(181 days)
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No
The provided text describes various types of contact lenses and their intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for conditions like keratoconus management and irregular cornea, which involve treating or managing a disease or condition, making it a therapeutic device.
No
Explanation: The device is a contact lens indicated for the correction of refractive errors and presbyopia, not for diagnosing conditions.
No
The device described is a contact lens, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of these contact lenses is for the correction of refractive errors (astigmatism, myopia, hyperopia, presbyopia) and for managing keratoconus and irregular corneas. This is a therapeutic and corrective function, not a diagnostic one.
- IVD Definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The contact lenses described here are applied directly to the eye and do not analyze bodily specimens.
The information provided clearly indicates these are medical devices for vision correction and management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system.
The Eni-Eye Q SH Multi (Efrofilcon 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-Eye Q SH Multi Toric (Efrofilcon 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 SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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).
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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
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 eagle or bird-like symbol with three curved lines forming its body and head. Below the bird-like symbol are three wavy lines, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Soflex Isralens Contact Lens Ltd. % Mr. Kevin Walls, RAC Principal Consultant Regulatory insight Inc. 5401 S Cottonwood Court Greenwood Village, CO 80121
Re: K110261
Trade/Device Name: 1) Eni-Eye SH Toric (Efrofilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear
-
- Eni-Eye O SH Multi (Efrofilcon A) Soft (Hydrophilic) Multifocal Contact lens for Daily Wear
JUL 2 8 2011
- Eni-Eye O SH Multi (Efrofilcon A) Soft (Hydrophilic) Multifocal Contact lens for Daily Wear
-
- Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
-
- Eni-Eye SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear
-
- Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea 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: July 8, 2011 Received: July 13, 2011
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.
1
Page 2-Mr. Kevin Walls, RAC
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device 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 round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toure of a rised 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 or and I with all the Act's requirements, including, but not limited to: registration and listing (21 oompy - manu: al: abeling (21 CFR Part 801); medical device reporting (reporting of medical CI it Fart 607); abouting (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou active specific ad reading a leanters offices/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/ReportalProblem/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 Fou may 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 yours,
Kesia Alexander
for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
510(k) Number (if known): _ K | 026 |
Device Name: Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use: The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system.
Prescription Use × 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Moridulike Virmani
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 5
510(k) Number_K 11026 1
3
510(k) Number (if known):
Device Name: The Eni-Eye Q SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
Indications for Use: The Eni-Eye Q SH Multi (Efrofilcon 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.
Prescription Use × 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miidulika Vismani
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 2 of 5
| CIALLA
AND THE FOR
| JULD' | A con come comments and consideration of the contribution of the first of the first of the first of the first of the first of the first of the first of the first of the first | ||
|---|---|---|---|
| -------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- |
4
510(k) Number (if known): K | | D2 6 |
Device Name: Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
Indications for Use: The Eni-Eye Q SH Multi Toric (Efrofilcon 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.
Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mridulika Virmani
(Division Sign-Off) (Division Sigi Oct)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 3 of 5
510(k) Number K110261
5
510(k) Number (if known): _ K 川ロスム
Device Name: ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear
Indications for Use: The ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
X
(subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hridulike Virman
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 4 of 5
510(k) Number K10261
6
510(k) Number (if known): K110261_
Device Name: Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear
Indications for Use: The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Ov
(21
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Horidulika Varmani (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 5 of 5
510(k) Number K110261