(25 days)
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Here's a summary of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) submission for a modification, not a detailed clinical study report with performance metrics in the typical sense.
The core of this submission is a comparison to a predicate device, arguing substantial equivalence rather than presenting new performance data for specific clinical metrics.
Description of the Device and Modification:
The device is the KOWA GENESIS-D, a hand-held mydriatic retinal camera intended to capture and save fundus images. The specific submission (K080681) is for a modification: the addition of an indirect diagnostic lens holder (K9L-LH51) as an optional accessory to the previously cleared KOWA GENESIS-D (predicate device K0530271).
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate):
The "acceptance criteria" in this context are implicitly that the modified device (KOWA GENESIS-D with indirect diagnostic lens holder) performs equivalently in its intended use as the original KOWA GENESIS-D. The submission argues that the modification (the lens holder) does not change the fundamental technology, safety, or effectiveness of the device.
| Acceptance Criteria (Features/Characteristics) | Reported Device Performance (KOWA GENESIS-D with indirect diagnostic lens holder) | Explanation/Proof |
|---|---|---|
| Intended Use (Capture & save fundus images with mydriatic) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Use Condition (with mydriatic) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Picture Angle (Horizontal: 30 deg, Vertical: 25 deg) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Working Distance (5mm) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Observation (Visual observation) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Storage Media (Flash memory card) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Camera Spec. (Color CCD, 2M pixels) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Image Data Format (JPEG & uncompressed) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Diopter Compensation (-15D to +35D) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Observation Light Source (Visible LED, 4VA) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Photographing Light Source (Xenon flash, 23WS) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Optional Goods (Indirect diagnostic parts, K9L-LH51) | Indirect diagnostic parts, K9L-LH51 (this is the addition) | This is the specific modification being submitted for. The predicate explicitly states "Not applicable" for this field, highlighting the change. |
| Power Consumption (60VA) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Weight of Camera Unit (approx. 1kg) | Same | Stated explicitly in Table B: "Same" as predicate. |
Study Details:
The provided document does not describe a clinical performance study in the typical sense (e.g., measuring sensitivity, specificity, accuracy against a reference standard). Instead, it's a 510(k) premarket notification focused on demonstrating substantial equivalence to a predicate device. This means the "study" is a comparison of technical specifications and intended use.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The "test" consists of comparing specifications. The data provenance for the original device (K0530271) is not in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was performed for this submission. The "ground truth" here is that the modified device has the same properties as the predicate device, which is established by the manufacturer's engineering comparison and verification.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.
- 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 is not an AI/CADe device, and no MRMC study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. It's a medical imaging hardware device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. The "truth" for this submission is that the technical specifications of the modified device are the same as the predicate, which is a manufacturing and design verification process.
- The sample size for the training set: Not applicable. This is not a machine learning/AI device, and no training set was used.
- How the ground truth for the training set was established: Not applicable. See point 7.
Summary of the "Study" (Substantial Equivalence Argument):
- Objective: To demonstrate that the KOWA GENESIS-D hand-held retinal camera with the addition of the indirect diagnostic lens holder (K9L-LH51) is substantially equivalent to the predicate device (KOWA GENESIS-D without the accessory).
- Methodology: A direct comparison of technical specifications, intended use, operating principles, basic design, materials, power supply, light source, and packaging was conducted between the modified device and the predicate.
- Conclusion: The submitter concluded that the KOWA GENESIS-D with the indirect diagnostic lens holder shares the "same fundamental technology and maintain the same level of safety performance" as the predicate device, therefore having "no significant differences in the technological characteristics and safety." The FDA concurred with this assessment, hence the 510(k) clearance.
{0}------------------------------------------------
9. Certification 9.1 Summary for public disclosure
Submitter information:
'은 대한민국 대학교
| Applicant: | Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-5623-8063Fax: +81-3-5623-8060 |
|---|---|
| Contact: | Satohiko Takanashi, PE |
| E-mail address: | s-takana@kowa.co.jp |
| Date summary prepared: | March 7, 2008 |
Device identification:
| Device trade name: | KOWA GENESIS-D |
|---|---|
| Classification name: | CAMERA, OPTHALMIC, AC-POWERED |
| Product code: | HKI |
Intended use:
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Comparison:
The KOWA GENESIS-D was chosen as a substantially equivalent device. This modification is addition of optional goods for the predicate device. The predicate device 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.
The KOWA GENESIS-D and indirect diagnostic lens holder with lens has the following similarities to those of the predicate device:
- has the same indicated use,
- uses the same operating principle,
- incorporates the same basic optical design without the lens holder and lens,
- incorporates the same materials,
- incorporates the same power supply parts and circuits,
- incorporates the same light source,
- is packaged.
Sunny of the country of
{1}------------------------------------------------
The only modification that was made is addition of the indirect diagnostic lens holder as an optional goods for the predicate device.
The comparison table of the predicate device and it with the indirect diagnostic lens holder is shown in Table B.
In summary, the predicate device with the indirect diagnostic lens holder described in this submission is substantially equivalent to the predicate device.
Conclusion:
:
The KOWA GENESIS-D and the indirect diagnostic lens holder with lens are equipped with the same fundamental technology and maintain the same level of safety performance. Therefore it has been concluded that there are no significant differences in the technological characteristics and safety of KOWA GENESIS-D that were cleared by addition the indirect diagnostic lens holder with lens.
Table A: Predicate device
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| KOWA GENESIS-D | Kowa Company, Ltd. | K0530271 | Nov. 3, 2005 |
{2}------------------------------------------------
| Table B. Predicate device comparisonKOWA GENESIS-D and indirectdiagnostic lens holder, K9L-LH51 | KOWA GENESIS-D | |
|---|---|---|
| Intended use | Same | A hand-held mydriatic retinal camerawhich captures fundus image. |
| Use condition | Same | with mydriatic |
| Picture angle | Same | Horizontal: 30 degreeVertical: 25 degree |
| Working distance | Same | 5mm |
| Observation | Same | Visual observation |
| Storage media | Same | Flash memory card |
| Camera spec. | Same | Color CCD camera2,000,000 pixels |
| Image data format | Same | JPEG and uncompressed format |
| Dioptercompensation | Same | $-15D~+35D$ |
| Observation LightSource | Same | Visible LED4VA(approx. 1W) |
| PhotographingLight Source | Same | Xenon flash lamp23WS |
| Optional goods | Indirect diagnostic parts,K9L-LH51 | Not applicable |
| Powerconsumption | Same | 60VA |
| Weight ofCamera unit | Same | approx. 1kg |
.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
KOWA Company, Ltd. c/o Satohiko Takanashi, PE 4-14, Nihonbashi-Honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan
Re: K080681
Trade/Device Name: Kowa Genesis-D Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 7, 2008 Received: March 10, 2008
Dear Mr. Takanashi:
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.
{4}------------------------------------------------
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Marina B. Egleston, und
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Notification
Indications for Use
K080681510(k) Number (if know):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
Derexhl 3/25/2008
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
.
.
Kowa Company, Ltd., Modification of KOWA GENESIS-D
510(k) Number
12
§ 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.