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 (Etafilcon 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate)	Reported Device Performance (Aquamax Etafilcon A)
Technological Characteristics
Production Method	Cast-Molded (K120028, K962804, K991134)	Cast-Molded
USAN Name	Etafilcon A (K120028, K962804, K991134)	Etafilcon A
Material Classification	Group 4 (High Water Ionic) (K120028, K962804, K991134)	Group 4 (High Water Ionic)
Water Content (%)	58% (K120028, K962804, K991134)	58%
Refractive Index	1.402 (K120028), 1.40 (K962804, K991134)	1.402
Oxygen Permeability (Dk) (x 10⁻¹¹ (cm²/sec)(ml O₂/ml-mmHg) @ 35°C) (edge corrected)	19.73 (K120028), 26 (K962804), 26.3 (K991134)	19.73
Percent Transmittance (% T) at 593nm	> 95% (K120028), > 85% (K962804, K991134)	> 95%
Percent Transmittance (% T) at 380-315nm (UVA)	< 50% (K120028), < 30% (K962804, K991134)	< 50%
Percent Transmittance (% T) at 315-280nm (UVB)	< 5% (K120028, K962804, K991134)	< 5%
Lens Design	Spherical, Aspherical (K120028); Spherical, Toric, Multifocal, Toric Multifocal (K962804); Spherical, Bifocal, Toric, Toric Bifocal (K991134)	Spherical, Aspherical, Toric, Multifocal
Packaging Solution	Borate buffered saline (K120028), N/A (K962804, K991134)	Borate buffered saline (with Tween 80, Sodium hyaluronate and Polyethylene Glycol)
Biocompatibility	Negative responses for standard tests	Negative responses for all tests
Microbiology	Minimum SAL of 10⁻⁵	Steam sterilization validated to deliver minimum SAL of 10⁻⁵
Shelf-life Sterility	Stereo through expiration date claimed	Lenses remained sterile for 5 years (accelerated conditions)
Bacteriostatic Validation	Microorganisms killed under tested conditions vs. control	Steam sterilizer effective, tested microorganisms killed
Leachability	No leachable monomers and additive residues at detection levels	No leachable monomers and additive residues at detection levels
pH and Osmolality of Packaging Solution	Within normal range for commercial soft lens (Consistent with K120028)	Within normal range, consistent with K120028
Manufacturing Verification (for Toric & Spherical Multifocal)	Meet prescribed specifications with established tolerances for diameter, power, and base curve (per 1994 FDA Guidance)	Verification studies conducted and ensured lenses met specifications/tolerances

2. Sample Sizes Used for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for most tests in quantitative terms (e.g., number of lenses, number of animals). The document indicates "All tests were conducted" and "Studies were conducted to determine leachable materials," implying standard testing protocols were followed, which would inherently involve specific sample sizes per test type (e.g., for cytotoxicity, sensitization, ocular irritation, material property measurements) but these numbers are not detailed in this summary.
Data Provenance: The studies were conducted by Pegavision Corporation (Taiwan). The report implies that these were internal studies to support the 510(k) submission. Therefore, it is retrospective in the sense that the data was generated to support the application, but the tests themselves would have been conducted prospectively on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. For non-clinical tests (biocompatibility, material characteristics, microbiology), "ground truth" is typically established by laboratory standards and validated methods rather than expert consensus on individual observations. For manufacturing verification, engineers and quality control personnel would assess against specifications.

4. Adjudication Method for the Test Set

This information is not applicable in the context of these non-clinical, objective tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, patient-reported outcomes) from multiple readers or clinicians require reconciliation for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done.
This device is a physical medical device (contact lenses), not an AI/software device that assists human readers. Therefore, this type of study is completely irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done.
As established above, this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests described:
- Material properties: Measured values compared against established standards and values of predicate devices.
- Biocompatibility: Negative responses (absence of toxicity, sensitization, irritation) based on standardized in vitro and in vivo models.
- Microbiology/Sterility: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validation studies using microbiological indicators and established protocols.
- Leachability: Absence of detectable levels of specific substances using analytical chemistry methods.
- Manufacturing Verification: Conformance to engineering specifications and tolerances for physical dimensions (diameter, power, base curve).

