Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly 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 +20.00 D to -20.00 D. Eye practitioners may prescribe the lens 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. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Device Description

Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) 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 UV 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aquamax (Polymacon) Soft (Hydrophilic) Contact Lenses:

The submission K123973 refers to a 510(k) premarket notification for contact lenses, which are inherently different from typical medical devices that might involve AI, image analysis, or complex algorithms requiring extensive performance criteria like sensitivity, specificity, or reader studies. This document, therefore, focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel technology.

As such, many of the requested categories (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable to this type of regulatory submission for contact lenses, which relies on the established safety and effectiveness of the material and manufacturing process. The "acceptance criteria" here are implicitly about matching the characteristics of the predicate devices and fulfilling non-clinical testing requirements.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its resemblance and comparable performance to the predicate devices. The study demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Predicate Devices: Soflens Multifocal K020927 & Frequency 38 K042824)	Aquamax (Polymacon) Reported Performance (Quarterly & Monthly)
Technological Characteristics
FDA Group	Group I (< 50% water, non-ionic polymer)	Group I (< 50% water, non-ionic polymer)
USAN Name	Polymacon	Polymacon
Production Method	Cast molding	Cast molding
Water content	38 %	38 %
Refractive Index	1.43	1.43
Oxygen permeability @35°C (cm²/sec)(mL O2/mL-mmHg)	10.3 x 10⁻¹¹ (Soflens); 8.0 x 10⁻¹¹ (Frequency 38)	12.1 x 10⁻¹¹
Power (Diopter)	+20.00 to -20.00 D	+20.00 to -20.00 D
% T at 593 nm	> 96 % (Soflens); > 97 % (Frequency 38)	> 95 %
% T at 380-316 nm (UV-A)	Not specified for predicates (but Aquamax states UV blocker)	< 50 %
% T at 315-280 nm (UV-B)	Not specified for predicates (but Aquamax states UV blocker)	< 5 %
Biocompatibility	Negative responses for cytotoxicity, maximization sensitization, ocular irritation	Negative responses recorded for all tests
Sterilization	Minimum SAL of 10⁻⁶	Achieved minimum SAL of 10⁻⁶
Bacteriostatic Validation	Microorganisms killed; no microbial growth for claimed shelf-life	Killed under tested conditions; no microbial growth for 5 years (accelerated)
Leachability	No leachable monomers and additive residues at detection levels	No leachable monomers and additive residues at detection levels
Shelf-life	Packages remained tight through expiration date	Seal of lens packages remained tight for 5 years (accelerated)

Study Details

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly specified in terms of number of lenses or subjects. The document refers to "tests" conducted, implying a certain number of samples for each non-clinical test (e.g., biocompatibility, sterilization, leachability).
Data provenance: Not specified, but generally refers to in-house laboratory testing based on FDA guidelines for non-clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a non-clinical evaluation comparing material properties and safety characteristics, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

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:

Not Applicable. This device is a contact lens, not an AI-powered diagnostic tool. No reader studies were conducted.

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

Not Applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used:

The "ground truth" here is based on established testing methodologies and standards for contact lens materials and safety. For instance:
- Technological characteristics: Measured physical properties (e.g., water content, refractive index, oxygen permeability) against known values for the material (Polymacon) and predicate devices.
- Biocompatibility: Results from standardized in vitro and in vivo animal model tests (cytotoxicity, sensitization, ocular irritation).
- Microbiology/Sterilization: Validation against a sterility assurance level (SAL) of 10⁻⁶ using standard methods.
- Leachability: Chemical analysis to detect leachable substances.

8. The sample size for the training set:

Not Applicable. This device is a contact lens, not an AI-powered system that requires a "training set."

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary of the Study:

The study presented in K123973 is a non-clinical study designed to demonstrate substantial equivalence of the Aquamax (Polymacon) Quarterly and Monthly Disposable Soft (Hydrophilic) Contact Lenses to two predicate devices: Soflens Multifocal (Polymacon) Visibility Tinted Contact lens (K020927) and Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens (K042824).

The study followed the May 1994 FDA guideline titled "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses."

The proof of meeting "acceptance criteria" (i.e., substantial equivalence) is established by showing that the Aquamax lenses:

Share the same technological characteristics with the predicate devices (same FDA Group, USAN name (Polymacon), production method, water content, refractive index, power range, and comparable oxygen permeability and % T at 593 nm). The new lenses also include UV blocking properties.
Pass a series of non-clinical safety tests:
- Biocompatibility: Negative responses for cytotoxicity, maximization sensitization, and ocular irritation.
- Microbiology/Sterilization: Validation of steam sterilization process to achieve a minimum SAL of 10⁻⁶ and shelf-life stability.
- Bacteriostatic Validation: Demonstration that microorganisms were killed and lens packages maintained sterility and integrity for a 5-year accelerated period.
- Leachability: No detectable leachable monomers or additive residues.

