Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs 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) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated 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.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs 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 form +0.25 to +3.00 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) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting 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

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 sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-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 a 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 part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

AI/ML Overview

The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) soft contact lenses. It asserts substantial equivalence to existing predicate devices rather than presenting a novel device that requires a new clinical study with specific acceptance criteria and performance data. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for a new device's clinical efficacy is not present in this document.

Instead, the submission relies on the established safety and effectiveness of the predicate devices.

Here's an breakdown of the available information regarding testing:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria for a new clinical study. Instead, it performed non-clinical tests to demonstrate that the proposed device is comparable to the predicate devices. The "Technological characteristics studies" table (page 8) presents a comparison of the proposed device's physical properties with those of the predicate devices.

Characteristic	Proposed Device (Aquamax)	K200296 Predicate (Pegavision)	K141670 Predicate (ACUVUE®)
Production Method	Cast-Molded	Cast-Molded	Cast-Molded
Lens Designs	Sphere & Asphere, Toric, Multifocal, Multifocal-Toric	Sphere & Asphere, Toric, Multifocal	Multifocal, Multifocal-Toric
USAN Name	Etafilcon A	Etafilcon A	Etafilcon A
Material Classification	Group IV high water ionic	Group IV high water ionic	Group IV high water ionic
Water Content (%)	58%	58%	58%
Refractive Index	1.402	1.402	1.402
Oxygen Permeability (edge corrected) @ 35°C	$19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg)	$19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg)	$21.4 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg)
Cosmetically tinted	N/A	To enhance or alter the appearance of the eye	To enhance or alter the appearance of the eye
Percent Transmittance:
% T at 380~780nm	> 95%	> 95%	> 95%
% T at 315-380nm	< 50%	< 50%	< 30%
% T at 280-315nm	< 5%	< 5%	< 5%
Packaging Solution	Saline (with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol)	Borate buffered saline (with Tween 80, Sodium Hyaluronate, Polyethylene Glycol)	Borate buffered saline

Non-clinical tests performed (page 7) and their relevance to acceptance criteria:

Physicochemical Properties Test: The results of this test would demonstrate that the lenses meet the established finished product specifications. The specific acceptance criteria are not detailed but are implied to be within acceptable ranges for contact lens safety and performance.
Biocompatibility Tests (according to ISO 10993 series):
- Cytotoxicity Test (ISO 10993-5): Proves the materials (lenses, packaging solution, plastic container) are not toxic to cells. Acceptance criteria would be no significant cytotoxic effect.
- Ocular Irritation Test (ISO 10993-10): Proves the materials are not irritating to the eye. Acceptance criteria would be a low or absent irritation score.
- Acute Systemic Toxicity Test (ISO 10993-11): Proves the materials do not cause acute systemic toxic effects. Acceptance criteria would be no significant systemic toxic response.
Extractable Test: Demonstrates that leachable substances from the device are within safe limits. Acceptance criteria would be that extractables are below specified toxicological thresholds.
Shelf Life Test and Sterility Test: Confirm the device maintains its properties and sterility over its intended shelf life. Acceptance criteria would include maintaining physical integrity, water content, and remaining sterile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No specific sample size for a clinical "test set" is mentioned because a clinical study was not required for this 510(k) submission. The non-clinical tests (physicochemical, biocompatibility, extractable, shelf life, sterility) would have their own sample sizes for the materials tested, but these are not detailed in this summary. The data provenance is implied to be from internal testing by Pegavision Corporation, Taiwan, as they are the submitter. These appear to be laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no clinical study was required for this 510(k), there was no "test set" in the context of human data requiring expert ground truth establishment. Non-clinical tests are evaluated against scientific standards and regulations (e.g., ISO standards).

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

Not applicable, as no clinical study and corresponding test set requiring adjudication was performed.

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. Therefore, an MRMC study related to AI assistance is irrelevant.

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 (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" is based on established scientific principles, regulatory standards (like ISO 10993), and the performance characteristics of the predicate devices. For example, for biocompatibility, the ground truth is an absence of toxicity or irritation defined by the standards. For material properties, it's the measured values compared against established ranges and predicate device data.

