CANON Fundus Camera CR-10 (CR-10)

K241049 · Canon, Inc. · HKI · May 15, 2024 · Ophthalmic

Device Facts

• Record ID: K241049
• Device Name: CANON Fundus Camera CR-10 (CR-10)
• Applicant: Canon, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: May 15, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Indications for Use

The CR-10 is intended to observe and record images of the human fundus through the pupil without mydriatic and without making contact with subject's eye.

Device Story

Canon CR-10 is an ophthalmic camera for capturing digital retinal images. It uses infrared LEDs for eye alignment and autofocus, and white LEDs for retinal illumination. The device captures images via a 2D sensor, transmitting data to a control PC running RX Capture for CR-10 software. Unlike the manual predicate (CR-2 AF), the CR-10 features fully automatic alignment and automatic switching between right and left eyes. It is operated by a clinician in a clinical setting. The system provides color, red-free, and cobalt photography modes. Output is displayed on a connected monitor for clinical review, aiding in the observation and documentation of the retinal fundus. The device benefits patients by enabling non-mydriatic, non-contact retinal imaging, reducing the need for pupil dilation and improving workflow efficiency.

Clinical Evidence

Bench testing only. Compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 10940, ANSI Z80.36) and biocompatibility evaluation per ISO 10993-1 for patient-contact materials (silicon rubber, polycarbonate). Software verification and validation performed per FDA guidance.

Technological Characteristics

Ophthalmic camera; 45-degree field of view; 35mm working distance; 4mm minimum pupil diameter (3.3mm in SP mode). Materials: silicon rubber (forehead rest), polycarbonate (chin rest). Light source: White LED (imaging), IR LED (alignment). Connectivity: USB to control PC. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 15004-1/2, ISO 10940, ANSI Z80.36.

Indications for Use

Indicated for observation and recording of human fundus images through the pupil without mydriatic or ocular contact.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Canon non-mydriatic retinal camera Model CR-2 AF and CR-2 Plus AF (K201122)

Reference Devices

• Ophthalmic Software Platform RX (K173689)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

May 15, 2024

Canon Inc.

% Roger Albright

Regulatory Program Manager Medical Devices

Ora Inc.

138 Haverhill Street, Suite 102

Andover, Massachusetts 01810

Re: K241049

Trade/Device Name: CANON Fundus Camera CR-10 (CR-10)

Regulation Number: 21 CFR 886.1120

Regulation Name: Ophthalmic Camera

Regulatory Class: Class II

Product Code: HKI

Dated: April 17, 2024

Received: April 17, 2024

Dear Roger Albright:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K241049 - Roger Albright

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Alexander Beylin -S 2024.05.15 11:31:12
-04'00'

for Elvin Ng

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

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K241049 - Roger Albright

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Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# **Indications for Use**

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K241049

Device Name
CANON Fundus Camera CR-10 (CR-10)

Indications for Use (Describe)

The CR-10 is intended to observe and record images of the human fundus through the pupil without mydriatic and without making contact with subject's eye.

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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FORM FDA 3881 (6/20)

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PSC Publishing Services [phone] EF

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510(k) Summary

K241049

# **510(k) Summary**

This summary of the special 510(k) premarket notification for the Canon Digital Retinal Camera CR-10 is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Submitter Information:

# **Owner/Company name, address**

CANON INC.

9-1, Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa 211-8501, Japan

Contact person:

Mr. Shigeo Watanabe
Watanabe Shigeo
General Manager

Telephone: [phone]

E-mail: [e-mail]

# **Contact/Application Correspondent**

Roger Albright
Ora, Inc.
138 Haverhill Street, Suite 102
Andover, MA 01810

Telephone: [phone]

E-mail: [e-mail]

# **Date Prepared**

10 May 2024

# **1. Device Information**

| Trade Name: | Canon Digital Retinal Camera CR-10 |
| --- | --- |
| Common Name: | Ophthalmic camera |
| Classification Name: | camera, ophthalmic, ac-powered |
| Product Code: | HKI |
| Classification Regulation: | 21 CFR 886.1120 |

The device is hereinafter called the CR-10.

# **2. Predicate Device**

The Canon Digital Retinal Camera CR-10 is substantially equivalent to the following legally marketed device:

| 510(k) number: | K201122 |
| --- | --- |
| Trade Name: | Canon non-mydriatic retinal camera Model CR-2 AF and CR-2 Plus AF |
| Common Name: | Ophthalmic camera |

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510(k) Summary

K241049

Classification Name: camera, ophthalmic, ac-powered

Product Code: HKI

Classification Regulation: 21 CFR 886.1120

The predicate device is hereinafter called the CR-2 AF.

