NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

K173086 · Visioneering Technologies, Inc. · LPL · Nov 7, 2017 · Ophthalmic

Device Facts

• Record ID: K173086
• Device Name: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
• Applicant: Visioneering Technologies, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

NaturalVue (etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses 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 +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses 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 -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. The lenses are intended for single-use disposable wear.

Device Story

NaturalVue contact lenses are visibility-tinted, UV-blocking, ionic hydrogel lenses; manufactured via cast molding. Input: patient refractive error requirements. Transformation: optical correction via lens geometry (spheric, aspheric, toric, multifocal, multifocal toric designs). Output: vision correction for daily wear. Used in clinical settings by eye care professionals to address ametropia and presbyopia. Benefits: daily disposable convenience; correction of refractive errors; UV protection. Packaging includes buffered saline with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including material properties (water content, refractive index, oxygen permeability), biocompatibility (cytotoxicity, irritation), and sterilization validation.

Technological Characteristics

Material: etafilcon A (42% copolymer of 2-HEMA and MAA, 58% water). Cross-linked with EGDMA and TMPTMA. UV blocker: benzotriazole monomer. Tint: C.I. Reactive Blue 19. Oxygen permeability: 19.73 x 10^-11 (cm²/sec)(ml O2/ml-mmHg). Packaging: Borate buffered saline with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol. Sterilization: Steam.

Indications for Use

Indicated for daily wear correction of ametropia (myopia, hyperopia), astigmatism, and/or presbyopia in aphakic/non-aphakic persons with non-diseased eyes. Power range +20.00 to -20.00D; astigmatic correction up to -10.00D; reading addition up to +3.00D.

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

• NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K150385)

Reference Devices

• ACUVUE (etafilcon A) Contact lens (K962804)
• ACUVUE (etafilcon A) contact lens (K991134)
• Aquamax (etafilcon A) Disposable Soft (Hydrophilic) Contact Lenses (K120028)
• NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K140025)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2017

Visioneering Technologies, Inc. % Penny Northcutt, FRAPS, RAC President/CEO REGSolutions, LLC 174 Watercolor Way Suite 103-403 Santa Rosa Beach, FL 32459

Re: K173086

Trade/Device Name: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: September 29, 2017 Received: September 29, 2017

Dear Penny Northcutt, FRAPS, RAC:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K173086

#### Device Name

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Indications for Use (Describe)

#### Spherical and Aspheric

NaturalVue (etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses 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 +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

#### Toric

NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses 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 -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

#### Multifocal

NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

#### Multifocal Toric

NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with nondiseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.

The lenses are intended for single-use disposable wear

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</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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Image /page/3/Picture/0 description: The image shows the logo for Visioneering Technologies, Inc. The logo features the letters "VTI" in a bold, sans-serif font, with a gradient of blue from light to dark. Below the letters, the words "VISIONEERING TECHNOLOGIES, INC." are written in a smaller, sans-serif font. A curved line extends from the bottom of the "V" to the top of the "I", with a blue sphere at the end of the line.

## 510k Summary

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

| DATE | October 26, 2017 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | Visioneering Technologies, Inc.<br>Stephen Snowdy, CEO<br>10745 Westside Way<br>Suite 200<br>Alpharetta, GA 30009<br>844-884-5367 X 102 (office phone)<br>404-863-8892 (cell phone)<br>[e-mail] (email) |
| OFFICIAL<br>CORRESPONDENT | Penny Northcutt, RAC, FRAPS<br>174 Watercolor Way, Suite 103-403<br>Santa Rosa Beach, FL 32459<br>678-428-6978 (phone)<br>866-630-4082 (fax)<br>[e-mail] (email) |
| TRADE NAME | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic)<br>Contact Lenses |
| COMMON NAME | Soft (hydrophilic) Contact Lenses (daily wear)<br>Soft (hydrophilic) Contact Lenses (disposable) |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT<br>CODE | Class II<br>Lenses, Soft Contact, Daily Wear, per 21 CFR 886.5925,<br>Product Code: LPL<br><br>Class II<br>Lens, Contact, (Disposable), per 21 CFR 886.5925, Product<br>Code: MVN |
| PREDICATE<br>DEVICE | K150385 Visioneering Technologies, Inc., NaturalVue<br>(etafilcon A) Daily Disposable Soft (Hydrophilic) Contact<br>Lenses |

## SUBSTANTIAL EQUIVALENCE:

It is Visioneering Technologies, Inc.'s conviction that the data submitted in this 510(k) provides evidence of substantial equivalence for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses with the same established safety profile and effectiveness of the predicate device K150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, with the addition of modified saline solution as cleared in K161739.

