Zilia Ocular FC (ZIL-10002)

{0}------------------------------------------------ November 20, 2023 Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Zilia Inc. % Christina Henza Regulatory Consultant Ultra Life Science Solutions Inc. 2811 Milton Ave #409 Janesville, Wisconsin 53545 Re: K230627 Trade/Device Name: Zilia Ocular FC (ZIL-10002) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: October 27, 2023 Received: October 27, 2023 #### Dear Christina Henza: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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). Sincerelv. ## Elvin Y. Na -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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K230627 Device Name Zilia Ocular Indications for Use (Describe) Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions. Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green, almost pastel. The background is a solid, light gray color, providing a subtle contrast to the text. 125 Charest Blvd. East, Suite 400 Quebec City, Quebec G1K 3G5 □ 1 833 501-6996 - ▷ info@ziliahealth.com - ලි www.ziliahealth.com #### 510(k) SUMMARY Zilia Inc. Zilia Ocular Fundus Camera (Zilia Ocular FC) This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. | SUBMITTER | | |---------------------|---------------------------------------------------------------------------------| | Company Name | Zilia Inc. | | Company Address | 125 Charest Boulevard East, Suite 400<br>Quebec City, Quebec, Canada<br>G1K 3G5 | | Contact Person | Patrick Sauvageau, O.D., M.Sc., CEO | | Phone | 1 833 501-6996 | | E-mail | patrick.sauvageau@ziliahealth.com | | Website | ziliahealth.com | | Date prepared | 2023-10-10 | | DEVICE INFORMATION | | | Trade Name | Zilia Ocular Fundus Camera | | Common Name | Zilia Ocular FC | | Classification Name | Ophthalmic Camera, AC powered | | 510(k) Number | K230627 | | Regulatory Class | Class II | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "zilia" in a light green color. The font is sans-serif and appears to be a custom design. The letters are evenly spaced and the overall impression is clean and modern. | Product Code | HKI | |-------------------|-----------------| | Regulation Number | 21 CFR 886.1120 | | PREDICATE DEVICE | | |---------------------|------------------------------------------| | Trade Name | NFC-700 Non-Mydriatic Auto Fundus Camera | | Classification Name | Ophthalmic Camera, AC powered | | 510(k) Number | K182199 | | REFERENCE DEVICE | | |---------------------|-----------------------------------------------------| | Trade Name | Mydriatic Hyperspectral Retinal Camera<br>(MHRC-C1) | | Classification Name | Ophthalmic Camera, AC powered | | 510(k) Number | K200254 | #### DEVICE DESCRIPTION The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus. The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images. The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer. The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "zilia" in a light green color. The font is sans-serif and the letters are rounded. The word is written in lowercase. The detailed technological characteristics and specifications of the Zilia Ocular FC are listed in the section Comparison Of Technological Characteristics With The Predicate Device located on page 6 of this summary. #### INDICATIONS FOR USE The Zilia Ocular FC is a non-contact imaging device for capturing, displaying, and storing images of the eye fundus under mydriatic conditions. The Zilia Ocular FC is intended for use as an aid to clinicians in the evaluation and documentation of ocular health. #### PERFORMANCE TESTING All necessary performance testing was conducted on the Zilia Ocular FC and demonstrated that the subject device is substantially equivalent to the predicate device, the NFC-700, in terms of safety and effectiveness. #### Electrical Safety and Electromagnetic Compatibility It was verified that the Zilia Ocular FC complies with the standard ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility under the ASCA pilot program. #### Recognized Consensus Standards For Ophthalmic Cameras The Zilia Ocular FC was found to comply with the following recognized consensus standards: - ISO 15004-1:2020 Ophthalmic instruments Fundamental requirements and test methods . - Part 1: General requirements applicable to all ophthalmic instruments; - ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods . - Part 2: Light hazard protection: - ANSI Z80.36-2021 American National Standard: Ophthalmics Light Hazard Protection . for Ophthalmic Instruments; - ISO 10940:2009 Ophthalmic instruments Fundus cameras; and . - IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability. #### Risk-Based Approach The risk management report was prepared to document the evaluation and the decisions made and all necessary safety measures in the design and manufacturing of the Zilia Ocular FC. All documentation in accordance with ISO 14971:2019 Medical devices - Application of risk management to medical devices was created including a Risk Management Plan, a Hazard and Risk Analysis, a Production Failure Mode and Effect Analysis (PFMEA), and a Risk Management Report. The risks related to all applicable hazards which were identified for the Zilia Ocular FC have been reduced to the acceptable level by mitigation. {6}------------------------------------------------ The Zilia Ocular FC is shown to be at least as safe and effective as the predicate device and the inherent risks are believed to be overcome by the benefits of the device use as indicated. Therefore, all residual risks post-mitigation have been deemed acceptable for this design. #### Biocompatibility The intact skin from the chin and forehead of the patient is intended to contact the Zilia Ocular FC for a short period of time. The biocompatibility of the Zilia Ocular FC was assessed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. #### Processing of Health Care Products The Zilia Ocular FC Instructions for Use document was assessed to comply with ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices. #### Software Evaluation The Zilia Ocular FC software was evaluated in accordance with IEC 62304:2006/AMD 1:2015 Medical device software - Software life cycle processes. The software for this device is considered to be a "Moderate Level of Concern" since a failure or latent flaw in the software could directly result in minor injury to the patient or user and due to the use of Off-the-shelf Software. #### Labeling The Zilia Ocular labeling was assessed to verify compliance to ISO 15223-1:2021 and ISO 20417:2021 and all applicable local requirements. #### Usabilitv Zilia applied the recommendations from the FDA's guidance Applying human factors and usability engineering to medical device:2016 and IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability:2010+AMD1:2013+AMD2:2020 to maximize the likelihood that the Zilia Ocular FC is safe and effective for the intended users, uses and use environments. #### Clinical Performance Data This section is not applicable because clinical data was not provided for this 510(k) submission. #### Animal Studies This section is not applicable as there is no data related to animal studies for this 510(k) submission. {7}------------------------------------------------ # ZI IC #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND REFERENCE DEVICE The proposed Zilia Ocular FC is substantially equivalent to the NFC-700 Non-Mydriatic Auto Fundus Camera (Crystalvue Medical Corporation) cleared in K182199 on 2019-01-02, certain technical differences are supported by the reference device Mydriatic Hyperspectral Retinal Camera (MHRC-C1) cleared in K200254 on 04/27/2020. The proposed indications for use are equivalent to the predicate and reference device, as the three devices are intended to capture, display, and store images of the eye fundus. The technological characteristics of the proposed Zilia Ocular FC encompass the functionalities of the NFC-700 and MHRC-C1. | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation number | 21 CFR 886.1120 | 21 CFR 886.1120 | 21 CFR 886.1120 | | Product code | HKI | HKI | HKI, NFJ | | Regulation name | Ophthalmic<br>Camera | Ophthalmic<br>Camera | Ophthalmic<br>Camera | | Regulatory class | Class II | Class II | Class II | | Intended<br>Use /<br>Indication<br>for use | Zilia Ocular is a<br>non-contact<br>imaging device<br>for capturing,<br>displaying, and<br>storing images of<br>the eye fundus<br>under mydriatic<br>conditions.<br>Zilia Ocular is<br>intended for use<br>as an aid to<br>clinicians in the<br>evaluation and<br>documentation of<br>ocular health. | NFC-700 is an AC-<br>powered ophthalmic<br>camera to take<br>photographs of the<br>eye and the<br>surrounding area.