(136 days)
No
The document describes standard image acquisition, storage, management, processing, and display functions, with no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an "ophthalmic software system indicated for acquiring, storing, managing, and display patient, diagnostic and image data" and "for review of patient, diagnostic and image data and measurement." It performs data management and display functions, but there is no indication that it is used for treatment, therapy, or diagnosis itself.
Yes
The "Intended Use / Indications for Use" section states that the device is indicated for acquiring, storing, managing, and displaying "patient, diagnostic and image data." It also indicates "review of patient, diagnostic and image data and measurement by trained healthcare professional," which implies processing data for diagnostic purposes.
Yes
The device description explicitly states that the imageSPECTRUM V6 "consists of three software" components and describes its functions solely in terms of software operations (acquiring, storing, managing, processing, displaying, reviewing, transferring, archiving data). While it interacts with Canon digital retinal cameras, the device itself is presented as a software system.
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 imageSPECTRUM V6 is an ophthalmic software system that works with digital retinal cameras to acquire, store, manage, and display images of the retina. It is used for review and measurement by healthcare professionals.
- Lack of biological sample analysis: The device does not analyze biological samples from the patient. It processes and manages images obtained from a camera.
Therefore, the imageSPECTRUM V6 falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
The imageSPECTRUM V6 is an ophthalmic imaging software for acquiring, storing, managing, processing and displaying patient, diagnostic and image data from Canon digital retinal cameras. The imageSPECTRUM V6 consists of three software; iS Capture. iS Review, and iS Server. The "iS Capture" has functions to communicate with Canon's retinal camera to take retinal images. The "iS Review" has functions for displaying, processing, and transferring retinal images. The "iS Server" has functions for storing and archiving retinal images.
The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital retinal cameras
Anatomical Site
Retina, human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professional
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)
Software verification and validation was performed to ensure that the software device performed as intended.
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.
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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September 25, 2020
Image /page/0/Picture/1 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' in blue, with 'ADMINISTRATION' written below in a smaller font.
Ryan Bouchard, Official Correspondent o/b/o Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, Kanagawa 211-8501 Japan
Re: K201273
Trade/Device Name: ImageSPECTRUM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ Dated: July 31, 2020 Received: August 5, 2020
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. 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 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) for
1
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 (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 Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201273
Device Name imageSPECTRUM V6
Indications for Use (Describe)
The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.
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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3
510(k) Summary
Submitter Canon Inc. 9-1, Imaikami-cho, Nakahara-ku, Kawasaki Kanagawa 211-8501 Japan
Contact person Mr. Akira Hirai Canon Inc. Medical Components Group TEL: 81-3-3758-2111 FAX: 81-44-739-6695 Email: hirai.akira@mail.canon
Date prepared July 29, 2020
Submission type Traditional 510(k)
Name of Device Trade Name: imageSPECTRUM V6 Common Name: Picture archiving and communications systems. Classification Name: System, Image Management, Ophthalmic Classification Regulation: 892.2050 Product Code: NFJ
Predicate Device Ophthalmic Software Platform RX (K173689)
Reference Device CR-2 Plus AF (K123208)
Device Description
The imageSPECTRUM V6 is an ophthalmic imaging software for acquiring, storing, managing, processing and displaying patient, diagnostic and image data from Canon digital retinal cameras. The imageSPECTRUM V6 consists of three software; iS Capture. iS Review, and iS Server. The "iS Capture" has functions to communicate with Canon's retinal camera to take retinal images. The "iS Review" has functions for displaying, processing, and transferring retinal images. The "iS Server" has functions for storing and archiving retinal images.
The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.
4
Statement of Substantial Equivalence
Canon Inc.'s imageSPECTRUM V6 is substantially equivalent to Canon Inc.'s Ophthalmic Software Platform RX cleared in K173689 and the reference device, Canon Inc.'s CR-2 PLUSAF cleared in K123208. imageSPECTRUM V6 has the same intended use and similar indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device. See Table 1 for a substantial equivalence chart comparing the similarities and differences between imageSPECTRUM V6 and the predicate and reference. Thus, imageSPECTRUM V6 is substantially equivalent to its predicates.