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## DESCRIPTION OF THE DEVICE:

The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibilitytinted, containing a UV blocker and are available in a spheric, toric, multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Each lens is supplied sterile in a blister pack containing buffered saline solution with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol.

## INTENDED USE/INDICATIONS FOR USE:

## NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

#### Spherical and Aspheric

NaturalVue (etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses 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 +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

#### Toric

NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses 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 -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

#### Multifocal

NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

#### Multifocal Toric

NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.

The lenses are intended for single-use disposable wear.

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## TECNOLOGICAL CHARACTERISTICS:

## Historical Clinical Use

Daily Wear disposable contact lenses made from etafilcon A lenses have been used widely. Their safety and effectiveness has been well established and documented. Their safety and effectiveness can be further exemplified by the following lenses, as well as many others as discussed in the 510(k), cleared by FDA:

- ACUVUE (etafilcon A) Contact lens, clear and visibility tint with UV blocker, K962804 ● submitted by Vistakon USA
- . ACUVUE (etafilcon A) contact lens, clear and visibility tint with UV blocker, K991134 submitted by Vistakon USA
- . Aquamax (etafilcon A) Disposable Soft (Hydrophilic) Contact Lenses, K120028 submitted by Pegavision Corporation, Taiwan
- . NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, K140025 submitted by Pegavision Corporation, Taiwan
- NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, K150385 ● submitted by Visioneering Technologies, Inc.

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K150385 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned predicate (and reference) devices.

## Non-Clinical Study

All tests were conducted in accordance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses.

The non-clinical performance tests have been performed to demonstrate the safety and effectiveness of NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to the predicate NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K150385). The evidence of substantial equivalence to the predicate lenses is described below.

## a) Material Properties Testing

The material properties of NaturalVue (etafilcon A) Soft (Hydrophilic) Contact Lenses were tested as illustrated in the following table.

| | Proposed Device | K150385 Predicate |
|------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | etafilcon A | etafilcon A |
| Material Classification | Group 4 high water ionic | Group 4 high water ionic |
| Water Content (%) | 58% | 58% |
| Refractive Index | 1.4023 | 1.4023 |
| Oxygen Permeability<br>(35°C) polarographic<br>method (ISO/Fatt) | $19.73 \times 10^{-11}$<br>(cm²/sec)(ml O2/ml-mmHg) | $19.73 \times 10^{-11}$<br>(cm²/sec)(ml O2/ml-mmHg) |
| Percent Transmittance<br>% T at 593nm | > 95% | > 95% |

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| | Proposed Device | K150385 Predicate |
|--------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| % T at 380-315nm<br>% T at 315-280nm | < 30%<br>< 5% | < 30%<br>< 5% |
| Lens Design | Spherical/Aspherical<br>Toric<br>Multifocal<br>Multifocal Toric | Spherical/Aspherical<br>Toric<br>Multifocal<br>Multifocal Toric |
| Packaging Solution | Borate buffered saline (with<br>Tween 80, Sodium<br>Hyaluronate, and<br>Polyethylene Glycol) | Borate buffered saline |

#### b) Biocompatibility

The standard cytotoxicity, maximization, and ocular irritation tests were carried out for the predicate K150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and therefore apply to NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. Negative responses were recorded for all tests. The validity of blister packaging for these lenses was demonstrated by passing the standard extraction tests.

#### c) Microbiology

The steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group 4. There is shelf-life stability supporting that these lenses remain sterile through the expiration date claimed for the product.

#### d) Bacteriostatic Validation

The steam sterilizer was tested for effectiveness by measuring and demonstrating the uniformity of temperature at different locations inside the sterilizer over test period. Tested microorganisms were killed under tested conditions as compared to control.

Lenses remained sterilized and there was no microbial growth for a period of 5 years tested under accelerated conditions. Seal of lens packages remained tight for a period of 5 years as demonstrated by the constant peeling strength tested under accelerated conditions.

#### e) Leachability

Studies were conducted to determine the leachable materials from the finished lenses. The results show that, at the levels of the detection reported, there are no leachable monomers and additive residues.

#### CONCLUSION:

Based on the performance and manufacturing verification studies, it can be concluded that the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are equivalent to the predicate device K150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses with respect to intended use, principles of operation, and technological characteristics, with the addition of modified saline solution as cleared in K161739.