(127 days)
No
The summary describes a standard soft contact lens with specific material properties and design parameters. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No.
The device is indicated for the correction of refractive error in non-diseased eyes (myopia or hyperopia) and for cosmetic purposes (to enhance or alter eye color), not to treat or cure a disease or condition.
No
Explanation: The device, EYEREVE contact lenses, is indicated for the correction of refractive error (myopia, hyperopia, astigmatism) in individuals with non-diseased eyes. Its purpose is to physically modify light entering the eye to improve vision, not to diagnose a condition or disease.
No
The device description clearly describes a physical contact lens made of specific materials with defined physical properties and dimensions. It is a tangible medical device, not software.
Based on the provided text, the EYEREVE Soft Contact Lenses are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- EYEREVE's Intended Use: The intended use of the EYEREVE contact lenses is clearly stated as the correction of refractive error in the eye. This is a direct interaction with the body (on the surface of the eye) for a therapeutic purpose (correcting vision), not for examining specimens outside the body to gain diagnostic information.
- Device Description: The device description details the physical properties and materials of the contact lens itself, not components or reagents used for analyzing biological samples.
- Performance Studies: The performance studies focus on the safety and effectiveness of the lens for its intended use (correcting vision), including toxicology and physicochemical properties, not on the accuracy or reliability of diagnostic measurements.
In summary, the EYEREVE Soft Contact Lenses are a medical device, but they fall under the category of devices used for correcting vision and are applied directly to the eye, which is not the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EYEREVE (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The EYEREVE (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.
Product codes
LPL, MVN
Device Description
The EYEREVE Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).
A UV absorbing monomer-2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyphenyl]ethyl methacrylate-is incorporated in the EYEREVE contact lens material to block UV radiation. The UV blocking characteristics of the lens are as follows:
o >95% in the UVB range of 280nm 315nm
o >67% in the UVA range of 316nm 380mm.
EYEREVE Soft Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:
Name of Colorant: Titanium Dioxide, Listing: 21 CFR § 73.3126
Name of Colorant: Phthalocyanine Green, Listing: 21 CFR § 73.3124
Name of Colorant: Carbazole Violet, Listing: 21 CFR § 73.3107
Name of Colorant: Reactive Blue 19, Listing: 21 CFR § 73.3127
Name of Colorant: C.I. Reactive black 5, Listing: 21 CFR § 73.3127
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:
Refractive Index: 1.40 (hydrated)
Light Transmission: greater than 98%
Light Transmission (tinted): greater than 96% (at region corresponding to pupil); Opaque or 0-10% (at region corresponding to iris)
Water Content: 54 % ± 2%
Oxygen Permeability: 21.50 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C)
The EYEREVE soft contact lenses will be manufactured in the sphere and toric design configurations with the following features and properties:
Chord Diameter: 12.80 mm to 15.00 mm
Center Thickness: 0.050 mm to 0.210 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
- Sphere Power: -20.00D to +20.00D in 0.25D steps
- Cylinder Power (toric): -0.25D to -4.00D in 0.25D steps
- Cylinder Axis (toric): 10° to 180° in 10° steps
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
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
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)
Pre-Clinical Performance:
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the EYEREVE (hioxifilcon D) finished contact lenses. The results support the claim that the EYEREVE (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.
Toxicology:
All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the test article is non-toxic.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test in accordance with ISO 10993-11 and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation.
Shelf Life:
The data presented supports substantial equivalence of the EYEREVE (hioxifilcon D) finished contact lenses to the already marketed predicate devices.
