(178 days)
No
The summary describes standard contact lenses and their material properties, intended use, and performance testing. There is no mention of any computational analysis, image processing, or AI/ML algorithms being used in the device itself or its function.
No.
The device is indicated for the correction of ametropia, which refers to refractive errors of the eye (like myopia, hyperopia, and astigmatism), and presbyopia, all of which are vision corrections rather than treatments for diseases or injuries. While it blocks UV radiation, this is a protective feature, not a therapeutic action.
No
The device is a contact lens intended for daily wear and correction of refractive errors, not for diagnosing medical conditions.
No
The device is a physical contact lens made of hydrogel material, not software. The description details the material composition, manufacturing process, and physical characteristics of the lenses.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that these are contact lenses designed to be worn on the eye for the correction of vision problems (ametropia, astigmatism, presbyopia) and to protect against UV radiation. They are a medical device, but they are not used to test or analyze biological samples in vitro.
The text focuses on the physical properties of the lenses, their intended wear schedule, and the types of vision correction they provide. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafficon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
- Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are 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 in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and into the eye, eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care professional
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)
Summary of Clinical Study
Etafilcon A lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by three lenses cleared by FDA.
- ACUVUE (Etafilcona A) Contact lens, clear and visibility tint with UV blocker, K 962804 Submitted by Vistakon USA
- ACUVUE (Etafilcon A) Contact lens, clear and visibility tint with UV blocker, K 991134 Submitted by Vistakon USA
- Aquamax (EtafilconA) Disposable Soft (Hydrophilic) Contact Lenses, K120028 Submitted by Pegavision Corporation, Taiwan
Clinical studies for Aquamx (Etafilcon A) Soft (Hydrophilic) Contact Lenses of the present device are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
Non-clinical Study
All tests were conducted in accordance with the May 1994 FDA guideline title Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses.
The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses ACUVUE Contact Lens clear and visibility tint with UV blocker (K962804 & K991134) and Aquamax Disposable Soft (Hydrophilic) Contact Lenses (K120028) visibility tint with UV Blocker.
a) Technological characteristics studies
The technological characteristics of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses were illustrated in a table comparing parameters like Production Method, USAN Name, Material Classification, Water Content (%), Refractive Index, Oxygen Permeability, Percent Transmittance (% T at 593nm, % T at 380-315nm, % T at 315-280nm), Lens design, and Packaging solution with predicate devices K120028, K962804, and K991134.
b) Biocompatibility
The standard cytotoxicity, maximization sensitization and ocular irritation tests were carried out for both Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and negative responses were recorded for all tests. The validity of blister package for lenses was demonstrated by passing the standard extraction tests.
c) Microbiology
Steam sterilization process had been validated to deliver a minimum SAL of 105, thereby complying with the requirement of FDA group IV. There is shelf-life stability supporting that these lenses remain sterile through the expiration date claimed for the product
d) Bacteriostatic Validation
The steam sterilizer was tested for effectiveness by measuring and demonstrating the uniformity of temperature at different location inside the sterilizer over test period. Tested microorganisms were killed under tested conditions as compared to control.
Lenses remained sterilized and there was no microbial growth for a period of 5 years tested under accelerated condition. Seal of lens packages remained tight for a period of 5 years as demonstrated by the constant peeling strength tested under accelerated condition.
e) Leachability
Studies were conducted to determine the leachable materials from the finished lenses. The results show that, at the levels of the detection reported, there are no leachable monomers and additive residues.
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.
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).
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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Pegavision Corporation Mr. Tony Hsu President 2F-1, No.5, Shing Yeh St. Guishan Dist Taoyuan City 333 Taiwan
Re: K161739
Trade/Device Name: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 1, 2016 Received: November 14, 2016
Dear Mr. Hsu:
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.
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
1
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/Resourcesfor You/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,
Denise L. Hampton -S
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
2
Indications for Use
510(k) Number (if known) K161739
Device Name
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafficon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
-
- Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are 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 in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
3
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).
Submitter Information
| Company: | PEGAVISION CORPORATION |
|---|---|
| 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City | |
| 333, Taiwan | |
| Contact Person: | Mr. Tony Hsu, President |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | tonyhsu@pegavision.com |
| Date Prepared: | June 03, 2016 |
Identification of Device
| Trade Name: | Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925,
Product Code LPL
Lens. Soft Contact (Disposable). 21CFR. 886.5925,
Product Code MVN |
| FDA Classification: | Class II |
| Predicate Device Name: | K120028 Pegavision Corporation, Aquamax (Etafilcon A) disposable soft (hydrophilic) contact lenses
K962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal, and Toric Multifocal soft (hydrophilic) daily wear contact lenses
K 991134 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) spherical, bifocal, toric and toric bifocal soft (hydrophilic) daily wear contact lenses, clear and visibility tint with UV blocker |
5
Description of Device
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
Indications for use
1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact
6
Lenses are 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 in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are 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 in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
7
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for frequent/planned replacement wear with cleaning. rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Summary of Clinical Study
Etafilcon A lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by three lenses cleared by FDA.
- ACUVUE (Etafilcona A) Contact lens, clear and visibility tint with UV blocker, K 962804 Submitted by Vistakon USA
- ACUVUE (Etafilcon A) Contact lens, clear and visibility tint with UV blocker, K 991134 Submitted by Vistakon USA
- Aquamax (EtafilconA) Disposable Soft (Hydrophilic) Contact Lenses, K120028 Submitted by Pegavision Corporation, Taiwan
Clinical studies for Aquamx (Etafilcon A) Soft (Hydrophilic) Contact Lenses of the present device are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
Non-clinical Study
All tests were conducted in accordance with the May 1994 FDA guideline title Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses.
The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses ACUVUE Contact Lens clear and visibility tint with UV blocker (K962804 & K991134) and Aquamax Disposable Soft (Hydrophilic) Contact Lenses (K120028) visibility tint with UV Blocker. The evidence of substantial equivalence to the predicate lenses is described below.
a) Technological characteristics studies
The technological characteristics of Aquamax (Etafilcon A) Soft (Hydrophilic)
8
| Proposed Device | K120028 Predicate | K962804 Predicate | K991134 Predicate | |
|---|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded | Cast-Molded |
| USAN Name | Etafilcon A | Etafilcon A | Etafilcon A | Etafilcon A |
| Material Classification | Group 4 | Group 4 | Group 4 | Group 4 |
| high water ionic | high water ionic | high water ionic | high water ionic | |
| Water Content (%) | 58% | 58% | 58% | 58% |
| Refractive Index | 1.402 | 1.402 | 1.40 | 1.40 |
| Oxygen Permeability | 19.73 x 10-11 | |||
| (cm²/sec)(ml | ||||
| O₂/ml-mmHg) | 19.73 x 10-11 | |||
| (cm²/sec)(ml | ||||
| O₂/ml-mmHg) | 26 x 10-11 | |||
| (cm²/sec)(ml | ||||
| O₂/ml-mmHg) | 26.3x 10-11 | |||
| (cm²/sec)(ml | ||||
| O₂/ml-mmHg) | ||||
| (edge corrected) @ 35°C | ||||
| Percent Transmittance | ||||
| % T at 593nm | > 95% | > 95% | > 85% | > 85% |
| % T at 380-315nm |