Verily Numetric Retinal Camera

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K242508 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 Specialist<br>269 E Grand Avenue, South San Francisco, California, 94080<br>Email: shahpoo@verily.com | | Proprietary Name | Verily Numetric Retinal Camera | | Common Name | Ophthalmic Camera | | Classification | Class II Medical Device<br>Regulation Number: 21 CPR 886.1120<br>Product Code: HKI | | Predicate Device | K182199,<br>NFC-700 Non-Mydriatic Auto Fundus Camera<br>Regulation 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. {5}------------------------------------------------ ### 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. {6}------------------------------------------------ ## 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). {7}------------------------------------------------ | Product Item | Verily Numetric<br>Retinal Camera | Crystalvue, NFC-700<br>Non-Mydriatic Auto<br>Fundus Camera | Comparison<br>Comments | |-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | K242508 | K182199 | | | Intended Use | Verily Numetric<br>Retinal Camera<br>provides<br>non-mydriatic, color<br>posterior segment<br>images of the eye as an<br>aid to clinicians in the<br>evaluation and<br>diagnosis of eye<br>disease. | NFC-700 provides<br>non-mydriatic, color<br>posterior chamber and<br>external images of the<br>eye as an aid to<br>clinicians in the<br>evaluation and<br>diagnosis of eye<br>disease. | Verily Numetric Retinal Camera<br>does not acquire external<br>images of the eye for sharing<br>with the end users. The camera<br>acquires and shares retinal<br>images only. All else is<br>identical. | | Indication for Use | Verily Numetric<br>Retinal Camera is a<br>non-contact, high<br>resolution digital<br>imaging device which<br>is suitable for<br>photographing,<br>displaying and storing<br>images of the retina<br>segment of the eye to<br>be evaluated under<br>non-mydriatic<br>conditions.<br>Verily Numetric<br>Retinal Camera is<br>indicated for in-vivo<br>viewing of the<br>posterior segment of<br>the eye. The images<br>are intended for use as<br>an aid to clinicians in<br>the evaluation,<br>diagnosis, and<br>documentation of<br>ocular health. | NFC-700 is a<br>non-contact, high<br>resolution digital<br>imaging device which<br>is suitable for<br>photographing,<br>displaying and storing<br>images of the retina<br>and external areas of<br>the eye to be evaluated<br>under non-mydriatic<br>conditions. NFC-700 is<br>indicated for in-vivo<br>viewing of the<br>posterior and external<br>area of the eye and the<br>images are intended for<br>use as an aid to<br>clinicians in the<br>evaluation, diagnosis<br>and documentation of<br>ocular health. | Verily Numetric Retinal Camera<br>does not acquire external<br>images of the eye. All else is<br>identical. | | Where Used | Professional healthcare<br>environment | Hospital | The camera has been<br>demonstrated to be safe and<br>effective in healthcare<br>environments. | | | | Design | | | Shape | Verily Numetric<br>Retinal Camera and<br>Chromebook | All in one | No significant differences.<br>Minor hardware differences of<br>the operator display do not raise<br>different questions of safety and<br>effectiveness. | | Dimensions<br>(WxDxH) | 257 x 420 x 360 (mm) | 282 x 485 x 492 (mm) | No significant differences.<br>Minor hardware differences do<br>not raise different questions of<br>safety and effectiveness | | Weight | 6 kg | 17 kg | Physical weight of the device<br>do not raise different questions<br>of safety and effectiveness. | | Eye Fixation | One (1) fixation point | 10 fixation points | Verily Numetric Retinal Camera<br>is designed to be used with a<br>single automated visual fixation<br>point. Both VNRC and<br>predicate are able to provide<br>gradable images to aid<br>clinicians in the evaluation and<br>diagnosis of eye disease. The<br>difference in number of<br>automated fixation points does<br>not limit the safety and<br>effectiveness of the device. | | Power Supply | AC 100V to 240V,<br>50/60Hz (Auto<br>selected) | AC 100V to 240V,<br>50/60Hz (Auto<br>selected) | Same | | Environment | Temp.: 15-30 °C /<br>Humidity: 20-75%RH | Temp.: 10-35 °C /<br>Humidity:<br>30-90%RH | No significant difference.