NaturalVue (etafilcon A) 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 Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission asserts substantial equivalence to a predicate device (K150385) with the addition of a modified saline solution.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria presented are in the form of material properties and performance characteristics, demonstrating equivalence to the predicate device.

Acceptance Criteria / Performance Characteristic	Proposed Device (NaturalVue etafilcon A)	K150385 Predicate (NaturalVue etafilcon A)
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 (35°C) polarographic method (ISO/Fatt)	19.73 x 10⁻¹¹ (cm²/sec)(ml O2/ml-mmHg)	19.73 x 10⁻¹¹ (cm²/sec)(ml O2/ml-mmHg)
Percent Transmittance % T at 593nm	> 95%	> 95%
% T at 380-315nm (UVA)	< 30%	< 30%
% T at 315-280nm (UVB)	< 5%	< 5%
Lens Design	Spherical/Aspherical, Toric, Multifocal, Multifocal Toric	Spherical/Aspherical, Toric, Multifocal, Multifocal Toric
Packaging Solution	Borate buffered saline (with Tween 80, Sodium Hyaluronate, and Polyethylene Glycol)	Borate buffered saline

Additional Performance Tests (Qualitative/Binary):

Biocompatibility: Negative responses for cytotoxicity, maximization, and ocular irritation tests. Validity of blister packaging demonstrated by passing extraction tests. (Applies to both proposed and predicate as they share the same material).
Microbiology (Sterilization): Steam sterilization validated to deliver minimum SAL of 10⁻⁶. Shelf-life stability supports sterility through expiration.
Bacteriostatic Validation: Steam sterilizer effectiveness confirmed. Microorganisms killed under tested conditions. Lenses remained sterilized with no microbial growth for 5 years (accelerated conditions). Package seal remained tight for 5 years (accelerated conditions).
Leachability: No leachable monomers and additive residues at detected levels.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical performance tests for material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. It does not describe a "test set" in the context of an algorithm or diagnostic device. Instead, it refers to the product itself and its components undergoing various testing.

Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many lenses were tested for water content, or how many individual cytotoxicity tests were conducted). It only states that "All tests were conducted in accordance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses."
Data Provenance: The tests are described as being performed to demonstrate safety and effectiveness of the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The data originates from these non-clinical studies conducted by or for Visioneering Technologies, Inc. There is no mention of country of origin for the underlying data, but the submission is to the U.S. FDA. The data is implicitly prospective in the sense that these tests were performed on the device or its components to support this specific 510(k) submission, rather than re-analyzing existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable to this submission. The device is a contact lens, not an AI/diagnostic algorithm that requires expert-established ground truth for its performance evaluation in the way a medical image analysis software would. The "ground truth" for contact lenses is established through standardized physical, chemical, and biological testing methods (e.g., measuring water content, oxygen permeability, cytotoxicity, sterility).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This question is not applicable as there is no "test set" in the context of human expert review and adjudication for an AI/diagnostic algorithm. The non-clinical tests described have quantifiable outcomes or pass/fail criteria based on established scientific methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a contact lens and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a contact lens and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests performed, the "ground truth" is based on:

Established scientific methodologies and standards: For material properties (e.g., water content, refractive index, oxygen permeability, transmittance), the ground truth is the measured physical/chemical properties.
Validated biological tests: For biocompatibility (cytotoxicity, maximization, ocular irritation), the ground truth is the biological response observed in animal or in-vitro models according to recognized standards.
Sterilization validation standards: For microbiology, the ground truth is the demonstration of a specific sterility assurance level (SAL).
Analytical chemistry techniques: For leachability, the ground truth is the detection or non-detection of leachable substances.

8. The sample size for the training set

This question is not applicable. The device is a contact lens and does not involve a "training set" for an AI algorithm.

9. How the ground truth for the training set was established

This question is not applicable. The device is a contact lens and does not involve a "training set" for an AI algorithm.

