(44 days)
KOWA nonmyd α-D (Type G), fundus camera, is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.
KOWA nonmyd α-D (Type G) is a non-mydriatic fundus camera equipped with a highly sensitive CCD camera. It does not require film and can display images immediately after image capture. It has a 45 degree/20 degree picture angle, a working distance of 0.30 mm, and a dioptric compensation of -33D to +40D. It uses a 2/3 inch 5 mega pixels CCD for photographing and a 1/3 inch CCD camera for observation. It has a 5.6 inch LCD Monitor for observation display and can use an outer monitor. Focusing is done by split luminous bars coincidence. It uses a Halogen lamp with infrared filter for observation light and Xenon flash for photographing light. It has fixed fixator selecting for internal fixation navigation and a same pathway, no beam split for switching light path of observation & photographing. Observation light adjustment is volume adjustment style and photographing light adjustment is step adjustment style (5 step). The camera stand is tabletop with a built-in power source, with horizontal movement of 40mm forward/backward and 100mm leftward/rightward, and vertical movement of 30mm. Shutter release is via a joystick upper button. The signal outlet is IEEE1394. The chinrest has a vertical movement of 60mm. External fixation targets are free-arm style (Option).
This 510(k) premarket notification for the KOWA nonmyd α-D (Type G) Fundus Camera does not describe a study with acceptance criteria and device performance in the way typically seen for AI/ML-based diagnostic devices.
Instead, this submission is a medical device equivalence claim to a predicate device (KOWA nonmyd α-D (Type D)). The "acceptance criteria" here are implicitly that the new device (Type G) is substantially equivalent to the predicate device (Type D) in terms of indications for use, fundamental technology, safety, and effectiveness.
Therefore, many of the requested sections about specific study methodologies like sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance are not present in this type of submission.
Here's how to interpret the available information based on the request:
1. A table of acceptance criteria and the reported device performance
Since this is an equivalence claim, the "acceptance criteria" are not quantitative performance metrics but rather the demonstration of substantial equivalence. The reported "performance" is that the device has equivalent features and functionality to the predicate device.
| Aspect of Equivalence | Acceptance Criteria (Implicit) | Reported Device Performance (KOWA nonmyd α-D (Type G)) |
|---|---|---|
| Indications for Use | Must be same or very similar to predicate. | Same indications for use: retinal image capturing without mydriatic, image storage via serial interface. |
| Fundamental Technology | Must employ similar fundamental technical characteristics. | Equipped with highly sensitive CCD camera (2/3 inch 5 mega pixels CCD), no film, immediate display, reduced flash. |
| Input/Output | Must be able to store images and interface with other systems. | Captures retinal images, stores to an image filing drive through serial interface (IEEE1394). |
| Image Resolution | Must be comparable or improved. | 2/3 inch 5 mega pixels CCD, which is an upgrade from the predicate's 1/2 inch 2.1 mega pixels CCD. |
| Optical Parameters | Picture angle, working distance, dioptric compensation, focusing, etc. must be equivalent. | Same picture angle (45/20 degree), working distance (30mm), working distance detection, dioptric compensation (-33D to +40D), focusing. |
| Light Sources | Observation and photographing light sources must be suitable for purpose. | Same: Halogen lamp (observation), Xenon flash (photographing). |
| Safety | Must comply with relevant safety standards. | Same: Compliance with EN60601-1-2: 2001 (EMC). |
| Effectiveness | Must provide an equivalent level of effectiveness. | Claimed to deliver "equivalent level safety and effectiveness" to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. It's a hardware device equivalence claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth establishment is mentioned as there's no clinical performance study on patient data for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned as there's no clinical performance study on patient data for diagnostic accuracy.
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
- No. Not applicable. This device is a fundus camera, primarily for image acquisition, not for an AI-assisted diagnostic function that would involve human reader interpretation with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not applicable. This is a hardware device; no standalone algorithmic performance is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth is used for a clinical performance study in this submission. The "ground truth" here is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set
- Not applicable / Not provided. This is a hardware device; there is no mention of an algorithm or training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this is not relevant.
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Summary for public disclosure
Submitter information:
| Applicant: | Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-3279-7329Fax: +81-3-3245-1109 |
|---|---|
| Contact: | Satohiko Takanashi, PE |
| E-mail address: | s-takana@kowa.co.jp |
| Date summary prepared: | August 11, 2006 |
Device identification:
| Device trade name: | KOWA nonmyd α-D (Type G) |
|---|---|
| Classification name: | CAMERA, OPTHALMIC, AC-POWERED |
| Product code: | HKI |
Intended use:
KOWA nonmyd α-D is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.
