Phoenix ICON, Phoenix ICON GO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized representation of a human figure. September 21, 2023 NeoLight, LLC Amy Oakes Vice President of Quality & Regulatory Affairs 6630 Owens Drive Pleasanton, California 94588 Re: K223575 Trade/Device Name: Phoenix ICON, Phoenix ICON GO Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dear Amy Oakes: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 6, 2023. Specifically, FDA is updating this SE Letter to correct typographical error in the trade name from "Pheonix" to "Phoenix", as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices (OHT1), 240-402-4662, elvin.ng(@fda.hhs.gov. Sincerely, 2023.09.21 Alexander Beylin -S 17:38:28 -04'00' for Elvin Ng Assistant Director Retina and Diagnostic Devices Team (THT1A3) Division of Ophthalmic Devices (DHT1A) Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices (OHT1) Office of Product Evaluation and Quality (OPEQ) Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 6, 2023 NeoLight, LLC Amy Oakes Vice President of Quality & Regulatory Affairs 6630 Owens Drive Pleasanton, California 94588 Re: K223575 Trade/Device Name: Pheonix ICON, Pheonix ICON GO Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: July 26, 2023 Received: July 27, 2023 Dear Amy Oakes: We have reviewed vour 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 {2}------------------------------------------------ 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 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 medical devices and radiation-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. Ng -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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223575 Device Name Phoenix ICON Phoenix ICON GO Indications for Use (Describe) General ophthalmic imaging including retinal, corneal, and external structures of the eye. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word "neolight" is written in a sans-serif font, with a small star above the "i". # SECTION 5: 510(K) SUMMARY As required by 21 CFR 807.92(c) # Submitter's Name and Address: NeoLight, LLC 6630 Owen Dr Pleasanton, CA 94588 USA ### Contact Name and Information: Amy Oakes Vice President of Quality & Regulatory Affairs Email: amy.oakes@theneolight.com Phone: (480) 304-2165 # Date Prepared: November 23, 2022 #### Device Information: | Trade Name: | Phoenix ICON, Phoenix ICON GO | |--------------------|--------------------------------| | Device: | Camera, Ophthalmic, Ac-Powered | | Review Panel: | Ophthalmic | | Product Code: | HKI | | Regulation Number: | 886.1120 | | Regulatory Class: | 2 | #### Predicate Device: | 510(k) Number | 510(k) Title | Manufacturer | |--------------------------------|--------------|-------------------------------| | K170527 | Phoenix ICON | Phoenix Technology Group, LLC | | Table 5.1: Predicate Device(s) | | | # Table 5.1: Predicate Device(s) #### Manufacturer: NeoLight, LLC 6630 Owen Dr Pleasanton, CA 94588 USA {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for "neolight". The logo consists of a circular icon on the left and the word "neolight" on the right. The icon shows a baby being held in a hand. The word "neolight" is written in a sans-serif font, and there is a star above the "i". ## Device Description: The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system. Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices. The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory. The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture. Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision. ## Indications for Use: General ophthalmic imaging including retinal, corneal, and external structures of the eye. ## Technological Characteristics: The Phoenix ICON and Phoenix ICON GO function on the same technological characteristics as the predicate version of the Phoenix ICON. Electric powered (AC or battery) LED light (white or blue) is directed to the object to be imaged (retina or external eye features) and returned light is captured and saved as an image for review by a trained medical practitioner. K223575 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "neolight". The logo consists of a circular graphic on the left and the word "neolight" on the right. The graphic shows a stylized image of a baby in a circle. The word "neolight" is in a sans-serif font and is a light blue color, with a star above the "i". Table 