(81 days)
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No
The provided text describes contact lenses and their intended use, with no mention of AI or ML technology.
No
The device is a contact lens used to correct vision (ametropia, presbyopia, astigmatism), not to treat a disease, injury, or to restore/modify body functions.
No
Explanation: The device is a contact lens designed for vision correction (ametropia, presbyopia, astigmatism) and does not diagnose medical conditions. Its intended use is to correct optical defects, not to identify or analyze diseases.
No
The device description and intended use clearly describe a physical contact lens, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the Eni-Eye contact lenses is to correct vision problems (ametropia, presbyopia, astigmatism) by being placed directly on the eye. They do not analyze or test any biological samples.
- The intended use clearly describes a therapeutic/corrective function. The lenses are designed to alter the way light enters the eye to improve vision, not to diagnose a condition based on a sample.
The description focuses on the physical properties and function of the contact lens itself, which is consistent with a medical device used for vision correction.
N/A
Intended Use / Indications for Use
- The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
- The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
- The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.
Product codes
LPL
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck form the first profile, and the subsequent profiles are suggested by the eagle's body and wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Soflex Contact Lens IndustriesLtd. c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127
JUN - 6 2003
Re: K030842
Trade/Device Name:
Eni - Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear, Eni -- Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear and Eni - Eye Toric (acofilcon 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 Dated: March 14, 2003 Received: March 16, 2003
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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Kevin Walls, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Rakyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K030842 510(k) Number (if known): __________
Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Device Name: Lens for Daily Wear
Eni-Eye Q (Acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
Eni-Eye Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
- Indications for Use: The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jonsel W.C. Brown, Ph.D.
(Division Sign-Off) Division of Ophthalmic Devices
K030842 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)