(37 days)
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Not Found
No
The summary describes standard sunglasses for eye protection from sunlight and does not mention any AI or ML components or functionalities.
No.
Explanation: The primary intended use of the device is to protect eyes from bright sunlight, which is a prophylactic function rather than a therapeutic one (treating or curing a disease or condition). It also explicitly states it "can't provide refractive corrections," further indicating it's not for vision correction therapy.
No
Explanation: The document states the device's main use is to protect the eyes from bright sunlight. It does not mention any diagnostic capabilities, such as detecting, monitoring, or diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (frames and lenses) and does not mention any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The described device is sunglasses. Its intended use is to protect the eyes from bright sunlight. It does not involve the examination of any biological specimens.
The provided information clearly indicates the device is a protective eyewear, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic. As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections.
Product codes
86 HQY
Device Description
The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic.
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
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Ms. Merry Chen Dugiao Glasses (Group) Co., Ltd. 279 Fugian Street, Duqiao Linhai, Zhejiang China
Re: K971551 -Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: April 1, 1997 Received: April 28, 1997
Dear Ms. Chen:
1:4
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.
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Page 2 - Ms. Merry Chen
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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INDICATION FOR USE STATEMENT
510(K) Number: K971551
Device Name: Sunglasses -
Indication For Use:
The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic.
As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections.
Am William
(Division Sign-Off)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K97155T
Over-the-Counter Use