(34 days)
Not Found
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No
The summary provides no indication of AI/ML technology; it describes sunglasses.
No
The device is intended to protect eyes from bright sunlight, which is a protective function, not a therapeutic one (treatment or mitigation of disease).
No
The device is described as protecting the eyes from bright sunlight, which is a protective function, not a diagnostic one. It does not mention any ability to identify or characterize diseases or conditions.
No
The provided text describes a device intended to be worn on the eyes for protection from sunlight, which strongly suggests a physical, hardware-based device (like sunglasses). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect the eyes from bright sunlight". This is a physical protection function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- No Mention of IVD Characteristics: The description lacks any elements typically associated with IVDs, such as analyzing biological samples, detecting biomarkers, or providing diagnostic results.
Therefore, this device, which appears to be sunglasses or a similar protective eyewear, falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
Product codes
86 HQY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
person
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
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Elegance Optical Mfy. Ltd. C/o Ms. Esther Lai International Development Group, Inc. 401 Broadway, Suite 613 New York, NY 10013
Re: K973934 Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: October 8, 1997 Received: October 15, 1997
Dear Mr. Lai:
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, Olisting 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.
1
Page 2- Ms. Lai
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
2
510(k) Number (if known): X973934
vice Name: Sunglasses
Indications For Use:
Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amwilliams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K973934
Pription Use ( 1 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)