the same analysis features as the predicate device; and all related test reports of safety show the Verily Numetric Retinal Camera is compliant with the same safety standards declared by the predicate device, NFC-700.
Biocompatibility Testing
The biocompatibility evaluation for Verily Numetric Retinal Camera has been conducted in accordance with ISO 10993-1.
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Effectiveness
The validation of effectiveness for the Verily Numetric Retinal Camera has been analyzed in detail and the image quality is similar to the predicate device. The results demonstrate that the Verily Numetric Retinal Camera is as effective as the predicate device, NFC-700.
Substantial Equivalence Discussion
Verily Numetric Retinal Camera is substantially equivalent to the predicate device, Crystalvue's NFC-700 Non-Mydriatic Auto Fundus Camera (a.k.a NFC-700) (K182199), as both the subject and predicate devices are intended as an aid to clinicians in the evaluation and diagnosis of eye disease. Both devices are indicated for photographing, displaying and storing images of the retina to be evaluated under non-mydriatic conditions. Similar to the predicate device, the subject device is classified as "Ophthalmic Camera" in accordance with 21 CPR 886.1120, Product Code HKI.
It is important to note that the method of alignment of the predicate device, NFC-700 camera is automatic, and that of the Verily Numetric Retinal Camera is interactive. The focusing on the Verily Numetric Retinal Camera is performed by the patient viewing a screen which is collocated in the same plane as the image sensor. It ensures that the fundus image is in sharp focus on the image sensor. These differences do not limit the camera's ability to be safe and effective.
The table below is a comparative summary of the similarities and differences between the Verily Numetric Retinal Camera (subject device) and the NFC-700 camera (predicate device) (K182199).
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| Product Item | Verily NumetricRetinal Camera | Crystalvue, NFC-700Non-Mydriatic AutoFundus Camera | ComparisonComments |
|---|---|---|---|
| 510(k) number | K242508 | K182199 | |
| Intended Use | Verily NumetricRetinal Cameraprovidesnon-mydriatic, colorposterior segmentimages of the eye as anaid to clinicians in theevaluation anddiagnosis of eyedisease. | NFC-700 providesnon-mydriatic, colorposterior chamber andexternal images of theeye as an aid toclinicians in theevaluation anddiagnosis of eyedisease. | Verily Numetric Retinal Cameradoes not acquire externalimages of the eye for sharingwith the end users. The cameraacquires and shares retinalimages only. All else isidentical. |
| Indication for Use | Verily NumetricRetinal Camera is anon-contact, highresolution digitalimaging device whichis suitable forphotographing,displaying and storingimages of the retinasegment of the eye tobe evaluated undernon-mydriaticconditions.Verily NumetricRetinal Camera isindicated for in-vivoviewing of theposterior segment ofthe eye. The imagesare intended for use asan aid to clinicians inthe evaluation,diagnosis, anddocumentation ofocular health. | NFC-700 is anon-contact, highresolution digitalimaging device whichis suitable forphotographing,displaying and storingimages of the retinaand external areas ofthe eye to be evaluatedunder non-mydriaticconditions. NFC-700 isindicated for in-vivoviewing of theposterior and externalarea of the eye and theimages are intended foruse as an aid toclinicians in theevaluation, diagnosisand documentation ofocular health. | Verily Numetric Retinal Cameradoes not acquire externalimages of the eye. All else isidentical. |
| Where Used | Professional healthcareenvironment | Hospital | The camera has beendemonstrated to be safe andeffective in healthcareenvironments. |
| Design | |||
| Shape | Verily NumetricRetinal Camera andChromebook | All in one | No significant differences.Minor hardware differences ofthe operator display do not raisedifferent questions of safety andeffectiveness. |
| Dimensions(WxDxH) | 257 x 420 x 360 (mm) | 282 x 485 x 492 (mm) | No significant differences.Minor hardware differences donot raise different questions ofsafety and effectiveness |
