(210 days)
Not Found
No
The summary describes a digital retinal camera for image acquisition and viewing, with no mention of AI/ML algorithms for image analysis, diagnosis, or other functions. The performance study focuses on safety and effectiveness compared to predicate devices, not on the performance of any AI/ML component.
No.
The device is described as a digital retinal camera used for acquiring images, not for treating or diagnosing.
No
The device is described as taking digital images of the retina. There is no mention of analysis, interpretation, or diagnosis being performed by the device, only image acquisition.
No
The device description explicitly states it is a "DIGITAL RETINAL CAMERA CX-1" and is "mounted with CX-1", indicating it is a hardware device used for capturing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "tak[e] digital images of retina of human eye." This describes an imaging device used to capture visual information from the body.
- Device Description: The description reinforces that it's a "DIGITAL RETINAL CAMERA" used for "taking digital images."
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health status. This device is used on the patient to capture images of the retina.
- No Mention of Analysis of Biological Samples: There is no indication that this device analyzes any biological samples.
Therefore, the device described is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI, NFJ
Device Description
The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina of human 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
§ 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
Appendix G: Summary
510(k) Summary
Prepared:
June 29, 2009 -
MAR 1 8 2010
Submitter/Holder: Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
Canon Inc. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Sheila Driscoll (from U.S. agent for Canon Inc.) 516-328-5602 516-328-2169
Proposed Device:
Reason For 510(k): Trade Name: Model Name: Classification Name(s):
New Model Canon CX-1 86HKI Ophthaimic camera 86NFJ System, image management, ophthalmic To be assigned
FDA 510(k) #:
Predicate Device:
Trade Name: Model Name: Classification Name: FDA 510(k) #:
Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon CF-1 86HKI Ophthalmic camera K063717
Canon CR-1 86HKI Ophthalmic camera K080883
Description of Device:
The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.
Intended Use:
The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
1
Appendix G: Summary
Comparison to Predicate:
The differences between CX-1 and CF-1 and CR-1 are as follows;
| CX-1 | CF-1 | CR-1 | |
|---|---|---|---|
| Type | Mydriatic | ||
| Non-Mydriatic | Mydriatic | Non-Mydriatic | |
| Angle of view | Mydriatic: 50 degree | ||
| Non-Mydriatic: 45 degree | Mydriatic: 50 degree | Non-Mydriatic: 45 degree | |
| Photography | |||
| mode | |||
| COLOR | |||
| FLUO | |||
| RED FREE | |||
| COBALT | |||
| FAF* | |||
| *Fundus Autofluorescence | |||
| angiography | |||
| COLOR | |||
| FLUO | |||
| RED FREE | |||
| COBALT | |||
| COLOR | |||
| Attachable | |||
| Digital camera | Bundled | None | None |
Conclusion:
The Performance Data demonstrate that CX-1 is as safe and effective as the predicate devices. The I crorination Data demonstrate marsion, similarity to the predicate devices (the DIGITAL DESC on the michilance in 1 and the DIGITAL RETINAL CAMERA CR-1), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RETINAL CAMERA CX-1 described in this submission is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol consisting of three overlapping, curved shapes, resembling a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Canon, Inc. c/o Mr. Jeff D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle, NC 27709
MAR 1 8 2010
Re: K092565
Trade/Device Name: Digital Retinal Camera CX-1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Codes: HKI, NFJ Dated: March 2, 2010 Received: March 3, 2010
Dear Mr. Rongero:
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 Amendmonte, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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 misbranching and adulteration.
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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA on a 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 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 100-1050.
3
ff 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/dcfault.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander Jr
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
4
Indications Statement
Kog2565 510(K)Number (if known) :
Device Name: CX-1
Indications for Use:
The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
Prescription Use _ X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF
Concurrence of CDRH, Office of Device Evaluation(ODE)
Ralfo
(Division Sign Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092565
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