| Proposed Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Model | imageSPECTRUM V6 | |||
| (iS Review V6.0, | ||||
| iS Capture V6.0, | ||||
| iS Server V6.0) | Ophthalmic Software | |||
| Platform RX | ||||
| (RX Capture for Retinal | ||||
| Camera, RX Server, RX | ||||
| Viewer) | CR-2 PLUSAF | |||
| (Retinal imaging control | ||||
| software) | ||||
| 510(k) Submitter | ||||
| [Number] | Canon Inc. | |||
| [K201273] | Canon Inc. | |||
| [K173689] | Canon Inc. | |||
| [K123208] | ||||
| Product Code and | ||||
| Classification | NFJ | |||
| 21CFR 892.2050 | NFJ | |||
| 21CFR 892.2050 | HKI | |||
| 21CFR 886.1120 | ||||
| Indications for Use | imageSPECTRUM V6 is an | |||
| ophthalmic software system | ||||
| indicated for acquiring, | ||||
| storing, managing, | ||||
| processing, and display of | ||||
| patient, diagnostic and | ||||
| image data from Canon | ||||
| digital retinal cameras. It is | ||||
| also indicated for review of | ||||
| patient, diagnostic and | ||||
| image data and | ||||
| measurement by trained | ||||
| healthcare professional. | The Ophthalmic | |||
| Software Platform RX | ||||
| is an ophthalmic | ||||
| software system | ||||
| indicated for acquiring, | ||||
| storing, managing, | ||||
| processing, and display | ||||
| of patient, diagnostic | ||||
| and image data from | ||||
| Canon digital retinal | ||||
| cameras. It is also | ||||
| indicated for review of | ||||
| patient, diagnostic and | ||||
| image data and | ||||
| measurement by trained | ||||
| healthcare professional. | The Digital Retinal Camera | |||
| CR-2 Plus AF is intended | ||||
| to be used for taking digital | ||||
| images of the retina of the | ||||
| human eye without a | ||||
| mydriatic. The CR-2 Plus | ||||
| AF has the following | ||||
| photography modes: color, | ||||
| red free, cobalt digital and | ||||
| fundus autofluorescence | ||||
| (FAF). | ||||
| User Management | Supported | Supported | Supported | |
| Patient Management | Supported | |||
| Backup (Archive) | ||||
| Restoration | Supported | |||
| Backup | ||||
| Restoration | Supported | |||
| Backup | ||||
| Restoration | ||||
| Devices that are compatible | Canon's retinal cameras | |||
| (CR-2 Plus AF) | Canon's retinal cameras | |||
| (CR-2 AF, CR-2 Plus | ||||
| AF, CX-1) | Canon's retinal cameras | |||
| (CR-2 Plus AF) | ||||
| Type of Retinal Camera | ||||
| image | Color, FA, FAF | Color, FA, FAF | Color, FA, FAF | |
| Capture | ||||
| Function | Communication | |||
| with retinal | ||||
| camera's | ||||
| firmware | Supported | - | Supported | |
| Capture | ||||
| Sequence | Supported | - | Supported | |
| Proposed Device | Predicate Device | Reference Device | ||
| Auto Exposure | ||||
| Control | Supported | - | Supported | |
| Auto Focus | ||||
| Control | Supported | - | Supported | |
| Auto Shot | ||||
| Control | Supported | - | Supported | |
| View Image | Single View | Single View | Single View | |
| Comparison | Both Eyes | Both Eyes | ||
| Comparison | Comparison | Comparison | ||
| Drawing Function | Supported | Supported | Supported | |
| Image Processing | Brightness | Brightness | Brightness | |
| Contrast | Contrast | Contrast | ||
| Zoom | Zoom | Zoom | ||
| RGB Filters | RGB Filters | RGB Filters | ||
| Redfree | Redfree | Redfree | ||
| Emboss | Emboss | - | ||
| Mosaic(optional) | Mosaic(optional) | Mosaic(optional) | ||
| Overlay | Overlay | - | ||
| Annotation | Drawing Function | Drawing Function | - | |
| Add text on the image | Add text on the image | - | ||
| Cup to Disc | Cup to Disc | Cup to Disc | ||
| Macular Grid | - | - | ||
| PDT Marker | - | - | ||
| PDT Counter | - | - | ||
| AVR | - | - | ||
| Protractor | - | - | ||
| Standalone Configuration | Supported | Supported | Unsupported | |
| Server Client Configuration | Supported | Supported | Unsupported | |
| DICOM Communication | Modality Worklist | Modality Worklist | Modality Worklist | |
| DICOM Storage | DICOM Storage | DICOM Storage | ||
| Commitment | Commitment | Commitment | ||
| - | MPPS | MPPS | ||
| STEREO Viewing | Supported | Supported | Supported | |
| Printing Image | Supported | Supported | Supported | |
| Software requirements | Microsoft Windows 10 | |||
| Pro(64-bit) | Microsoft Windows 10 | |||
| Pro(64-bit) | Microsoft Windows 7 | |||
| Professional SP1(32-bit/64- | ||||
| bit) | ||||
| Hardware requirements | CPU: Core-i7 2GHz or | |||
| Greater, | ||||
| RAM: 4GB or more, | ||||
| Display Screen resolution: | ||||
| 1920x1080 | CPU: Core i3 2.4GHz | |||
| or Greater, | ||||
| RAM: 4G or More, | ||||
| Display: 1920x1080 | ||||
| pixels | CPU: Core 2 Duo 2.4 GHz | |||
| or higher, | ||||
| RAM: 2GB or more | ||||
| Display: Screen | ||||
| resolution(1280x800pixel) | ||||
| or higher, | ||||
| Hard disk: 7,200 rpm or | ||||
| higher | ||||
| Viewing Reports by Multiple | ||||
| Users | Supported | Supported | Unsupported |
Table 1 imageSPECTRUM V6 Substantial Equivalence Table
5
Summary of Differences
The differences between the proposed device and the predicate and reference devices are summarized below along with the possible effects these differences may have on safety and efficacy. For all items where either the predicate device or the reference device has a matching
6
function, no safety or efficacy questions are raised. The items which are unique to the proposed device are listed below:
Annotation: The Annotation tools can be used to label (i.e., with text), measure or bring attention to a specific area in an image. Annotation tools are present in the predicate and reference device however additional annotation tools have been added to the proposed device.
The annotation tools that have been added to the proposed device are Macular Grid, PDT Marker, PDT Counter, AVR, and Protractor.
- Macular Grid: Overlays a grid over the macula. ●
- PDT Marker: This tool allows the user to circumscribe a PDT lesion, recording inner and ● outer diameters, as well as square area.
- PDT Counter: This tool is used to size and count various lesions.
- A VR: Provides a tool to measure artery and vein diameters. Reports multiple artery to vein ratios.
- Protractor: Creates a protractor graphic on the image for easy measurement purposes. ●
The tools provided are to aid in viewing and measuring features within the image. There are no safety or efficacy questions raised by any of these tools. Instructions for the use of the tools are provided in the User Manual.
Performance Data
Software verification and validation was performed to ensure that the software device performed as intended.
Conclusion
Canon concluded that the Canon imageSPECTRUM V6 is substantially equivalent to the predicate devices based on identical intended use and substantially equivalent technological characteristics and the similarities in functional design.