(10 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on the device's function as a retinal camera and its predicate device.
No.
The device is described as a camera for taking pictures of the retina, which is a diagnostic function rather than a therapeutic one. It does not mention any treatment or intervention.
No
The device is described as a "Retinal Camera" used for "taking pictures of retina". Its intended use is image acquisition, not the interpretation or diagnosis of medical conditions.
No
The device description explicitly states it is a "Retinal Camera," which is a hardware device used for photography. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Canon Non-Mydriatic Retinal Camera CR-DGi 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 CR-DGi is a camera that takes pictures of the retina in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is to "tak[e] pictures of retina of human eye," which is a direct imaging function, not a diagnostic test performed on a sample.
Therefore, the CR-DGi falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
CR-DGi is an improved model of CR5-45NM.
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
Optometrist and Ophthalmologist
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
Section 7: Summary
510(k) Summary
Prepared:
April 16, 2003
Submitter:
Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Company Address: Lake Success, NY 11042 Ms. Sheila Driscoll Contact Person: Phone Number: (516) 328-5602 Fax Number: (516) 328-5169
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon Inc. Canon CR-DGi HKI, Ophthalmic cameras To be assigned
Predicate Device: Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CR 45 NM 86HKI, , Ophthalmic cameras K980246
Description Of Device: CR-DGi is an improved model of CR5-45NM.
CR-DGi is intended to be used for taking pictures of retina of human eye Intended Use: without a mydriatic.
1
Appendix D: Substantial Equivalence Comparison D-2 Table of comparison
| CR6-45NM | CR-DGi | ||
|---|---|---|---|
| Angle of view | 45° (37° when S.P switch is ON) | Same | |
| Actual image size | $\phi$ 22mm (on 35mm film) | ||
| $\phi$ 74mm (on Polaroid film) | Same | ||
| Min. diameter of pupil | |||
| required | 4.0mm - | ||
| (3.7mm when S.P switch is ON) | Same | ||
| P | |||
| E | |||
| R | |||
| F | |||
| O | |||
| R | |||
| M | |||
| A | |||
| N | |||
| C | |||
| E | Working distance (WD) | 45mm | Same |
| Focusing | By aligning the split lines | Same | |
| Data to be printed | Hand-written data | None | |
| Eye fixation lamp | Internal (during observation of eye front | ||
| image and retinal image) | Internal (during observation of eye | ||
| front image and retinal image) | |||
| External | |||
| Light source for | |||
| photography | Max. 300WS | Same | |
| Image unit | EOS Digital Camera (with Adapter) | ||
| 35mm film unit | |||
| Polaroid film unit | |||
| 3CCD TV Camera (with Adapter) | EOS Digital Camera | ||
| Working range | |||
| Vertical | 37mm | Same | |
| Forward & back | 40mm | Same | |
| Right & left | 100mm | Same | |
| Chin rest (vertically) | 70mm | Same | |
| External dimension | W325xL496xH570mm | Same | |
| Weight | Approx. 24kg | Approx. 23kg | |
| Intended use | Taking picture of retina of human eye | Same | |
| Energy used | 300VA | Same | |
| Energy delivered | NA | Same | |
| Target population | Optometrist and Ophthalmologist | Same | |
| Physical safety | UL544 | Same | |
| Compliance with standards | UL544 | Same | |
| Biocompatibility | NA | Same | |
| Labeling Packaging | Printed model name is changed |
・
. •••
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2003
Canon U.S.A., Inc. c/o Mr. Joseph Murnane Senior Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, NY 11747
Re: K031629
Trade/Device Name: Canon Non-Mydriatic Retinal Camera, Model CR-DGI Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: May 27, 2003 Received: May 27, 2003
Dear Mr. Murnane:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Joseph Murnane
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A Kalipi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
| 510(K)Number(if known): | K031629 |
|---|---|
| ------------------------- | --------- |
Page 1 of 1
| Device Name: | CANON Non-Mydriatic RETINAL CAMERA CR-DGi |
|---|---|
| -------------- | ------------------------------------------- |
Indications for Use:
.
Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K031629 |
|---|---|
| --------------- | --------- |
/