miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus

K242056 · Benq Materials Corporation · LPL · Apr 17, 2025 · Ophthalmic

Device Facts

• Record ID: K242056
• Device Name: miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
• Applicant: Benq Materials Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The color lens may enhance or alter the apparent color of the eye. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required. miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The lenses may enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

Device Story

Soft silicone hydrogel contact lenses (miafilcon A/B) for daily wear; intended for correction of myopia and hyperopia in patients with ≤ 1.00D astigmatism. Available in clear (DELiGHT) or color-enhanced (CONFiDENCE) versions. Lenses are cast-molded, spherical, and include UV-blocking monomers. Prescribed by eye care professionals for either frequent replacement (requiring chemical disinfection) or single-use daily disposable wear. Lenses are placed directly on the cornea by the patient to improve visual acuity; color variants provide cosmetic enhancement. Safety and efficacy are maintained through biocompatible materials and standard optical design.

Clinical Evidence

Two multi-center, open, parallel, randomized controlled studies conducted in China. Study 1 (n=192) compared miafilcon A to olifilcon A; Study 2 (n=192) compared miafilcon B to olifilcon B. Primary endpoints included safety (adverse reactions, slit lamp findings) and effectiveness (visual acuity). Results showed no statistically significant differences in safety or efficacy between test and control groups. No sight-threatening adverse events reported.

Technological Characteristics

Silicone hydrogel (copolymer of NVP and Siloxane macromer); water content 46-48%; oxygen permeability 121-155 x 10⁻¹¹ (cm²/sec)(ml O₂/ml.mmHg); refractive index 1.405-1.407; UV-blocking benzotriazole monomer; cast-molded; steam sterilized; spherical design; diameter 13.0-15.0mm; base curve 8.0-9.2mm.

Indications for Use

Indicated for phakic or aphakic persons with non-diseased eyes requiring correction of myopia or hyperopia with refractive astigmatism ≤ 1.00D.

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

• OxyPure Color Silicone Hydrogel Soft Contact Lenses (K171447)
• Si-Hy (olifilcon B) color silicone hydrogel soft contact lens (K180322)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 17, 2025

BenQ Materials Corporation
% Jennifer Ting
RA Manager
Jens Medical Consulting Ltd.
3F, No 364, Jixian Rd, Luzhou Distr.
New Taipei City, 24747
Taiwan

Re: K242056

Trade/Device Name: miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus/ miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus/ miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus/ miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (hydrophilic) contact lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: March 8, 2025
Received: March 14, 2025

Dear Jennifer Ting:

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 (the 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 available 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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K242056 – Jennifer Ting
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-reporting-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/medical-devices/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.

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K242056 – Jennifer Ting
Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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

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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FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242056 | |
| Device Name miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus/ miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus/ miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus/ miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus | |
| Indications for Use (Describe) miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The color lens may enhance or alter the apparent color of the eye. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required. miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The lenses may enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required. | |
| 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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**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 FDA 3881 (8/23)
Page 2 of 2

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510(K) SUMMARY_K242056

Preparation Date: April 14, 2025

## 5.1 Establishment Information:

Name BenQ Materials Corporation
Address 29 Jianguo E. Road, Gueishan, 33341, Taoyuan, Taiwan, R.O.C.
Phone No. 886-3-3748800
Fax No. 886-3-3748888

## 5.2 US Agent:

Name David Lennarz Registrar Corp.
Address 144 Research Drive Hampton, VA 23666 USA
Phone No (734) 757 2240177
E-mail David.Lennarz@ Registrarcorp.Com

## 5.3 Device Identification:

Proprietary Name miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus
miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus
miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus
miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

Common Name Soft (hydrophilic) Contact Lenses
Classification Name Lenses, Soft Contact, Daily Wear (Disposable), (21 CFR 886.5925, Product Code LPL, MVN)
Classification II

## 5.4 Legally Marketed Equivalent Device:

Predicate Device Name OxyPure Color Silicone Hydrogel Soft Contact Lenses/K171447
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens/K180322

Manufacturer Visco Vision Inc.
Product Code LPL, MVN

page 1

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# 5.5 Device Description

## miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus

- They are daily wear soft contact lens for frequent replacement
- They are in a spherical lens design with UV blocker.
- They are available in hemispherical shell.
- The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
- The water content is 46%.
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm.
- The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
- The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
- The lens is supplied in a sterile state, packaged in a buffered saline solution.

## miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

- They are daily wear soft contact lens for daily disposable
- They are in a spherical lens design with UV blocker.
- They are available in hemispherical shell.
- The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer.
- The water content is 48%.
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm.
- The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose.
- The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye.
- The lens is supplied in a sterile state, packaged in a buffered saline solution.

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# 5.6 Indication for Use:

miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The color lens may enhance or alter the apparent color of the eye.

Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity.

The lenses may enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

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# 5.7 Technological characteristics

## miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus/ miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus

The spherical lens design specification:

- Diameter 13.0 mm to 15.0 mm
- Center Thickness 0.08mm @ -3.00D (Varies with Power)
- Base Curve 8.0 mm to 9.2 mm
- Power -12.00D to +8.00D

The physical properties of the lenses are:

- Refractive index: 1.407 (hydrated)
- Light transmittance: > 94%
- Water content: 46% by weight in normal saline
- Oxygen permeability 155 x 10⁻¹¹ (cm²/sec)(ml O₂/ml.mmHg) measured at 35°C (intrinsic Dk-Colormetric method)

## miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus/ miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

The spherical lens design specification:

- Diameter 13.0 mm to 15.0 mm
- Center Thickness 0.08mm @ -3.00D (Varies with Power)
- Base Curve 8.0 mm to 9.2 mm
- Power -12.00D to +8.00D

The physical properties of the lenses are:

- Refractive index: 1.405 (hydrated)
- Light transmittance: > 94%
- Water content: 48% by weight in normal saline
- Oxygen permeability 121 x 10⁻¹¹ (cm²/sec)(ml O₂/ml.mmHg) measured at 35°C (intrinsic Dk-Colormetric method)

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# 5.8 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Device | Predicate (K171447) |
| Product Name | miacare (miafilcon A)DELiGHT Contact Lens with EautraSil Plus | miacare (miafilcon A)CONFiDENCE Color Contact Lens with EautraSil Plus | OxyPure Color Silicone Hydrogel Soft Contact Lenses |
| Manufacturer | BenQ Materials Corp. | BenQ Materials Corp. | Visco Vision Inc. |
| Intended Use | Myopia, Hyperopia | Myopia, Hyperopia | Myopia, Hyperopia |
| USAN Name | miafilcon A | miafilcon A | olifilcon A |
| Material | Silicone Hydrogel | Silicone Hydrogel | Silicone Hydrogel |
| Lens Design | Spherical | Spherical | Spherical |
| Classification | Class II | Class II | Class II |
| Type | Group 5C (Nonionic, Water < 50 wt%) | Group 5C (Nonionic, Water < 50 wt%) | Nonionic, Water < 50 wt% |
| Water Content | 46 % | 46 % | 47 % |
| Oxygen Permeability (DK, 35℃) | 155(Fatt method) | 155(Fatt method) | 150(Fatt method) |
| Base Curve Range | 8.0~9.2 | 8.0~9.2 | 8.0~9.2 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 | 13.0~15.0 |
| Center Thickness | 0.08 mm at -3.00D (Varies with design and power ) | 0.08 mm at -3.00D (Varies with design and power ) | 0.08 mm at -3.00D (Varies with design and power ) |
| Powers | -12.00D to +8.00D | -12.00D to +8.00D | -20.00D to +20.00D |
| Replacement Schedule | Daily wear or Daily Disposable (Single use) | Daily wear or Daily Disposable (Single use) | Daily wear or Daily Disposable (Single use) |
| Refractive Index | 1.407 | 1.407 | 1.410 (hydrated) |
| Light Transmittance | 94% | 94% | 94% |
| Method of Manufacture | Cast-Molded | Cast-Molded | Cast-Molded |
| Surface Treatment | No | No | NA |
| Sterilization | steam | Steam | steam |
| Packaging | Blister pack | Blister pack | Blister pack |
| Blue handling tint | Yes, reactive Blue19 | No | No |
| color additive for print | No | - Iron Oxide - Titanium dioxide - [Phthalocyaninato(2-)] copper - Carbazole violet | - Iron oxide - Titanium dioxide - Phthalocyanine green - Carbazole violet |

