The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 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 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A 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 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 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

AI/ML Overview

This document is a 510(k) summary for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device testing (e.g., sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this document.

However, I can extract information related to the device attributes and the comparisons made to establish equivalence, which can be seen as meeting "acceptance criteria" for chemical/physical properties rather than AI performance.

Here's a breakdown of what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance (Analogous for Contact Lenses)

In the context of contact lenses, "acceptance criteria" are not thresholds for AI performance, but rather specifications and physical/chemical properties that demonstrate the new devices (Vexillum Zephyr and OxyPure A) are substantially equivalent to the predicate device (OxyPure Color). The table below summarizes these comparisons.

Category	Acceptance Criteria (Predicate Device K171447: OxyPure Color)	Reported Device Performance (New Devices: Vexillum Zephyr & OxyPure A)	Result of Comparison
Applicant	Visco Vision Inc	Visco Vision Inc	Same
Classification	Class II	Class II	Same
Regulation Number	886.5925	886.5925	Same
Product Code	LPL, MVN	LPL, MVN	Same
Intended Use	Myopia, Hyperopia, astigmatism, Presbyopia	Myopia, Hyperopia, astigmatism, Presbyopia	Same
Replacement Schedule	Daily Wear	Daily Wear	Same
USAN Name	olifilcon A	olifilcon A	Same
FDA Category (Group)	Group 5C (Nonionic, Water < 50 wt %)	Group 5C (Nonionic, Water < 50 wt %)	Same
Manufacturing Method	Cast Molded	Cast Molded	Same
Lens Design	Spherical	Spherical	Same
Water Content	47%	47%	Same
Light Transmittance	94%	94%	Same
Refractive Index	1.410 (hydrated)	1.410 (hydrated)	Same
Oxygen Permeability (DK, 35°C)	150 (Fatt method)	150 (Fatt method)	Same
Diameter Range	13.0 to 15.0 mm	13.0 to 15.0 mm	Same
Power Range	-20.00D to +20.00D	-20.00D to +20.00D	Same
Center Thickness	0.08mm @ -3.00D (Varies with Power)	0.08mm @ -3.00D (Varies with Power)	Same
Base Curve	8.0 mm to 9.2 mm	8.0 mm to 9.2 mm	Same
Blue handling tint	No	Reactive Blue19 (for both new devices)	Different
Color Additives in Dye	Iron oxide, Titanium dioxide, Phthalocyanine green, Carbazole violet	Reactive Blue19 (for both new devices)	Different
Leachability	no leachable monomers and addictive residues	no leachable monomers and addictive residues	Same
Packaging	Blister Pack	Blister Pack	Same
Packaging Solution	Sterile isotonic borate buffered saline	Vexillum Zephyr: sterile isotonic borate buffered saline with Tangible polymersOxyPure A: sterile isotonic borate buffered saline	Different
Coating on the lens surface	No	Vexillum Zephyr: Yes, coating with Tangible Polymer during sterilization processOxyPure A: No	Different
Sterilization Method	Steam	Steam	Same
Shelf Life	5 years	5 years	Same
Sterility of Device	SAL= 10^-6	SAL= 10^-6	Same
Tensile Strength (Mpa)	0.78 ± 0.2	0.80 ± 0.2	Different
Modulus (Mpa)	0.60 ± 0.1	0.60 ± 0.1	Same
Elongation at break (%)	195 ± 20	250 ± 50	Different
Toughness (J/m3)	0.87 ± 0.05	1.10 ± 0.05	Different
Compliance Standard (Biocompatibility)	ISO10993-1, ISO10993-5, ISO10993-10, ISO10993-11	ISO10993-1, ISO10993-5, ISO10993-10, ISO10993-11	Same
Compliance Standard (Sterilization & Shelf Life)	ISO 17665-1, ISO11737-1, ISO 11987	ISO 17665-1, ISO11737-1, ISO 11987	Same
Compliance Standard (Performance)	ISO18369-3, ISO18369-4, ASTM D792-13	ISO18369-3, ISO18369-4, ASTM D792-13	Same

Study Proving Device Meets Criteria:

The study proving the devices meet the "acceptance criteria" (i.e., are substantially equivalent) is based on non-clinical bench testing and comparison of technical characteristics to the predicate device.

