(87 days)
Canon non-mydriatic retinal camera CR series (CR-2 plus AF and CR-2 AF) is intended to be used for taking digital images of the retina of the human eye without mydriatic. The CR-2 plus AF has the following photography modes: color, red-free, cobalt digital and fundus autofluorescence (FAF). The CR-2 AF has the following photography modes: color, red-free, cobalt digital and additional infrared photography for anterior segment.
The Canon non-mydriatic retinal camera CR series is composed of two retinal cameras and its control software and is used for taking digital images of a human retina without mydriatic.
Two retinal cameras: The CR-2 Plus AF and CR-2 AF
- Both models take digital photographic retinal images of patient's eyes across an angle of view of 45 degrees, and have autofocus and automatic shooting of retinal image, and automatic switching from anterior segment image to retinal image.
- The CR-2 Plus AF camera is identical to the camera cleared under K123208. The photography mode includes color, red-free, cobalt and fundus autofluorescence (FAF).
- The CR-2 AF camera is modified version of the predicate CR-2 Plus AF (K123208). Most of the specifications are identical to the predicate; however, the photography mode does not include fundus autofluorescence (FAF) photography.
- Both the CR-2 AF and the CR-2 Plus AF uses infrared light to observe the anterior segment, but CR-2 AF can save such an image.
Two Software: Retinal image control software (RICS) and Non-myd RC Capture Utility software (CU) programs - RICS software program supports browsing, processing, and storage function of the images. It also supports the output of the images to the DICOM storage server, export in DICOM or JPEG format and output to a printer.
- CU software program is a simplified version of RICS, without most of the graphic user interface and the database. It allows user to capture and transfer the retinal images from the retinal camera to the PC.
Both RICS and CU software programs are compatible with both CR-2 AF and CR-2 Plus AF cameras.
The provided document, a 510(k) Premarket Notification for the Canon non-mydriatic retinal camera CR series, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for an AI/algorithm-driven diagnostic device.
Therefore, the document does not contain the specific information required to answer many of the questions, particularly those related to acceptance criteria, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document discusses the technical specifications and modifications of the CR-2 AF camera compared to its predicate (CR-2 Plus AF) and confirms compliance with various electrical safety, EMC, performance, and software validation standards. It emphasizes that the changes do not introduce new risks or affect the basic design principle, usage, effectiveness, and safety.
Given the information in the provided document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical acceptance criteria or performance metrics (e.g., sensitivity, specificity, AUC) for a diagnostic output. Its performance evaluation focuses on technical compliance and equivalence.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Performance testing" and "Software Verification and Validation" but does not detail a specific test set with sample sizes, data provenance, or whether it was retrospective or prospective in a clinical performance context. The testing appears to be primarily for engineering performance and software functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical test set for diagnostic accuracy requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study or AI assistance is mentioned in the context of this device. The device is a retinal camera, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the device's performance appears to be its ability to capture images to a certain standard and its compliance with safety regulations, not diagnostic accuracy against a clinical ground truth. A "qualitative assessment of the function of the anterior segment infrared image" was performed, but details are absent.
8. The sample size for the training set
Not applicable, as this is a hardware device with control software, not a machine learning model that requires a training set of images for diagnostic prediction.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Performance Information from the Document:
The document describes the Canon non-mydriatic retinal camera CR series (Model CR-2 AF and CR-2 Plus AF).
- Intended Use: To be used for taking digital images of the retina of the human eye without mydriatic.
- Key Differences (CR-2 AF vs. Predicate CR-2 Plus AF):
- Photography Modes: CR-2 AF includes color, red-free, cobalt, and infrared for anterior segment. It does not have fundus autofluorescence (FAF) photography, which the predicate and CR-2 Plus AF model do.
- Light Source: CR-2 AF uses White LED (lower output) instead of Xenon tube (required for FAF).
- Software: Introduction of "Non-myd RC Capture Utility software (CU)" as a simplified version of RICS, without GUI and database, for capturing and transferring images.
- Physical: CR-2 AF is slightly lighter and smaller due to the light source change.
- Performance Data:
- Non-clinical tests: Electrical safety, Electromagnetic Compatibility, Performance testing, and Software Verification and Validation.
- Compliance:
- ANSI/AAMI ES 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- ISO 15004-1
- ISO 10940
- ANSI Z80.36 (eye safety limits of Group 1 instrument for light hazard)
- ISO10993 series (biocompatibility of patient contact parts, concluded no new concerns)
- Software Validation: Validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
- Qualitative Assessment: A qualitative assessment of the function of the anterior segment infrared image for CR-2 AF camera was performed.
