(103 days)
Not Found
No
The description focuses on hardware improvements (Auto Flash Adjustment, Advanced Internal Fixation Lamp) and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as information about training/test sets and performance studies typically associated with AI/ML devices.
No
The device is used for taking pictures of the retina, which is a diagnostic function, not a therapeutic one. It facilitates diagnosis rather than providing treatment.
No
The intended use is purely for taking pictures of the retina, which is an imaging function, not a diagnostic one. There is no mention of analysis, interpretation, or disease detection.
No
The device description explicitly mentions hardware components like "Auto Flash Adjustment" and "Advanced Internal Fixation Lamp," indicating it is a physical device, not software-only.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's intended use is "Taking pictures of retina of human eye." This is an imaging procedure performed directly on the patient's body, not on a sample taken from the body.
- Anatomical Site: The anatomical site is the "retina of human eye," which is an in-vivo (within the living body) location.
Therefore, the CR6-45NM, as described, is an ophthalmic imaging device, specifically a retinal camera, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CR6-45NM is intended to be used for taking pictures of retina of human eye without a mydriatic.
Taking pictures of retina of human eye.
Product codes
86HKI
Device Description
CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 6 1098
510(K)Summary
1.Date Prepared: January 29, 1998 2.Applicant's Name: Canon USA, Inc. One Canon Plaza. Lake Success, NY 11042 Mr. Glenn Impal/Mr. Ken Shadoff Phone: (516)328-5600 Fax. (516)328-5169 Canon CR6-45NM 3.Model Name: 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control Number. 4.Predicate Model: Canon CR5-45NM 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control Number. K941234 CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed 5.Device Description: Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier. CR6-45NM is intended to be used for taking pictures of retina of human eye 5.Intended Use: without a mydriatic. 7.Summary of Technological
Characteristics:
See the attached comparison chart.
1
COMPARISON CHART
| CR5-45NM | CR6-45NM | |||
|---|---|---|---|---|
| P | 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 | |||
| R | Min. diameter of pupil required | 4.0mm | ||
| (3.7mm when S.P switch is ON) | Same | |||
| F | Working distance(WD) | 45mm | Same | |
| Focusing | By aligning the split lines | Same | ||
| O | Data to be printed | Hand-written data | Same | |
| R | Eye fixation lamp | Internal(during observation of retinal image) | Internal(during observation of eye front image and retinal image) | |
| M | Light source for photography | Max. 300WS | Same | |
| A | Working range | Vertical | 37mm | Same |
| N | Forward & back | 40mm | ||
| Right & left | 100mm | |||
| Chin rest(vertically) | 70mm | |||
| E | External dimension | W325xL480xH585mm | W325xL496xH570mm | |
| Weight | Approx. 24kg | Same | ||
| Intended use | Taking picture of retina of human eye | Same | ||
| Design | See Attachment | See Attachment | ||
| Energy | used | 300VA | Same | |
| delivered | NA | Same | ||
| Materials | See Attachment | |||
| Target population | General Population | Same | ||
| Physical safety | UL544 | Same | ||
| Compliance with standards | UL544 | Same | ||
| Biocompatibility | NA | Same | ||
| Labeling | Packaging | See Attachment | See Attachment | |
| Inserts | See Attachment | See Attachment | ||
| Prompts | See Attachment | See Attachment | ||
| Software | Exclusive pre-installed software | Same |
2
:
.
Materials
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
| CR5-45NM | CR6-45NM | |
|---|---|---|
| 1 | ABS resin | Same |
| 2 | Aluminum die cast | |
| ADC10 | Same | |
| 3 | robber | |
| NBR | Same | |
| 4 | ABS resin | Same |
| 5 | Aluminum casting | |
| AC2A | Aluminum die cast | |
| ADC10 | ||
| 6 | PBT resin | PC resin |
| 7 | Stainless steel stick | |
| SUS303BG | Same | |
| 8 | PBT resin | Same |
| 9 | ABS resin | Same |
,
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 6 1898
Mr. Ken Shadoff Product Safety Engineer Quality Management Department Cannon, USA One Canon Plaza Lake Success, NY 11042-1198
Re: K980246
Trade Name: Non-Mydriatic Retinal Camera, Model CR6-45NM Regulatory Class: II Product Code: 86 HKI Dated: March 11, 1998 Received: April 28, 1998
Dear Mr. Shadoff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. * Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Ken Shadoff
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(K) Number (IF Known): K980246 Device Name: CAMERA, OPHTHALMIC, AC-POWERED_ Indications For Use:
Taking pictures of retina of human eye.
Evelyn R. Bera
(Division Sign-Off)
Division of Ophthalmic Devices
Division of Ophthalmic Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -(Per 21 CFR 201.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)