(14 days)
Not Found
Not Found
No
The summary describes non-prescription sunglasses, which are a simple optical device and there is no mention of AI or ML in the provided text.
No
Explanation: The device is described as non-prescription sunglasses for general use to protect eyes from strong sunlight, which is a protective function, not a therapeutic one.
No
The intended use states that the device is "Non-prescription sunglasses...to protect eyes from strong sunlight," which is a protective function, not a diagnostic one. There is no mention of identifying, detecting, or monitoring any health condition or disease.
No
The device is described as non-prescription sunglasses, which are a physical product, not software.
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 eyes from strong sunlight." This is a physical protection function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While "Not Found" is listed, the intended use clearly indicates a non-diagnostic purpose.
- No Mention of Biological Specimens: There is no mention of the device interacting with or analyzing biological specimens (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No Diagnostic Claims: The intended use does not make any claims about diagnosing, monitoring, or screening for any disease or condition.
Therefore, based on the information provided, non-prescription sunglasses for general use are not considered In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Non-prescription sunglasses are for general use to protect eyes from strong sunlight
Product codes
86 HQY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
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
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows a date, "DEC - 8 1997". The month is December, the day is the 8th, and the year is 1997. The text is in a bold, sans-serif font. The background is white.
Mr. Alexander B. Kim President Morning Calm Corp. 1106 Seong An Officetel 87-36, Duryu- 2Dong, Dalseo-Gu Daegu, 704-062 Korea
Re: K974414
Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: November 13, 1997 Received: November 24, 1997
Dear Mr. Kim:
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 - Mr. Alexander B. Kim
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
| 40(k) Number (if known): | K974414 |
|---|---|
| Device Name: | Sunglasses |
| Indications For Use: | Non-prescription sunglasses are for general use to protect eyes from strong sunlight |
(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
Division of Ophthalmic Devices
510(k) Number K974414
Image /page/2/Picture/5 description: The image contains the words "cription Use" and "21 CFR 801.109)". The text is in a sans-serif font and is black. The text is likely part of a larger document or label.
Over-The-Counter Use ✓