(188 days)
Not Found
No
The summary describes a retinal imaging device with image capture, filing, and transfer capabilities. There is no mention of AI, ML, or advanced image processing beyond basic display and storage. The performance studies focus on safety and standard compliance, not algorithmic performance metrics typically associated with AI/ML.
No.
The device is described as a "retinal image shooting device" intended for "taking pictures of retinal images," which indicates a diagnostic imaging purpose, not a therapeutic one.
No
The device is described as a retinal image shooting device to take pictures, and its intended use is for taking pictures of retinal images. It does not state that it analyzes, interprets, or diagnoses medical conditions, only that it captures images. While these images may later be used for diagnostic purposes by a clinician, the device itself is not presented as performing diagnostics.
No
The device description explicitly states it is a "retinal image shooting device" and mentions hardware components like an LCD monitor, USB ports, and an Ethernet port. It also details performance studies related to electrical safety, electromagnetic compatibility, optical safety, and biocompatibility, which are typical for hardware medical devices.
Based on the provided information, the KOWA VX-20 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "taking pictures of retinal images." This describes a process of capturing images of a part of the body, not performing tests on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description focuses on the device's ability to capture different types of retinal images and store/transfer them. It doesn't mention any analysis or testing of biological samples.
- Anatomical Site: The device operates on the "Retinal," which is an in-vivo (within the living body) site. IVD devices typically work with in-vitro (outside the living body) samples.
- Lack of IVD-related terms: The description and performance studies do not mention any terms commonly associated with IVD devices, such as "sample," "reagent," "assay," "analyte," "diagnosis based on sample analysis," etc.
- Performance Studies: The performance studies focus on safety standards (electrical, optical, biocompatibility), software validation, and risk management, which are typical for medical devices that interact with the body, but not specifically for IVD performance (like accuracy of measuring an analyte).
In summary, the KOWA VX-20 is a medical device used for capturing images of the retina for diagnostic purposes, but it does not perform in vitro diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI, NFJ
Device Description
The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF).
The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor.
The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.
Mentions image processing
The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Retinal images captured with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF).
Anatomical Site
Retinal
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)
The KOWA VX-20 is tested in accordance with ISO10940. The KOWA VX-20 met all requirements of the standard.
To guarantee Electrical safety, IEC60601-1 test was performed. The KOWA VX-20 met all requirements of the standard.
To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The KOWA VX-20 met all requirements of the standard.
To guarantee Optical safety, ISO15004-2 evaluation was performed. The KOWA VX-20 met all requirements of Group 2 instrument in the standard.
To make sure Software validity of the KOWA VX-20 embedded softwares, evaluation based on FDA guidance, "Guidance for the content of premarket submissions for software contained in medical devices, 2005", was performed. The levels of concern of these software items are moderate. The validation of these software items is performed as a part of system function test. All functions are tested and confirmed good working to required items.
To guarantee biocompatibility, biocompatibility assessment was performed. The materials were used the same of the other legally marked devices in US or were evaluated under the Material Safety Data Sheet (MSDS).
The KOWA VX-20 was evaluated in accordance with ISO14971: 2007. The risk management of the device was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI12330
FEB 1 6 2012
owa) Kowa Company. Ltd.
ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)3-3279-7646 FAX: +81-(0)3-3279-7621
510(k) Summary
Submitter information:
| Applicant: | Kowa Company, Ltd.
4-14, Nihonbashi-honcho 3-Chome
Chuo-ku, Tokyo, 103-8433 Japan
Phone: +81-3-3279-7646
Fax: +81-3-3279-7621 |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Hiroyuki Koide |
| Date summary prepared: | August 10, 2011 |
| Device identification:
Device trade name:
Classification name: | KOWA VX-20
Camera, Ophthalmic, AC-powered |
Classification name:
System, Image Management, Ophthalmic HKI, NFJ
Identification of predicate devices:
Product code:
Kowa Company believes that this device is substantially equivalent to: KOWA VX-10α manufactured by Kowa, 510(k)# K091683, Canon CX-1 Retinal Camera manufactured by Canon, 510(k)# K092565.
Device description:
The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF).
The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor.
The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.
Intended use:
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
Technical characteristics: Performance
1
510(k) Notification
The KOWA VX-20 is tested in accordance with ISO10940. The KOWA VX-20 met all requirements of the standard.
Electrical safety
To guarantee Electrical safety, IEC60601-1 test was performed. The KOWA VX-20 met all requirements of the standard.
Electromagnetic compatibility
To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The KOWA VX-20 met all requirements of the standard.
Optical safety
To guarantee Optical safety, ISO15004-2 evaluation was performed. The KOWA VX-20 met all requirements of Group 2 instrument in the standard.
Software evaluation
To make sure Software validity of the KOWA VX-20 embedded softwares, evaluation based on FDA guidance, "Guidance for the content of premarket submissions for software contained in medical devices, 2005", was performed.
The levels of concern of these software items are moderate.
The validation of these software items is performed as a part of system function test. All functions are tested and confirmed good working to required items.
Biocompatibility
To guarantee biocompatibility, biocompatibility assessment was performed. The materials were used the same of the other legally marked devices in US or were evaluated under the Material Safety Data Sheet (MSDS).
Risk Management
The KOWA VX-20 was evaluated in accordance with ISO14971: 2007. The risk management of the device was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.
Conclusion
KOWA VX-20 is equipped with the fundamental technology to the predicate devices for retinal image capturing and also delivers the equivalent level of safety. Therefore, it is concluded that there is no difference in the basic functions and safety between KOWA VX-20 and the predicate devices.
2
510(k) Notification
| Table A: Predicate Device Comparison | |||
|---|---|---|---|
| Device Name | KOWA VX-20 | KOWA VX-10α | Canon CX-1 Retinal |
| Cameras | |||
| 510(k) number | - | K091683 | K092565 |
| Indications for use | Same as | ||
| KOWA VX-10α | The device is intended for | ||
| taking pictures of fundus | |||
| images with mydriatic or | |||
| without mydriatic. | The device is intended to be | ||
| used for taking digital | |||
| images of retinal of human | |||
| eye with non-mydriatic and | |||
| mydriatic. | |||
| Photography mode | Non-mydriatic, | ||
| Mydriatic color, | |||
| FA, | |||
| Red free, | |||
| FAF (optional) | Non-mydriatic | ||
| Mydriatic color | |||
| FA | COLOR | ||
| FLUO (FA) | |||
| RED FREE | |||
| COBALT | |||
| FAF |
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kowa Company, Ltd. c/o Mr. Hiroyuki Koide Section Manager, Regulatory Affairs Section 4-14 , Ninonbashihonco 3-Chrome Chuo-ku, Tokyo 103-8433 Japan
Re: K112330
Trade/Device Name: KOWA VX-20 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, NFJ Dated: January 19, 2012 Received: January 20, 2012
FEB 1 6 2012
Dear Mr. Koide:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
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 (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.
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/ReportaProblem/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Notification
Indications for Use 4.0
KII2330 510(k) Number (if know):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
Over-The-Counter Use_ X Prescription Use_ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR
(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
Mausha L. Burke nicholas
... Neurological and Ear, ﻻﺋﻦ: ﺍﻧﺘﻈﺎﺭ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻭﺭ ﺍ
112330 . ., .; .; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Kowa Company Ltd., KOW.1 VX-20