(35 days)
Not Found
Not Found
No
The summary describes standard non-prescription sunglasses and contains no mention of AI, ML, or related concepts.
No
The device is described as "Sunglasses" intended to protect eyes from bright sunlight, which is not considered a therapeutic function. Therapeutic devices are typically used to treat, alleviate, or cure a disease or condition.
No
The device is described as sunglasses intended to protect eyes from bright sunlight and does not mention any function related to diagnosing a condition or disease.
No
The device is described as sunglasses, which are a physical hardware 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 the eyes from bright sunlight. This is a physical function, not a diagnostic one.
- Device Description: It's described as "Sunglasses, Nonprescription," which are not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Using reagents or calibrators.
Therefore, the COIL Pathfinder Sunglasses are a non-diagnostic device intended for eye protection.
N/A
Intended Use / Indications for Use
COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.
Product codes
86 HQY
Device Description
Sunglasses, Nonprescription, Class I
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Adult and Child
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)
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/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Ms. Janice Popielewski COIL, A Division of COIN Controls, Inc. c/o Medical Reports Exchange, Inc. 1314 North Hunter St. Suite 202 Baltimore, MD 21202
Re: K971495 Trade Name: Pathfinder Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: April 22, 1997 Received: April 24, 1997
Dear Ms. Popielewski:
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
Page 2 - Ms. Janice Popielewski
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 at (301) 443-6597.
Sincerely yours,
Alberl 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):
Device Name: Sunglasses, Nonprescription, Class I 886.5850, 86HQY
Indications for Use: ---------------------------------------------------------------------------------------------------------------------------------------------------------
. The The The State of the States of the States of the States of the States of the States of the States of the States of the States of the States of the States of the Childre
COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.
Target Population: Adult and Child
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
An Williams
Division of Ophthalmic Devices
| Prescription Use | OR | Over-the-Counter |
|---|---|---|
| Use | ||
| (Per 21 CFR 801.109) |