The Phoenix Clinical ICON is a battery and AC-powered, cart-based, non-sterile, wide-field, handheld, high resolution, real-time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix Clinical ICON are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The Phoenix Clinical ICON may be used in hospitals, medical clinics, and physician's offices. The Phoenix Clinical ICON is a system comprised of a hand-held camera with an interchangeable LED based light source incorporated into the hand piece that is attached to the cart contains the battery, the keyboard controls, monitor, attached foot pedal, and computer with software. The hand piece is designed such that the glass lens in the tip will come into contact with the cornea. LED light is emitted into the eye to illuminate the retina for image capture. The Phoenix ICON is operated by attaching the appropriate module (white or blue LED) to the handpiece and, after the software is running, placing the camera lens in direct contact with the patient's cornea. The Phoenix Clinical ICON software can capture either video or still images and store them on the cart computer for later review. The Phoenix Clinical ICON may be connected to, under IT supervision, IT networks.

AI/ML Overview

The Phoenix Clinical ICON device is compared to a predicate device (RetCam 3 K102859) to establish substantial equivalence for general ophthalmic imaging. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria (Predicate Device K102859)	Reported Device Performance (Phoenix Clinical ICON K170527)
Intended Use	General ophthalmic imaging including retinal, corneal, and external structures of the eye.	General ophthalmic imaging including retinal, corneal, and external structures of the eye.
Observation Light Source Type, Wavelength (White Light)	White light LED	10W White light LED, 450-675nm
Observation Light Source Type, Wavelength (FA Module)	Blue light LED	10W Blue light LED, 450-460nm
Maximum Light Source Output Power (White Light)	21 mW/cm^2	6.1 mW/cm^2
Maximum Light Source Output Power (FA Module)	85 mW/cm^2	28 mW/cm^2
Light Intensity Control	Zero to maximum	Zero to maximum
External Fixation Light	None	None
Field of View	30 to 130 degrees	100 degrees
Resolution	Varies with lens between 13 microns and 47 microns	Single lens at 12 microns
Frame Rate	30 frames per second	30 frames per second
Insert Filter (White Light)	No insert filter needed.	No insert filter needed.
Insert Filter (FA Module)	Change light source at cart and remove objective lens and insert yellow barrier filter, filters >510nm	Use blue LED module and flip filter on hand piece, barrier filter blocking band 500nm, edge wavelength 515nm
Imaging Lens	Flat field inserted	Flat field external camera
Eye Contact Materials	Goniosol or GenTeal	Goniosol or GenTeal
Imaging Format	.TIF/.JPEG/.AVI/.BMP	.TIF/.JPEG/.AVI
Light Safety	Compliant with relevant standards (Implied)	Compliant with ISO 15004-2:2007 Group 2 instrument requirements.
Image Quality	Equivalent to predicate based on clinical panel and resolution (Implied)	Supportive of substantial equivalence to the predicate device.
Retinal Coverage	Entire retina can be imaged with multiple images. (Implied for predicate)	Can very adequately cover the retina with six images.

2. Sample Size Used for the Test Set and Data Provenance:

The document doesn't explicitly state the sample size for the test set in terms of cases or patients. However, it mentions that "images from the predicate device and the ICON were presented to a panel." This suggests that the test set consisted of images from both devices.

The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. It appears that images were acquired from both the predicate device and the ICON for comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Number of Experts: Five
Qualifications: "Five clinicians" were used for the comparison of image quality. Specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "clinicians."

4. Adjudication Method for the Test Set:

The document describes that the "images from the predicate device and the ICON were presented to a panel of five clinicians for comparison in four parameters of image quality." This implies a consensus or comparative evaluation method, but no specific adjudication method like 2+1 or 3+1 is mentioned. It seems to be a qualitative comparison by a panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A formal MRMC comparative effectiveness study, designed to quantify the improvement of human readers with AI vs. without AI assistance, was not performed. The study involved a panel of clinicians qualitatively comparing images from the new device and the predicate device. There is no AI component mentioned in the context of assisting human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone algorithm performance study was not performed. The device, Phoenix Clinical ICON, is an ophthalmic camera for image acquisition, not an AI-powered diagnostic algorithm. The testing focused on the device's ability to capture images with comparable quality and safety to a predicate device.

7. Type of Ground Truth Used:

For establishing image quality equivalence, the ground truth was based on:

Expert Consensus/Qualitative Comparison: A "panel of five clinicians" compared images from both devices in terms of image quality.
Bench Performance Metrics: ISO standards (ISO 10940:2009 for image quality and ISO 15004-2:2007 for light safety) and objective metrics like "vascular edges as a resolution target" and use of the "NIH analytical tool ImageJ" were used. This suggests a blend of objective measurements and expert assessment.

8. Sample Size for the Training Set:

The document does not mention any "training set." This device is an imaging system, not an AI/ML algorithm that would typically require a training set. The evaluation is for hardware performance and image capture capabilities.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2017

Phoenix Technology Group, Inc. Dba Phoenix Clinical Christopher A. Henderson Director of Regulatory Affairs and Ouality Assurance 6630 Owens Drive Pleasanton, CA 94588

Re: K170527

Trade/Device Name: Phoenix Clinical Icon Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: August 15, 2017 Received: August 16, 2017

Dear Christopher A. Henderson:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bradley S. Cunningham -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170527

Device Name Phoenix Clinical ICON

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"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."

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TECHNOLOGY GROUP

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92 510(k).