### 3. Description of the Device

The Canon Digital Retinal Camera CR-10 system takes digital photographic retinal images of patient's eyes across an angle of view of 45 degrees through the pupil without making a contact with subject's eye, in a naturally dilated state without using mydriatics with fully automatic alignment.

CR-10 is controlled by RX Capture for CR-10 software on a control PC connected by USB. Operators can start an imaging session by pushing a start button on the GUI of the software. As with the predicate CR-2 AF, infrared light illumination by IR LEDs is used for eye position alignment and auto focus adjustment. To capture the retinal images after alignment, visible illumination light by White LEDs irradiates subject's eye and the reflection light from the eye returns to a 2-dimensional imaging sensor. The image data detected by the sensor is sent to the control PC vis USB connection and the control software shows image on the GUI and records the data to a storage device.

CR-10 is modified from the predicate device CR-2 AF (K201122). CR-2 AF is operated manually by operators using a joystick and IR observation image, but on CR-10 once an operator pushes the start button, the capturing procedure is progressed automatically. Optical design and main components including light source, imaging sensor and optical lenses are the same and illumination light power is same so that the performance and image quality are equivalent. The CR-10 has the following photography modes: color, red-free, and cobalt. The CR-2 AF predicate has the same modes and also includes additional infrared photography for anterior segment, which is not offered on the CR-10.

Figure 1: Patient View


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510(k) Summary

K241049

Figure 2: Operator View


#### 4. Indications for Use

The indications for use for the CR-10 are:

The CR-10 is intended to observe and record images of the human fundus through the pupil without mydriatic and without making contact with subject's eye.

The wording of the indications for use is different however the intent for use is the same.

#### 5. Statement of substantial equivalence

For its indications, the CR-10 has the same characteristics and intended use as the CR-2 for the observation and recording of the retinal fundus as shown in the comparison table below.

Both the CR-10 and the CR-2 are indicated as fundus cameras intended for observation and recording of images of the retinal fundus.

**Table 1: Comparison Table of Technological Characteristics**

| Feature | Digital Retinal Camera CR-10 | Digital Retinal Camera CR-2 AF | Differences |
| --- | --- | --- | --- |
| Manufacturer | Canon Inc. (K241049) | Canon Inc. (K201122) | |
| Classification | 21 CFR 886.1120 | 21 CFR 886.1120 | Identical |
| Product Code | HKI | HKI | Identical |
| Indications for use | The CR-10 is intended to observe and record images of the human fundus through the pupil without mydriatic and without making contact with subject's eye. | 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. | equivalent |
| Technological Characteristics: | | | |

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510(k) Summary

K241049

| Feature | Digital Retinal Camera CR-10 | Digital Retinal Camera CR-2 AF | Differences |
| --- | --- | --- | --- |
| Light source | White LED | White LED | Identical |
| Angular field of view | 45 ° | 45 ° | Identical |
| Min. diameter of pupil required | φ4mm (φ3.3mm at SP mode) | φ4mm (φ3.3mm at SP mode) | Identical |
| Working distance (WD) | 35mm | 35mm | Identical |
| Focusing and Photographing | Alignment, focusing, photographing and changing Right/Left eyes automatically. | Focusing and photographing automatically while performing alignment manually. | Modified to automatically perform alignment and changing Right/Left eyes. The output is fundamentally the same as the predicate device. |
| Photography mode | Color/D-RedFree/D-Cobalt | Color/D-RedFree/D-Cobalt/Anterior IR | Modified The CR-10 does not include Anterior IR. |
| Eye fixation lamp | Internal (during observation of eye front image and retinal image), External | Internal (during observation of eye front image and retinal image), External | Identical |
| Vertical motion of Chin rest | Electric | Electric | Identical |
| Working range - Vertical - Forward and back - Right and left - Chin rest (vertically) | 30mm 70mm 100mm 62mm | 30mm 70mm 100mm 60mm | Identical |
| External dimensions | 335(W)×490(D)×473(H) mm | 305(W)×500(D)×473(H) mm | Modified The external dimensions of the CR-10 are slightly different. |
| Weight | Approx.21kg | Approx.15kg | Modified The weight of the CR-10 is more than that of the CR-2 AF |
| Biocompatibility | Patient's contact part Forehead rest: silicon rubber Chin rest: polycarbonate | Patient's contact part Forehead rest: silicon rubber Chin rest: polycarbonate | Identical |
| Monitor | Monitor in compliance with the following standards can be | 3.0 inch LDC monitor built-in EOS | Modified |