Physicochemical & Mechanical Properties:
The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical property testing demonstrate consistent material properties between the EYEREVE (hioxifilcon D) contact lenses and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 & Human Services. The logo consists of a circular seal 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 body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Vision Science Co., Ltd. % Mr. Bret Andre Consultant/Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln. West Linn. OR 97068
Re: K161124
Trade/Device Name: EYEREVE (hioxifilcon D) 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: July 13, 2016 Received: July 18, 2016
Dear Mr. Andre:
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. Bret Andre
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 of medical device-related adverse events) (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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 Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
Indications for Use (Describe)
The EYEREVE (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The EYEREVE (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K161124 |
|---|---|
| Applicant information: | |
| Date Prepared: | April 15th, 2016 |
| Name: | |
| Address | VISION SCIENCE CO., LTD. |
| 7, Jain-Ro 7-Gil, Jain-myeon | |
| Gyeongsan-si, Gyeongsangbuk-do, | |
| South Korea 712852 | |
| Contact Person: | Oh, In-Whan |
| President | |
| Phone number: | +82-53-857-3578 |
| Consultant: | Bret J Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln | |
| West Linn, OR 97068 | |
| United States | |
| (503) 372-5226 | |
| Device Information: | |
| Device Classification: | Class II |
| Classification Number: | LPL; MVN |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Trade Name: | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens |
| for Daily Wear |
5
Predicate Devices:
The EYEREVE (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the following predicate device(s):
"Extreme H2O 54% (hioxifilcon D) Soft Contact Lens" Hydrogel Vision Corporation 510(k) number; K051430
"Clalen 54 (Hioxifilcon D) Soft Contact Lens" Interojo Inc. 510(k) number; K153766
"ISENS (polymacon)" ~ Reference Predicate Vision Science Co., Ltd. 510(k) number; K132714
"55 UV (methafilcon A)" ~ Reference Predicate Optical Connection Inc. 510(k) number; K051095
Device Description:
The EYEREVE Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).
A UV absorbing monomer-2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]|ethyl methacrylate-is incorporated in the EYEREVE contact lens material to block UV radiation. The UV blocking characteristics of the lens are as follows:
- o >95% in the UVB range of 280nm 315nm
- o >67% in the UVA range of 316nm 380mm.
EYEREVE Soft Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:
6
| Name of Colorant | Listing |
|---|---|
| Titanium Dioxide | 21 CFR § 73.3126 |
| Phthalocyanine Green | 21 CFR § 73.3124 |
| Carbazole Violet | 21 CFR § 73.3107 |
| Reactive Blue 19 | 21 CFR § 73.3127 |
| C.I. Reactive black 5 | 21 CFR § 73.3127 |
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:
| Refractive Index | 1.40 (hydrated) |
|---|---|
| Light Transmission | greater than 98% |
| Light Transmission (tinted) | greater than 96% (at region corresponding to pupil); |
| Opaque or 0-10% (at region corresponding to iris) | |
| Water Content | 54 % ± 2% |
| Oxygen Permeability | 21.50 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C) |
The EYEREVE soft contact lenses will be manufactured in the sphere and toric design configurations with the following features and properties:
| Chord Diameter: | 12.80 mm to 15.00 mm |
|---|---|
| Center Thickness: | 0.050 mm to 0.210 mm |
| Base Curve: | 8.0 mm to 9.8 mm |
| Power Range | |
| - Sphere Power: | -20.00D to +20.00D in 0.25D steps |
| - Cylinder Power (toric): | -0.25D to -4.00D in 0.25D steps |
| - Cylinder Axis (toric): | 10° to 180° in 10° steps |
7
Indications for Use:
The EYEREVE (hioxifileon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The EYEREVE (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear. with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.
Pre-Clinical Performance:
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the EYEREVE (hioxifilcon D) finished contact lenses. The results support the claim that the EYEREVE (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.
Toxicology:
All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the test article is non-toxic.
Systemic Toxicity: The lens material meets the requirements of the systemic injection test in accordance with ISO 10993-11 and is considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation.
8
Shelf Life
The data presented supports substantial equivalence of the EYEREVE (hioxifilcon D) finished contact lenses to the already marketed predicate devices.
Physicochemical & Mechanical Properties
The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical property testing demonstrate consistent material properties between the EYEREVE (hioxifilcon D) contact lenses and the predicate devices.
