VENNETO by AMSURE SPORTS, INC. | FDA 510(k) Summary

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Device Description

AI/ML Overview

The provided text is related to a 510(k) premarket notification for "Venneto Sunglasses." This type of regulatory document, particularly for Class I devices like sunglasses, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with acceptance criteria, human-in-the-loop performance, or AI assistance.

Therefore, the input does not contain information about:

Acceptance criteria and reported device performance in a table format.
Sample sizes for test sets, data provenance, ground truth establishment, or training sets.
The number or qualifications of experts.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies.
The type of ground truth used (pathology, outcomes data, etc.).

The document solely confirms that the Venneto Sunglasses are classified as a Class I device and are substantially equivalent to pre-amendment devices, allowing them to be marketed under general controls.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Ms. Wendy W. C. Siu Treasurer Amsure Sports, Inc. 1818 Naio Street, Suite B Honolulu, Hawaii 96817

Re: K974045 Trade Name: Venneto Sunglasses Regulatory Class: I Product Code: 86HQY Dated: October 20, 1997 Received: October 24, 1997

Dear Ms. Siu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Wendy W.C. Siu

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K974045

Device Name: Sunglasses

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
297404

Prescription Use (Per 21 CFR 801.109) OR

510(k) Number

Over-The-Counter Use XXX

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.5850 Sunglasses (nonprescription).

(a)
Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.