Applicant:	Phoenix Technology Group, Inc.6630 Owens DrivePleasanton, CA 94588
Contact Person	Christopher HendersonDirector of QA and RAPhone: (925) 462-5000 x204Facsimile: (925) 485-1155E-Mail: chenderson@phoenixtechnologygroup.com
Date Prepared:	September 13, 2017
Trade Name(s):	Phoenix Clinical ICON, Phoenix ICON
Common Name:	Ophthalmic Imaging System, Retinal Camera, Fundus Camera
Classification:	II
Classification Name(s):	Ophthalmic Camera
Regulation Number:	886.1120
Product Code:	HKI
Classification Panel:	Ophthalmic
Predicate Device(s):	RetCam 3 K102859

General Information

Device Description:

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PHOENIX TECHNOLOGY GROUP

Substantial Equivalence Summary of the ICON and the predicate device:

The design of the Phoenix ICON is substantially equivalent to the design of the predicate device. The methods of action and use are identical and the user functions (handpiece, software, procedure of image obtaining) are all identical in functionality between the ICON and the predicate. The intended use of both devices being "General Ophthalmic Imaging of retinal, corneal, and external structures" is identical. The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, technology, and materials.

Device	K102859(Predicate)		K170527
Features	White Light Module	FA Module	White Light Module	FA Module
Observation Light Source
Light source type, wavelength	White light LED,	Blue light LED	10W White light LED, 450-675nm	10W Blue light LED, 450-460nm
Maximum Light source output power	21 mW/cm^2	85 mW/cm^2	6.1 mW/cm^2	28 mW/cm^2
Light intensity control	Zero to maximum	Zero to maximum	Zero to maximum	Zero to maximum
External fixation light (if any)	none	None	none	none
Camera
Field of View	30 to 130 degrees	30 to 130 degrees	100 degrees	100 degrees
Resolution	Varies with lens between 13 microns and 47 microns	Varies with lens between 13 microns and 47 microns	Single lens at 12 microns	Single lens at 12 microns
Frame Rate	30 frames per second	30 frames per second	30 frames per second	30 frames per second
Other Accessories
Insert filter	No insert filter needed.	Change light source at cart and remove objective lens and insert yellow barrier filter, filters >510nm	No insert filter needed.	Use blue LED module and flip filter on hand piece, barrier filter blocking band 500nm, edge wavelength 515nm
Imaging lens	Flat field inserted	N/A	Flat field external camera	N/A
Eye Contact Materials	Goniosol or GenTeal	Goniosol or GenTeal	Goniosol or GenTeal	Goniosol or GenTeal

Discussion of key technological differences between the ICON and the predicate:

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TECHNOLOGY GROUP

Performance
ImagingFormat	.TIF/.JPEG/.AVI/.BMP	.TIF/.JPEG/.AVI/.BMP	.TIF/.JPEG/.AVI	.TIF/.JPEG/.AVI
ImagingResolution	Varies with lensbetween 13 micronsand 47 microns	Varies with lensbetween 13 micronsand 47 microns	Single lens at 12microns	Single lens at 12microns

There are several key technological differences noted above in the Phoenix Clinical ICON system:

Changes in light sources: Optical radiation hazard evaluation was performed that these changes will not affect the device safety.
Changes in optical system, accessories and imaging: The image quality testing results were supportive of substantial equivalence to the predicate device.
-The predicate device has an LED source that is delivered to the hand piece that is generated on the cart where the application device has the LED source located in the hand piece that allows for the swapping of modules from white light to blue light for fluorescein angiography. This change has no affect in regards to safety or effectiveness and is merely a function of usability.

Indications for Use:

General ophthalmic imaging including retinal, corneal, and external structures of the eye.

Bench Testing Summary:

Testing per ISO 10940:2009:

ISO 10940:2009 - Ophthalmic instruments: fundus cameras was utilized as the first step for validation of substantial equivalence of image quality. The results were supportive of substantial equivalence to the predicate device.

Light safety testing per ISO 15004-2:

The Phoenix Clinical ICON was tested according to 15004-2:2007 to determine acceptable light safety limits for both the white and blue light. The test results demonstrate the ICON is in compliance with the of Group 2 instrument requirements provided by the standard.

Retinal imaging testing compared to predicate device:

Using vascular edges as a resolution target and the NIH analytical tool ImageJ. The images from the predicate device and the ICON were presented to a panel of five clinicians for comparison in four parameters of image quality.

The entire retina can be imaged as a set of multiple images with both cameras. In the figure below it can be seen that the ICON can very adequately cover the retina with six images from the RetCam.

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PHOENIX TECHNOLOGY GROUP

Image /page/6/Figure/2 description: The image shows two diagrams comparing the field of view of two different camera systems. The diagram on the left, labeled "ICON six images", shows six overlapping blue circles within a square grid. The diagram on the right, labeled "RetCam 130 five images", shows five overlapping gray circles within a similar grid. Both diagrams include a dashed red circle encompassing the overlapping circles, and the grids are labeled with degree measurements from -90 to +90.

Angle measured from the center of the eye

The resolution results were supportive of substantial equivalence to the predicate device.

Conclusion:

The bench performance tests and qualitative comparison of the retinal images support our conclusion of substantial equivalence of Phoenix Clinical ICON to the RetCam predicate.

Company Contact:

Christopher Henderson Director of Quality Assurance and Regulatory Affairs Phone: (925) 485-1100 x204 E-Mail: chenderson@phoenixtechnologygroup.com

Regulation Number and Section

§ 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.