The conclusion is that the proposed CR-2 AF is substantially equivalent to the predicate CR-2 Plus AF (K123208) because the differences do not affect the basic design principle, usage, effectiveness, and safety, and therefore do not raise any new questions regarding safety and effectiveness.
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July 23, 2020
Canon Inc. Akira Hirai General Manager 9-1, Imaikami-cho Nakahara-ku, Kawasaki, Kanagawa 211-8501 Japan
Re: K201122
Trade/Device Name: Canon non-mydriatic retinal camera CR series (Model CR-2 AF and CR-2 Plus AF) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: June 18, 2020 Received: June 22, 2020
Dear Akira Hirai:
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 Advice (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 Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number
Device Name
Canon non-mydriatic retinal camera CR series (Model CR-2 AF and CR-2 Plus AF)
Indications for Use (Describe)
Canon non-mydriatic retinal camera CR series (CR-2 plus AF and CR-2 AF) is intended to be used for taking digital images of the retina of the human eye without mydriatic. The CR-2 plus AF has the following photography modes: color, red-free, cobalt digital and fundus autofluorescence (FAF). The CR-2 AF has the following photography modes: color, red-free, cobalt digital and additional infrared photography for anterior segment.
| 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
Submitter
Canon Inc. 9-1, Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa 211-8501, Japan
Contact person
Mr. Akira Hirai Canon Inc. TEL: 81-3-3758-2111 FAX: 81-44-739-6695 Email: hirai.akira@mail.canon
Date prepared
July 21, 2020
Submission type Special 510(k)
Name of Device
| Trade/Device Name: | Canon non-mydriatic retinal camera CR series (Model CR-2 AF and CR-2 Plus AF) |
|---|---|
| Regulation Number: | 21 CFR 886.1120 |
| Regulation Name: | Ophthalmic Camera |
| Regulatory Class: | Class II |
| Product Code: | HKI |
Predicate Device
| K123208 | |
|---|---|
| Trade/Device Name: | Digital Retinal Camera CR-2 Plus A |
| Regulation Number: | 21 CFR 886.1120 |
| Regulation Name: | Ophthalmic Camera |
| Regulatory Class: | Class II |
| Product Code: | HKI |
Device Description
The Canon non-mydriatic retinal camera CR series is composed of two retinal cameras and its control software and is used for taking digital images of a human retina without mydriatic.
Two retinal cameras: The CR-2 Plus AF and CR-2 AF
- Both models take digital photographic retinal images of patient's eyes across an angle of view of 45 degrees, ● and have autofocus and automatic shooting of retinal image, and automatic switching from anterior segment image to retinal image.
- The CR-2 Plus AF camera is identical to the camera cleared under K123208. The photography mode includes color, red-free, cobalt and fundus autofluorescence (FAF).
- The CR-2 AF camera is modified version of the predicate CR-2 Plus AF (K123208). Most of the specifications are identical to the predicate; however, the photography mode does not include fundus autofluorescence (FAF) photography.
- . Both the CR-2 AF and the CR-2 Plus AF uses infrared light to observe the anterior segment, but CR-2 AF can save such an image.
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Two Software: Retinal image control software (RICS) and Non-myd RC Capture Utility software (CU) programs
- . RICS software program supports browsing, processing, and storage function of the images. It also supports the output of the images to the DICOM storage server, export in DICOM or JPEG format and output to a printer.
- CU software program is a simplified version of RICS, without most of the graphic user interface and the database. It allows user to capture and transfer the retinal images from the retinal camera to the PC.
Both RICS and CU software programs are compatible with both CR-2 AF and CR-2 Plus AF cameras.
Indications for Use
Canon non-mydriatic retinal camera CR series (CR-2 plus AF and CR-2 AF) is intended to be used for taking digital images of the retina of the human eye without mydriatic. The CR-2 plus AF has the following photography modes: color, red-free, cobalt digital and fundus autofluorescence (FAF). The CR-2 AF has the following photography modes: color, red-free, cobalt digital and additional infrared photography for anterior segment.
The Indication for Use for predicate device, Digital Retinal Camera CR-2 Plus AF is the follows:
"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)."
It appears the intended for use of Canon non-mydriatic retinal camera CR series and predicate device is identical.