<br>NFC-700 is a non-<br>contact, high<br>resolution digital<br>imaging device<br>which is suitable<br>for photographing,<br>displaying and<br>storing images of<br>the retina and<br>external areas of<br>the eye to be<br>evaluated under<br>non-mydriatic | The MHRC-C1 is<br>intended to capture<br>images of the retina<br>at multiple<br>wavelengths<br>(colors) under<br>mydriatic<br>conditions. | | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | | | | conditions.<br>NFC-700 is<br>indicated for in-vivo<br>viewing of the<br>posterior and<br>external area of the<br>eye and the images<br>are intended for use<br>as an aid to<br>clinicians in the<br>evaluation,<br>diagnosis and<br>documentation of<br>ocular health. | | | Prescription<br>use | Rx Only | Rx Only | Rx Only | | Fundus<br>image | Mydriatic, color<br>image | Non-mydriatic,<br>color image | Mydriatic,<br>monochrome | | Record<br>media | Digital | Digital | Digital | | Contact<br>areas with<br>the patients | Chin and<br>forehead | Chin and forehead | Chin and forehead | | Mean for<br>alignment | Manual<br>positioning | Fully automatic 3D<br>tracking | Manual<br>positioning | | Main<br>technology | AC-powered<br>ophthalmic camera<br>on a support frame<br>with: | AC-powered<br>ophthalmic camera<br>on a support frame<br>with: | AC-powered<br>ophthalmic camera<br>on a support frame<br>with: | | | • A patient chin<br>and forehead rest<br>for patient head | • A patient chin<br>and forehead rest<br>for patient head | • A patient chin<br>and forehead rest<br>for patient head | | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | | | placement. | placement. | placement. | | | • Visual fixation<br>target for patient<br>to maintain<br>patient's gaze<br>and the pupil's<br>alignment. | • Visual fixation<br>target for patient<br>to maintain<br>patient's gaze<br>and the pupil's<br>alignment. | • Visual fixation<br>target for patient<br>to maintain<br>patient's gaze<br>and the pupil's<br>alignment. | | | • Camera optical<br>head alignment<br>features to allow<br>the user to<br>observe, align,<br>and target the<br>desired image of<br>the patient's eye<br>area. | • Camera optical<br>head alignment<br>features to allow<br>the user to<br>observe, align,<br>and target the<br>desired image of<br>the patient's eye<br>area. | • Camera optical<br>head alignment<br>features to allow<br>the user to<br>observe, align,<br>and target the<br>desired image of<br>the patient's eye<br>area. | | | • NIR lighting<br>during alignment<br>and white LED<br>lighting during<br>focusing and<br>imaging. | • NIR lighting<br>during alignment<br>and initial<br>observation to<br>not cause pupil<br>constriction. | • Monochromatic<br>light (700 nm)<br>during alignment. | | | • Camera to record<br>the given images<br>provides lighting<br>with mask to<br>illuminate the<br>selected area for<br>the imaging. | • Camera to record<br>the given images<br>provides lighting<br>with mask to<br>illuminate the<br>selected area for<br>the imaging. | • Camera to record<br>the given images<br>provides lighting<br>with mask to<br>illuminate the<br>selected area for<br>the imaging. | | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | | | · Software and<br>control user<br>interfaces to<br>operate the<br>device. | · Software and<br>control user<br>interfaces to<br>operate the<br>device. | · Software and<br>control user<br>interfaces to<br>operate device. | | Operation<br>Principle | The optical design<br>of the fundus<br>camera is based on<br>the principle of<br>monocular indirect<br>ophthalmoscopy.<br>1. Fundus<br>observation:<br>Alignment to the<br>pupil is made<br>using two NIR<br>LEDs. Indicators<br>shown on the<br>screen help the<br>user center the<br>device with the<br>pupil. A white<br>LED is used to<br>focus and image<br>the eye fundus. | The optical design<br>of the fundus<br>camera is based on<br>the principle of<br>monocular indirect<br>ophthalmoscopy.<br>1. Fundus<br>observation:<br>A built-in light<br>ray from the<br>infrared light<br>LED source to<br>illuminate the<br>fundus.<br>Alignment of<br>the device is<br>performed by<br>built-in eye<br>tracking<br>indicator and<br>working<br>distance<br>indicator to<br>automatically<br>adjust the<br>system to the<br>best XYZ<br>position<br>automatically. | The optical design<br>of fundus camera is<br>based on the<br>principle of<br>monocular indirect<br>ophthalmoscopy.