KOWA VX-10I by KOWA CO. LTD. | FDA 510(k) Summary

I am sorry, but the provided text is a 510(k) clearance letter for the Kowa VX-10i Fundus Camera. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain information regarding:

Acceptance criteria or reported device performance in a table format.
Details of a study proving the device meets acceptance criteria.
Sample sizes for test sets or training sets.
Data provenance.
Number or qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
Standalone algorithm performance.
Type of ground truth used.
How ground truth for the training set was established.

The letter's purpose is to grant market clearance based on substantial equivalence, not to present detailed performance study results.

Summary

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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.

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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

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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 ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.