The Vexillum (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses 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.

The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

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

The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

Device Description

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B 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. 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 Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B 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 Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

AI/ML Overview

The provided document discusses the 510(k) premarket notification for two soft contact lenses: Vexillum (olifilcon B) with Tangible Polymers and Daily Breeze (olifilcon B). It asserts substantial equivalence to a predicate device (Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, K160344).

It is important to note that this document does not describe a study involving an AI/Machine Learning device. It pertains to contact lenses and their physical/chemical properties. Therefore, many of the requested criteria (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through non-clinical bench testing and comparisons of material, design, and performance characteristics.

Here's an attempt to answer the applicable parts of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a typical AI/ML study (e.g., target specificity and sensitivity values). Instead, it demonstrates "substantial equivalence" by comparing various parameters of the new devices (Vexillum and Daily Breeze) against a legally marketed predicate device (Si-Hy, K160344). The acceptance criterion, implicitly, is that the new devices are "substantially equivalent" to the predicate in terms of their intended use, technological characteristics, and performance characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's a table summarizing the comparison parameters and their reported performance/characteristics, which effectively serve as the "acceptance criteria" for substantial equivalence in this context:

Category	Acceptance Criteria (Predicate: Si-Hy (olifilcon B) K160344)	Reported Device Performance (Vexillum)	Reported Device Performance (Daily Breeze)	Result of Comparison
Applicant	Visco Vision Inc	Visco Vision Inc	Visco Vision Inc	Same
Classification	Class II	Class II	Class II	Same
Regulation number	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 Schedule	Daily Disposable (Single use)	Daily Disposable (Single use)	Daily Disposable (Single use)	Same
USAN Name	olifilcon B	olifilcon B	olifilcon B	Same
FDA Category (Group)	Group 5C (Nonionic, Water < 50 wt %)	Group 5C (Nonionic, Water < 50 wt %)	Group 5C (Nonionic, Water < 50 wt %)	Same
Manufacturing Method	Cast Molded	Cast Molded	Cast Molded	Same
Lens Design	Spherical, toric or multifocal	Spherical, toric or multifocal	Spherical, toric or multifocal	Same
Water Content	47%	47%	47%	Same
Light Transmittance	94%	94%	94%	Same
Refractive Index	1.410 (hydrated)	1.410 (hydrated)	1.410 (hydrated)	Same
Oxygen Permeability (DK, 35°C)	120 (Fatt method)	120 (Fatt method)	120 (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 handling tint	Reactive Blue19	Reactive Blue19	Reactive Blue19	Same
Leachability	no leachable monomers and addictive residues	no leachable monomers and addictive residues	no leachable monomers and addictive residues	Same
Packaging	Blister Pack	Blister Pack	Blister Pack	Same
Packaging Solution	sterile isotonic borate buffered saline	sterile isotonic borate buffered saline with Tagible polymers	sterile isotonic borate buffered saline	Different (for Vexillum)
Coating on the lens surface	No	Yes, coating with Tangible Polymer during the sterilization process	No	Different (for Vexillum)
Sterilization method	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	0.80±0.2	Same
Modulus (Mpa)	0.50 ± 0.1	0.50 ± 0.1	0.50 ± 0.1	Same
Elongation at break (%)	200± 20%	200± 20%	200± 20%	Same
Toughness (J/m3)	0.90±0.05	0.90±0.05	0.90±0.05	Same
Biocompatibility	ISO10993-1, -5, -10, -11	ISO10993-1, -5, -10, -11	ISO10993-1, -5, -10, -11	Same
Sterilization & Shelf life	ISO 17665-1, ISO11737-1, ISO 11987	ISO 17665-1, ISO11737-1, ISO 11987	ISO 17665-1, ISO11737-1, ISO 11987	Same
Performance (Measurement Methods)	ISO18369-3, ISO18369-4, ASTM D792-13	ISO18369-3, ISO18369-4, ASTM D792-13	ISO18369-3, ISO18369-4, ASTM D792-13	Same

The crucial acceptance here is based on the conclusion that while differences exist in "Packaging Solution" and "Coating on the lens surface" for Vexillum, these differences "do not raise any new questions of safety or effectiveness."

Study Proving Device Meets Acceptance Criteria:

The study used to prove the device meets these "acceptance criteria" is a non-clinical bench testing and comparative study against a predicate device.

Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each bench test. However, it indicates that "bench tests were performed in accordance with following FDA Recognized Consensus Standards." These standards (e.g., ISO and ASTM) dictate the required sample sizes for specific tests.
- Data Provenance: The company is Visco Vision Inc., located in Taoyuan City, TAIWAN. The studies would have been conducted by them or their contracted labs. This is a premarket submission, so it's prospective in the sense of demonstrating performance for a new device, but the tests themselves follow established methodologies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device (contact lens), not an AI/ML diagnostic system requiring expert interpretation of medical images. "Ground truth" is established through standardized laboratory measurement techniques (e.g., spectrophotometry for UV transmission, tensile strength testing, chemical analysis for leachables). The "experts" are the lab technicians and scientists performing these tests according to recognized standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for physical/chemical testing, not for subjective interpretation of data requiring adjudication. Compliance with a standard means the results fall within defined tolerances.
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:
- Not Applicable. This is not an AI/ML device, nor does it involve human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device. The "standalone" performance here refers to the physical and chemical properties of the contact lens itself as measured in a lab setting (e.g., water content, oxygen permeability).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of these contact lenses is established through standardized physical, chemical, and biological test methods (bench tests) as defined by international standards (e.g., ISO, ASTM). These methods are designed to objectively measure properties like oxygen permeability, water content, tensile strength, sterility, and biocompatibility. The predicate device's performance also serves as a "ground truth" benchmark for comparison.
The sample size for the training set:
- Not Applicable. This isn't an AI/ML device, so there is no "training set." The development of the contact lens material (olifilcon B) and manufacturing processes would involve research and development, but not in the sense of "training data" for a machine learning model.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 19, 2018