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510(k) Summary

K241049

| Feature | Digital Retinal Camera CR-10 | Digital Retinal Camera CR-2 AF | Differences |
| --- | --- | --- | --- |
| | connectable. Touch panel monitor is also available. -Compliant to IEC 60601-1 or IEC62368-1:2014/2018, and CISPR 32 Class B or CISPR35, or equivalent standard -Specification Screen resolution: 1920 x 1080 pixels Screen colors: 24 bits or more | | |
| Software | RX Capture for CR-10 | Retinal imaging control software (RICS) NM2 or Non-myd RC Capture Utility | Modified The RX Capture for CR-10 controls the CR-10 and takes and records retinal images. |
| Compliance with standards | IEC 60601-1 IEC 60601-1-2 ISO 10993-1 ISO 15004-1 ISO 15004-2 ISO 10940 | IEC 60601-1 IEC 60601-1-2 ISO 10993-1 ISO 15004-1 ISO 15004-2 ISO 10940 | Identical |

Substantial Equivalence Discussion for the Canon CR-10 per the 510(k) Decision-Making Flowchart.

(1) The predicate device is the Canon Digital Retinal Camera CR-2 AF cleared in K201122.
(2) Both devices have a same intended use. For the CR-10 the indications for use have been modified slightly but are considered to be equivalent in intent. No new indications are presented in the CR-10 indications for use (IFU).
(3) The functional technological characteristics of the CR-10 and the predicate fundus camera are the same. The CR-10 includes some convenience features that are not available in the CR-2 AF such as:
- Automatic alignment and image acquisition for both eyes sequentially.
- The ability to use a touch screen in addition to the standard keyboard and mouse to navigate and control the functions of the device.
- The addition of voice guidance.
(4) The differences in technological characteristics do not raise different questions of safety and effectiveness. The differences are designed as convenience features and do not impact the functioning of the retinal camera as compared to the predicate device.

The differences between the CR-10 and the CR-2 AF predicate are as follows:

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510(k) Summary

K241049

- Focusing and Photographing: To improve the operability, the CR-10 can automatically perform alignment and changing Right/Left eyes. This improvement is for reduction of operator's burden and the output from this device is fundamentally the same as the predicate device. This change has been evaluated and does not raise different questions of safety and effectiveness.

- Photography mode: The CR-10 does not include Anterior IR. All other modes are the same.

- External dimensions: The external dimensions of the device are slightly different.

○ CR-10: 335(W)×490(D)×473(H) mm
○ CR-2 AF: 305(W)×500(D)×473(H) mm

- Weight: The weight of the CR-10 is greater.

○ CR-10: 21 kg
○ CR-2 AF: 15 kg

- Monitor: The CR-10 is designed to use a large monitor which complies with the designated safety standard, and which can include a touch-screen monitor whereas the CR-2 AF included a built-in 3.0 inch LCD monitor. A large monitor is helpful to view the examination data.

- Software: The CR-10 uses RX Capture for CR-10 to control the CR-10 and allows the user to take and record retinal images. This software functions the same as the functions provided by the RICS in the CR-2 AF.

The CR-10 has also been designed to use the optional Ophthalmic Software Platform RX (K173689), the same as the predicate device CR-2 AF.

These changes have been evaluated and do not raise different questions of safety and effectiveness.

(5a) The testing methods used are per applicable recognized consensus standards as well as well understood bench and clinical testing protocols.
(5b) The testing data demonstrate substantial equivalence.

### 6. Performance Data

Non-clinical tests were conducted to evaluate the safety and effectiveness of the CR-10, including:

- Electrical safety,
- Electromagnetic Compatibility,
- Performance testing, and
- Software Verification and Validation

The CR-10 complies with the Recognized Consensus Standards indicated for devices under 21 CFR 886.1120, product code HKI, specifically ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 15004-1, ISO 10940 and ANSI Z80.36.

The contact parts with patient in the CR-10 are the same materials as those used in the predicate device CR-2 AF (K201122) 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).

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510(k) Summary

K241049

### 7. Conclusion

Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate device confirmed with performance testing, the CR-10 is technologically and functionally equivalent to the predicate device, CR-2 AF (K201122). The differences between the proposed device and the predicate device are not significant and do not raise new issues of safety or effectiveness of the device. The CR-10 is as safe and effective as the predicate device, and thus, may be considered substantially equivalent.

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