(25 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The device is described as protective eyewear.
No
The device is intended to protect eyes from sunlight, which is a preventative measure, not a therapeutic treatment for a disease or condition.
No
The "Intended Use / Indications for Use" states the device is "TO PROTECT THE EYES FROM SUNLIGHT," which is a protective function, not a diagnostic one.
No
The provided information describes a device intended to be worn by children to protect their eyes from sunlight. This strongly suggests a physical device (like sunglasses or goggles) and lacks any 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 BE WORN BY CHILDREN TO PROTECT THE EYES FROM SUNLIGHT." This describes a physical barrier for protection, not a test performed on biological samples to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
This device appears to be a non-diagnostic protective device.
N/A
Intended Use / Indications for Use
INTENDED TO BE WORN BY CHILDREN TO PROTECT THE EYES FROM SUNLIGHT.
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
CHILDREN
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)
Not Found
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.
Not Found
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
§ 886.5850 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling its emblem. The emblem is a stylized representation of a human figure, composed of three wavy lines, symbolizing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Mr. Irwin Sherman President Tamfort Ltd. c/o Locker Greenberg & Brainin, P.C, 420 Fifth Ave. New York, NY 10018
Re: K972014 Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: May 27, 1997 Received: May 30, 1997
Dear Mr. Sherman:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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 L. 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 of 1
510(k) Number (if known):_ K972014
Device Name: SUNGLASSES
Indications For Use:
INTENDED TO BE WORN BY CHILDREN TO PROTECT THE EYES FROM SUNLIGHT.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
EEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K972014
Prescription Use (Per 21 CFR 801 109)
਼ਸ
Over-The-Counter Use √
(Optional Format 1-2-96)
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