(113 days)
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
KOWA GENESIS-Df is a hand-held mydriatic retinal camera which captures fundus image. It is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured. It uses a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.
This 510(k) notification describes a device (KOWA GENESIS-Df) that is substantially equivalent to a predicate device (KOWA GENESIS-D). The acceptance criteria and supporting study information are therefore focused on demonstrating this substantial equivalence, rather than establishing de novo performance metrics for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (KOWA GENESIS-Df) |
|---|---|---|
| Intended Use | Device is intended to capture and save fundus images with mydriatic. | Meets Criteria: The KOWA GENESIS-Df is intended to capture and save fundus images with mydriatic. This is identical to the predicate device's intended use. |
| Fundamental Technology | Device employs fundamental technology similar to the predicate device. | Meets Criteria: KOWA GENESIS-Df uses the same basic structures (e.g., highly sensitive CCD camera, immediate image viewing, lower flash light intensity for comfort) as the KOWA GENESIS-D. The primary changes are enhancements (improved optical system for fluorescence angiography, electrical circuit and capacitance enlargement). |
| Safety Performance | Device maintains a level of safety performance equivalent to the predicate device. | Meets Criteria: Evaluation of light hazard, electrical safety, and EMC was performed. It was checked that device safety is a level equivalent to KOWA GENESIS-D. The device uses a visible LED light for observation, similar to the predicate, and a Xenon flash lamp for photography (23WS, same as predicate, but with an improved optical system for fluorescence). The maximum rated flash bulb from the predicate is used. |
| Functionality Comparison | All key functional specifications (use condition, picture angle, working distance, observation, storage media, camera spec., image data format, diopter compensation, observation light source, photographing light source, power consumption, weight) are either identical ("SAME to GENESIS-D") or represent an improvement while maintaining essential equivalence. | Meets Criteria: - Intended Use, Use Condition, Picture Angle, Working Distance, Observation, Storage Media, Camera Spec., Image Data Format, Diopter Compensation, Observation Light Source, Weight of Camera unit: All are explicitly stated as "SAME to GENESIS-D".- Photographing Light Source: Xenon flash lamp 23WS (same as predicate) but "with improved optical system" for fluorescence angiography. This is an enhancement within a substantially equivalent framework.- Power Consumption: 150VA (higher than predicate's 60VA) due to enlarged power supply for fluorescence function, but this change was evaluated for safety. |
2. Sample Size Used for the Test Set and the Data Provenance
This 510(k) notification does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or performance against a ground truth dataset of patient images. Instead, it focuses on technical and safety comparisons to a predicate device.
- Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The submission relies on technical specifications, engineering comparisons, and safety/EMC testing.
- Data Provenance: Not applicable for patient data. The provenance relates to engineering test data and specifications, likely from Kowa Company, Ltd. (Japan) where the device is manufactured and designed. The submission itself is prospective, detailing a new device based on an existing one.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission does not involve evaluation of diagnostic performance against expert-established ground truth. The "ground truth" for the claims made in this document relates to the technical specifications and safety profile of the predicate device, against which the new device is compared. This would involve internal engineering expertise at Kowa Company, Ltd.
4. Adjudication Method for the Test Set
Not applicable, as no clinical "test set" was described for diagnostic performance evaluation.
