(24 days)
Not Found
No
The document describes standard sunglasses with UV and blue light protection, with no mention of AI or ML capabilities.
No
The device is described as non-prescription sunglasses intended to protect the eyes from sunlight, not to treat or diagnose a medical condition.
No
Explanation: The device is described as non-prescription sunglasses intended to protect eyes from sunlight, not to diagnose any condition.
No
The device is described as physical sunglasses, which are hardware, not software.
Based on the provided information, the Optim-Eyes 450 sunglasses are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to protect the eyes from sunlight and blue light. This is a physical protection function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as non-prescription sunglasses made of standard materials. This aligns with a protective eyewear device, not a diagnostic instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a person's health condition.
- Performance Studies: The performance studies focus on physical properties like drop ball testing and UV/blue light blocking, which are relevant to protective eyewear, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Optim-Eyes 450 sunglasses do not perform any such function.
N/A
Intended Use / Indications for Use
The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.
Product codes
86 HQY
Device Description
The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.
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)
All sunglass lots are drop ball tested in accordance with 21 C.F.R. § 801.410. The lenses meet and exceed current ANSI Z80.3 UV standards for "high and prolonged use", blocking virtually 100% both UVB and UVA radiation. In addition they strongly attenuate short-wave blue light.
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.
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
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
Optim-Eyes 450 Sunglasses 510(k) Summary
JUN 1 3 1997
1. Device Name
Classification Name: Proprietary Name:
Sunglasses (non-prescription), Class I Optim-Eyes 450 sunglasses
Device Sponsor 2.
Taylor/Fox Enterprises, L.L.C. 626 Santa Monica Blvd., Suite 101 Santa Monica, CA 90401 310-624-6277
3. Description of the Device
The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.
Safety and Effectiveness 4.
All sunglass lots are drop ball tested in accordance with 21 C.F.R. § 801.410.
The lenses meet and exceed current ANSI Z80.3 UV standards for "high and prolonged use", blocking virtually 100% both UVB and UVA radiation. In addition they strongly attenuate short-wave blue light.
Substantial Equivalence 4.
The Optim-Eyes 450 sunglasses are substantially equivalent to commercially available sunglass products, including the Blublocker sunglasses (K900382).
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Mr. Adam Taylor Taylor/Fox Enterprises L.L.C. c/o King & Spalding 1730 Pennsylvania Ave. N.W. Washington, D.C. 20006
Re: K971875 Trade Name: Optim-Eyes 450 Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: May 5, 1997 Received: May 20, 1997
Dear Mr. Taylor:
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 I'lectronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Adam Taylor
11
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
3
510(k) Number (if known):
续
Optim-Eyes 450 sunglasses Device Name:
indications For Use:
二
く)
())
The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
Number K971875
Prescription Use (Pex 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)