(280 days)
General ophthalmic imaging including retinal, corneal, and external structures of the eye.
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.
The provided document does not contain details about specific acceptance criteria for a device's performance in a clinical study or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the NeoLight Phoenix ICON and Phoenix ICON GO ophthalmic cameras, aimed at demonstrating substantial equivalence to a predicate device (K170527, Phoenix ICON by Phoenix Technology Group, LLC).
The document focuses on comparing technological characteristics and safety testing, not on clinical performance acceptance criteria or a study to demonstrate such.
However, based on the Performance Testing section (Table 5.3) related to Simulated Use, it states:
Characteristic: Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images.
Results: Pass.
While this indicates some form of performance assessment related to image quality, it does not provide the specific acceptance criteria (e.g., quantitative metrics, thresholds) or the detailed methodology of the study. It also doesn't present the "reported device performance" in a manner typical for clinical trials (e.g., sensitivity, specificity, or reader agreement scores).
Therefore, a table of acceptance criteria and reported device performance, as well as several other requested details, cannot be fully extracted from the provided text.
Here's an attempt to answer the questions based only on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual quality of captured images is equivalent to predicate device | Passed (Equivalent visual quality of captured images) |
Note: The document only provides a high-level "Pass" result for "Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images." It does not specify quantitative acceptance criteria or detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Simulated Use" testing for "Image Clarity - Comparison between subject and predicate images." However, it does not specify the sample size used for this comparison, nor does it provide any information on data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide any information about the number or qualifications of experts used for establishing ground truth or evaluating image clarity.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the image clarity comparison.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes the device as an "Ophthalmic Camera" for "General ophthalmic imaging." It is a imaging acquisition device and does not include AI functionality. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission, and no such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an ophthalmic camera. Its function is to capture images. It does not appear to incorporate an algorithm that independently processes or interprets images to provide a diagnosis or finding, nor does it claim AI capabilities. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The "Simulated Use" test assesses the visual quality of the captured images, not the performance of an interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Image Clarity" assessment, the implicit "ground truth" was a visual comparison to the predicate device's images to ensure equivalent visual quality. The document does not specify a separate, independent ground truth method like expert consensus on pathology, or outcomes data.
8. The sample size for the training set
The document concerns an ophthalmic camera, not an AI/ML algorithm requiring a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As the device is an ophthalmic camera and not an AI/ML algorithm, there is no training set and therefore no ground truth for a training set.
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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
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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
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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
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Indications for Use
510(k) Number (if known)
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)
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Image /page/4/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 inside the circle appears to be a stylized image of a person or animal in a curled position. 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
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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.
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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) | SubjectPhoenix ICON | SubjectPhoenix ICON Go | Comparison |
|---|---|---|---|---|
| Features | May be used withFluoresceinAngiography | Models sold with orwithout FluoresceinAngiography | Models sold with orwithout FluoresceinAngiography | Identical |
| Light Sources | ||||
| Source | LED | LED | LED | Identical |
| Wavelength | 450-675 nm (white)450-460 nm (blue) | 450-675 nm (white)450-460 nm (blue) | 450-675 nm (white)450-460 nm (blue) | Identical |
| Source Power | 10 W | 10 W | 10 W | Identical |
| MaximumIntensity | 19 mW/cm² (white)20 mW/cm² (blue) | 12 mW/cm² (white)16 mW/cm² (blue) | 12 mW/cm² (white)16 mW/cm² (blue) | Reduced maximum outputpower does not negativelyimpact safety or efficacy |
| IntensityAdjustment | 0-19 mW/cm² (white)0-20 mW/cm² (blue) | 0-12 mW/cm² (white)0-16 mW/cm² (blue) | 0-12 mW/cm² (white)0-16 mW/cm² (blue) | Reduced maximum outputpower does not negativelyimpact safety or efficacy |
| RetinalIrradiance* | 6.6 mW/cm² (white)6.9 mW/cm² (blue) | Group 2 Instrument | Group 2 Instrument | Equivalent |
| ExternalFixation Light | None | None | None | Identical |
| Camera & Lensing | ||||
| CMOS Sensor | Sony IMX265, 1/1.8" | Sony IMX265LLR/LQR,1/1.8" | Sony IMX265LLR/LQR,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(video) | 30 frames per second | 30 frames per second | 30 frames per second | Identical |
| Imaging Lens | Flat field externalcamera (white only) | Flat field externalcamera (white only) | Flat field externalcamera (white only) | Identical |
| Filters | 500 & 515 nm edgeblocking (blue only) | 500 & 515 nm edgeblocking (blue only) | 500 & 515 nm edgeblocking (blue only) | Identical |
| Data Capture | Still or Video Images | Still or Video Images | Still or Video Images | Identical |
| File Format | .TIF.JPEG.AVI.BMP | .TIF.JPEG*.AVI | .TIF.JPEG*.AVI | Removal of obsolete filetype does not negativelyimpact safety or efficacy |
| Data Archive | Archive to InternalDatabaseOrExport to externalsystem via USB orlocal networkconnection | Archive to InternalDatabaseOrExport to externalsystem via USB or localnetwork connection | Archive to InternalDatabaseOrExport to externalsystem via USB or localnetwork connection | Identical |
*Predicate Test Method ISO 15004:2-2007 / Subject Test Method ANSI Z80.36:2021
Table 5.2: Specification Comparison to Predicate Device
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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 ofInternational Standard ISO 10993-1, Biological evaluation of medicaldevices – 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 &Dimensional | Visual and Dimensional inspection to internal specifications | Pass |
| Simulated Use | Image Clarity - Comparison between subject and predicate images toensure equivalent visual quality of the captured images | Pass |
| Light Safety | ANSI Z80.36:2021 | Pass |
| PackagingValidation | 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.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.