Sphere/Asphere:
Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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:
Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:
Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric:
Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with nondiseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.

Device Description

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens contains C.I. Reactive Blue 247 (21 CFR Part 73.3100 ) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel (Hvdrophilic) Daily Wear Soft Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315mm - 380mm). The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.

AI/ML Overview

This document is an FDA 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (such as test sets, expert ground truth, MRMC studies, standalone performance, etc.) is not present in this document.

The document focuses on demonstrating substantial equivalence of a new contact lens (Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens) to legally marketed predicate devices, primarily K232139, K222954, and K210436.

Instead of AI/ML performance metrics, the acceptance criteria for this medical device are related to its physical properties, biocompatibility, and intended use, demonstrating that it is as safe and effective as existing contact lenses.

Here's an attempt to extract relevant information from the provided text, reinterpreting "acceptance criteria" and "study" in the context of a contact lens submission:

Acceptance Criteria and Device Performance (Reinterpreted for a Contact Lens)

Acceptance Criteria: To demonstrate substantial equivalence, the new device must meet specific physical, chemical, and biological performance standards comparable to predicate devices. This includes demonstrating:
- Absence of cytotoxicity, systemic toxicity, and ocular irritation.
- Stability, sterility, and package integrity over the labeled shelf life.
- Compatibility with common cleaning and disinfection solutions.
- Consistent material properties (refractive index, water content, oxygen permeability, UV transmission, tensile strength, modulus, elongation to break, specific gravity) within acceptable tolerances.
- Similar indications for use and general function as the predicate devices.
Reported Device Performance: The document states that the non-clinical performance testing (toxicology, shelf life, solution compatibility, preservative uptake and release, and bench tests) supports the claim that the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the currently marketed predicate devices. Specific numerical results demonstrating compliance with each criterion are not provided in this summary, but the conclusion confirms they were met.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted)

Acceptance Criterion (for Contact Lens Equivalence)	Reported Device Performance
Biocompatibility/Toxicology
In-Vitro Cytotoxicity (ISO 10993-5)	Not cytotoxic
Systemic Toxicity (ISO 10993-11)	Meets systemic injection test requirements; no acute systemic toxicity
Acute Ocular Irritation (ISO 10993-10)	No ocular irritation
Biocompatibility of packaging materials/solution	Addressed in previously submitted assessments
Shelf Life
Stability, Sterility, Package Integrity	Data supports establishment of proposed shelf life
Solution Compatibility
Physical compatibility with cleaning/disinfection	Confirmed (peroxide and MPDS)
Preservative Uptake and Release	Referenced in K232139 (predicate)
Bench Performance (Material Properties)
Refractive Index	Consistent with predicate
Water Content	Consistent with predicate
Oxygen Permeability (Dk)	Consistent with predicate
% Transmission (Visible & UV)	Consistent with predicate
Tensile Strength	Consistent with predicate
Modulus	Consistent with predicate
% Elongation to break	Consistent with predicate
Specific Gravity	Consistent with predicate
Quantification of Polymerization Residuals	Consistent with predicate

Information Not Applicable or Not Found (as per AI/ML context):

Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. The "test set" here refers to the actual manufactured devices undergoing physical and biological testing. The number of batches or lenses tested for each criterion is not specified in this summary. The "data provenance" would refer to internal lab testing.
Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a contact lens is established through objective physical, chemical, and biological measurements, not expert consensus on images.
Adjudication method for the test set: Not applicable. Compliance is measured objectively.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance.
Standalone (algorithm-only) performance: Not applicable. This is a physical medical device.
Type of ground truth used: For this device, the "ground truth" is derived from established standard test methods (e.g., ISO 10993 for biocompatibility, methods for Dk, water content, etc.) that yield objective measurements of the device's properties.
Sample size for the training set: Not applicable. There is no AI model being trained.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document outlines the non-clinical and clinical (by reference to predicate) evidence used to demonstrate the substantial equivalence of a new contact lens. It does not contain the specific AI/ML-related details requested in the prompt because the device is a physical product, not an AI algorithm.

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2024

Innova Vision Inc. % Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K240519

Trade/Device Name: Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: January 31, 2024 Received: February 23, 2024

Dear Bret Andre:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

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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,

J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240519

Device Name

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens

Indications for Use (Describe)

Sphere/Asphere:

Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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:

Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:

Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric:

Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with nondiseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from

-0.25 to -2.25 diopters.

When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.