Substantial Equivalence:
The EYEREVE (hioxifilcon D) soft contact lenses will be manufactured according to specified process controls and a cGMP quality assurance program currently in place as established by the ISENS reference predicate device (K132714).
The final packaging and sterilization of the EYEREVE (hioxifilcon D) soft contact lenses will be carried out in accordance with procedures specified for the ISENS reference predicate device (K132714).
The EYEREVE (hioxifilcon D) soft contact lenses are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.
The following table depicts the pre-clinical characteristics of the EYEREVE (hioxifilcon D) materials, as well as the predicate devices.
9
Substantial Equivalence Matrix
| | Vision Science
Co., Ltd.
EYEREVE
(Subject Device) | Hydrogel Vision
Corp.
Extreme H2O
54% (Predicate
Device) | Interojo Inc.
Clalen 54
(Predicate Device) | Vision Science
Co., Ltd.
ISENS
(Predicate
Device) | Optical
Connection
UV 55
(Predicate
Device) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily
wear for the correction
of refractive error in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | Indicated for daily wear
for the correction of
refractive error in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | Indicated for daily wear
for the correction of
refractive error in aphakic
and not aphakic persons
with non-diseased eyes
with myopia or hyperopia. | Indicated for daily
wear for the
correction of
refractive error in
aphakic and not
aphakic persons with
non-diseased eyes
with myopia or
hyperopia. | Indicated for daily
wear for the
correction of
refractive error in
aphakic and not
aphakic persons with
non-diseased eyes
with myopia or
hyperopia. |
| Functionality | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina | The contact lenses act
as a refractive medium
that focus light rays
from near and distant
objects on the retina | The contact lenses act as a
refractive medium that
focus light rays from near
and distant objects on the
retina | The contact lenses
act as a refractive
medium that focus
light rays from near
and distant objects
on the retina | The contact lenses act
as a refractive
medium that focus
light rays from near
and distant objects on
the retina |
| Indications | Soft (hydrophilic)
Contact Lens (21
CFR 886.5925) | Soft (hydrophilic)
Contact Lens (21
CFR 886.5925) | Soft (hydrophilic)
Contact Lens (21 CFR
886.5925) | Soft (hydrophilic)
Contact Lens (21
CFR 886.5925) | Soft (hydrophilic)
Contact Lens (21
CFR 886.5925) |
| Production
Method | Fully molded | Fully molded | Fully molded | Fully molded | Fully molded |
| USAN name | hioxifilcon D | hioxifilcon D | hioxifilcon D | polymacon | methafilcon A |
| Water Content
(%) | 54±2% | 54±2% | 54±2% | 38±2% | 55±2% |
| Oxygen
Permeability | $21.50 x 10^{-11}$
(cm²/sec)(mlO₂)/(ml x
mmHg @ 35°C))
(revised Fatt method) | $14.86 x 10^{-11}$
(cm²/sec)(mlO₂)/(ml x
mmHg @ 35°C))
(revised Fatt method) | $18.42 x 10^{-11}$
(cm²/sec)(mlO₂)/(ml
x mmHg @ 35°C))
(revised Fatt
method) | $12.48 x 10^{-11}$
(cm²/sec)(mlO₂)/(ml
x mmHg @ 35°C))
(revised Fatt
method) | $18.90 x 10^{-11}$
(cm²/sec)(mlO₂)/(ml x
mmHg @ 35°C))
(revised Fatt method) |
| FDA Group | FDA Group 2
(>50% H₂O, non-
ionic polymer) | FDA Group 2
(>50% H₂O, non-
ionic polymer) | FDA Group 2
(>50% H₂O, non-
ionic polymer) | FDA Group 1
(50% H₂O, non-
ionic polymer) |
| Refractive
Index
(hydrated) | 1.40 | 1.41 | 1.40 | 1.43 | 1.41 |
| UV Blocker | Yes | No | Yes | No | Yes |