Summary of the Study and Conclusion:

The study presented is a non-clinical evaluation to demonstrate the substantial equivalence of the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses to a previously cleared predicate device (K150385). The central argument for substantial equivalence relies on:

Identical material composition (etafilcon A): The USAN name, material classification (Group 4 high water ionic), water content (58%), refractive index (1.4023), oxygen permeability (19.73 x 10⁻¹¹), % T at 593nm (>95%), UVA transmittance (<30%), and UVB transmittance (<5%) are all identical to the predicate device.
Identical production method: Cast-molded.
Identical range of lens designs.
Historical Clinical Use: The submission leverages the well-established safety and effectiveness of etafilcon A lenses, citing several predicate and reference devices, including the K150385.
Non-Clinical Performance Tests: Comprehensive testing was conducted in accordance with FDA guidance for daily wear contact lenses, covering:
- Material Properties: Confirmed the listed characteristics are equivalent to the predicate.
- Biocompatibility: Demonstrated material safety based on negative responses in cytotoxicity, maximization, and ocular irritation tests.
- Microbiology: Validated the steam sterilization process to achieve a minimum SAL of 10⁻⁶ and confirmed shelf-life sterility.
- Bacteriostatic Validation: Confirmed sterilizer effectiveness and lens sterility/package integrity over time (accelerated conditions).
- Leachability: Showed no detectable leachable monomers or additive residues.
Modification: The only significant difference highlighted is the modified saline solution (addition of Tween 80, Sodium Hyaluronate, and Polyethylene Glycol), which was previously cleared under K161739, implying its safety and compatibility.

The conclusion is that based on these performance and manufacturing verification studies, the proposed device is equivalent to the predicate device with respect to intended use, principles of operation, and technological characteristics, especially given the prior clearance of the modified saline solution.

Summary

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

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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

FORM FDA 3881 (7/17)

Page 1 of 1

Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

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.Stephen Snowdy, CEO10745 Westside WaySuite 200Alpharetta, GA 30009844-884-5367 X 102 (office phone)404-863-8892 (cell phone)ssnowdy@vtivision.com (email)
OFFICIALCORRESPONDENT	Penny Northcutt, RAC, FRAPS174 Watercolor Way, Suite 103-403Santa Rosa Beach, FL 32459678-428-6978 (phone)866-630-4082 (fax)pennynorthcutt@theregsolutions.com (email)
TRADE NAME	NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic)Contact Lenses
COMMON NAME	Soft (hydrophilic) Contact Lenses (daily wear)Soft (hydrophilic) Contact Lenses (disposable)
DEVICECLASSIFICATIONAND PRODUCTCODE	Class IILenses, Soft Contact, Daily Wear, per 21 CFR 886.5925,Product Code: LPLClass IILens, Contact, (Disposable), per 21 CFR 886.5925, ProductCode: MVN
PREDICATEDEVICE	K150385 Visioneering Technologies, Inc., NaturalVue(etafilcon A) Daily Disposable Soft (Hydrophilic) ContactLenses

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.

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

DESCRIPTION OF THE DEVICE:

INTENDED USE/INDICATIONS FOR USE:

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

Spherical and Aspheric

Toric

Multifocal

Multifocal Toric

The lenses are intended for single-use disposable wear.

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

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(35°C) polarographicmethod (ISO/Fatt)	$19.73 \times 10^{-11}$(cm²/sec)(ml O2/ml-mmHg)	$19.73 \times 10^{-11}$(cm²/sec)(ml O2/ml-mmHg)
Percent Transmittance% T at 593nm	> 95%	> 95%

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

	Proposed Device	K150385 Predicate
% T at 380-315nm% T at 315-280nm	< 30%< 5%	< 30%< 5%
Lens Design	Spherical/AsphericalToricMultifocalMultifocal Toric	Spherical/AsphericalToricMultifocalMultifocal Toric
Packaging Solution	Borate buffered saline (withTween 80, SodiumHyaluronate, andPolyethylene 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.

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.