RetCam Envision

{0}------------------------------------------------ April 13, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a stacked format. Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta Director of Global Regulatory Affairs, QARA 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada ## Re: K203500 Trade/Device Name: RetCam Envision Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 9, 2021 Received: March 10, 2021 Dear Mr. Mehta: 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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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). Sincerely, # 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203500 Device Name RetCam Envision #### Indications for Use (Describe) General ophthalmic imaging including retinal, corneal, and external imaging. · Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). · Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants. ## * References: 1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4): 471-479. 2. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt"><label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label></span> | <span style="font-size:10pt"><label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label></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/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the letter "s". # 510K Summary Date: April 11, 2021 Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1 - Contact Person: Sanjay Mehta Director, Global Regulatory Affairs Natus Medical Incorporated Tel.: (905) 287 5055 Fax .: (905) 829-5304 E-mail: sanjay.mehta@natus.com Proprietary Name: RetCam Envision™ Common Name: Camera, Ophthalmic, Ac-Powered Regulation Number : 21CFR 886.1120 Classification Name: Ophthalmic camera. Product code: HKI Device Class: Il Predicate Device: RetCam 3 ; RetCam Shuttle ; RetCam Portable (K182263) {4}------------------------------------------------ ## Description: Image /page/4/Picture/2 description: The image shows the word "natus" in a teal sans-serif font. The letters are spaced closely together, and the word appears to be a logo or brand name. A registered trademark symbol is located to the bottom right of the letter "s". ## Overview: RetCam Envision The RetCam Envision system is a contact type wide-field fundus ophthalmic imaging system used for general ophthalmic imaging including retinal, corneal, and external imaging. Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants. ## Operating Principle of the RetCam Envision A fundus camera comprised of handpiece, detachable lens piece, LED light sources, control panel, footswitch and application software running on a PC are used to acquire still images and video of the eye. The LED light is used to illuminate the retina uniformly and the image is transferred from the handpiece to the PC for display storage, review & transfer. The camera focus and image light intensity as well as the image capture is controlled by the user via a button panel on the cart or a footswitch. Controls are also available via the keyboard mouse and touchscreen. ## RetCam Envision features includes: - . Integrated Wide Field Digital Imaging System - Light weight Handpiece with interchangeable lenses featuring RetCam light shaping . technology - 130 Degree Field Of View (FOV) . - . Brilliant Color, Red Free, and Fluorescein Angiography (FA) imaging capabilities - High Resolution Still Image and Video Capture via console, footswitch or touchscreen . - . Height adjustable system cart with touchscreen display and battery operation - . Integrated, searchable patient database - . Bidirectional DICOM interface # System Setup Overview {5}------------------------------------------------ ## 510(k): K203500 RETCAM ENVISION Image /page/5/Picture/1 description: The image shows the logo for Natus Medical Incorporated. The logo is in a teal color and features the word "natus" in a bold, sans-serif font. A registered trademark symbol is located to the right of the "s" in "natus." The RetCam Envision Cart, Light Sources, Camera Handpiece, Lenses, Control pan Footswitch operate in conjunction with the RetCam 7 Software running on an onboard PC to enable the capture, review, annotation, storage, and transfer of images and video of the eye and it' The LED light source provides illumination of the eye via the camera (handpiece and lenspiece). Still and video images are transmitted from the handpiece to the onboard PC for display on the monitor and storage on the PC. Image focus, illumination intensity and image/video capture are controlled by the user using either the buttons on the cart top control panel or via the footswitch. The user selects the white LED light source for color imaging and the blue LED light source for imaging during Fluorescein Angiography. The user interacts with the RetCam software to enter or select patient demographics, start exams, capture images and video, review and select images for storage, exporting and transfer via bidirectional DICOM communication. The RetCam Envision display monitor is a touchscreen. Image /page/5/Picture/5 description: The image shows a Natus RetCam Envision