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
Not applicable. This device is an ophthalmic camera, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on hardware and functional comparison, not a comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (ophthalmic camera) and does not involve a standalone algorithm for diagnostic or screening purposes.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established technical specifications, safety data (light hazard, electrical safety, EMC), and functional performance of the predicate device, KOWA GENESIS-D (K050271). The new device (KOWA GENESIS-Df) is compared directly against these documented characteristics to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI algorithm being trained as part of this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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5100k) notification
5.0 510(k) Summary
Applicant:
Contact:
AUG 0-7 2009
Kowa Company, Ltd. 4-14, Nihonbashi-honcho 3-Chome Chuo-ku, Tokyo, 103-8433 Japan
Akihiro Fujita
April 10 , 2009
KOWA GENESIS-Df
Date Summary Prepared:
Device Trade Name:
Classification name:
Product Code:
CAMERA, OPHTHALMIC, AC-POWERED HKI
Intended use:
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
Comparison:
KOWA GENESIS Df makes basics structures are the same as that of KOWA GENESIS-D. The reflectance of the reflective mirror of a flash lamp and the transmissivity of the optical pass system of an optical fiber were raised by having added the function of Fluorescent angiography (PA). Moreover, design change of electrical circuit and capacitance were enlarged compared with KOWA GENESIS-D. Therefore, evaluation of light hazard, electrical safety, and EMC was performed, and it was checked that device safety is a level equivalent to KOWA GENESIS-D.
The KOWA GENESIS-Df is similar to the KOWA GENESIS-D in that it is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured. Both devices are equipped with highly sensitive CCD cameras, and use a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort.
Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting.
Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.
The function comparison of KOWAGENESIS-Df and the predicate devices is shown in the comparison table below:
Kowa Company, Lid., KOWA GENESIS-Df
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51000 notification
| Predicate Device | Manufacturer | 510(k)No. | Date Cleared |
|---|---|---|---|
| KOWA GENESIS-D | Kowa Company, Ltd. | K050271 | Nov. 03, 2005 |
Table 5-2: Predicate device comparison table
| KOWA GENESIS-Df | KOWA GENESIS-D | |
|---|---|---|
| Intended use | A hand-held mydriatic retinal camera which captures fundus image. | A hand-held mydriatic retinal camera which captures fundus image. |
| Use condition | SAME to GENESIS-D | with mydriatic |
| Picture angle | SAME to GENESIS-D | Horizontal: 30 degreeVertical: 25 degree |
| Working distance | SAME to GENESIS-D | 5mm |
| Observation | SAME to GENESIS-D | Visual observation |
| Storage media | SAME to GENESIS-D | Flash memory card |
| Camera spec. | SAME to GENESIS-D | Color CCD camera2,000,000 pixels |
| Image data format | SAME to GENESIS-D | JPEG and uncompressed format |
| Diopter compensation | SAME to GENESIS-D | $-15D~+35D$ |
| Observation Light Source | SAME to GENESIS-D | Visible LED4VA(approx. 1W) |
| Photographing Light Source | Xenon flash lamp23WSwith improved optical system* | Xenon flash lamp23WS |
| Power consumption | 150VA | 60VA |
| Weight of Camera unit | approx. 1kg | approx. 1kg |
- The maximum rated of the flash bulb currently used is using the KOWA GENESIS-D. For fluorescence photographing function loading, capacity of the power supply was enlarged, inputs energy was enlarged, and amount of luminescence was increased by improving the efficiency of optical systems.
Conclusion:
The KOWA GENESIS-Df is equipped with the same fundamental technology as the predicate devices and maintains the same level of safety performance. Therefore it has been concluded that there are no significant differences in the fundamental function or safety between KOWA GENESIS-Df and the predicate devices.
Kowa Company, Ltd., KOWA GENESIS-DJ
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
KOWA Company, Ltd. c/o Mr. Akihiro Fujita General Manager 4-14, Nihonbashihoncho 3-chome Chuo-ku, Tokyo Japan 103-8433
AUG 0-7 2009
Re: K091098
Trade Name: KOWA Genesis-Df Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: July 3, 2009 Received: July 6, 2009
Dear Mr. Fujita:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If 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/default.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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander Jr.
Malyina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) notification
Indication for Use
510(k) Number (if known):
$\qquad K09/098$
Device Name: KOWA GENESIS-Df
Indication For Use: KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or Over the Counter Use … (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
8/7/2009
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Kowa Company, Ltd., KOWA GENESIS-Df
SIS-D/
510(k) Number K091098
§ 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.