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| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Device | Predicate (K180322) |
| Product Name | miacare (miafilcon B)DELiGHT 1-dayContact Lens withEautraSil Plus | miacare (miafilcon B)CONFiDENCE 1-dayColor Contact Lens withEautraSil Plus | Si-Hy (olifilcon B)Color Silicone HydrogelSoft Contact Lens |
| Manufacturer | BenQ Materials Corp. | BenQ Materials Corp. | Visco Vision Inc. |
| Intended Use | Myopia, Hyperopia | Myopia, Hyperopia | Myopia, Hyperopia, Astigmatism, Presbyopia |
| USAN Name | Miafilcon B | Miafilcon B | Olifilcon B |
| Material | Silicone Hydrogel | Silicone Hydrogel | Silicone Hydrogel |
| Lens Design | Spherical | Spherical | Spheric, toric or multifocal |
| Classification | Class II | Class II | The same |
| Type | Group 5C (Nonionic, Water < 50 wt%) | Group 5C (Nonionic, Water < 50 wt%) | Group 5C (Nonionic, Water < 50 wt %) |
| Water Content | 48 % | 48 % | 47 % |
| Oxygen Permeability (DK, 35℃) | 121(Fatt method) | 121(Fatt method) | 120(Fatt method) |
| Base Curve Range | 8.0~9.2 | 8.0~9.2 | 8.0~9.2 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 | 13.5~15.0 |
| Center Thickness | 0.08 mm at -3.00D (Varies with design and power ) | 0.08 mm at -3.00D (Varies with design and power ) | Varies with design and power (0.08 mm at -3.00D) |
| Powers | -12.00D to +8.00D | -12.00D to +8.00D | -20.00D to +20.00D in 0.25 steps |
| Replacement Schedule | Daily Disposable (Single use) | Daily Disposable (Single use) | Daily Disposable (Single use) |
| Refractive Index | 1.405 | 1.405 | 1.410 |
| Light Transmittance | 94% | 94% | 94% |
| Method of Manufacture | Cast-Molded | Cast-Molded | The same |
| Surface Treatment | No | No | No |
| Sterilization | steam | Steam | The same |
| Packaging | Blister pack | Blister pack | The same |
| Blue handling tint | Yes, reactive Blue19 | No | NA |
| Color additives for print | No | - Iron oxide-[Phthalocyaninato (2-)] copper-Titanium dioxide-Carbazole violet | - Iron oxide-[Phthalocyaninato (2-)] copper-Titanium dioxide-Phthalocyanine green-Carbazole violet |

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# 5.9 Nonclinical Tests Performed

5.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.

5.9.2 The biocompatibility evaluation was conducted in accordance with the FDA 1994 Guidance: "Class II Daily Wear Contact Lenses- Premarket Notification [510(k)] Guidance Document."

For lens materials (both miafilcon A and miafilcon B), the tests included:

- Cytotoxicity (ISO 10993-5)
- Guinea Pig Maximization Skin Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Acute ocular irritation (10993-10)
- 22 Day Contact Lens Wear Study in Rabbits (ISO 9394).

For primary packing components:

- Cytotoxicity (ISO 10993-5)
- Acute ocular irritation (ISO 10993-23)
- Acute Systemic Toxicity (ISO 10993-11)

For the primary packaging solution:

- Cytotoxicity (ISO 10993-5)
- Acute ocular irritation (ISO 10993-10)

The biocompatibility results are acceptable in ocular environment.

# 5.10 Clinical Studies

## miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus

The clinical performance result proves that the safety and effectiveness of the miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is non-inferior to the OxyPure Color Silicone Hydrogel Soft Contact Lenses marketed by Visco Vision Inc.

