(53 days)
No
The document describes contact lenses and their material properties, manufacturing process, and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The contact lenses are indicated for the correction of refractive ametropia (e.g., myopia, hyperopia, astigmatism, presbyopia), which falls under vision correction rather than therapeutic treatment for a disease or condition.
No
The device is described as contact lenses for the "correction of refractive ametropia," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a physical contact lens made from a co-polymer material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ILICON contact lenses are described as devices for correcting refractive errors (myopia, hyperopia, astigmatism, presbyopia) by being placed directly on the eye. They are a physical means of altering vision, not a test performed on a biological sample.
- Intended Use: The intended use clearly states the correction of refractive ametropia and presbyopia. There is no mention of diagnosing, monitoring, or screening for any disease or condition using a biological sample.
- Device Description: The description focuses on the material composition and physical characteristics of the contact lens itself.
- Performance Studies: The performance studies described are related to the safety and physical properties of the lens, not the accuracy of a diagnostic test.
Therefore, the ILICON contact lenses fall under the category of medical devices, specifically ophthalmic devices, but not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that 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 ILICON (ocufilcon 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.
The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that 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 ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 5.0 diopters that 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.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The ILICON (ocufiocon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere, toric, and multifocal design configurations.
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
Eye care practitioners
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)
Non-clinical Testing: A series of preclinical testing was performed to demonstrate the safety and effectiveness of the ILICON (ocufilcon D) finished contact lenses. The results support the claim that the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are substantially equivalent to the currently marketed predicate devices.
Toxicology studies were conducted in accordance with GLP regulations:
- In-Vitro Cytotoxicity: Performed in accordance with ISO 10993-5, results indicated non-toxic.
- Systemic Toxicity: Met requirements of systemic injection test in accordance with ISO 10993-11, considered non-toxic.
- Acute Ocular Irritation: Performed in accordance with ISO 10993-10, produced no ocular irritation.
Shelf Life: Testing performed to evaluate stability, sterility, and package integrity, data supports substantial equivalence.
Physicochemical & Mechanical Properties: Tests completed include refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results demonstrated consistent material properties between the subject and predicate devices.
Clinical Testing: Not required.
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.
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.
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).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 12, 2018
VizionFocus, Inc. % Bret Andre, MS, ABOc Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068
Re: K182247
Trade/Device Name: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 15, 2018 Received: August 20, 2018
Dear Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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.
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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours.
J. Angelo Green
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) K182247
Device Name
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
Indications for Use (Describe)
The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that 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 eve.
The ILICON (ocufilcon 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.
The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that 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 ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eves that may exhibit astigmatism up to 5.0 diopters that 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.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
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.
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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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:
SUBMITTER I.
| Date Prepared: | August 15th, 2018 |
|---|---|
| Name: | |
| Address: | VIZIONFOCUS INC. |
| No.66, Youyi Rd., Zhunan Township. | |
| Miaoli County 350. | |
| Taiwan (R.O.C.) | |
| Contact Person: | |
| Phone number: | Angus Shih |
| General Manager | |
| 037-582900 | |
| Consultant: | |
| Phone number: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| (503) 372-5226 |
II. DEVICE
| Trade Name: | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses
(Tinted, Color) |
|-------------------------|--------------------------------------------------------------------------------------|
| Common
Name: | Contact Lens, Daily Wear |
| Classification
Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory
Class: | Class II |
| Product Code: | LPL; MVN |
Purpose of 510(k) Submission:
~ New Device ~
5
III. PREDICATE DEVICE
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the following predicate device(s):
- "EZvue color (ocufilcon D)" By I-SEE VISION TECHNOLOGY INC. 510(k) number: K150293
- "BIOMEDICS (ocufilcon D)" By Coopervision, Inc. 510(k) number; K091339
IV. DEVICE DESCRIPTION
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The ILICON (ocufiocon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Rutile TiO2 | 21 CFR § 73.3126 |
| Iron Oxide | 21 CFR § 73.3125 |
| (Pathalocyaninto(2-))Copper | 21 CFR § 74.3045 |
| Carbazole Violet | 21 CFR § 73.3107 |
| Phthalocyanine Green | 21 CFR § 73.3124 |
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).
6
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere, toric, and multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D | |
| (in 0.25D steps) | When 0.00 1.50 D → ± 5° | |
| Multifocal Add Power | +0.25D to +4.00D (0.50D steps) | ±0.37 D |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability | ||
| (x 10-11(cm²/sec)(mlO2)/(ml | ||
| x mmHg)) | 19.6 | ±20% |
| Light Transmission - Tinted | ||
| (@ 380-780nm) | 95% | ±5% |
| Ultraviolet Radiation | ||
| Transmittance | 50% H2O, ionic polymer) |
- FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- 트 Intended use - daily wear contact lenses
- Actions
- 트 Indications for use
- Design configurations available (spherical, toric, multifocal)
- UV absorber
- 트 Cast molded production method
- Pad-printing contact lens tinting method
8
The following matrix illustrates the production method, lens function and material characteristics of the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color), as well as the predicate devices.
| | Vizionfocus
ILICON
(Subject Device) | Coopervision
Frequency 55 UV
(K020392) | I-SEE EZvue
UV and color
(K150293) |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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
and/or presbyopia. | Indicated for daily wear
for the correction of
refractive error in
aphakic and not
aphakic persons with
non-diseased eyes with
myopia or hyperopia. | For the correction
of visual acuity in
not aphakic
persons with non-
diseased eyes with
myopia or
hyperopia and may
exhibited
refractive
astigmatism up to
2.00 diopters that
does not interfere
with visual acuity. |
| Actions | 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 |
| FDA Classification | Soft (hydrophilic)
Contact Lens (21 CFR
886.5925) | Soft (hydrophilic)
Contact Lens (21 CFR
886.5925) | Soft (hydrophilic)
Contact Lens (21
CFR 886.5925) |
| FDA Group | FDA Group 4
(>50% H2O, ionic
polymer) | FDA Group 4
(>50% H2O, ionic
polymer) | FDA Group 4
(>50% H2O,
ionic polymer) |
| Production Method | Fully molded | Fully molded | Fully molded |
| USAN name | ocufilcon D | ocufilcon D | ocufilcon D |
| Water Content (%) | 55±2 % | 55±2 % | 55±2 % |
| Oxygen Permeability
x 10-11 (cm²/sec)(mlO2)/(ml x
mmHg @ 35°C)) (revised
Fatt method) | 19.6 | 22.0 | 16 |
| Refractive Index
(hydrated) | 1.410 | 1.40 | 1.410 |
| Modulus (MPa) | 0.49 | 0.48 | - |
| UV Blocker | Yes | Yes | Yes |
| Pad-Printed Tinting | Yes | No | Yes |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Testing
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the ILICON (ocufilcon D) finished contact lenses. The results support the claim that the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) 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 finished lenses and packaging materials are non-toxic.
- · Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.
- · Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation for the finished lenses and packaging materials.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the ILICON (ocufilcon D) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the 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 and mechanical property testing demonstrate consistent material properties between the ILICON (ocuffileon D) contact lenses and the predicate devices.
10
Clinical Testing
Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from ocufilcon D materials has been demonstrated previously.
VIII. CONCLUSIONS
Validity of Scientific Data
Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Substantial Equivalence
Information presented in this Premarket Notification establishes that the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.