<br>Professional healthcare<br>environments are within the<br>environmental ranges of both<br>cameras. | | Light source<br>I.Observation:<br>2. Flash: | 1. Infrared LED<br>2. White LED | 1. Infrared LED<br>2. White LED | Same | | Type of<br>Photography | Color posterior eye<br>image | Color / Digital red-free<br>/ Anterior eye image | The Verily Numetric Retinal<br>Camera only acquires color<br>images of the posterior<br>segment. | | Operation Principle | The Verily Numetric<br>Retinal Camera takes<br>images of the fundus<br>in the following<br>manner:<br>I.Focusing: The<br>patient interactively<br>focuses an image<br>shown on a<br>microdisplay (located<br>at the same optical<br>plane as the image<br>sensor) into best<br>qualitative focus by<br>turning a knob on an<br>external peripheral<br>device which<br>modulates the camera<br>optics.<br>2. Image Capture:<br>The patient is shown<br>a fixation target and<br>through an interactive<br>session with position<br>feedback, the patient<br>aligns their pupil to<br>the camera. The pupil<br>location is<br>determined using<br>eye-tracking. White<br>light from LEDs<br>illuminate the fundus.<br>The light reflection<br>from the fundus is<br>captured by a color<br>CMOS sensor. | The optical design of<br>fundus camera is<br>based on the<br>principle of<br>monocular indirect<br>ophthalmoscopy.<br>1. Fundus<br>observation:<br>A built in light ray<br>from the infrared<br>light LED source to<br>illuminate the<br>fundus. Alignment<br>of the device is<br>performed by a<br>built- in eye tracking<br>indicator and<br>working distance<br>indicator to adjust<br>the system to the<br>best XYZ position<br>automatically.<br>2. Image capture:<br>System uses<br>split-image technique<br>to do image focus<br>adjustment<br>automatically to<br>capture the best<br>quality of image.<br>White light from<br>LEDs Flash module<br>irradiates the fundus.<br>The light reflected<br>from eye portions<br>forms an image, and | The method of alignment of the<br>NFC-700 is automatic, and that<br>of the Verily Numetric Retinal<br>Camera is interactive.<br>The focusing is performed by<br>the user viewing a screen which<br>is collocated in the same plane<br>as the image sensor, it ensures<br>that the fundus image is in<br>focus on the image sensor.<br>These differences do not limit<br>the camera's ability to be safe<br>and effective. | | | | | | | | | the image is captured<br>by built-in color<br>CMOS camera<br>module for fundus<br>image capture. | | | Material of Chinrest | No Chinrest | ABS | There is no chin rest for the<br>Verily Numetric Retinal Camera<br>device. | | Material of Forehead<br>Rest | Silicone | TPE | The Verily Numetric Retinal<br>Camera device contains a<br>facerest that contacts the<br>forehead and cheek area.<br>The biocompatibility<br>has been tested by a<br>recognized lab, thus there is no<br>impact to safety. | | Safety | Compliance with<br>• IEC 60601-1 | Compliance with<br>• IEC 60601-1 | Same | | EMC | Compliance with<br>IEC 60601-1-2 | Compliance with<br>• IEC 60601-1-2 | Same | | Performance | | | | | Image (resolution) | 2.1 MP | 12MP | The difference in image<br>resolution does not affect the<br>safety and effectiveness of the<br>device. The VNRC camera<br>meets all optical performance<br>specifications recommended by<br>ISO 10940 standard. | | Alignment | Interactive Guided<br>Alignment | Fully automatic 3D<br>tracking | The captured image is brought<br>into focus and alignment<br>interactively by the patient for<br>the Verily Numetric Retinal<br>Camera instead of<br>automatically by the instrument<br>for the NFC-700. The<br>differences in the method of | | | | | alignment does not affect the<br>safety and effectiveness of the<br>device. | | Field-of-View | 45° | 45° | Same | | Minimum Pupil Size | 3.0 mm | 4.0 mm | The Verily Numetric Retinal<br>Camera is able to image<br>patients with smaller pupils than<br>the predicate. This difference<br>does not limit the camera's<br>ability to be safe and effective. | | Operation Range<br>(Focus<br>Adjustment<br>Range):<br>1. Without<br>compensation<br>lens:<br>2. With<br>compensation<br>lens: | -20 to +20D | -15 to +10D<br>-30D to -10D or +5D<br>to +30D | Verily Numetric Retinal Camera<br>passes the ISO 10940<br>specification of+/- 15D without<br>the need of a compensation<br>lens. The difference does not<br>affect safety and effectiveness. | | Interface | USB2.0 / Wi-Fi | USB2.0 / Ethernet /<br>HDMI | Differences in data modality<br>transfer do not impact the<br>safety and effectiveness of the<br>device. | | Performance<br>Item | Verily Numetric Retinal Camera Acceptance<br>Criteria | Test Result | | | Resolving power | ≥ 60 line pairs/mm at the center of the field<br>≥ 40 line pairs/mm at the mid field (r/2)<br>≥25 line pairs/mm at the periphery of the field (r) | Pass | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ 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 an…