(84 days)
Not Found.
No
The summary describes standard image acquisition, storage, management, processing, and display software. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The processing mentioned appears to be standard image manipulation rather than AI/ML-driven analysis.
No
The device is described as an ophthalmic software system for acquiring, storing, managing, processing, and displaying patient, diagnostic, and image data from retinal cameras. It does not mention any therapeutic function or intervention.
No
Explanation: The device is described as an ophthalmic software system for acquiring, storing, managing, processing, and displaying patient, diagnostic, and image data. While it handles "diagnostic data," its primary function is data management and display from retinal cameras, not directly making diagnoses.
Yes
The device description explicitly states it is an "ophthalmic software system" and details three software components (RX Capture, RX Server, RX Viewer) that perform the described functions. While it interacts with retinal cameras, the device itself is presented as the software platform for managing and processing the data from those cameras.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Ophthalmic Software Platform RX acquires, stores, manages, processes, and displays images of the eye from retinal cameras. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for handling image data from retinal cameras, not for analyzing biological specimens.
Therefore, while it's a medical device used in ophthalmology, it falls under the category of imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic retinal cameras.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.
The Ophthalmic Software Platform RX consists of three types of software including the RX Capture for Retinal Camera, RX Server and RX Viewer.
RX Capture for Retinal Camera software
This is a software executed on a Capture PC. This software acquires images from a retinal camera that the control software captures and puts on the Capture PC. This software acquires images of eye, stores images and processes images. Also, this software displays acquired and processed images which are stored in a Server's database.
RX Viewer software
This is a software executed on a Viewer PC. This software processes images and displays acquired and processed images which are stored on the RX Capture for Retinal Camera or RX Server's database.
RX Server software
This is a software executed on a Viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in its' own database.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Image data from Canon's mydriatic and non-mydriatic retinal cameras.
Anatomical Site
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)
Not Found.
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.
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 23, 2018
Canon Inc. - Medical Equipment Group % Ryan Bouchard Director Medical Devices Ora, Inc. 300 Brickstone Square Andover, MA 01810
Re: K173689
Trade/Device Name: Ophthalmic Software Platform RX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: December 21, 2017 Received: December 26, 2017
Dear Ryan Bouchard:
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.
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
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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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
510(k) Number (if known)
Device Name Ophthalmic Software Platform RX
Indications for Use (Describe)
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic retinal cameras.
| 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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510(k) SUMMARY
This summary of the 510(k) premarket notification for the Canon Ophthalmic Software Platform RX is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
a. Owner Company name, address
Canon Inc. Medical Equipment Group 9-1, Imaikami-cho Nakahara-ku, Kawasaki Kanagawa 211-8501 Japan
Contact person: Shinji Mori Manager Phone: 011-81-3-3758-2111 Fax: 011-81-44-739-6493 mori.shinji@canon.co.jp Email:
b. Contact/Application Correspondent
Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com
c. Date Prepared
February 23, 2018
d. Name of Device
Ophthalmic Software Platform RX Trade Name: Common Name: System, Image Management, Ophthalmic Picture archiving and communication systems Classification Name: Classification Regulation:21 CFR 892.2050
e. Predicate Devices
The Ophthalmic Software Platform RX is substantially equivalent to the Topcon IMAGEnet 5 PC Software System (K132438).
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f. Device Description
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.
The Ophthalmic Software Platform RX consists of three types of software including the RX Capture for Retinal Camera, RX Server and RX Viewer.
RX Capture for Retinal Camera software
This is a software executed on a Capture PC. This software acquires images from a retinal camera that the control software captures and puts on the Capture PC. This software acquires images of eye, stores images and processes images. Also, this software displays acquired and processed images which are stored in a Server's database.
RX Viewer software
This is a software executed on a Viewer PC. This software processes images and displays acquired and processed images which are stored on the RX Capture for Retinal Camera or RX Server's database.
RX Server software
This is a software executed on a Viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in its' own database.
g. Indications for Use
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.
h. Statement of Substantial Equivalence
Canon's Ophthalmic Software Platform RX is substantially equivalent to the IMAGEnet 5 cleared in K132438. As explained in more detail below, the Ophthalmic Software Platform RX has the same intended use and similar indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device.
The Ophthalmic Software Platform RX has an intended use, which is the same as the predicate device. Both the Ophthalmic Software Platform RX and the predicate device are indicated for acquisition, storage and
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management of digital images, patient data and diagnostic data from computerized diagnostic instruments.
The Ophthalmic Software Platform RX and the predicate device are both ophthalmic picture archiving and communications systems that collect, store, and manage digital images of the eye. Both the Ophthalmic Software Platform RX and the predicate device can be used with both mydriatic and non-mydriatic retinal cameras. Both software devices support color, FA and FAF images while IMAGEnet 5 also supports ICG images. This minor difference between the devices does not impact the safety or effectiveness of the Ophthalmic Software Platform RX.
The minor differences between the subject device and the predicate devices do not raise new questions of safety or effectiveness. The Ophthalmic Software Platform RX is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.
i. Software Verification and Validation
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
j. Conclusions
Canon's Ophthalmic Software Platform RX is as safe and effective as the previously cleared IMAGEnet 5 (K132438). The Ophthalmic Software Platform RX has the same intended use and similar indications for use. similar principles of operation, and similar technological characteristics as the previously cleared predicate device and is therefore substantially equivalent.