POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens

K221517 · INTEROJO, Inc. · LPL · Oct 4, 2022 · Ophthalmic

Device Facts

• Record ID: K221517
• Device Name: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
• Applicant: INTEROJO, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye. The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Device Story

Soft (hydrophilic) contact lenses; manufactured via cast molding; composed of polymacon (HEMA crosslinked with EGDMA); 38% water content. Available in clear or tinted versions; tinted lenses use pad-printed pigments (phthalocyanine blue/green, titanium dioxide, iron oxide, reactive black 5, carbazole violet) entrapped in the lens matrix. Prescribed by eye care practitioners for daily wear; frequent/planned replacement schedule; requires chemical disinfection. Lenses act as refractive medium to focus light on retina. Benefits include vision correction and cosmetic eye color enhancement.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by non-clinical toxicology (ISO 10993-5, -10, -11), shelf-life stability, and physicochemical/mechanical property testing (refractive index, water content, oxygen permeability, light transmission, tensile strength, modulus).

Technological Characteristics

Material: Polymacon (HEMA/EGDMA copolymer). FDA Group 1 (non-ionic, <50% water). Water content: 38%. Oxygen permeability: 10.26 x 10^-11 (cm²/sec)(mlO2)/(ml x mmHg). Refractive index: 1.438. Design: Aspheric/Toric. Manufacturing: Cast molded; pad-printed tinting. Sterilization: Steam. Standards: ISO 18369-2:2017 (tolerances).

Indications for Use

Indicated for daily wear correction of refractive error (myopia, hyperopia, early presbyopia up to 1.25D) in non-aphakic, non-diseased eyes. Aspheric lenses for astigmatism ≤1.50D; Toric lenses for astigmatism ≤5.00D. Available clear or tinted.

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

• HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (K020608)

Reference Devices

• Clalen 54 (hioxifilcon D) & Clalen 58 (hioxifilcon A) Soft Contact Lenses (K153766)

Submission Summary (Full Text)

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October 04, 2022

Interojo Inc. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

Re: K221517

Trade/Device Name: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: August 30, 2022 Received: August 30, 2022

Dear Mr. Bret Andre:

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

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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 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([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

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# Indications for Use

510(k) Number (if known) K221517

### Device Name

POLYVUE (polymacon) Soft (hydrophilic) Contact Lens; POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens

### Indications for Use (Describe)

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

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

| <span style="font-size:10pt;"> <span style="font-family:Wingdings;">ü</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### The assigned 510(k) number is: K221517

#### I. SUBMITTER

- August 22nd, 2022 Date Prepared: Name: INTEROJO INC. Address: 28& 25 Sandan-Ro 15 Beon-Gil PYONGTAEK-CITY Gyeonggi, SOUTH KOREA Contact Person: Si-Chul, Rho CEO [phone] Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Phone number: [phone]
#### II. DEVICE

| Trade Name: | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens;<br>POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|
| Common<br>Name: | Contact Lens, Daily Wear |
| Classification<br>Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory<br>Class: | Class II |
| Product Code: | LPL |

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### III. PREDICATE DEVICE

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the following predicate device:

- I "HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully castmolded lens)" By PolyVue Technologies, Inc. 510(k) number; K020608 Primary Predicate
- I "Clalen 54 (hioxifilcon D) & Clalen 58 (hioxifilcon A) Soft Contact Lenses" By Interojo, Inc. 510(k) number; K153766 Reference Predicate

### IV. DEVICE DESCRIPTION

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The POLYVUE (polymacon) Soft (hydrophilic) Contact Lens is available clear or tinted for visibility using phthalocyanine blue. The POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens contains a unique tinted pattern to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives:

| Color Additive | Listing |
|----------------------|----------------|
| Phthalocyanine blue | 21 CFR 74.3045 |
| Phthalocyanine green | 21 CFR 73.3124 |
| Titanium dioxide | 21 CFR 73.3126 |
| Iron Oxide | 21 CFR 73.3125 |
| Reactive black 5 | 21 CFR 73.3121 |
| Carbazole violet | 21 CFR 73.3107 |

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material-in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.