Discussion of Substantial Equivalence
The CR-2 AF is modified from the predicate CR-2 Plus AF (K123208) and most of the specifications are identical to the predicate CR-2 Plus AF, the major differences are in the following aspects:
- The photography mode: The CR-2 AF has the following photography modes: color, red-free, cobalt . and infrared photography for anterior segment. The CR-2 AF doesn't have the fundus autofluorescence photography (FAF) mode while the CR-2 Plus AF (K123208) has.
- . The light source: The CR-2 Plus AF (K123208) needs to equip a large power supply box, capacitor and Xenon tube for the FAF photography because the FAF photography needs high light intensity for photographing images but the CR-2 AF doesn't have FAF photography feature and therefore the CR-2 AF adopts a White LED as a light source, whose output is lower than that of Xenon tube.
It is verified that there is no new risk associated with the light source change. The light hazard protection evaluation of CR-2 AF was evaluated to meet the eye safety limits of the Group 1 instrument based on ANSI Z80.36:2016 - Ophthalmics - Light Hazard Protection for Ophthalmic Instruments.
- The graphic user interface: Software CU is derived from the RICS by modifying the graphic user interface and removing the database from the RICS. CU can save the retinal images to the designated folder to transfer the images to the 3rd party software.
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Therefore, the above differences between the proposed device device do not affect the basic design principle, usage, effectiveness and safety of use of the subject device.
| Differences between both retinal camera models are shown in Table below. | |||
|---|---|---|---|
| Proposed | Predicate | ||
|---|---|---|---|
| Device Name | CR-2 AF | CR-2 Plus AF | |
| 510(k) Submitter[Number] | Canon Inc.K201122 | Canon Inc.[K123208] | |
| Product Code | HKI | HKI | |
| Indications for Use | The CR-2 AF is intended to be used for takingdigital images of the retina of the human eyewithout mydriatic. | The CR-2 Plus AF is intended to be used fortaking digital images of the retina of thehuman eye without mydriatic.The CR-2 Plus AF has the followingphotography modes: color, red free, cobaltdigital and fundus autofluorescence (FAF). | |
| Device design | |||
| Lightsource | ObservationFlash | Infrared LEDWhite LED | Infrared LEDXenon tube |
| Angular field of view | 45/43 ° (digital magnification)(35°when S.P switch is ON) | 45/43 ° (digital magnification)(35°when S.P switch is ON) | |
| Actual image size | cp13.7 mm (on sensor array) | cp13.7 mm (on sensor array) | |
| Min. diameter of pupilrequired | cp4mm(cp3.3mm when S.P switch is ON) | cp4mm(cp3.3mm when S.P switch is ON) | |
| Working distance (WD) | 35mm | 35mm | |
| Focusing andPhotographing | Focusing by aligning the split linesautomatically and photographingautomatically | Focusing by aligning the split linesautomatically and photographingautomatically | |
| Switching function | Automatically Switching function fromanterior segment to fundus after anteriorsegments is aligned. | Automatically Switching function fromanterior segment to fundus after anteriorsegments is aligned. | |
| Photography mode | color, red free, cobalt digital and infrared foranterior segment | color, red free, cobalt digital and fundusautofluorescence (FAF) | |
| Anterior segment | Observation and capture | Observation | |
| Eye fixation lamp | Internal (during observation of eye frontimage and retinal image),External | Internal (during observation of eye frontimage and retinal image),External | |
| External dimensions | W305×D500×H473mm | W305×D500×H513mm | |
| Weight | Approx.15kg | Approx.19.9kg | |
| Control software | Selectable from the followings:Retinal imaging control software;Non-myd RC Capture Utility | Retinal imaging control software |
Performance Data
Non-clinical tests including Electrical safety, Electromagnetic Compatibility, Performance testing, and Software Verification and Validation were conducted to evaluate safety and effectiveness of the CR-2 AF. The CR-2 AF complies with the Recognized Consensus Standard, specifically ANSI/AAMI ES 60601-1. IEC 60601-1-2. IEC 60601-1-6. ISO 15004-1, ISO 10940 and ANSI Z80.36. A qualitative assessment of the function of the anterior segment infrared image for CR-2 AF camera has been performed. The contact parts with patient in the CR-2 AF are the same materials as those used in the predicate device CR-2 Plus AF (K123208) and have been evaluated according to ISO10993 series that is concluded to have no new biocompatibility concern. The software was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
Conclusion
Based on the performance data, identical intended use and functional technological characteristics and the similarities in functional design, the proposed CR-2 AF is substantially equivalent to the CR-2 Plus AF (K123208) and does not raise any new questions regarding safety and effectiveness.
§ 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.