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured product, not an AI model requiring a training set. The term "training set" is typically associated with machine learning and AI algorithms.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary of the Study per the Document:

The study presented in this 510(k) summary is a series of non-clinical, laboratory-based tests designed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) contact lenses and their substantial equivalence to legally marketed predicate devices. The "study" encompasses:

Technological Characteristics Comparison: Direct comparison of material properties and design specifications with three predicate devices (K120028, K962804, K991134). The current device largely matches the most relevant predicate (K120028) for key properties like oxygen permeability and percentage transmission, and is in acceptable ranges for others.
Biocompatibility Testing: According to standard cytotoxicity, maximization sensitization, and ocular irritation tests.
Microbiology and Sterilization Validation: Validation of the steam sterilization process to ensure a minimum SAL of 10⁻⁵ and demonstration of sterility throughout the shelf life.
Bacteriostatic Validation: Testing of the steam sterilizer's effectiveness in killing microorganisms.
Leachability Studies: To confirm the absence of leachable monomers and additive residues.
Manufacturing Verification Studies: For the new toric and multifocal lens designs, ensuring they meet specified tolerances for key parameters like diameter, power, and base curve.

The overarching "study" proves adherence to the "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses" (May 1994) and establishes substantial equivalence based on these non-clinical tests. Clinical studies were deemed "not required" due to the well-documented safety and effectiveness of etafilcon A lenses and the similarity to predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular 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

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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

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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.

1. 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.

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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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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 LensesAquamax (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 LPLLens. 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 lensesK962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal, and Toric Multifocal soft (hydrophilic) daily wear contact lensesK 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

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Description of Device

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

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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.

2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical

Toric

Multifocal

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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)

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	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)(mlO₂/ml-mmHg)	19.73 x 10-11(cm²/sec)(mlO₂/ml-mmHg)	26 x 10-11(cm²/sec)(mlO₂/ml-mmHg)	26.3x 10-11(cm²/sec)(mlO₂/ml-mmHg)
(edge corrected) @ 35°C
Percent Transmittance
% T at 593nm	> 95%	> 95%	> 85%	> 85%
% T at 380-315nm	< 50%	< 50%	< 30%	< 30%
% T at 315-280nm	< 5%	< 5%	< 5%	< 5%
Lens design	SphericalAsphericalToricMultifocal	SphericalAspherical	SphericalToricMultifocalToric Multifocal	SphericalBifocalToricToric bifocal
Packaging solution	Borate bufferedsaline (with Tween80, Sodiumhyaluronate andPolyethyleneGlycol)	Borate buffered saline	N/A	N/A

Contact Lenses are illustrated in the following Table.

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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.

Substantial Equivalence Statement

The pH and Osmolality of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses(Proposed Device) are within the normal range of packaging solution for commercial soft lens. It's consistent with our previously approved Aquamax (Etafilcon A) lenses (K120028).

In addition, we've conducted manufacturing verification studies for the two alternate lens designs (toric and spherical multifocal) to ensure that lenses meet prescribed

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specification with established tolerances according to the 1994 FDA Contract Lens Guidance for diameter, power, and base curve.

In conclusion, it is PEGAVISION's conviction that data submitted in this 510(K) to validate the claim of substantial equivalency, substantiates our ability to manufacture soft contact lenses, the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, with the same established safety profile and effectiveness as the predicate devices – Aquamax Disposable Soft (Hydrophilic) Contact Lenses and, the ACUVUE (Etafilcon A) Contact Lens clear and visibility tint with UV blocker cleared via K962804 and K991134.

Regulation Number and Section

§ 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.