(413 days)
K02216
No
The document describes standard digital imaging and archiving capabilities with image processing software, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The focus is on image capture, storage, and display, similar to the predicate device.
No.
This device is an imaging system designed to capture, archive, and display images of the retina, not to provide therapy or treatment.
No
Explanation: The device is described as an "Imaging System" intended to "capture, archive, and display digital images." It acts as an "accessory attachment" to a fundus camera. While it processes images, its stated function does not involve analysis or interpretation of these images to provide a diagnosis or aid in one. Its predicate device also contains "Diagnostic" in its name, however, the device itself is only described to capture, archive, and display images.
No
The device description explicitly states it is an "accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform," indicating it includes hardware components in addition to software.
Based on the provided information, the Fundus Photo Digital Imaging System Model CFD-440 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture, archive, and display digital images of the retina and surrounding areas of the eye." This describes an imaging system for visualizing anatomical structures, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces that it's an "automated imaging device used in conjunction with an ophthalmic fundus camera." It's an accessory for capturing images of the eye itself, not for analyzing biological samples.
- Input: The input is "Digital images acquired by the fundus camera," which are images of the eye, not in vitro samples.
- Anatomical Site: The anatomical site is the "retina and surrounding areas of the eye," which is an in vivo (within the living body) site, not an in vitro (outside the living body) sample.
IVD devices are specifically designed to perform tests on biological specimens to provide diagnostic information. This device is designed to capture images of a living organ.
N/A
Intended Use / Indications for Use
The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive and display digital images of the retina and surrounding areas of the eye.
The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.
Product codes (comma separated list FDA assigned to the subject device)
HKI, NFF, NFG
Device Description
The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera. Thus the Fundus Photo Digital Imaging System Model CFD-440 has the same intended use and indications as the predicate device.
The CFD-440 utilizes a universal adapter design to attach with various fundus camera models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
Anatomical Site
retina and surrounding areas of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Fundus Photo has performed software verification, validation and performance tests. The results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device.
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.
K02216
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.
K090466, K080883, K941234, K980246, K031629, K063717, K041546, K954780
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
Ko93.071
Fundus Photo, LLC
3015 Locust Street * Saint Louis, MO 63103 USA Voice 314.533.6000 * Fax 314.534.6000
510(k) Summary
NOV 1 7 2010
Name of device: Fundus Photo Digital Imaging System Model CFD-440
Common or usual name: Camera, Ophthalmic (AC Powered)
Classification Name: Ophthalmic Camera (per 21 CFR 886.1120)
Product Code: HKI, Subsequent Product Code: NFF, NFG
Submitter: Fundus Photo, LLC 3015 Locust Street Saint Louis, MO 63103 Phone: (314) 406-3600 Facsimile: (314) 534-6000 Contact Person: Dale Brodsky Date Prepared: September 09, 2010
Predicate Device
| Trade Name | Manufacturer | 510 (k) |
|---|---|---|
| Zeta Diagnostic Retinal Imaging System | Zeta Development Laboratories | K02216 |
Intended Use
The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive and display digital images of the retina and surrounding areas of the eye.
1
Fundus Photo, LLC
3015 Locust Street * Saint Louis, MO 63103 USA Voice 314.533.6000 * Fax 314.534.6000
Device Description
The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera. Thus the Fundus Photo Digital Imaging System Model CFD-440 has the same intended use and indications as the predicate device.
The CFD-440 utilizes a universal adapter design to attach with various fundus camera models. The following table illustrates examples of the fundus camera model with corresponding current Canon Digital EOS camera used for each model listed.