<br>1. Fundus<br>observation:<br>A positioning<br>system is used to<br>align the camera<br>relative to the<br>patient's eye.<br>Monochromatic<br>light (700 nm) is<br>used during<br>alignment. The<br>fundus is<br>observed through<br>a video feed on<br>an LCD monitor. | | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | | 2. Image capture: | System uses real-<br>time image<br>analysis to<br>perform image<br>focus adjustment<br>automatically to<br>capture the best<br>quality of image.<br>White light<br>emitted from<br>LEDs irradiates<br>the eye fundus.<br>The light<br>reflected from the<br>eye fundus forms<br>an image, and the<br>image is captured<br>by a built-in color<br>CMOS camera<br>module for<br>fundus image<br>capture. | 2. Image capture:<br>System uses<br>split-image<br>technique to do<br>image focus<br>adjustment<br>automatically to<br>capture the best<br>quality of image.<br>White light from<br>LEDs Flash<br>module irradiates<br>the fundus. The<br>light reflected<br>from eye portions<br>forms an image,<br>and the image is<br>captured by a<br>built-in color<br>CMOS camera<br>module for<br>fundus image<br>capture. | 2. Image capture:<br>Focus is achieved<br>manually through<br>a focus wheel.<br>System uses a<br>tunable light<br>source that<br>sequentially<br>presents the<br>retina with<br>monochromatic<br>light in the<br>spectral range<br>905 nm to 450<br>nm in steps of 5<br>nm. | | Alignment/<br>visualization<br>light source | Near-infrared LED<br>during pupil<br>alignment<br>White LED during<br>focusing and<br>imaging | Near-infrared LED<br>during alignment<br>White LED during<br>imaging | Monochromatic<br>light (700 nm)<br>during alignment<br>Monochromatic<br>light (sequential<br>from 905 nm to 450<br>nm in steps of 5 nm)<br>during imaging | | Field of<br>view | 25° | 45° | 31.5° | | Feature | Zilia Ocular<br>Fundus Camera<br>(Zilia Ocular FC)<br>(K230627) | NFC-700<br>(K182199) | MHRC-C1<br>(K200254) | | Working<br>distance | 55 mm<br>from lens to<br>cornea | 25 mm<br>from lens to<br>cornea | 46.7 mm<br>from lens to<br>cornea | | Minimum<br>pupil<br>diameter | 4 mm | 4 mm | 6 mm | | Focus | Manual or<br>automatic | Manual or<br>automatic | Manual | | Exposure | Manual | Automatic | Automatic | | Compensation for<br>ametropia | -15D to +15D | -15D to + 10D<br>(without<br>compensation lens)<br>-30D to -10D or<br>+5D to +30D (with<br>compensation lens) | -15D to +15D | | Internal<br>fixation<br>targets | 5 points | 10 points | None | | External<br>fixation<br>target | 1 point,<br>mobile | None | 1 point,<br>mobile | | Camera<br>resolution -<br>pixel<br>size/pitch | CMOS 5 MP -<br>3.45 $μ$ m (pixel<br>pitch) | CMOS 12 MP -<br>5.12 $μ$ m (pixel<br>pitch) | Not available | {8}------------------------------------------------ #### Zilia Ocular FC Premarket Notification Image /page/8/Picture/1 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green. There are two dots above the "i" letters, which are also light green. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green. The letters are lowercase and evenly spaced. {10}------------------------------------------------ #### Zilia Ocular FC Premarket Notification ### zilia {11}------------------------------------------------ ## zilia {12}------------------------------------------------ #### Zilia Ocular FC Premarket Notification ### zilia Considering the above, the Zilia Ocular FC proposes an equivalent technology and methods as the predicate and reference devices to address the same indications. The noted differences in their detailed specifications do not present any new questions of safety or effectiveness, whereby the devices are substantially equivalent. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image contains the word "zilia" in a sans-serif font. The color of the text is a light green. The letters are all lowercase. #### CONCLUSION As described in this 510(k) Summary, comprehensive testing and analysis was conducted on the Zilia Ocular FC to ensure that the device is equivalent to the predicate and reference devices cleared under K182199 and K200254 when used in accordance with its Instructions for Use. Based on the information in this submission, Zilia Ocular FC has the same intended use, technological characteristics, and operation principles as its predicate and reference devices. Therefore, Zilia Ocular FC is substantially equivalent to the predicate device.