PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.
PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. The lens is 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) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. 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 ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 30% in the UVA range of 315-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

AI/ML Overview

This is a 510(k) premarket notification for cosmetic contact lenses, not an AI/ML device. Therefore, the requested information about acceptance criteria and study design for an AI/ML device is not applicable here.

The document discusses the substantial equivalence of the Aquamax (Etafilcon A) contact lenses to existing predicate devices (ACUVUE and Discon Plus contact lenses) based on non-clinical performance tests and technological characteristics.

The document does not contain information about:

Acceptance criteria for an AI/ML device.
A "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics.
Sample sizes for test sets and data provenance for AI/ML.
Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML context.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Training set information for an AI/ML model.

Instead, it focuses on demonstrating substantial equivalence through:

Technological characteristics comparison: This involves comparing physical and chemical properties of the lenses (e.g., water content, refractive index, oxygen permeability, transmittance) to predicate devices.
Biocompatibility tests: Standard tests for cytotoxicity, sensitization, and ocular irritation with negative responses.
Microbiology tests: Validation of steam sterilization process and shelf-life stability to ensure sterility.
Bacteriostatic validation: Verification of sterilizer effectiveness and lens sterility over time.
Leachability studies: Confirmation of no leachable monomers or additive residues from the finished lenses.

The document states, "Clinical studies for Aquamx Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices." This further confirms that no clinical studies (and by extension, no AI/ML specific performance studies) were conducted or reported for this submission.

Summary

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K120028

APR 1 7 2012-

510(k) SUMMARY

Submitter Information

(Company:

Date Prepared:

PEGAVISION CORPORATION

2F-1 No.5, Shing Yeh St. Shan Ding Vil. Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan Mr. Tony Hsu. President Contact Person: Phone: 886-3-329-8808 Fax: E-Mail:

886-3-329-8897 tonyhsu@pegavision.com.tw

Dec. 27, 2011

Identification of Device

Trade Name:	Aquamax (Etafilcon A) Bi-Weekly Disposable 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
	Lenses, Soft Contact (Disposable), 21CFR. 886.5925,Product Code MVN
FDA Classification:	Class II

Indication for use

1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from

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0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.

1. PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. The lens is 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.

Description of Device

Summary of Clinical Study

Etafilcon A lenses have been used widely. Its safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA

ACUVUE (Etafilcona A) Contact lens, clear and visibility tint with UV blocker, K .

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962808 Submitted by Vistakon USA

Discon Plus (Etafilcon A) Contact Lens, visibility tint with UV blocker, K083288, . submitted by Innova Vision, Taiwan.
Clinical studies for Aquamx Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses 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) Bi-Weekly Disposable 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); and Discon Plus Contact Lens 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) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.

Characteristic	Aquamax(Etafilcon A)Bi-WeeklyDisposable Soft(Hydrophilic)Contact Lenses	Aquamax(Etafilcon A) DailyDisposable Soft(Hydrophilic)Contact Lenses	ACUVUE(K962804)	Discon Plus(K083288)
FDA Group	Group IV> 50 % water, ionicpolymer	Group IV> 50 % water,ionic polymer	Group IV> 50 % waterionic polymer	Group IV> 50 % waterionic polymer
USAN Name	Etafilcon A	Etafilcon A	Etafilcon A	Etafilcon A
Production Method	Cast molding	Cast molding	Cast molding	Cast molding

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Characteristic	Aquamax(Etafilcon A)Bi-WeeklyDisposable Soft(Hydrophilic)Contact Lenses	Aquamax(Etafilcon A) DailyDisposable Soft(Hydrophilic)Contact Lenses	ACUVUE(K962804)	Discon Plus(K083288)
Water content	58 %	58 %	58 %	58 %
Refractive Index	1.402	1.402	1.40	1.407
Oxygenpermeability (edgecorrected)) @35°C	19.3 x 10-11(cm²/sec)(mLO₂/mL-mmHg)	19.3 x 10-11(cm²/sec)(mLO₂/mL-mmHg)	26 x 10-11(cm²/sec)(mLO₂/mL-mmHg)	24 x 10-11(cm²/sec)(mLO₂/mL-mmHg)
Power(Diopter)	0.00 to -12.00 D	00.00 to -12.00 D	+ 20.00 to -20.00D	+ 20.00 to -20.00D
% transmittance:
% T at 593 nm	>95 %	>95 %	>85 %	>93 %
% T at 380-315 nm	<30 %	<30 %	<30 %	<30 %
% T at 315-280 nm	<5 %	<5 %	<5 %	<5 %

The oxygen permeability data for predicate lenses were copied from 510(K) summary of respective lens. Actual measurement of oxygen permeability for ACUVUE gave substantially equivalent value within error of measurement.

b) Biocompatibility

The standard cytotoxicity, maximization sensitization and ocular irritation tests were carried out for both Aquamax (Etafilcon A) Bi-Weekly Disposable 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 106, 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

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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 S 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

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) Bi-Weekly Disposable 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 - ACUVUE (Etafilcon A) Contact Lens clear and visibility tint with UV blocker cleared via K962804; and Discon Plus Contact Lens visibility tint with UV Blocker cleared via K083288.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 7 2012

Pegavision Corporation c/o Mr. Tony Hsu President 2F-1 No.5, Shing Yeh St. Shan Ding Vil. Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan

Re: K120028

Trade/Device Name: Aquamax (Etafilcon A) Disposable Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Codes: LPL, MVN Dated: March 8, 2012 Received: March 12, 2012

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.

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Page 2 - Mr. Tony Hsu

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Image /page/6/Picture/8 description: The image shows a stylized signature or symbol. It features a looping, cursive-like design with a prominent vertical stroke that curves at the bottom. There is a smaller, more angular element at the top, resembling a letter or abbreviation. The overall impression is that of a personal mark or artistic flourish.

Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120028

Indications for Use

510(k) Number (if known): 《120078 Device Name: PEGAVISION Aquamax (Etafilcon A) Disposable Soft (Hydrophilic) Contact Lenses Indications for Use:

1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eve Care Practitioners may prescribe the lens for single-use daily disposable wear.
1. PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eve Care Practitioners may prescribe the lens 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.

Prescription Use AND/OR Over-The-Counter Use ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marc Robboy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120028

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.