device, which is a medical imaging system used for pediatric ophthalmology. The device is mounted on a mobile cart with wheels and features a large display screen at the top, which shows a retinal image. Below the screen is a control panel with various buttons and a trackpad, and the base of the cart has foot pedals for hands-free operation. The device is white with teal accents. {6}------------------------------------------------ ### Device-patient interaction Accessories List: The RetCam Envision is a contact type wide field fundus ophthalmic imaging system. The lens piece concave tip is held over the eye which is covered in a transparent coupling gel. The lens tip is held in the gel so that there is no air gap between the lens tip and the eye to ensure no distortion of light or image capture. The RetCam Envision User Manual provides detailed instructions on the thorough cleaning and high level disinfection of the detachable lenses. The Lenspiece is the only part of the device that may come in contact with the patient. Image /page/6/Picture/5 description: The image shows a close-up of a blue and silver device. The device has a cylindrical shape with a silver tip. There is a silver band around the blue part of the device with the letters "LP1" visible on it. The background is a dark gray color. ## Indications for Use General ophthalmic imaging including retinal, corneal, and external imaging. - Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). . - . Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants. ### *References: 1. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4):471-479. 2. Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003: 121(12):1684-1694. ## Comparison to Predicate Device {7}------------------------------------------------ # 510(к): K203500 RETCAM ENVISION | Feature | Subject Device<br>RetCam Envision | PREDICATE DEVICE<br>RetCam Ophthalmic<br>Imaging Systems<br>(K182263) | Similarities or<br>Differences | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Indications for<br>Use | General ophthalmic<br>imaging including<br>retinal, corneal, and<br>external imaging.<br>Photodocumentation of<br>pediatric ocular<br>diseases including<br>retinopathy of<br>prematurity (ROP)<br>Screening for Type 2<br>pre-threshold<br>retinopathy of<br>Prematurity (ROP)<br>(zone1, stage 1 or 2,<br>without plus disease, or<br>zone 2 stage 3 without<br>plus disease) or<br>treatmentrequiring<br>ROP, defined as Type<br>1 ROP (zone 1, any<br>stage, with plus<br>disease; zone 1, stage<br>3 without plus disease;<br>or zone 2, stage 2 or 3,<br>with plus disease) or<br>threshold ROP (at least<br>5 contiguous or 8 non-<br>contiguous clock hours<br>of stage 3 in zone 1 or<br>2, with plus disease)* in<br>35-37 week<br>postmenstrual infants. | General ophthalmic<br>imaging including retinal,<br>corneal, and external<br>imaging.<br>Photodocumentation of<br>pediatric ocular diseases<br>including retinopathy of<br>prematurity (ROP)<br>Screening for Type 2<br>pre-threshold retinopathy<br>of Prematurity (ROP)<br>(zone1, stage 1 or 2,<br>without plus disease, or<br>zone 2 stage 3 without<br>plus disease) or<br>treatmentrequiring ROP,<br>defined as Type 1 ROP<br>(zone 1, any stage, with<br>plus disease; zone 1,<br>stage 3 without plus<br>disease; or zone 2,<br>stage 2 or 3, with plus<br>disease) or threshold<br>ROP (at least 5<br>contiguous or 8 non-<br>contiguous clock hours<br>of stage 3 in zone 1 or 2,<br>with plus disease)* in 35-<br>37 week postmenstrual<br>infants. | Identical | | Feature | Subject Device | PREDICATE DEVICE | Similarities or<br>Differences | | | RetCam Envision | RetCam Ophthalmic<br>Imaging Systems<br>(K182263) | | | Principle of<br>Operation | Digital camera in a<br>handpiece with multiple<br>field of view lenses<br>used to capture color<br>ophthalmic images. | Digital camera in a<br>handpiece with multiple<br>field of view lenses used<br>to capture color<br>ophthalmic images. | On board computer<br>only | | | An on board computer<br>is used to store, view,<br>retrieve, and export the<br>digital ophthalmic<br>images. | An on board computer<br>(RetCam 3) or laptop<br>computer (RetCam<br>Shuttle and RetCam<br>Portable) is used to<br>store, view, retrieve, and<br>export the digital | Light source<br>replaced with LED. | | | A White or RGB, and<br>Blue LED light source<br>is used in all RetCam<br>configurations to<br>provide illumination to<br>the eye through the<br>handpiece. | ophthalmic images.