Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens

K201080 · Visco Vision, Inc. · LPL · Jul 15, 2020 · Ophthalmic

Device Facts

• Record ID: K201080
• Device Name: Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
• Applicant: Visco Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity. The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D. The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity. Evecare practitioners prescribe the lens for single-use disposable wear.

Device Story

Daily Breeze B lenses are single-use, daily-wear soft contact lenses composed of olifilcon B (53% copolymer of NVP and Siloxane macromer, 47% water). Lenses include a Reactive Blue 19 tint for handling and a benzotriazole UV-absorbing monomer. Available in spherical, toric, and multifocal designs. Supplied sterile in blister packs with isotonic buffered saline. Prescribed by eyecare practitioners for patients with refractive ametropia. Lenses function by correcting refractive errors through physical placement on the cornea. Benefits include vision correction and convenience of daily disposal. No electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing including biocompatibility (ISO 10993), sterilization/stability (ISO 17665, ISO 11987), and physicochemical/optical performance (ISO 18369).

Technological Characteristics

Material: olifilcon B (53% copolymer of NVP and Siloxane macromer, 47% water). UV blocker: benzotriazole. Tint: Reactive Blue 19. Oxygen permeability: 120 (Fatt method). Refractive index: 1.410. Sterilization: steam autoclave. Standards: ISO 10993, ISO 17665, ISO 11987, ISO 18369.

Indications for Use

Indicated for phakic or aphakic persons with non-diseased eyes for correction of myopia, hyperopia, astigmatism (up to 1.00D for spherical/multifocal, -0.75D to -2.25D for toric), and presbyopia (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

• Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens (K160344)

Submission Summary (Full Text)

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

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.

July 15, 2020

Visco Vision Inc. Evan Huang Director of Global QA No. 1. Xingye St., Guishan Dist., Taoyuan City, TW 33341 Taiwan

Re: K201080

Trade/Device Name: Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: April 17, 2020 Received: April 22, 2020

Dear Evan Huang:

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) K201080

### Device Name

Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens

### Indications for Use (Describe)

The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.

The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.

The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.

Evecare practitioners prescribe the lens for single-use disposable wear.

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

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

### 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}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is simple and clear, with a focus on the brand name and its expertise in silicone hydrogel.

## 510(k) Summary

### K201080

#### Establishment Information: 1.

| Company Name: | Visco Vision Inc |
|------------------|---------------------------------------------------------------|
| Company Address: | No. 1, Xingye St., Guishan Dist., Taoyuan City, 33341, TAIWAN |
| Telephone: | [phone] |
| Fax: | [phone] |

#### Contact Person: 2.

| Name: | Evan Huang |
|-----------|-------------------------------|
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
| E-mail: | [e-mail] |

#### Preparation Date: 3.

2020/04/08

#### Device Identification: 4.

| Classification Name: | Soft (hydrophilic) contact lens. |
|----------------------|-----------------------------------------------------------------------------|
| Regulation Number: | 886.5925 |
| Product Code: | LPL, MVN |
| Device Class: | Class 2 |
| Panel: | Ophthalmic |
| Device Name: | Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens |
| Trade Name: | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens |
| | Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens |
| | Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens |

#### Predicate Device: 5.

- ◆ K160344, Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens
#### Device Description 6.

The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used

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

Image /page/4/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is horizontally aligned and centered.

to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

#### Indications for Use: 7.

The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single-use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single-use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear and single-use for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 diopters with add powers from +0.25 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eyecare practitioners prescribe the lens for single-use disposable wear.

#### Technological characteristic 8.

# 8.1 Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lenses characteristics:

| • Diameter Range : | 13.0 to 15.0 mm, ±0.2mm |
|----------------------|-------------------------------------------------------------|
| • Base Curve : | 8.0 to 9.2 mm, ±0.2mm |
| • Center Thickness : | 0.00 mm for 3.00D (varies with power) + [0.010 mm, -0.10 to |

- 0.09 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc | Center Thickness : .

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

Image /page/5/Picture/0 description: The image shows the logo for VISCO, a company that specializes in silicone hydrogel. The word "VISCO" is written in large, bold, blue letters. Below the company name is the tagline "The Silicone Hydrogel Expert" in a smaller, gray font. The logo is simple and professional, and it clearly communicates the company's area of expertise.

