(103 days)
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.
CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier.
The provided 510(k) summary for K980246 describes a new non-mydriatic retinal camera, the Canon CR6-45NM, and compares it to a predicate device, the Canon CR5-45NM. The submission focuses on demonstrating substantial equivalence rather than reporting on a study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, the requested information elements related to AI/software performance, such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, are not explicitly provided or relevant in this context.
However, I can extract and present the available information regarding the device's characteristics and the comparison to the predicate device, which implies the "acceptance criteria" were met by demonstrating substantial equivalence based on technological characteristics and intended use.
Here's the breakdown of the information as requested, with "N/A" for elements not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
This submission focuses on demonstrating substantial equivalence to a predicate device (Canon CR5-45NM). The "acceptance criteria" implicitly revolve around ensuring the new device's technological characteristics and intended use are sufficiently similar to the predicate device, and that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | CR5-45NM (Predicate) Performance/Characteristics | CR6-45NM (New Device) Performance/Characteristics | Differences/Improvements (New Device) |
|---|---|---|---|
| Angle of View | 45° (37° with S.P switch ON) | Same | None |
| Actual Image Size | $\phi$ 22mm (35mm film), $\phi$ 74mm (Polaroid film) | Same | None |
| Min. Diameter of Pupil Required | 4.0mm (3.7mm with S.P switch ON) | Same | None |
| Working Distance (WD) | 45mm | Same | None |
| Focusing Method | By aligning the split lines | Same | None |
| Data to be Printed | Hand-written data | Same | None |
| Eye Fixation Lamp | Internal (during observation of retinal image) | Internal (during observation of eye front image and retinal image) | Advanced Internal Fixation Lamp (supports eye front image observation) |
| Light Source for Photography | Max. 300WS | Same | None |
| Working Range (Vertical) | 37mm | Same | None |
| Working Range (Forward & Back) | 40mm | Same | None |
| Working Range (Right & Left) | 100mm | Same | None |
| Chin Rest (Vertically) | 70mm | Same | None |
| External Dimension | W325xL480xH585mm | W325xL496xH570mm | Minor dimensional variations |
| Weight | Approx. 24kg | Same | None |
| Intended Use | Taking pictures of retina of human eye | Same | None |
| Energy Used | 300VA | Same | None |
| Target Population | General Population | Same | None |
| Physical Safety Standards | UL544 | Same | None |
| Compliance with Standards | UL544 | Same | None |
| Biocompatibility | NA (Not Applicable/Not Assessed) | Same | None |
| Key Material Differences | Aluminum casting AC2A (Component 5), PBT resin (Component 6) | Aluminum die cast ADC10 (Component 5), PC resin (Component 6) | Material change for two components |
| Software | Exclusive pre-installed software | Same | None |
| Operational Improvement | N/A | Auto Flash Adjustment | New feature for easier operation |
Summary of "Study" Proving Acceptance:
The "study" or justification for acceptance is a 510(k) Pre-market Notification which aims to demonstrate substantial equivalence to a legally marketed predicate device (Canon CR5-45NM). The submitter, Canon USA, Inc., stated that "CR6-45NM is an improved model of CR5-45NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, making operation easier." The FDA reviewed the comparison chart and other information and concluded that the device is substantially equivalent for its stated indications for use.
2. Sample size used for the test set and the data provenance
N/A. This 510(k) submission for a non-mydriatic retinal camera (a hardware device with some software) does not detail a "test set" in the context of performance evaluation for an AI/software algorithm. The substantial equivalence argument relies on comparing the technical specifications and intended use to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Not applicable to this type of hardware device submission. No "ground truth" establishment by experts is described for performance evaluation.
4. Adjudication method for the test set
N/A. Not applicable for this hardware device submission.
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
N/A. This is a hardware device (retinal camera) and not an AI-assisted diagnostic tool in the sense of an algorithm interpreting images for human readers. No MRMC study was performed or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. Not applicable. This device is a camera and its function is to capture images, not to perform standalone diagnostic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. Not applicable. The "ground truth" in this context would likely refer to established engineering and medical standards for retinal imaging, satisfied by the performance of the predicate device and the new device's comparable or improved features.
8. The sample size for the training set
N/A. Not applicable. There is no information about a "training set" as this is not an AI/machine learning algorithm seeking to be cleared.
9. How the ground truth for the training set was established
N/A. Not applicable.
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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.
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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 |
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:
.
Materials
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
| CR5-45NM | CR6-45NM | |
|---|---|---|
| 1 | ABS resin | Same |
| 2 | Aluminum die castADC10 | Same |
| 3 | robberNBR | Same |
| 4 | ABS resin | Same |
| 5 | Aluminum castingAC2A | Aluminum die castADC10 |
| 6 | PBT resin | PC resin |
| 7 | Stainless steel stickSUS303BG | Same |
| 8 | PBT resin | Same |
| 9 | ABS resin | Same |
,
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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.
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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
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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)
§ 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.