<br>A standard Halogen light<br>source is used in all<br>RetCam configurations<br>to provide illumination to<br>the eye through the<br>handpiece. | Light safety meets<br>requirements of ISO<br>15004-2:2007 and<br>ANSI Z80.36:2016 | | Technological Characteristics | | | | | Imaging Options | Color, Red Free, Black<br>& White | Color, Red Free, Black &<br>White | Same | | Eye contact<br>materials | Biocompatible, coated<br>glass | Biocompatible, coated<br>glass | Identical eye<br>contact material | | Lenses | Coated glass with 130<br>degree common fields<br>of view | Coated glass with 130,<br>120, 80, 30 degree<br>common fields of view<br>lens options) | Same lens<br>materials and max<br>(130 Deg) Field of<br>view. | | Portrait lens (for<br>external non-<br>contact imaging | Yes | Yes | Same | | Detachable<br>Lenses | Detachable and<br>Interchangeable | Detachable and<br>Interchangeable | Same | | Feature | Subject Device<br>RetCam Envision | PREDICATE DEVICE<br>RetCam Ophthalmic<br>Imaging Systems<br>(K182263) | Similarities or<br>Differences | | Lens Disinfection<br>Type | Supports High Level<br>Disinfection | Supports High Level<br>Disinfection | Same | | Handpiece &<br>Lens | Handpiece 0.8 lbs<br>Lens 0.2 lbs<br>Combined 1 lbs<br>(excluding cable<br>weight). | Combined Handpiece<br>and lens weight 2.7 lbs<br>(Excluding cable) | Lighter, improved<br>over predicate. | | Camera Specifications | | | | | Camera sensor<br>type | 3 CMOS Chip, Color | 1 CMOS Chip; color | Similar with<br>improved<br>technology over<br>predicate | | Effective<br>Pixels/Resolution | 1920x1080 pixels<br>Scaled to 4:3 780x600<br>pixels<br>Video: 30 frames per<br>second | 1600x1200 pixels<br>Scaled to 4:3 780x600<br>pixels<br>Video: 14 frames per<br>second | Same resulting<br>image size 780x600<br>improved<br>technology over<br>predicate | | Interface<br>connection to the<br>RetCam<br>computer | USB 3 | USB 3 | Same as predicate | | Ambient<br>operating<br>temperature | 50° F to 95° F (10° C<br>to 35° C) | 0-50°C/32-122 °F | | | Image sensor<br>height | 1/2.9" 2.1MP | 1/2" | Similar | | RETCAM ENVISION | | | | | Feature | Subject Device<br>RetCam Envision | PREDICATE DEVICE<br>RetCam Ophthalmic<br>Imaging Systems<br>(K182263) | Similarities or<br>Differences | | Required power | Ratings: 100-240 V~<br>50/60 Hz, 400 VA<br>Fuses: 3AG 6.3A 250V<br>slo-blo 5 x 20 mm<br>Power consumption:<br>400 W maximum with<br>all options<br>Detachable hospital-<br>grade power cord | 100-<br>2******************40V<br>50/60Hz | | | Light Source | White, and Blue LED | White and Blue Halogen | Improvement over<br>predicate, complies<br>with ISO and ANSI<br>safety standards | | System Cart | Height adjustable<br>Includes integrated<br>device controls | Fixed height<br>Includes integrated<br>device controls | Improved over<br>predicate | | Foot switch for<br>focus, brightness<br>and image<br>capture | Yes | Yes | Identical | | DICOM | Yes | Yes | Same | | Backup Battery | Lithium Ion | Lead Acid | Improved<br>technology | {8}------------------------------------------------ # 510(к): K203500 RETCAM ENVISION {9}------------------------------------------------ {10}------------------------------------------------ The RetCam Envision System and the predicate device RetCam Opthamlic Imaging System are equivalent in features and technical characteristics. There are no major differences that significantly alter the intended use or raise new issues of safety or effectiveness. {11}------------------------------------------------ # Brief Summary of Performance Testing Image /page/11/Picture/2 description: The image shows the word "natus" in a teal sans-serif font. The letters are closely spaced and have rounded edges. A small registered trademark symbol is located to the right of the letter "s". | Electrical Safety | The RetCam Envision was verified for performance in accordance with the following standard:<br>• IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, and IEC 62366: 2007, Am1: 2014, Medical devices - Application of usability engineering to medical devices | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electromagnetic<br>Compatibility | The RetCam Envision was verified for performance in accordance with the following standard:<br>• IEC 60601-1-2 Edition4.0: 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests. | | Packaging and<br>Handling Verification | The packaged Natus RetCam Envision components have successfully passed packaging and handling verification per ISTA-2B: Packaged Products weighing over 150 lbs (68 kg). | | Performance Testing<br>– Bench Verification<br>& Validation | The Natus RetCam Envision has successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level.<br>The Bench testing verification and validation was performed to confirm Device meets the functional and performance characteristics.<br>Additionally, the modified/subject RetCam Ophthalmic Imaging Systems have been tested internally and met defined acceptance criteria. The tests included:<br>• Image Comparison Test<br>• Optics verification and Validation Test<br>• Software Test<br>• Mechanical design Test<br>• Light Safety Test<br>• EMC and Electrical Safety Test<br>• Biocompatability Test<br>• Packaging ISTA Test | Results indicate that the RetCam Envision system complies with its predetermined specifications and the applicable standards. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is horizontally oriented. A registered trademark symbol is located to the right of the letter "s". ## Conclusions The substantial equivalence of the RetCam Envision with RetCam 3 (K182263) was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the RetCam Envision is similar to that of the predicate device(s). Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the RetCam Envision is as safe, as effective, and performs as well as or better than the predicate device.