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The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:

| Parameter | Range | Tolerance* |
|-------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm | When ≤ 0.10 mm → ±0.010 mm + 10%<br>When > 0.10 mm → ±0.015 mm + 5% |
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +10.00 D to -20.00D<br>(in 0.25D steps) | When 0.00 < $ F'v $ ≤ 10.00 D → ±0.25 D<br>When 10.00 < $ F'v $ ≤ 20.00 D → ±0.50 D |
| Cylinder Power (F'c) | -0.25D to -4.00D in 0.25D steps | When 0.00 < $ F'c $ ≤ 2.00 D → ±0.25 D<br>When 2.00 < $ F'c $ ≤ 4.00 D → ±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps | When 0.00 < $ F'c $ ≤ 1.50 D → ± 8°<br>When $ F'c $ > 1.50 D → ± 5° |
| Surface Appearance | - | Lenses should be clear with no surface defect |
| Oxygen Permeability<br>(x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | 8.9 | ±20% |
| Light Transmission - Clear<br>(@ 380-780nm) | 95% | ±5% |
| Light Transmission - Tinted<br>(@ 380-780nm) | 95% | ±5% |
| Water Content | 38% | ±2% |
| Refractive Index | 1.440 (hydrated) | +0.005 |

* ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances

### V. INDICATIONS FOR USE

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic)

Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eves with mvopia or hyperopia and early presbyopia up to 1,25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

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Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the predicate device (K020608) in terms of the following:

- 트 USAN contact lens material (polymacon)
- FDA Group 1 (<50% H2O, non-ionic polymer)
- 트 FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- I Intended use - daily wear contact lenses
- Actions
- 트 Indications for use
- 트 Aspheric lens design

The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the predicate device (K153766) in terms of the following:

- FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- 트 Intended use - daily wear contact lenses
- I Actions
- 트 Indications for use
- 트 Lens design
- Cast molded production method
- Pad-printing contact lens tinting method
- I Packaging system and storage solution

The following matrix illustrates the production method, lens function and material characteristics of the POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses, as well as the predicate devices.

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| | Interojo Inc.<br>POLYVUE and POLYVUE<br>COLOR<br>(Subject Device) | PolyVue Technologies, Inc.<br>HD/HDT<br>(K020608) | Interojo, Inc.<br>Clalen 54 & Clalen 58<br>(K153766) |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Actions | The contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina | The contact lenses act as a refractive<br>medium that focus light rays from<br>near and distant objects on the retina | The contact lenses act as a refractive<br>medium that focus light rays from<br>near and distant objects on the retina |
| FDA Classification | Soft (hydrophilic) Contact Lens<br>(21 CFR 886.5925) | Soft (hydrophilic) Contact Lens (21<br>CFR 886.5925) | Soft (hydrophilic) Contact Lens (21<br>CFR 886.5925) |
| FDA Group | FDA Group 1<br>(<50% H2O, non-ionic<br>polymer) | FDA Group 1<br>(<50% H2O, non-ionic polymer) | FDA Group 2<br>(>50% H2O, non-ionic polymer) |
| Production<br>Method | Fully molded | Fully molded | Fully molded |
| USAN name | polymacon | polymacon | hioxifilcon D<br>hioxifilcon A |
| Water Content<br>(%) | 38±2% | 38±2% | 54±2%<br>59±2% |
| Oxygen<br>Permeability<br>x 10-11<br>(cm²/sec)(mlO2)/(ml x<br>mmHg @ 35°C))<br>(revised Fatt method) | 10.26± 20% | 8.9± 20% | 18.42± 20%<br>20.76± 20% |
| Refractive Index<br>(hydrated) | 1.438 ± 0.005 | 1.440 ± 0.005 | 1.404 ± 0.005<br>1.403 ± 0.005 |
| UV Blocker | No | No | Yes |
| Pad-Printed<br>Tinting | Yes | Yes | Yes |
| Primary<br>Packaging | blister base, foil seal | blister base, foil seal | blister base, foil seal |
| Sterilization<br>Method | Steam sterilization | Steam sterilization | Steam sterilization |

