(205 days)
RetCam 3 K102859
No
The summary describes a standard ophthalmic imaging device and its hardware and software for image capture and storage. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as an "imaging device" used for "general ophthalmic imaging" and captures "video or still images." Its purpose is diagnostic imaging, not therapeutic intervention.
No
The device is an imaging device used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. Its purpose is to capture and store images, not to provide a diagnosis or aid in diagnosis by analyzing the images. The performance studies focus on image quality and safety, not diagnostic accuracy.
No
The device description explicitly states it 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." This clearly indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: The Phoenix Clinical ICON is an imaging device that captures images of the eye's structures (retina, cornea, external structures) in vivo (within the living body). It does not analyze biological specimens in vitro.
- Intended Use: The intended use is for "General ophthalmic imaging," which is a diagnostic imaging procedure performed directly on the patient.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
Therefore, the Phoenix Clinical ICON falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
General ophthalmic imaging including retinal, corneal, and external structures of the eye.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal, corneal, and external structures of the eye.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RetCam 3 K102859
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they also resemble a bird-like shape.
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.
1
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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 Drive
Pleasanton, CA 94588 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Christopher Henderson
Director of QA and RA
Phone: (925) 462-5000 x204
Facsimile: (925) 485-1155
E-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:
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.
4
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 | ||||
|---|---|---|---|---|
| Imaging | ||||
| Format | .TIF/.JPEG/.AVI/.BMP | .TIF/.JPEG/.AVI/.BMP | .TIF/.JPEG/.AVI | .TIF/.JPEG/.AVI |
| Imaging | ||||
| 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 |
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.
6
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