| Weight | 6 kg | 17 kg | Physical weight of the devicedo not raise different questionsof safety and effectiveness. |
| Eye Fixation | One (1) fixation point | 10 fixation points | Verily Numetric Retinal Camerais designed to be used with asingle automated visual fixationpoint. Both VNRC andpredicate are able to providegradable images to aidclinicians in the evaluation anddiagnosis of eye disease. Thedifference in number ofautomated fixation points doesnot limit the safety andeffectiveness of the device. |
| Power Supply | AC 100V to 240V,50/60Hz (Autoselected) | AC 100V to 240V,50/60Hz (Autoselected) | Same |
| Environment | Temp.: 15-30 °C /Humidity: 20-75%RH | Temp.: 10-35 °C /Humidity:30-90%RH | No significant difference.Professional healthcareenvironments are within theenvironmental ranges of bothcameras. |
| Light sourceI.Observation:2. Flash: | 1. Infrared LED2. White LED | 1. Infrared LED2. White LED | Same |
| Type ofPhotography | Color posterior eyeimage | Color / Digital red-free/ Anterior eye image | The Verily Numetric RetinalCamera only acquires colorimages of the posteriorsegment. |
| Operation Principle | The Verily NumetricRetinal Camera takesimages of the fundusin the followingmanner:I.Focusing: Thepatient interactivelyfocuses an imageshown on amicrodisplay (locatedat the same opticalplane as the imagesensor) into bestqualitative focus byturning a knob on anexternal peripheraldevice whichmodulates the cameraoptics.2. Image Capture:The patient is showna fixation target andthrough an interactivesession with positionfeedback, the patientaligns their pupil tothe camera. The pupillocation isdetermined usingeye-tracking. Whitelight from LEDsilluminate the fundus.The light reflectionfrom the fundus iscaptured by a colorCMOS sensor. | The optical design offundus camera isbased on theprinciple ofmonocular indirectophthalmoscopy.1. Fundusobservation:A built in light rayfrom the infraredlight LED source toilluminate thefundus. Alignmentof the device isperformed by abuilt- in eye trackingindicator andworking distanceindicator to adjustthe system to thebest XYZ positionautomatically.2. Image capture:System usessplit-image techniqueto do image focusadjustmentautomatically tocapture the bestquality of image.White light fromLEDs Flash moduleirradiates the fundus.The light reflectedfrom eye portionsforms an image, and | The method of alignment of theNFC-700 is automatic, and thatof the Verily Numetric RetinalCamera is interactive.The focusing is performed bythe user viewing a screen whichis collocated in the same planeas the image sensor, it ensuresthat the fundus image is infocus on the image sensor.These differences do not limitthe camera's ability to be safeand effective. |
| the image is capturedby built-in colorCMOS cameramodule for fundusimage capture. | |||
| Material of Chinrest | No Chinrest | ABS | There is no chin rest for theVerily Numetric Retinal Cameradevice. |
| Material of ForeheadRest | Silicone | TPE | The Verily Numetric RetinalCamera device contains afacerest that contacts theforehead and cheek area.The biocompatibilityhas been tested by arecognized lab, thus there is noimpact to safety. |
| Safety | Compliance with• IEC 60601-1 | Compliance with• IEC 60601-1 | Same |
| EMC | Compliance withIEC 60601-1-2 | Compliance with• IEC 60601-1-2 | Same |
| Performance | |||
| Image (resolution) | 2.1 MP | 12MP | The difference in imageresolution does not affect thesafety and effectiveness of thedevice. The VNRC camerameets all optical performancespecifications recommended byISO 10940 standard. |
| Alignment | Interactive GuidedAlignment | Fully automatic 3Dtracking | The captured image is broughtinto focus and alignmentinteractively by the patient forthe Verily Numetric RetinalCamera instead ofautomatically by the instrumentfor the NFC-700. Thedifferences in the method of |
| alignment does not affect thesafety and effectiveness of thedevice. | |||
| Field-of-View | 45° | 45° | Same |
| Minimum Pupil Size | 3.0 mm | 4.0 mm | The Verily Numetric RetinalCamera is able to imagepatients with smaller pupils thanthe predicate. This differencedoes not limit the camera'sability to be safe and effective. |
