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 nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myoropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.

Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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 are intended for single-use disposable wear.

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 +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

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 +6.00 to -12.25diopters and astigmatic corrections from -0.25 to -3.50 diopters.

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 persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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.

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.

Device Description

The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in spherical, aspherical, toric and multifocal designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. . 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 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR section 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin as a color indicator to induce the package solution as pink color.

AI/ML Overview

The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) contact lenses. It does not describe a study that involves an AI/ML device, nor does it contain information about acceptance criteria and reported device performance in the context of an AI/ML device.

The document discusses the substantial equivalence of the Aquamax contact lenses to previously cleared predicate devices based on non-clinical studies (physicochemical properties, biocompatibility, packaging solution, plastic container, extractable, shelf life, and sterility tests) and the fact that Etafilcon A lenses have been widely used and their safety/effectiveness well documented.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The questions provided are specifically tailored for AI/ML device evaluations.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2021

Pegavision Corporation Estela Lin Regulatory Affair Senior Engineer 2F-1, No.5, Shing Yeh St. Taoyuan, Guishan Dist. 33341 Taiwan

Re: K211448

Trade/Device Name Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) 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: October 28, 2021 Received: November 2, 2021

Dear Estela Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation titled "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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211448

Device Name

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Indications for Use (Describe)

Spherical and Aspherical

Toric

Multifocal

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

CONTINUE ON A SEPARATE PAGE IF NEEDED.
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Type of Use (Select one or both, as applicable)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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Indications for Use

510(k) Number (if known) K211448

Device Name

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses

Indications for Use (Describe)

Spherical and Aspherical

Toric

Multifocal

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).

Company:	PEGAVISION CORPORATION2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333,Taiwan
Contact Person:	Mr. TS Yang, President
Phone:	886-3-329-8808
Fax:	886-3-329-8897
E-Mail:	TSYang@pegavision.com
Date Prepared:	December 01, 2021

Submitter Information

Identification of the Predicate Device

Trade Name:	Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic)Contact LensesAquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Common Name:	Soft (hydrophilic) Contact Lenses (daily wear)
ClassificationName:	Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, ProductCode LPLLens. Soft Contact (Disposable). 21CFR. 886.5925, ProductCode MVN
FDA Classification:	Class II
Predicate DeviceName:	K200296 Pegavision ProductsPegavision (Etafilcon A) Color Soft (Hydrophilic) ContactLensesPegavision (Etafilcon A) Color Daily Disposable Soft(Hydrophilic) Contact Lenses

Description of Device

The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

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and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in spherical, aspherical, toric and multifocal designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. . 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 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR section 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin as a color indicator to induce the package solution as pink color.

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 +6.00 to -12.00 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 +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 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 and/or non-aphakic persons with

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non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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 are intended for single-use disposable wear.

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

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 +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 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 +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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.

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.

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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 the lenses cleared by FDA.

Clinical studies for Aquamax (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.

Summary of Non-clinical Study

a) Non-Clinical Testing performed

The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994. Includes:

-Physicochemical Properties Test
Biocompatibility Test -

Contact Lenses (Etafilcon A)
------------------------------

Cytotoxicity Test (according to ISO 10993-5)
Maximization Sensitization Test (according to ISO 10993-10)
. Ocular Irritation Test (according to ISO 10993-10)
. Acute Systemic Toxicity Test (according to ISO 10993-11)

Packaging Solution

Cytotoxicity Test (according to ISO 10993-5) .
. Ocular Irritation Test (according to ISO 10993-10)

Plastic Container (Foil& PP Blister)

Cytotoxicity Test (according to ISO 10993-5) .
. Ocular Irritation Test (according to ISO 10993-10)
Acute Systemic toxicity test (according to ISO 10993-11) .

Extractable Test -

-Shelf Life Test and Sterility Test
The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses (K200296). The evidence of substantial equivalence to the predicate lenses is described below.

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Technological characteristics studies b)

The technological characteristics of Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.

	Proposed Device	K200296 Predicate
Production Method	Cast-Molded	Cast-Molded
USAN Name	Etafilcon A	Etafilcon A
Material Classification	Group IVhigh water ionic	Group IVhigh water ionic
Water Content (%)	58%	58%
Refractive Index	1.402	1.402
Oxygen Permeability (edgecorrected) @ 35°C	19.73 x 10-11(cm²/sec)(mlO2/ml-mmHg)	19.73 x 10-11(cm²/sec)(mlO2/ml-mmHg)
TransmittanceVisible light @ 380~780nmUVA @ 380-315nmUVB @ 315-280nm	> 95%< 50%< 5%	> 95%< 50%< 5%
Lens design	Spherical and AsphericalToricMultifocal	Spherical and AsphericalToricMultifocal
Packaging solution	Borate buffered saline (with Tween80, Sodium hyaluronate,Polyethylene Glycol, andCyanocobalamin)	Borate buffered saline(with Tween 80, Sodiumhyaluronate, Polyethylene Glycol)

Substantial Equivalence Statement

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for daily wear submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the predicate devices - Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses (K200296). Successful results from chemical/physical, stability, biocompatibility tests, extractable test confirm the lenses are within established finished product specification, remain stable, and are non-toxic and biocompatible with the ocular environment. Differences between the devices are the package solution, which cited in this section do not raise any new issues of substantial equivalence.

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Conclusion

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses do not raise questions of safety and effectiveness. Therefore, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate devices - Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses (K200296).

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.