| | Indications for Use |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interojo Inc.<br>POLYVUE and<br>POLYVUE<br>COLOR<br>(Subject Device) | The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for<br>daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased<br>eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who<br>exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.<br>The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.<br>The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses<br>for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased<br>eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who<br>exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to<br>enhance or alter the apparent color of the eye. |
| | Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning,<br>disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be<br>disinfected using a chemical disinfecting system. |
| PolyVue<br>Technologies,<br>Inc.<br>HD/HDT<br>(K020608) | The HD (polymacon) ASPHERIC Soft Contact Lenses for daily wear are indicated for the correction of visual<br>acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25<br>diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the<br>astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or<br>alter the apparent color of the eye.<br>The HDT (polymacon) ASPHERIC TORIC Soft Contact Lenses for daily wear are indicated for the correction of<br>visual acuity in not aphakic persons with otherwise non-diseased eyes with myopia or hyperopia, possesses<br>refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available<br>clear or tinted and may be used to enhance or alter the apparent color of the eye. |
| | Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be<br>disinfected using a chemical disinfecting system. |
| | The Clalen 54 (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of<br>refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may<br>be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not<br>interfere with visual acuity. The lens is available clear or tinted for visibility and handling. |
| Interojo, Inc.<br>Clalen 54 &<br>Clalen 58<br>(K153766) | The Clalen 54 (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive<br>error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses<br>refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted for visibility and handling. |
| | The Clalen 54 (hioxifilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of<br>refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may<br>be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D, and who exhibit refractive<br>astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available<br>clear or tinted for visibility and handling. |
| | The Clalen 54 (hioxifilcon D) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction<br>of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses<br>refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add<br>power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling. |
| | The Clalen 58 (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of<br>refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may<br>be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not<br>interfere with visual acuity. The lens is available clear or tinted for visibility and handling. |
| | The Clalen 58 (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive<br>error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses<br>refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted for visibility and handling. |
| | The Clalen 58 (hioxifilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of<br>refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may<br>be worn by presbyopic persons requiring an add power ranging from +1.25D to +2.50D, and who exhibit refractive<br>astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available<br>clear or tinted for visibility and handling. |
| | The Clalen 58 (hioxifilcon A) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction<br>of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses<br>refractive astigmatism not exceeding 5.00 diopters. The lens may be worn by presbyopic persons requiring an add<br>power ranging from +1.25D to +2.50D. The lens is available clear or tinted for visibility and handling. |
| | Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners<br>in consultation with their patients. |
| | Frequent/Planned Replacement Wear: |
| | Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be<br>disinfected using a chemical disinfecting system. |
| Disposable Wear: | |
| Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed<br>for daily disposable wear the lens is to be discarded after each removal. | |

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#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# Non-clinical Testing

A series of non-clinical testing was performed to demonstrate the safety and effectiveness of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses. The results support the claim that the POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are substantially equivalent to the currently marketed predicate device. A summary of the results from the non-clinical studies is presented below.

# Toxicology:

All non-clinical toxicology tests were conducted in accordance with the GLP regulation.

- · In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses extracts are non-toxic.
- · Sensitization: Skin sensitization testing was performed in accordance with ISO 10993-10 with the results confirming the lens extracts do not cause sensitization.
- · Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-10 and finished lens extracts were non-irritating.
- · Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.

# Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the POLYVUE and POLYVUE COLOR (polymacon) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate device.

### Physicochemical & Mechanical Properties:

The following tests were completed to verify substantial equivalence to predicate devices: refractive index, water content, oxygen permeability, light transmission, tensile strength, modulus, elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistency of the material properties between the POLYVUE and POLYVUE COLOR (polymacon) contact lenses and the predicate device.

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# Clinical Testing

Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously.

# VIII. CONCLUSIONS

## Validity of Scientific Data

Laboratories conducted non-clinical studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

### Substantial Equivalence

Information presented in this Premarket Notification establishes that the POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

### Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.