Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

K201268 · Plexus Optix, Inc. · LPL · Oct 21, 2020 · Ophthalmic

Device Facts

• Record ID: K201268
• Device Name: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
• Applicant: Plexus Optix, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Spherical and Aspheric Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Toric Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters. The lenses are intended for single-use disposable wear.

Device Story

Soft, hydrophilic, daily-wear contact lenses; Hioxifilcon A material; visibility-tinted; contains UV blocker. Designs include spherical, aspheric, and toric. Manufactured via photo-polymerization/cast-molding. Used by patients for vision correction of ametropia. Prescribed by eye care professionals. Single-use disposable. Benefits include refractive error correction and UV radiation blocking.

Clinical Evidence

No clinical data. Safety and effectiveness established via non-clinical bench testing, including physicochemical properties (refractive index, oxygen permeability, water content, extractables, mechanical properties, light transmittance) and biocompatibility (ISO 10993-5, -10, -11).

Technological Characteristics

Non-ionic hydrogel (Hioxifilcon A); 59% water content; 41% polymer (2-HEMA, GMA, EGDMA). Contains benzotriazole UV-absorbing monomer. Visibility-tinted with Reactive Blue 19. Cast-molded via photo-polymerization. Packaged in borate saline solution (with or without sodium hyaluronate).

Indications for Use

Indicated for daily wear for correction of myopia, hyperopia, and astigmatism in aphakic/non-aphakic persons with non-diseased eyes. Powers +10.00 to -20.00D; astigmatism correction -0.50 to -6.00D.

Regulatory Classification

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.

Predicate Devices

• 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (K040303)

Reference Devices

• 59% Extreme H2O (hioxifilcon A) Soft Contact Lens (K992692)
• BENZ-G 5X (hioxifilcon A) Soft (Spherical) Daily Wear Contact Lens (K983773)
• Aquamax (K161739)

Submission Summary (Full Text)

{0}------------------------------------------------

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

October 21, 2020

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

Re: K201268

Trade/Device Name: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: September 15, 2020 Received: September 18, 2020

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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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-safety-reportingcombination-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 entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K201268

Device Name

Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Indications for Use (Describe)

Spherical and Aspheric

Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric

Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

The lenses are intended for single-use disposable wear.

Type of Use (Select one or both, as applicable)

X 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.*

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:

> 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."

{3}------------------------------------------------

# 510(k) SUMMARY

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

# Establishment Information

| | Plexus Optix, Inc. |
|----------|------------------------------------------|
| Company: | 3333 Quality Drive |
| | Rancho Cordova, CA 95670 |
| Contact: | Dave Delle Donne, SVP Commercial Markets |
| Phone: | 916-8514989 |
| Email: | [e-mail] |

# Application Correspondent

#### PEGAVISION CORPORATION

| Company: | 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333,<br>Taiwan |
|-----------------|----------------------------------------------------------------------|
| Contact Person: | Estela Lin, Regulatory Affair Senior Engineer |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| Email: | [e-mail] |
| Date Prepared: | April 09, 2020 |

# Identification of Device

| Trade Name: | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic)<br>Contact Lenses (59% Water) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, Product<br>Code LPL<br>Lens. Soft Contact (Disposable). 21CFR. 886.5925,<br>Product Code MVN |
| FDA Classification: | Class II |
| Predicate Device Name: | K040303 Hydrogel Vision Corporation<br>59% Extreme H2O (hioxifilcon A) Soft Contact Lens for<br>Daily Wear (cast-molded, with a visibility tint) |

{4}------------------------------------------------

## Description of Device

The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, GMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution. one is borate solution (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121.

### Indications for use

# Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

#### Spherical and Aspheric

Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

#### Toric

Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

The lenses are intended for single-use disposable wear.

{5}------------------------------------------------

## Technological characteristics studies

The technological characteristics of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) and Predicate Device (K040303) are illustrated in the following Table.

| | Proposed Device | K040303 Predicate |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group 2<br>high water non-ionic | Group 2<br>high water non-ionic |
| Water Content (%) | 59% | 59% |
| Refractive Index | 1.400 | 1.404 |
| Oxygen Permeability<br>(edge corrected) @ 35°C | 20.6 x 10-11<br>(cm²/sec)(mlO2/ml-mmHg) | 18 x 10-11<br>(cm²/sec)(mlO2/ml-mmHg) |
| Transmittance<br>Visible light @<br>380~780nm | > 95% | > 95% |
| Transmittance<br>UVA @ 380-315nm<br>UVB @ 315-280nm | < 50%<br>< 5% | N/A<br>N/A |
| Lens design | Spherical and Aspheric<br>Toric | Spherical<br>Toric |
| Indications for Use | Indicated for daily wear for the<br>correction of refractive ametropia<br>in aphakic and/or non-aphakic<br>persons with non-diseased eyes that<br>are myopia or hyperopia and/or<br>astigmatism. | Indicated for daily wear for the<br>correction of visual acutiy in<br>aphakic or not-aphakic persons<br>with non-diseased eyes that are<br>myopia or hyperopia and/or<br>astigmatism. |

## Summary of Clinical Study

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

- 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint)
K040303 Submitted by Hydrogel Vision Corporation

- 59% Extreme H2O (hioxifilcon A) Soft Contact Lens K992692 Submitted by Benz Research and Development
- BENZ-G 5X (hioxifilcon A) Soft (Spherical) Daily Wear Contact Lens K983773 Submitted by Benz Research and Development

{6}------------------------------------------------

Clinical studies for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) of the present device are not required for the premarket notification, as the USAN name and process are the same as the above-mentioned predicate devices.

## Non-clinical Study

All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).

Non-Clinical testing performed includes:

- Physicochemical Properties
- -Refractive Index
- Oxygen Permeability -
- Water content -
- Extractables -
- Mechanical Property -
- -Light Transmittance
- Biocompatibility Testing

Contact Lens: 59% Hioxifilcon A Soft Contact Lens [Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)]

- 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) -

Package Solution: Saline 1

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

Primary Packaging: Foil and 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)
- Shelf Life Test and Sterility Test ●

{7}------------------------------------------------

## Substantial Equivalence Statement

The physical and chemical properties of Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (Proposed Device) are similar with the commercial soft lens (K040303). It's consistent with 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) (K040303).

In addition, Ethos Aquell lens contains a UV absorber which is the same as that used in Aquamax (K161739). Ethos Aquell lenses were manufactured by the same photo curing process as that of Aquamax (K161739).

We've conducted manufacturing verification studies for the two alternate lens designs (Spherical/Aspheric and Toric) to ensure that lenses meet prescribed specification with established tolerances according to the 1994 FDA Contract Lens Guidance for diameter, power, and base curve.

In conclusion, the information submitted in this premarket notification supports the substantial equivalency, the Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), with the same established safety profile and effectiveness as the predicate devices - 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) (K040303).