(198 days)
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No
The summary describes a standard soft contact lens for vision correction and cosmetic enhancement, with no mention of AI/ML technology or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device is indicated for enhancing the color/size/definition of the iris, correcting refractive ametropia (myopia), and protecting against UV radiation. While correcting ametropia could be argued as therapeutic, the primary indication as a contact lens for vision correction and aesthetic enhancement, rather than treating an underlying disease or condition, makes it primarily a corrective and cosmetic device.
No
Sensory aids (like contact lenses) that do not actively measure or assess a physiological state or parameter are not considered diagnostic devices. This device is indicated for enhancing the color/size/definition of the iris and/or correcting refractive ametropia.
No
The device description explicitly states it is a "Soft (hydrophilic) contact lens," which is a physical medical device, not software.
Based on the provided information, the FreshKon® Contact Lens is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- FreshKon® Contact Lens Function: The description clearly states the contact lens is for:
- Enhancing the appearance of the eye (color, size, definition).
- Correcting refractive errors (myopia).
- Protecting against UV radiation.
- No Sample Testing: The device is worn directly on the eye and does not involve testing any biological samples.
Therefore, the FreshKon® Contact Lens falls under the category of a medical device, but specifically a contact lens for vision correction and cosmetic enhancement, not an IVD.
N/A
Intended Use / Indications for Use
The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Product codes
LPL, MVN
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, cornea, iris
Indicated Patient Age Range
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Intended User / Care Setting
Eye Care Professionals
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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§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
February 15, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Oculus Private Ltd. % Mr. Kevin Walls, RAC Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton CO 80127
Re: K122315
Trade/Device Name: FreshKon® 1-Day Alluring Eyes (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Mosaic (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Colors Fusion (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Dezigner (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (hydrophilic) contact lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: February 4, 2013
Received: February 5, 2013
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Kevin Walls, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
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for N
for Malvina B Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K122315
Device Name:_FreshKon® 1-Day Alluring Eyes (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Mosaic (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Colors Fusion (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Dezigner (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
Indications For Use:
The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joseph C 2013.02 11 55:28 -05.00
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K122315