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

( Prescription Use (Part 21 CFR 801 Subpart D)

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510 (k) SUMMARY

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

K240519 The assigned 510(k) number is:

I. SUBMITTER

January 29th 2024 Date Prepared:

Name:	INNOVA VISION, INC.
Address:	2F., No. 20, Prosperity Rd. 1,Hsinchu Science Park 300091,Hsinchu, Taiwan
Contact Person:	Celine HsuSenior Engineer
Phone number:	+886-3-5927299
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear SoftContact Lens
CommonName:	Contact Lens, Daily Wear
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Codes:	LPL; MVN

Purpose of 510(k) Submission:

~ Device Change ~

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III. PREDICATE DEVICE

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the following predicate devices:

"Innova Vision (inifilcon A) Silicone Hvdrogel Soft (Hydrophilic) Contact Lens" ■ By Innova Vision, Inc. 510(k) number; K232139 Primary Predicate
"Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens" By Innova Vision, Inc. 510(k) number; K222954 Primary Predicate
"Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere" By Alcon Laboratories Inc. 510(k) number: K210436 Reference Predicate

IV. DEVICE DESCRIPTION

Parameter	Range	Tolerance
Chord Diameter	13.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.050 mm to 0.580 mm	When ≤ 0.10 mm $\rightarrow$ ±0.010 mm + 10%When > 0.10 mm $\rightarrow$ ±0.015 mm + 5%
Base Curve	8.0 mm to 9.8 mm	±0.20 mm
Back Vertex Power (F'v)	-20.00 D to +20.00 D(in 0.25 D steps)	When 0.00 < $ F'v $ ≤ 10.00 D $\rightarrow$ ±0.25 DWhen 10.00 < $ F'v $ ≤ 20.00 D $\rightarrow$ ±0.50 D
Cylinder Power (F'c)	-0.25 D to -2.25 D(in 0.25 D steps)	When 0.00 < $ F'c $ ≤ 2.00 D $\rightarrow$ ±0.25 DWhen 2.00 < $ F'c $ ≤4.00 D $\rightarrow$ ±0.37 D

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Cylinder Axis	10° to 180° in 10° steps(in 10° steps)	When 0.00 $ < F'c \le 1.50 D \rightarrow \pm 8^\circ $When $ F'c > 1.50 D\rightarrow \pm 5^\circ $
Multifocal Power	+0.25 D to +4.00 D(in 0.25 D steps)	±0.25D
Oxygen Permeability(x 10-11 (cm2•mlO2)/(sec•ml•mmHg))	100	±20%
Visible Light Transmittance	>95%	±5%
Ultraviolet radiation Transmittance	< 5% TUVB<50% TUVA	TUVB (280 to 315nm) < 0.05 TVTUVA (315 to 380nm) < 0.05 TV
Water Content	40%	±2%
Refractive Index	1.410	±0.005

V. INDICATIONS FOR USE

Sphere/Asphere:

Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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:

Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with nondiseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:

Multifocal Toric:

Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

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removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear. Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the primary predicate device identified (K232139) regarding the following features:

E FDA category - Group V
FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) ■
USAN Material (inifilcon A)
트 Intended use – daily wear contact lenses
Actions
Indications for use (same lens design configurations)
Benzotriazole UV absorbing monomer (same monomer)
트 Cast molded production method (same manufacturing facility and quality controls)
Injection molded polypropylene blister packaging (same packaging)

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the reference predicate device identified (K222954) regarding the following features:

FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) ■
Intended use - daily wear contact lenses
Indications for use
Cast molded production method (same manufacturing facility and quality controls)
Injection molded polypropylene blister packaging (same packaging and storage solution)
Buffer solution (same formulation)

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the reference predicate device identified (K210436) regarding the following features:

트 FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Intended use daily wear contact lenses ■
트 Indications for use
Cast molded production method
Handling tint (Reactive Blue 247)

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The following matrix illustrates the production method, lens function and material characteristics of the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens, as well as the predicate devices.