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

Re: K181349

Trade/Device Name: Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses; Daily Breeze (olifilcon B) 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 27, 2018 Received: August 27, 2018

Dear Evan Huang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

J. Angelo Green

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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Indications for Use

510(k) Number (if known) K181349

Device Name

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lenses

Indications for Use (Describe)

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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.

510(k) Summarv--K181349

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:	2018.5.15
Device Name:
Trade Name:	Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel SoftContact LensesDaily Breeze (olifilcon B) 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:

K 160344, Si-Hy (olifilcon B) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses

Device Description for Vexillum (olifilcon B) 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/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 centered in the image. The font is sans-serif.

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 (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens 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.

The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eves and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lens for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be dscarded upon removal. Therefore, no cleaning or disinfecting is requried.

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 Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lenses

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Image /page/6/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is simple and clear, with a focus on the company name and its expertise in silicone hydrogels.

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

The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be dscarded upon removal. Therefore, no cleaning or disinfecting is reguried.

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Image /page/7/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is centered and the background is white. The image appears to be a logo or branding material.

Category	Vexillum(olifilcon B) withTangible PolymersSilicone HydrogelSoft Contact LensesNew device	Daily Breeze(olifilcon B) SiliconeHydrogel SoftContact LensesNew device	Si-Hy (olifilcon B)Silicone HydrogelSoft Contact LensesK160344	Result ofComparasion
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
ReplacementSchedule	Daily Disposable(Single use)	Daily Disposable(Single use)	Daily Disposable(Single use)	same
USAN Name	olifilcon B	olifilcon B	olifilcon B	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, toric ormultifocal	Spherical, toric ormultifocal	Spherical, toric ormultifocal	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)	120(Fatt method)	120(Fatt method)	120(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 handling tint	Reactive Blue19	Reactive Blue19	Reactive Blue19	same
Category	Vexillum(olifilcon B) withTangible PolymersSilicone HydrogelSoft Contact LensesNew device	Daily Breeze(olifilcon B) SiliconeHydrogel SoftContact LensesNew device	Si-Hy (olifilcon B)Silicone HydrogelSoft Contact LensesK160344	Result ofComparasion
Leachability	no leachablemonomers andaddictive residues	no leachablemonomers andaddictive residues	no leachablemonomers andaddictive residues	same
Packaging	Blister Pack	Blister Pack	Blister Pack	same
PackagingSolution	sterile isotonic boratebuffered saline withTagible 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	0.80±0.2	same
Modulus (Mpa)	0.50 ± 0.1	0.50 ± 0.1	0.50±0.1	same
Elongation atbreak (%)	200± 20%	200± 20%	200± 20%	same
Toughness (J/m3)	0.90±0.05	0.90±0.05	0.90±0.05	same
Compliance standard
Biocompatibility	ISO10993-1	ISO10993-1	ISO10993-1	same
	ISO10993-5	ISO10993-5	ISO10993-5
	ISO10993-10	ISO10993-10	ISO10993-10
	ISO10993-11	ISO10993-11	ISO10993-11
Sterilization andShelf life	ISO 17665-1	ISO 17665-1	ISO 17665-1	Same
	ISO11737-1	ISO11737-1	ISO11737-1
	ISO 11987	ISO 11987	ISO 11987
performance	ISO18369-3	ISO18369-3	ISO18369-3	Same
Category	Vexillum(olifilcon B) withTangible PolymersSilicone HydrogelSoft Contact LensesNew device	Daily Breeze(olifilcon B) SiliconeHydrogel SoftContact LensesNew device	Si-Hy (olifilcon B)Silicone HydrogelSoft Contact LensesK160344	Result ofComparasion
	ISO18369-4ASTM D792-13	ISO18369-4ASTM D792-13	ISO18369-4ASTM D792-13

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Substantial Equivalence Comparison

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses, The Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lenses, and the The Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, have same intended use, Replacement Schedule, classification name/product code, len materials, manufacturing and sterilization method, perfomance parameter ranges, lens design, mechanical properties, physical properties, mechanical properties, biocompatibility, shelf life, Elongation at break and other reference devices have same technical characteristic as new devices to support the substantial equivalence. The differences among those three devices are Packaging Solution and Coating on the lens surface.

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

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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.

Conclusions:

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses and Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lenses have the same intended use and technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their packing solution and Coating on the lens surface do not raise any new questions of safety or effectiveness. Thus, Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses and Daily Breeze (olifilcon B) 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.