The document explicitly states that clinical studies were "not required" because the USAN name (Polymacon) and manufacturing process are the same as the predicate devices, whose safety and effectiveness are "well documented." This approach is typical for 510(k) submissions of devices that are very similar to already cleared devices.

Summary

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KI23973

1.4 510(k) SUMMARY

APR 2 3 2013

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. Shan Ding Vil. Kwei Shan Hsiang,
	Taoyuan Hsien 333, Taiwan
Contact Person:	Mr. Tony Hsu, President
Phone:	886-3-329-8808
Fax:	886-3-329-8897
E-Mail:	tonyhsu@pegavision.com.tw
Date Prepared:	Dec. 17, 2012

Identification of Device

Trade Name:	Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic)Contact LensesAquamax (Polymacon) Monthly 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 LPLLenses, Soft Contact (Disposable), 21CFR. 886.5925,Product Code MVN
FDA Classification:	Class II

Indication for use

Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly 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

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K123973

prescribed in spherical powers ranging from +20.00D to -20.00D.

Eye Care Practitioners may prescribe the lens 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.
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Description of Device

Summary of Clinical Study

Polymacon 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

Soflens Multifocal (Polymacon) Visibility Tinted Contact lens, K 020927 . Submitted by Bausch & Lomb Inc.
Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens, K 042824, . submitted by Cooper Vision Inc.

Clinical studies for Aquamx (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly 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.

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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 (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens (K020927); and Frequency 38 (Polymacon) Soft (Hydrophilic) Contact Lens (K042824). The evidence of substantial equivalence to the predicate lenses is described below.

a) Technological characteristics studies

The technological characteristics of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.

Characteristics	Aquamax(Polymacon)QuarterlyDisposable Soft(Hydrophilic)Contact Lens	Aquamax(Polymacon)MonthlyDisposable Soft(Hydrophilic)Contact Lens	Soflens Multifocal(Polymacon)Visibility TintedContact Lens	Frequency 38(Polymacon) Soft(hydrophilic)Contact Lens
FDA Group	Group I< 50 % water, non-ionic polymer	Group I< 50 % water, non-ionic polymer	Group I< 50 % waternon-ionic polymer	Group I<50 % waterNon-ionic polymer
USAN Name	Polymacon	Polymacon	Polymacon	Polymacon
Production Method	Cast molding	Cast molding	Cast molding	Cast molding
Water content	38 %	38 %	38 %	38 %
Refractive Index	1.43	1.43	1.43	1.43
Oxygenpermeability (edgecorrected)) @35°C	$12.1 x 10^{-11}$(cm²/sec)(mLO2/mL-mmHg)	$12.1 x 10^{-11}$(cm²/sec)(mLO2/mL-mmHg)	$10.3 x 10^{-11}$(cm²/sec)(mLO2/mL-mmHg)	$8.0 x 10^{-11}$(cm²/sec)(mLO2/mL-mmHg)

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K123973

Characteristic	Aquamax(Polymacon)QuarterlyDisposable Soft(Hydrophilic)Contact Lenses	Aquamax(Polymacon)MonthlyDisposable Soft(Hydrophilic)Contact Lenses	Soflens Multifocal(Polymacon)Visibility TintedContact Lens(K020927)	Frequency 38(Polymacon) Soft(hydrophilic)Contact Lens(K042824)
Power(Diopter)	+20.00 to -20.00 D	+20.00 to -20.00 D	+ 20.00 to -20.00D	+ 20.00 to -20.00D
% T at 593 nm	> 95 %	> 95 %	> 96 %	> 97 %
% T at 380-316 nm	< 50 %	< 50 %	-	-
% T at 315-280 nm	< 5 %	< 5 %	-	-

The oxygen permeability data for predicate Frequency 38 lenses were copied from 510(K) summary of respective lens. Actual measurement of oxygen permeability for Soflens Multifocal 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 (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly 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 10°, 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

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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 (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses, with the same established safety profile and effectiveness as the predicate devices -Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens via K020927 and Frequeny 38 (Polymacon) Soft (Hydrophilic) Contact Lens via K042824.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

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

April 23, 2013

Pegavision Corporation % Mr. Tony Hsu President 2F-A No. 5 Shing Yeh St. Shan Ding Vil. Taoyuan, Kwei Shan Hsiang China (Taiwan) 33341

Re: K123973

Trade/Device Name: Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lens; Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 18, 2013 Received: March 19, 2013

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.

Deborah Falls -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

Enclosure

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K123973

Indications for Use

510(k) Number (if known): K123973

Device Name: Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses. Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses

Indications for Use:

Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or notaphakic 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 +20.00 D to -20.00 D. Eye practitioners may prescribe the lens 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.

Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Joseph C. Hutter
2013.04.18 14:15:15 -04'00'

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

510(k) Number K123973

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.