(107 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms in medical imaging. The description focuses solely on the device's function as a fundus camera.
No
The device is described as a fundus camera, intended for taking pictures of fundus images. It does not mention any therapeutic function or intervention.
No
Explanation: The KOWA VX-10i Fundus Camera is intended for taking pictures of fundus images. While these images may be used later for diagnosis by a human expert, the device itself is described as an imaging tool ("taking pictures") rather than one that interprets or analyzes these images to provide a diagnosis directly. There is no mention of analysis, interpretation, or diagnostic outputs from the device itself.
No
The device description explicitly states "KOWA VX-10i Fundus Camera," indicating it is a hardware device designed for capturing fundus images. The summary does not mention any software component as the primary or sole medical device.
Based on the provided information, the KOWA VX-10i is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for taking pictures of fundus images". This describes an imaging device used to capture images of a part of the body (the fundus of the eye).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health based on laboratory analysis. It's purely about capturing images.
Therefore, the KOWA VX-10i is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KOWA VX -10i is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Product codes
HKI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three lines representing the body and head, and three curved lines representing the legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kowa Co. Ltd. c/o Richard Phillips, Ph.D. Quintiles Consulting, Inc. 1801 Rockville Pike, Suite 300 Rockville, MD 20852
NOV 0 1 2006
Re: K062021
Trade/Device Name: Kowa VX-10i Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: October 23, 2006 Received: October 23, 2006
Dear Dr. Phillips:
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.
1
Page 2 - Richard Phillips, Ph.D.
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. Egbert Simund
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
2
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: KOWA VX-10i
Indications For Use:
KOWA VX -10i is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marsha L. Burke Nicholas
Division Sion-Off Division of Ophthalmic Ear, Nose and Throat Devises
KO62021 510(k) Number __
Page 1 of ____________________________________________________________________________________________________________________________________________________________________