Comparison:
The KOWA nonmyd o -D (Type D) was chosen as a substantially equivalent device. The predicate device is non-mydriatic fundus camera and they are equipped with highly resolution CCD camera, so it do not require any film and can display images immediately after image capture. Also, because it uses a highly sensitive CCD camera the flash required for filming is reduced compared to previous fundus cameras which use film.
Similar to the predicate device the KOWA nonmyd a-D (Type G) is equipped with a highly sensitive CCD camera so they do not require film and can display images immediately after image capture.
KOWA nonmyd a-D(Type G) has the same picture angle as the predicate device.
A comparison table between the KOWA nonmyd a-D(Type G) and predicate device are provided in Table B and C. The KOWA nonmyd a-D(Type G) has incorporated similar technical characteristics to the predicate device.
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Conclusion:
KOWA nonmyd α-D(Type G) is equipped with the same fundamental technology features, which are equivalent to the predicate device, and also delivers the equivalent level safety and effectiveness. Thus it is concluded that there is no significant difference in the basic functions, safety and effectiveness between KOWA nonmyd α-D (Type G) and the predicate device.
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| KOWA nonmyd α-D(Type D) | Kowa Company, Ltd. | K053026 | Nov.10,2005 |
| KOWA nonmyd α-D (Type G) | KOWA nonmyd α-D (Type D) | |
|---|---|---|
| IndicationsFor Use | KOWA nonmyd α-D (Type G) isintended for use with retinal imagecapturing without mydriatic. Theretina image can be stored to animage filing drive through serialinterface. | The KOWA nonmyd series, non-mydriatic fundus cameras, are intendedfor use with retina image capturing. Theretinal image can be stored to an externalhard disk drive or transferred in otherformats through memory card or serialinterface depending on the outputinterface available for each device. |
| Saved image format | Same | BMP, JPEG |
| Picture angle | Same | 45degree/20degree |
| Working distance | Same | .30 mm |
| Working distancedetection method | Same | Anterior (Observation)Fundus (Focusing on blight spots) |
| CCD camera forobservation | Same | 1/3 inch CCD camera |
| CCD camera forphotographing | 2/3 inch 5mega pixels CCD | Type D:1/2 inch 2.1mega pixels CCD |
| Observation Display(B/W) | Same | 5.6 inch LCD Monitor |
| Display | Same | Outer Monitor Use |
| Dioptriccompensation | Same | Total -33D to +40D |
| Focusing | Same | Sprit luminous bars coincidence |
Table B. Predicate device comparison
The state of the state of the state of the states and the season
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| Table C. Predicate Device Comparison | ||
|---|---|---|
| KOWA nonmyd α-D (Type G) | KOWA nonmyd α-D (Type D) | |
| Observation LightSource | Same | Halogen lamp (Max 12V 100W) withinfrared filter |
| PhotographingLight Source | Same | Xenon flash (Max 50WS) |
| Internal FixationNavigation | Same | Fixed fixator selecting |
| Switching light pathof observation &photographing | Same | Same pathway, no beam split |
| Observation lightadjustment | Same | Volume adjustment style |
| Photographing lightadjustment | Same | Step adjustment style (5 step) |
| Camera stand (Base) | ||
| Type | Same | Tabletop; power source built in |
| HorizontalMovement | Same | Forward/Backward: 40mmLeftward/Rightward: 100mm |
| Vertical Movement | Same | 30mm |
| Shutter Release | Same | Joystick upper button |
| Signal outlet | IEEE1394 | Type D: USB |
| Chinrest | ||
| Vertical Movementof chinrest | Same | 60mm |
| External FixationTargets | Same | Free-arm style (Option) |
| Compliance with safety standards | ||
| EMC | Same | EN60601-1-2: 2001 |
| Dimension | ||
| Size | Same | Type D:310mm(W)x504mm(D)x548mm(H) |
| Weight | Same | Type D: 21kg |
:
Table C. Predicate Device Comparison
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 27 2006
KOWA Company, Ltd. c/o Satohiko Takanashi, PE 4-14. Nihonbashi-Honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan
Re: K062356
Trade/Device Name: Kowa nonmyd α-D (type G) Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 11, 2006 Received: September 12, 2006
Dear Takanashi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as stated in the encreations of the enactment date of the Medical Device Amendments, or to Connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rice, inc. that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the act include requirements for annual registration, listing of general controls provincitive, 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 If your device is classified (see are roy als. Existing major regulations affecting your device can may be subject to suell additions, 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 i least of advised that I Dr overan that your device complies with other requirements of the Act mat I Dri has made a acternmentations administered by other Federal agencies. You must or any I caetar statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I ratt 0077, lacemig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Satohiko Takanashi, PE
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychler-SiMD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if know):
$
Device Name:
Indications for Use:
KOWA nonmyd α-D (Type G), fundus camera, is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.
Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(?).EASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
Dexendis 9/22/2006
(Division Sign-Off)
510(k) Number K062356
§ 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.