| Operation Range(FocusAdjustmentRange):1. Withoutcompensationlens:2. Withcompensationlens: | -20 to +20D | -15 to +10D-30D to -10D or +5Dto +30D | Verily Numetric Retinal Camerapasses the ISO 10940specification of+/- 15D withoutthe need of a compensationlens. The difference does notaffect safety and effectiveness. |
| Interface | USB2.0 / Wi-Fi | USB2.0 / Ethernet /HDMI | Differences in data modalitytransfer do not impact thesafety and effectiveness of thedevice. |
| PerformanceItem | Verily Numetric Retinal Camera AcceptanceCriteria | Test Result | |
| Resolving power | ≥ 60 line pairs/mm at the center of the field≥ 40 line pairs/mm at the mid field (r/2)≥25 line pairs/mm at the periphery of the field (r) | Pass |
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The differences in technological characteristics associated with the subject device and the predicate device, NFC-700 (K182199) have been evaluated through performance testing for the target population and there are no new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.
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Non-Clinical Performance Data
Non-clinical performance testing for the Verily Numetric Retinal Camera includes analysis using raw data collected via a retrospective clinical study. Bench testing includes verification and validation of specifications. All tests confirmed that the subject device met the predetermined acceptance criteria and that the features driving performance are substantially equivalent to those present in the specified predicate device.
The Verily Numetric Retinal Camera has been tested and found to be in full compliance with the following FDA-recognized consensus standards:
- 트 ANSI Z80.36-2021 (Group 1 Instrument)
- ISO 10940 Second edition 2009
- IEEE ANSI C63.27-2017 l
- I AAMI TIR69:2017/(R2020)
Software Validation
The software verification and validation testing were conducted and documentation was provided as recommended by IEC-62304:2015, "Medical Device Software- Software Life Cycle Processes." The software for Verily Numetric Retinal Camera is classified as Class A according to the classification of IEC 62340:2015, and has been evaluated to be Basic Documentation Level as per FDA Guidance document - "Content of Premarket Submissions for Device Software Functions (June 2023)." Software used in the Verily Numetric Retinal Camera conforms to the safety principles and is demonstrated through the risk management process for medical devices.
Bench Testing Summary:
The VNRC has undergone performance testing before release to ensure that the device hardware and its software meet the functional requirements and to demonstrate equivalence to the predicate device.
A summary of the results of performance testing and the device requirements follows:
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| Field of view | 45 degrees | Pass |
|---|---|---|
| Pixel pitch tolerance | <7% | Pass |
| Alignmentillumination | The alignment illumination is done via Near | Pass |
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| Infrared (NIR) LEDs during eye tracking. Theintensity of the NIR LEDs is controlled by SW. | ||
|---|---|---|
| Flash illumination | The flash illumination is done via white LEDsduring the image capture. The intensities anddurations of the white LEDs are controlled by SW. | Pass |
| Range of focus | -20D to +20D (no compensating lens) | Pass |
| Minimum pupil size | 3.0mm | Pass |
| Alignment | Interactive alignment using 3D tracking. | Pass |
| Image quality | The gradability of images captured by VNRC iscomparable to the predicated device on the samepopulation. | Pass |
Conclusion
In summary, the comprehensive testing and analysis demonstrates that the Verily Numetric Retinal Camera is safe and effective for the specified intended use. This testing, in addition to the comprehensive comparison to the predicate device, NFC-700 (K182199), demonstrates the Verily Numetric Retinal Camera is substantially equivalent to the predicate device.
§ 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.