5.2 below shows the comparison of characteristics between the Predicate and Subject Devices. | Characteristic | Predicate (K170527) | Subject<br>Phoenix ICON | Subject<br>Phoenix ICON Go | Comparison | |-----------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Features | May be used with<br>Fluorescein<br>Angiography | Models sold with or<br>without Fluorescein<br>Angiography | Models sold with or<br>without Fluorescein<br>Angiography | Identical | | <b>Light Sources</b> | | | | | | Source | LED | LED | LED | Identical | | Wavelength | 450-675 nm (white)<br>450-460 nm (blue) | 450-675 nm (white)<br>450-460 nm (blue) | 450-675 nm (white)<br>450-460 nm (blue) | Identical | | Source Power | 10 W | 10 W | 10 W | Identical | | Maximum<br>Intensity | 19 mW/cm² (white)<br>20 mW/cm² (blue) | 12 mW/cm² (white)<br>16 mW/cm² (blue) | 12 mW/cm² (white)<br>16 mW/cm² (blue) | Reduced maximum output<br>power does not negatively<br>impact safety or efficacy | | Intensity<br>Adjustment | 0-19 mW/cm² (white)<br>0-20 mW/cm² (blue) | 0-12 mW/cm² (white)<br>0-16 mW/cm² (blue) | 0-12 mW/cm² (white)<br>0-16 mW/cm² (blue) | Reduced maximum output<br>power does not negatively<br>impact safety or efficacy | | Retinal<br>Irradiance* | 6.6 mW/cm² (white)<br>6.9 mW/cm² (blue) | Group 2 Instrument | Group 2 Instrument | Equivalent | | External<br>Fixation Light | None | None | None | Identical | | <b>Camera &amp; Lensing</b> | | | | | | CMOS Sensor | Sony IMX265, 1/1.8" | Sony IMX265LLR/LQR,<br>1/1.8" | Sony IMX265LLR/LQR,<br>1/1.8" | Similar | | Field of View | 100 degrees | 100 degrees | 100 degrees | Identical | | Resolution | 2048 x 1536 ppi | 2048 x 1544 ppi | 2048 x 1544 ppi | Similar | | Frame Rate<br>(video) | 30 frames per second | 30 frames per second | 30 frames per second | Identical | | Imaging Lens | Flat field external<br>camera (white only) | Flat field external<br>camera (white only) | Flat field external<br>camera (white only) | Identical | | Filters | 500 & 515 nm edge<br>blocking (blue only) | 500 & 515 nm edge<br>blocking (blue only) | 500 & 515 nm edge<br>blocking (blue only) | Identical | | Data Capture | Still or Video Images | Still or Video Images | Still or Video Images | Identical | | File Format | *.TIF<br>*.JPEG<br>*.AVI<br>*.BMP | *.TIF<br>*.JPEG<br>*.AVI | *.TIF<br>*.JPEG<br>*.AVI | Removal of obsolete file<br>type does not negatively<br>impact safety or efficacy | | Data Archive | Archive to Internal<br>Database<br>Or<br>Export to external<br>system via USB or<br>local network<br>connection | Archive to Internal<br>Database<br>Or<br>Export to external<br>system via USB or local<br>network connection | Archive to Internal<br>Database<br>Or<br>Export to external<br>system via USB or local<br>network connection | Identical | *Predicate Test Method ISO 15004:2-2007 / Subject Test Method ANSI Z80.36:2021 Table 5.2: Specification Comparison to Predicate Device {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for "neolight". The logo consists of a circular graphic on the left and the word "neolight" on the right. The graphic shows a stylized image of a baby being held in a hand. The word "neolight" is written in a sans-serif font, and there is a star above the "i" in "neolight". ## Function and Safety Testing: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Phoenix ICON Go. | Characteristic | Standard(s) / Test Method | Results | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Biocompatibility | ISO 10993-1 in conjunction with FDA Guidance Document “Use of<br>International Standard ISO 10993-1, Biological evaluation of medical<br>devices – Part 1: Evaluation and testing within a risk management process” | Pass | | Cleaning Validation | >3 log reduction in active microbials | Pass | | Electrical Safety | IEC 60601-1:2005+A1 | Pass | | | IEC 60601-1-6:2010 (3rd Ed) +A1:2013 | Pass | | | IEC/EN 60601-1-2:2014 (4th Ed) | Pass | | | IEC 62366:2015 | Pass | | Visual &<br>Dimensional | Visual and Dimensional inspection to internal specifications | Pass | | Simulated Use | Image Clarity - Comparison between subject and predicate images to<br>ensure equivalent visual quality of the captured images | Pass | | Light Safety | ANSI Z80.36:2021 | Pass | | Packaging<br>Validation | ASTM D4169-16 | Pass | Table 5.3: Performance Testing ### Conclusion: NeoLight, LLC concludes that the Phoenix ICON and Phoenix ICON GO are substantially equivalent to the predicate device described herein.