	Innova Vision SiliconeHydrogelBy Innova Vision Inc.(Subject Device)	Innova Vision SiliconeHydrogelBy Innova Vision Inc.(K232139)	Innova Vision HydrogelBy Innova Vision Inc.(K222954)	TOTAL30 by AlconLaboratories, Inc.(K210436)
Intended Use	Daily wear,Soft (hydrophilic) contact lens	Daily wear,Soft (hydrophilic) contact lens	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contactlens
Actions	In its hydrated state, thecontact lens, when placed onthe cornea, acts as a refractingmedium to focus light rays onthe retina	In its hydrated state, thecontact lens, when placed onthe cornea, acts as a refractingmedium to focus light rays onthe retina	In its hydrated state, thecontact lens, when placed onthe cornea, acts as arefracting medium to focuslight rays on the retina	In its hydrated state, thecontact lens, when placedon the cornea, acts as arefracting medium to focuslight rays on the retina
FDA Classification	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)
FDA ClassificationProduct Code(s)	LPL; MVN	LPL; MVN	LPL; MVN	LPL; MVN
FDA Group	FDA Group V	FDA Group V	FDA Group II	FDA Group V
USAN name	inifilcon A	inifilcon A	etafilcon A	lehfilcon A
Water Content (%)	$40\pm2$ %	$40\pm2$ %	$58\pm2$ %	$55\pm2$ %
Oxygen Permeabilityx 10-11 (cm2/sec)(mlO2)/(ml xmmHg (@ 35℃)) (revised Fattmethod)	100	100	24	123
Refractive Index(hydrated)	1.410	1.410	1.400	1.40
UV Blocker	Yes - benzotriazole	Yes - benzotriazole	Yes - benzotriazole	Yes - two benzotriazolemonomers
Manufacturing	Cast-Molded (Heat Curing)	Cast-Molded (UV Curing)	Cast-Molded (UV Curing)	Cast-Molded
Color	Blue Handling TintReactive Blue 247	Blue Handling TintC.I. Reactive Blue No. 19	Blue Handling TintC.I. Reactive Blue No. 19	Blue Handling TintReactive Blue 247
Buffer Contains H2O2	Yes	No	Yes	No

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The following matrix compares the indications for use of the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens with the predicate device.

	Indications for Use
InnovaVisionSiliconeHydrogelBy InnovaVision Inc.(SubjectDevice)	Sphere/Asphere:Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses areindicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakicpersons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may beworn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere withvisual acuity.
	Toric:Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for thecorrection of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakicpersons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmaticcorrections from -0.25 to -2.25 diopters.
	Multifocal:Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated forthe correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopiain aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn bypersons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visualacuity.
	Multifocal Toric:Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses areindicated for the optic correction of distance and near vision in presbyopic phakic or aphakicpersons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from+0.25 to +4.00 diopters and astigmatism correction from -0.25 to -2.25 diopters.
	Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel Soft(Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning,disinfection and scheduled replacement or for single-use disposable wear.
	When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) SiliconeHydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfectedeach time the lens is removed. The contact lens is to be discarded after the recommendedwearing period as prescribed by the Eye Care Professional. When prescribed forfrequent/planned replacement wear, the lenses may be disinfected using a chemical disinfectiononly.
	When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel(Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.
InnovaVisionSiliconeHydrogelBy Innova	Same as the subject device
Vision Inc.(K232139)

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InnovaVisionHydrogelBy InnovaVision Inc.(K222954)	Same as the subject device
TOTAL30 byAlconLaboratories,Inc.(K210436)	TOTAL30 (lehfilcon A) spherical soft contact lenses are indicated for the optical correction ofrefractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseasedeyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere withvisual acuity.
	TOTAL30 Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction ofrefractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseasedeyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere withvisual acuity.
	TOTAL30 for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the opticalcorrection of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons withnondiseased eyes with up to 6.00 diopters (D) of astigmatism.
	TOTAL30 Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correctionof presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic oraphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters(D) or less and who may have up to approximately 1.50 diopters of astigmatism that does notinterfere with visual acuity.
	TOTAL30 Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the opticalcorrection of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakicor aphakic persons with non-diseased eyes who may require a reading addition of +3.00diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
	The lenses are to be prescribed for daily wear with removal for cleaning and disinfection(chemical not heat) prior to reinsertion, or disposal, as recommended by the eye careprofessional. Lenses should be discarded and replaced with a new pair each month, or moreoften if recommended by the eye care professional.

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PERFORMANCE DATA VII.

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

Non-Clinical Performance Testing

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens. The results support the claim that the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the currently marketed predicate devices. Refer below to a summary of the results from the non-clinical studies.

Toxicology:

All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses are not cytotoxic.
· Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11 and do not produce acute systemic toxicity.
· Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-10, and the extracts from finished lenses produced no ocular irritation.

The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens uses the same blister packaging materials and packaging solution as the predicate devices. Biocompatibility testing for the packaging materials and solution was addressed in previously submitted biocompatibility assessments.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

Solution Compatibility

The physical compatibility of Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed.

Preservative Uptake and Release

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lenses were analyzed for uptake and release of preservatives found in lens care products. Preservative uptake and release testing is referenced in K232139.

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Performance Testing - Bench:

The following bench tests were completed: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens and the predicate device.

Clinical Testing

Clinical performance testing for the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens was addressed by the predicate device.

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelflife stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Innova Vision (inifilicon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

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

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.