| Fundus Camera | Digital Camera Model |
|---|---|
| Name/Model/510(k)# | |
| Canon CR-1 Mark II (K090466) | Canon EOS 50D |
| Canon CR-1 (K080883) | Canon EOS 50D |
| Canon CR5-45NM (K941234) | Canon EOS XSi |
| Canon CR6-45NM (K980246) | Canon EOS XSi |
| Canon CR-DGi (K031629) | Canon EOS 5D Mark II |
| Canon CF-1 (K063717) | Canon EOS 5D Mark II |
| Canon CF-60DSI (K041546) | Canon EOS 5D Mark II |
| Kowa FX-500 (K954780) | Canon EOS 5D Mark II |
Substantial Equivalence
Principles of Operation
The Fundus Photo Digital Imaging System Model CFD-440 and the predicate device have the same intended use: capture, and display digital images of the retina and surrounding areas of the eye. The Fundus Photo Digital Imaging System Model CFD-440 and predicate device have equivalent principles of operation and technological characteristics. Each of the devices is a digital ophthalmic imaging system attached to an FDA-approved fundus camera. The user views the patient's retina through the existing fundus camera or external display. The fundus camera acquires and transfers to the capture camera (film or digital, CMOS or CCD) to display images of the retina and surrounding areas of the eye. These digitized images are then archived for future use and record documentation.
2
Fundus Photo, LLC
3015 Locust Street * Saint Louis, MO 63103 USA Voice 314.533.6000 * Fax 314.534.6000
Hardware
The Fundus Photo Digital Imaging System Model CFD-440 and predicate device are operated by a PC with keyboard and a hand operated mouse. While there may be some minor differences in capture camera devices (film or digital, CMOS or CCD), types of processor (i.e. Intel or AMD), memory and software platform, these minor differences do not raise any new issues of safety or effectiveness.
Software
The Fundus Photo Digital Imaging System Model CFD-440 and the predicate device have the same basic software functions: image capture, display, storage, analysis and retrieval.
The Fundus Photo system has additional features: Daily activity log, gamma and sharpening image control, automatic storage to hard drive of captured images, image enhancement control from the print preview, ability to retrieve deleted patient data and images, export for email, record of the photographer name in addition to the doctor name, support for displaying Adobe, Excel and Word documents and support for network and external hard drive archiving.
Fundus Photo has performed software verification, validation and performance tests. The results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device.
Performance Characteristics
The Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of the following components: digital camera(s), computer, monitor, adapter, cables, instructions for use and image processing software. This complete system provides capture and hardware capabilities used in conjunction with an ophthalmic fundus camera or similar capture device that acquires images of the retina and surrounding areas of the eye. These images are then transferred from the digital camera to the computer system where the images are stored to the hard drive automatically. Images can be viewed, modified, transferred or printed. The Fundus Photo Digital Imaging System Model CFD-440 does not contact the patient.
The Fundus Photo Digital Imaging System Model CFD-440 user software interface allows acquired images from the fundus camera to be captured, displayed, stored and retrieved. Image focus and orientation of the retina and surrounding areas of the eye are controlled with the fundus camera optics by the user in the same manner as when using traditional film camera backs. With verification and monitoring by the user, the software allows the user to monitor the capture process, verifying the device is operating correctly. Images acquired by the fundus camera are then, in turn, captured by the Fundus Photo Digital Imaging System Model CFD-440 and stored automatically
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Fundus Photo, LLC 3015 Locust Street * Saint Louis, MO 63103 USA Voice 314.533.6000 * Fax 314.534.6000
as individual images on the hard drive of the computer to be displayed or recalled electronically as the user requires.
Conclusion
The Fundus Photo Digital Imaging System Model CFD-440 has the same intended use, indications and equivalent principals of operation to the predicate device. The Fundus Photo Digital Imaging System Model CFD-440 has similar technological characteristics (operation, hardware and software) to the predicate device.
The minor differences between the Fundus Photo Digital Imaging System Model CFD-440 product and those of the predicate device do not raise any new questions of safety or effectiveness. Thus, the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the Zeta Diagnostic Retinal Imaging System.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fundus Photo, LLC c/o Mr. Dale Brodsky President 3015 Locust Street Saint Louis, MO 63103
NOV 1 7 2010
Re: K093071
Trade Name: Fundus Photo Digital Imaging System Model CFD-440 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: September 9, 2010 Received: September 13, 2010
Dear Mr. Brodsky:
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debra Fails
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Fundus Photo, LLC 3015 Locust Street * Saint Louis, MO 63103 USA Voice 314.533.6000 * Fax 314.534.6000
...
NOV 1 7 2010
Indications for Use Statement
510(k) Number (if Known)
Device Name: Fundus Photo Ophthalmic Digital Imaging System Model CFD-440
10930
Indications for Use:
The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X Or
Over-the-counter Use
Dexy Sisi
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093071