A multi-center, open, parallel, randomized controlled comparison study with 90 days follow-up was conducted in mainland China. One hundred and ninety-two (192) subjects from 3 hospitals were enrolled in the study with 96 subjects wore the test lenses (miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus) and 96 subjects wore the control lenses (OxyPure Color soft hydrophilic contact lens (olifilcon A). Of the 192 subjects, 172 subjects completed all scheduled visits (85 subjects in the test group and 87 subjects in the control group). There were 174 females and 18 males in the study

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(female/male = 9.67/1). The average age of the subjects was 30.22 years (30.41 years in the test group and 30.03 years in the control group).

Patient Accountability:

| Stage | Investigational Device Arm Total | Control Arm Total | Total |
| --- | --- | --- | --- |
| Enrollment | 96 | 96 | 192 |
| Treatment | 95 | 96 | 191 |
| Primary Safety Endpoint Analysis | 85 | 87 | 172 |
| Primary Effectiveness Endpoint Analysis | 85 | 87 | 172 |

The clinical study shows that no significant difference between the study device and control device in terms of safety and efficacy. Both groups show that the CVA could reach equal or higher than 1.0 and the color lens will enhance or alter the apparent color of the eye.

No adverse reaction was reported for both test group and control group related to hazardous, sight-threatening condition for both the trial group and control group in terms of corneal ulcers, severe corneal abrasion $&gt;2\mathrm{mm}$ in diameter, iritis, other ocular infections or inflammations, corneal scarring, or permanent loss of vision.

No statistic significant difference between test lens and control lens with respect to safety data including adverse reaction data, slip lamp findings, symptoms/problems/complications, Keratometry (K) readings, refractive changes (absolute value) and visual acuity (VA) data, average wearing time (AWT), discontinuations and lens replacement.

# miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus

The clinical performance result proves that the safety and effectiveness of the miacare (miafilcon B) CONFiDENCE Color Contact Lens with EautraSil Plus is non-inferior to the Si-Hy (olifilcon B) Color Silicone Hydrogel soft contact lens currently marketed by Visco Vision Inc.

A multi-center, open, parallel, randomized controlled comparison study with 90 days follow-up was completed in mainland China. One hundred and ninety-two (192) subjects from 3 hospitals were enrolled in the study with 96 subjects wore the test lenses (miacare (miafilcon B) CONFiDENCE Color Contact Lens with EautraSil Plus) and 96 subjects wore the control lenses (Si-Hy Color silicone hydrogel soft contact lens (olifilcon B). Of the 192 subjects enrolled, 192 subjects completed all scheduled visits (96 subjects in the test group and 96 subjects in the control group). There were 179 females and 13 males in the study (female/male = 13.77/1). The average age of the subjects was 29.745 years (29.68 years in the test group and 29.81 years in the control group).

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Patient Accountability:

| Stage | Investigational Device Arm Total | Control Arm Total | Total |
| --- | --- | --- | --- |
| Enrollment | 96 | 96 | 192 |
| Treatment | 96 | 96 | 192 |
| Primary Safety Endpoint Analysis | 96 | 96 | 192 |
| Primary Effectiveness Endpoint Analysis | 96 | 96 | 192 |

The clinical study shows that no significant difference between the study device and control device in terms of safety and efficacy. Both groups show that the CVA could reach equal or higher than 1.0 and the color lens will enhance or alter the apparent color of the eye.

No adverse reaction was reported for both test group and control group related to hazardous, sight-threatening condition was found for both the trial group and control group in terms of corneal ulcers, severe corneal abrasion $&gt;2\mathrm{mm}$ in diameter, iritis, other ocular infections or inflammations, corneal scarring, or permanent loss of vision.

No statistic significant difference between test lens and control lens with respect to safety data including adverse reaction data, slip lamp findings, symptoms/problems/complications, Keratometry (K) readings, refractive changes (absolute value) and visual acuity (VA) data, average wearing time (AWT), discontinuations and lens replacement.

# 5.11 Conclusion

Based on the non-clinical and clinical tests, it is concluded that the contact lenses, miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus, miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus, miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus, and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus are substantially equivalent to the predicate devices. The lens material is not the same. However, it doesn't raise any questions of safety and effectiveness. These devices are as safe, as effective and performs as well as the predicate devices.