+8.00 to -12.00 D (JF ´ L| ≤ 10,00 D: ±0.25D; 10,00 D < |F ´ L| ≤ 20,00 D: ±0.50D)

# 8.2 Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses characteristics:

| • Diameter Range : | 13.0 to 15.0 mm, ±0.2mm |
|----------------------|------------------------------------------------------------------------------------|
| • Base Curve : | 8.0 to 9.2 mm, ±0.2mm |
| • Center Thickness : | 0.09 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc] |
| • Power : | +8.00 to -12.00 D( F´ L ≤ 10,00 D: ±0.25D; 10,00 D < F´ L ≤<br>20,00 D: ±0.50D) |
| • Cylinder: | -0.75D ~ -2.25D |
| • Axis: | 10° to 180° (in 10° increments) |

# 8.3 Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses characteristics:

| • Diameter Range : | 13.0 to 15.0 mm, ±0.2mm |
|----------------------|-------------------------------------------------------------------------------------|
| • Base Curve : | 8.0 to 9.2 mm , ±0.2mm |
| • Center Thickness : | 0.09 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc] |
| • Power : | +8.00 to -12.00 D ( $ F´L $ ≤ 10,00 D: ±0.25D; 10,00 D < $ F´L $ ≤ 20,00 D: ±0.50D) |
| • Additional Powers: | +0.25D ~ +2.75D |

#### Substantial Equivalence Comparison 9.

All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.

| Category | Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens | Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens | Result of Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Applicant | Visco Vision Inc | Visco Vision Inc | Same |
| Indications for use | The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens are indicated as daily wear single use soft contact lens for | The Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens are indicated as daily wear single use soft contact lens for the correction of refractive | Same |
| Category | Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens | Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens | Result of Comparison |
| | the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes | ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes | |
| Classification | class II | class II | Same |
| Regulation number | 886.5925 | 886.5925 | Same |
| Product code | MVN | MVN | Same |
| Intended use | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism, Presbyopia | Same |
| Replacement Schedule | Daily Disposable (Single use) | Daily Disposable (Single use) | Same |
| USAN Name | olifilcon B | olifilcon B | Same |
| FDA Category (Group) | Group 5C (Nonionic, Water < 50 wt %) | Group 5C (Nonionic, Water < 50 wt %) | Same |
| Manufacturing Method | Molded | Molded | Same |
| Lens Design | Spherical, toric, or multifocal | Spherical, toric, or multifocal | Same |
| Water Content | 47 % (<50%) | 47 % (<50%) | Same |
| Light Transmittance | 94% | 94% | Same |
| Refractive Index | 1.410 | 1.410 | Same |
| Oxygen Permeability (DK, 35°C) | 120 (Fatt method) | 120 (Fatt method) | Same |
| Diameter Range (mm) | 13.0~15.0 | 13.0~15.0 | Same |
| Power Range | +8.00 to -12.00 D | -20.00D to +20.00D | Different |
| Center Thickness | 0.09mm @ -3.00D (Varies with Power) | 0.08mm @ -3.00D (Varies with Power) | Different |
| Base Curve (mm) | 8.0~9.2 | 8.0~9.2 | Same |
| Blue handling tint | Reactive Blue19 | Reactive Blue19 | Same |
| Sterilization | Steam Sterilization | Steam Sterilization | Same |

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

Image /page/6/Picture/0 description: The image shows the logo for VISCO. The word "VISCO" is written in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in smaller, gray letters.

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

Image /page/7/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is simple and clear, with a focus on the company name and its expertise in silicone hydrogels.

### 10. Non-clinical tests

## 10.1 Biocompatibility

The safety tests, such as biocompatibility have been performed in accordance with ISO10993. Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

# 10.2 Sterilization and Stability Testing

- ◆ ISO17665-2 sterilization Of Health Care Products Moist Heat Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
- ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- · ISO 11987 Ophthalmic optics-Contact lenses-Determination of shelf-life.

# 10.3 Performance Data

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

- ◆ ISO18369-3 Ophthalmic optics Contact lenses Part 3: Measurement Methods
- · ISO18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
- + ISO18369-2 Ophthalmic optics Contact lenses Part 2: Tolerances

# 11. Clinical study

This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.

## 12. Conclusions:

Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens and Si-Hy (olifilcon B) Silicone Hydrogel soft contact lens have the same manufacturing process, operating principles. sterilization and materials as the above predicate devices. Being similar with respect to the physical/chemical/optical amd performance characteristic to the predicated deice, this meets the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses.May 1994. the information provided herein supports the claim of substantial equivalence. it shows that "Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens" is as safe, as effective and performs as well as the predicate device.