8. The sample size for the training set:

Not applicable. There is no training set in the context of an algorithm or AI.

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

Not applicable. There is no training set in the context of an algorithm or AI.

In summary:

This 510(k) submission for Aquamax contact lenses relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving the safety and effectiveness of a novel device through new clinical trials with defined acceptance criteria. The "study" referenced involves a series of non-clinical tests (physicochemical properties, biocompatibility, extractables, shelf life, sterility) to confirm that the new device's materials and manufacturing process yield a product with comparable characteristics and safety profiles to the predicates. The success of these non-clinical tests, along with the inherent similarity to established predicate devices, forms the basis for the FDA's substantial equivalence determination.

Summary

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February 2, 2022

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

Re: K211603

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: December 23, 2021 Received: December 27, 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211603

Device Name

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

Indications for Use (Describe)

Sphere and Asphere

Toric

Multifocal

Multifocal-Toric

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.

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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 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:	January 28, 2022

Submitter Information

Identification of 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)
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:	K200296, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact LensesK141670, ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV (ultraviolet) Blocker for Daily Wear

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 sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-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 a 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 part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

Indications for use

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

Sphere and Asphere

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere and Asphere designs 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) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs 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

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Multifocal-Toric

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting 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 two lenses cleared by FDA.

Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision ● (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, K200296 Submitted by Pegavision Corporation, Taiwan.
ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV (ultraviolet) Blocker for Daily Wear, K141670 Submitted by Johnson & Johnson Vision Care, Inc.

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Clinical studies for Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and 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)
	• 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) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses, which have the same lens materials, packaging solution, and manufacturing process with predicate lenses Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (K200296). In addition, the Multifocal and Multifocal-Toric lens designs are the same with predicate lenses ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (K141670).The evidence of substantial equivalence to the predicate lenses is described below.

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b) Technological characteristics studies

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

	Proposed Device	K200296 Predicate	K141670 Predicate
Production Method	Cast-Molded	Cast-Molded	Cast-Molded
Lens Designs	Sphere and Asphere, Toric,Multifocal, Multifocal-Toric	Sphere and Asphere, Toric,Multifocal	Multifocal,Multifocal-Toric
USAN Name	Etafilcon A	Etafilcon A	Etafilcon A
MaterialClassification	Group IVhigh water ionic	Group IVhigh water ionic	Group IVhigh water ionic
Water Content (%)	58%	58%	58%
Refractive Index	1.402	1.402	1.402
OxygenPermeability (edgecorrected) @ 35°C	$19.73 x10^{-11}$(cm²/sec)(mlO2/ml-mmHg)	$19.73 x 10^{-11}$(cm²/sec)(mlO2/ml-mmHg)	$21.4 x 10^{-11}$(cm²/sec)(mlO2/ml-mmHg)
Cosmetically tinted	N/A	To enhance or alter theappearance of the eye	To enhance or alter theappearance of the eye
PercentTransmittance% T at 380~780nm% T at 315-380nm% T at 280-315nm	> 95%< 50%< 5%	> 95%< 50%< 5%	> 95%< 30%< 5%
Packaging Solution	Saline A: Borate buffered salineSaline B: Borate buffered saline(with Tween 80, SodiumHyaluronate, and PolyethyleneGlycol)	Borate buffered saline(with Tween 80, SodiumHyaluronate, PolyethyleneGlycol)	Borate buffered saline

Substantial Equivalence Statement

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the predicate devices (K200296 & K141670).

Successful results from the chemical/physical, stability, biocompatibility tests, extractable test and care solution compatibility confirm the lenses are within established finished product specification, remain stable, and are non-toxic and biocompatible with the ocular environment.

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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. Information submitted in the 510(k) establishes that the proposed devices have the same materials and manufacture process with the predicate devices - Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses (K200296), and the same lens designs of Multifocal and Multifocal-Toric with the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV (ultraviolet) Blocker for Daily Wear (K141670). Therefore, 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, and substantial equivalence to the predicate devices.

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.