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

K222885 · Pegavision Corporation · LPL · May 31, 2023 · Ophthalmic

Device Facts

• Record ID: K222885
• Device Name: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
• Applicant: Pegavision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: May 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 eves 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. Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia 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. Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs 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 1.00 diopters or less that does not interfere with visual acuity. The lenses are intended for single-use disposable wear.

Device Story

Single-use, daily-wear soft contact lenses; Hioxifilcon A hydrogel material (HEMA/GMA copolymer); visibility-tinted with Reactive Blue 19; contains benzotriazole UV-absorbing monomer. Cast-molded manufacturing. Available in sphere, asphere, toric, and multifocal designs. Prescribed by eye care professionals for vision correction. Benefits include refractive error correction and UV protection. No electronic components or software.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via non-clinical bench testing, including physicochemical properties (refractive index, oxygen permeability, water content, extractables, mechanical properties, light transmittance), biocompatibility (cytotoxicity, ocular irritation, acute systemic toxicity), and shelf-life/sterility testing.

Technological Characteristics

Material: Hioxifilcon A (HEMA/GMA copolymer); 59% water content; non-ionic hydrogel. UV-blocking: Benzotriazole monomer (95% UVB, 50% UVA). Manufacturing: Cast-molded. Refractive index: 1.400. Oxygen permeability: 23.2 x 10^-11 (cm²/sec)(mlO2/ml-mmHg). Visibility tint: Reactive Blue 19.

Indications for Use

Indicated for daily wear for correction of myopia, hyperopia, presbyopia, and/or astigmatism in aphakic/non-aphakic persons with non-diseased eyes. Powers: +10.00 to -20.00D (Sphere/Asphere/Toric); +6.00 to -12.25D (Multifocal). Astigmatism correction: -0.50 to -6.00D (Toric). Reading addition: +0.25D to +3.00D (Multifocal).

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

• Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268)
• Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

May 31, 2023

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

## Re: K222885

Trade/Device Name: Pegavision (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: April 27, 2023 Received: April 27, 2023

# 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.

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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 devicerelated 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-regulatoryinformation/postmarketing-safety-reporting-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-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/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 -S

Image /page/1/Picture/6 description: The image shows the letters 'FDA' in a light blue color. The letters are large and take up most of the frame. The background is white.

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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K22885

### Device Name

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

### Indications for Use (Describe)

### Sphere and Asphere

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 eves 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

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia 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.

### Multifocal

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs 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 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

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

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY

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

510(k) Number: K222885

| Submitter Information | |
|-----------------------|-------------------------------------------------------------------|
| Company: | PEGAVISION CORPORATION |
| | 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333, Taiwan |
| Contact Person: | Estela Lin, Regulatory Affair Senior Engineer |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | [e-mail] |
| Date Prepared: | April 27, 2023 |

# Identification of Device

| Trade Name: | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, Product Code LPL<br>Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN |
| FDA Classification: | Class II |
| Predicate Device Name: | K201268, Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)<br>K213119, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |

# Description of Device

The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, 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

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solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens 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. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

# Indications for use

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

### Sphere and Asphere -

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +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 -

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

### Multifocal -

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

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# Technological characteristics studies

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

| | Proposed Device | K201268 Predicate | K213119 Predicate |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A | Hioxifilcon A |
| Material<br>Classification | Group II<br>high water non-ionic | Group II<br>high water non-ionic | Group II<br>high water non-ionic |
| Water Content (%) | 59% | 59% | 59% |
| Refractive Index | 1.400 | 1.400 | 1.400 |
| Oxygen<br>Permeability (edge<br>corrected) @ 35°C | $23.2 x 10^{-11}$<br>(cm²/sec)(mlO2/ml-mmHg) | $20.6 x 10^{-11}$<br>(cm²/sec)(mlO2/ml-mmHg) | $25 x 10^{-11}$<br>(cm²/sec)(mlO2/ml-mmHg) |
| Transmittance<br>Visible light @<br>380~780nm | > 95% | > 95% | > 95% |
| Transmittance<br>UVA @ 380-315nm<br>UVB @ 315-280nm | < 50%<br>< 5% | < 50%<br>< 5% | < 50%<br>< 5% |
| Lens design | Sphere and Asphere<br>Toric<br>Multifocal | Sphere and Asphere<br>Toric | Sphere and Asphere<br>Toric<br>Multifocal<br>Multifocal Toric |
| Indications for Use | Indicated for daily wear for<br>the correction of refractive<br>ametropia in aphakic and/or<br>non-aphakic persons with<br>non-diseased eyes that are<br>myopia or hyperopia and/or<br>presbyopia and/or<br>astigmatism. | Indicated for daily wear for<br>the correction of refractive<br>ametropia in aphakic and/or<br>non-aphakic persons with<br>non-diseased eyes that are<br>myopia or hyperopia and/or<br>astigmatism. | Indicated for daily wear for<br>the correction of refractive<br>ametropia and emmetropia<br>in aphakic and/or<br>non-aphakic persons with<br>non-diseased eyes that are<br>myopia or hyperopia and/or<br>presbyopia 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. The predicate devices are K201268 and K213119.

- K201268_Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact ● Lenses (59% Water)
- K213119, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

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Clinical studies for Pegavision (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 Pegavision (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 Test
- Cytotoxicity Test -
- Ocular Irritation Test ।
- Acute Systemic Toxicity Test ।
- Shelf Life Test and Sterility Test

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# Substantial Equivalence Statement

The physical and chemical properties of Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (Proposed Device) are similar with the commercial soft lens (K201268). It's consistent with Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268). Besides, Multifocal Deisgn is similar with Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119). The proposed device lenses are the same ingredient materials (monomer, UV absorber, dye) as predicated devices K201268 and K213119.

We've conducted manufacturing verification studies for the three alternate lens designs (Sphere/Asphere, Toric and Multifocal) 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 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), with the same established safety profile and effectiveness as the predicate devices - Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268) and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119).