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of AI. The "test" consists of various physical, chemical, and mechanical tests on the contact lenses. The specific number of lenses tested for each parameter (e.g., tensile strength, oxygen permeability) is not provided in this summary but is implied to be sufficient for standard quality control and regulatory submission.
- Data Provenance: The document does not specify the country of origin for the testing data, but the applicant's address is Taiwan. The studies are non-clinical bench tests, implying they are laboratory-based, not patient-based data. They are presumably prospective in the sense that they were specifically conducted for this submission.
Number of Experts and Qualifications for Ground Truth:
- Not Applicable. This document is not evaluating AI performance or subjective diagnostic interpretations. Ground truth, in this context, refers to the objective measurements of the lens properties themselves, assessed through established laboratory procedures according to recognized ISO and ASTM standards. No human expert "ground truth" establishment in the diagnostic sense is mentioned.
Adjudication Method for Test Set:
- Not Applicable. As there are no human-in-the-loop diagnostic interpretations requiring adjudication, this concept does not apply.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This confirms that no clinical studies, including MRMC studies, were conducted.
Standalone Performance (Algorithm Only):
- Not Applicable. This is not an AI device.
Type of Ground Truth Used:
- For the physical and chemical properties, the "ground truth" is established through objective laboratory measurements following recognized international standards (ISO, ASTM). Examples include:
  - Spectrophotometry for UV transmission.
  - Fatt method for oxygen permeability.
  - Standardized tests for tensile strength, modulus, elongation, and toughness.
  - Biocompatibility testing as per ISO 10993 series.
  - Sterility testing.
- For the overall determination of substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device (OxyPure Color Silicone Hydrogel Soft Contact Lenses, K171447). The new devices are compared to this established benchmark.
Sample Size for Training Set & How Ground Truth for Training Set was Established:
- Not Applicable. There is no training set as this is not an AI/machine learning device. The entire process relies on direct measurement and comparison to a known good (predicate) device, and adherence to established industry standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of human figures. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

September 13, 2019

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

Re: K183670

Trade/Device Name: Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 8, 2019 Received: August 8, 2019

Dear Mr. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for 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) K183670

Device Name

Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for VISCO. The logo is in blue and gray. The text below the logo says "The Silicone Hydrogel Expert".

510(k) Summary

Company Name:	Visco Vision Inc
Company Address:	No. 1, Xingye St., Guishan Dist.,Taoyuan City, 33341, TAIWAN
Telephone:	+886-3-359-6868
Fax:	+886-3-349-0202
Contact Person:	Evan Huang
Summary Preparation Date:	2018.10.05
Device Name:
Trade Name:	Vexillum Zephyr (olifilcon A) with Tangible Polymers SiliconeHydrogel Soft Contact LensesOxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses
Classification Name:	Soft (hydrophilic) contact lens.
Regulation Number:	886.5925
Product Code:	LPL, MVN
Device Class:	Class 2
Panel:	Ophthalmic

PREDICATE DEVICE:

K171447, OxyPure Color Silicone Hydrogel Soft Contact Lenses

Device Description for Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses

Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with 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

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Image /page/4/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 horizontally aligned and centered.

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.

Intended Use:

The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear 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.

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.

Device Description for OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses

OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with 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

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Image /page/5/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 horizontally aligned and centered.

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.

Intended Use:

The OxyPure A (olifilcon A) Silicone Hydrogel soft contact lenses are daily wear indicated 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.

Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Category	VexillumZephyr (olifilcon A) with TangiblePolymers SiliconeHydrogel SoftContact LensesNew device	OxyPure A(olifilcon A) SiliconeHydrogel SoftContact LensesNew device	OxyPure ColorSilicone HydrogelSoft ContactLensesK171447	Result ofComparison
Applicant	Visco Vision Inc	Visco Vision Inc	Visco Vision Inc	Same
Classification	class II	class II	class II	Same
Regulationnumber	886.5925	886.5925	886.5925	Same
Product code	LPL, MVN	LPL, MVN	LPL, MVN	Same
Intended use	Myopia, Hyperopia,astigmatism,Presbyopia	Myopia, Hyperopia,astigmatism,Presbyopia	Myopia, Hyperopia,astigmatism,Presbyopia	Same
Replacement	Daily Wear	Daily Wear	Daily Wear	Same
Category	VexillumZephyr (olifilconA) with TangiblePolymers SiliconeHydrogel SoftContact LensesNew device	OxyPure A(olifilcon A) SiliconeHydrogel SoftContact LensesNew device	OxyPure ColorSilicone HydrogelSoft ContactLensesK171447	Result ofComparison
Schedule
USAN Name	olifilcon A	olifilcon A	olifilcon A	Same
FDA Category(Group)	Group 5C (Nonionic,Water < 50 wt % )	Group 5C (Nonionic,Water < 50 wt % )	Group 5C (Nonionic,Water < 50 wt % )	Same
ManufacturingMethod	Cast Molded	Cast Molded	Cast Molded	Same
Lens Design	Spherical	Spherical	Spherical	Same
Water Content	47%	47%	47%	Same
LightTransmittance	94%	94%	94%	Same
Refractive Index	1.410 (hydrated)	1.410 (hydrated)	1.410 (hydrated)	Same
OxygenPermeability (DK,35°C )	150(Fatt method)	150(Fatt method)	150(Fatt method)	Same
Diameter Range	13.0 to 15.0 mm	13.0 to 15.0 mm	13.0 to 15.0 mm	Same
Power Range	- 20.00D~ +20.00D	- 20.00D~ +20.00D	- 20.00D~ +20.00D	Same
Center Thickness	0.08mm @ -3.00D(Varies with Power)	0.08mm @ -3.00D(Varies with Power)	0.08mm @ -3.00D(Varies with Power)	Same
Base Curve	8.0 mm to 9.2 mm	8.0 mm to 9.2 mm	8.0 mm to 9.2 mm	Same
Blue handlingtint	Reactive Blue19	Reactive Blue19	No	Different
Color Additivesin dye	Reactive Blue19	Reactive Blue19	* Iron oxide* Titanium dioxide* Phthalocyaninegreen* Carbazole violet	Different
Leachability	no leachablemonomers andaddictive residues	no leachablemonomers andaddictive residues	no leachablemonomers andaddictive residues	Same
Category	VexillumZephyr (olifilconA) with TangiblePolymers SiliconeHydrogel SoftContact LensesNew device	OxyPure A(olifilcon A) SiliconeHydrogel SoftContact LensesNew device	OxyPure ColorSilicone HydrogelSoft ContactLensesK171447	Result ofComparison
Packaging	Blister Pack	Blister Pack	Blister Pack	Same
PackagingSolution	sterile isotonic boratebuffered saline withTangible polymers	sterile isotonic boratebuffered saline	sterile isotonic boratebuffered saline	Different
Coating on thelens surface	Yes, coating withTangible Polymerduring thesterilization process	No	No	Different
Sterilizationmethod	Steam	Steam	Steam	Same
Shelf Life	5 years	5 years	5 years	Same
Sterility of Device	SAL= $10^{-6}$	SAL= $10^{-6}$	SAL= $10^{-6}$	Same
Tensile strength(Mpa)	0.80±0.2	0.80±0.2	0.78±0.2	Different
Modulus (Mpa)	0.60 ± 0.1	0.60 ± 0.1	0.60±0.1	Same
Elongation atbreak (%)	250± 50	250± 50	195± 20	Different
Toughness (J/m3)	1.10±0.05	1.10±0.05	0.87±0.05	Different
Compliance standard
Biocompatibility	ISO10993-1ISO10993-5ISO10993-10ISO10993-11	ISO10993-1ISO10993-5ISO10993-10ISO10993-11	ISO10993-1ISO10993-5ISO10993-10ISO10993-11	same
Sterilization andShelf life	ISO 17665-1ISO11737-1ISO 11987	ISO 17665-1ISO11737-1ISO 11987	ISO 17665-1ISO11737-1ISO 11987	Same
performance	ISO18369-3ISO18369-4ASTM D792-13	ISO18369-3ISO18369-4ASTM D792-13	ISO18369-3ISO18369-4ASTM D792-13	Same

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Image /page/6/Picture/0 description: The image shows the logo for VISCO. The logo is in blue and gray. The text below the logo says "The Silicone Hydrogel Expert".

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Image /page/7/Picture/0 description: The image shows the logo for VISCO. The logo is in blue and gray. The text below the logo says "The Silicone Hydrogel Expert".

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Image /page/8/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 area of expertise.

Substantial Equivalence Comparison

The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses, The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses, and OxyPure Color Silicone Hydrogel Soft Contact Lens, have same Lens design, intended use, Replacement Schedule, classification name/product code, len materials, manufacturing and sterilization method, perfomance parameter ranges, mechanical properties, physical properties, biocompatibility, shelf life and other reference devices have same technical characteristic as new devices to support the substantial equivalence. The differences among those three devices are Blue handling tint, Color Additives in dye, Packaging Solution, Coating on the lens surface, Tensile strength, Elongation at break and Toughness.

Non-clinical tests

The safety tests, such as biocompatibility have been performed and meet the requirement of following FDA Recognized Consensus Standards.

Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.

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
ISO11987 Ophthalmic optics -- Contact lenses and contact lens care products --Determination of physical compatibility of contact lens care products with contact lenses
ISO17665-2 terilization 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
ASTM D792-13 Standard Test Methods For Density And Specific Gravity (Relative ● Density) Of Plastics By Displacement. (Materials)

Clinical study

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

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Image /page/9/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 horizontally aligned and centered.

Conclusions:

Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses and OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses have the same Lens design,intended use and technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their Blue handling tint, Color Additives in dye, packing solution, Coating on the lens surface , Tensile strength, Elongation at break and Toughness do not raise any new questions of safety or effectiveness. Thus, Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses and OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are substantially equivalent to the predicate devices with respect to its intended use, technological characteristics and performance characteristics.

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.