(121 days)
Sphere/Asphere: Innova Vision Sphere and Asphere (mifilcon 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 acuty.
Multifocal Toric: Innova Vision Multifocal Toric (inifiloon 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.
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 Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) 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 Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 (316nm - 380nm).
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.
The provided text describes the 510(k) premarket notification for the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens. The document focuses on demonstrating the substantial equivalence of this new device to legally marketed predicate devices rather than providing acceptance criteria and a study proving a device meets specific performance criteria for an AI/ML-based medical device.
The information requested in the prompt, related to AI/ML device performance metrics such as sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML models, is not present in the provided 510(k) summary for a contact lens.
This document discusses:
- Non-Clinical Performance Testing: Including toxicology (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation, skin sensitization, 22-day ocular irritation), shelf life, solution compatibility, preservative uptake and release, and bench performance tests (refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, quantification of polymerization residuals).
- Clinical Testing: A single-masked, bilateral, multi-center, randomized concurrent-control study comparing the Innova Vision lenses to Acuvue Vita lenses.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's questions are tailored for AI/ML device evaluations, which are distinct from the premarket notification requirements and testing specified for contact lenses in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 16, 2023
Innova Vision Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068
Re: K232139
Trade/Device Name: Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 16, 2023 Received: October 16, 2023
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.
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).
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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-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. 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
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Indications for Use
510(k) Number (if known) K232139
Device Name
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere/Asphere:
Innova Vision Sphere and Asphere (mifilcon 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 nondiseased 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 acuty.
Multifocal Toric:
Innova Vision Multifocal Toric (inifiloon 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.
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 Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Soft (Hydrophilic) 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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.
The assigned 510(k) number is: K232139
I. SUBMITTER
- Date Prepared: October 10th 2023
| 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 Soft (Hydrophilic) Contact 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:
~ New Device ~
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III. PREDICATE DEVICE
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the following predicate device(s):
- I "ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens" By Johnson & Johnson Vision Care, Inc. 510(k) number; K160212 Primary Predicate
- "Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens" By Innova Vision, Inc. 510(k) number; K213119 Reference Predicate
DEVICE DESCRIPTION IV.
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) 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 Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 (316nm - 380nm).
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.060 mm to 0.580 mm | When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±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 → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D→±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 → ±0.25 DWhen 2.00 < F'c ≤4.00 D→±0.37 D |
| Cylinder Axis | 10° to 180° in 10° steps(in 10° steps) | When 0.00 < F'c ≤ 1.50 D → ±8°When F'c > 1.50 D→±5° |
| Multifocal Power | +0.25 D to +4.00 D | ±0.25 D |
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| (in 0.25 D steps) | ||
|---|---|---|
| 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 (316 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 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 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 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.
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) Silicone Hydrogel Soft (Hydrophilic) 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
{7}------------------------------------------------
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 Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the primary predicate device identified (K160212) regarding the following features:
- FDA category Group V I
- FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- Intended use daily wear contact lenses ■
- Actions
- 트 Indications for use
- 트 Cast molded production method
- Injection molded polypropylene blister packaging
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the reference predicate device identified (K213119) regarding the following features:
- FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
- Intended use daily wear contact lenses ■
- Actions
- 트 Indications for use (same as predicate)
- Lens design configurations (same designs as predicate) ■
- Benzotriazole UV blocking monomer (same as predicate)
- 트 Cast molded production method (same manufacturing facility, processes, and quality controls)
- Injection molded polypropylene blister packaging (same packaging and storage solution) I
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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 device.
| Innova Vision SiliconeHydrogel(Subject Device) | Johnson & JohnsonVision CareAcuvue Vita(K160212) | Innova Vision Hydrogel(K213119) | |
|---|---|---|---|
| Intended Use | Daily wear,Soft (hydrophilic) contact lens | Daily wear,Soft (hydrophilic) contact lens | Daily wear,Soft (hydrophilic) contact lens |
| Actions | In its hydrated state, the contactlens, when placed on the cornea,acts as a refracting medium to focuslight rays on the retina | In its hydrated state, the contact lens,when placed on the cornea, acts as arefracting medium to focus light rayson the retina | In its hydrated state, the contactlens, when placed on thecornea, acts as a refractingmedium to focus light rays onthe retina |
| FDA Classification | Soft (hydrophilic) Contact Lens (21CFR 886.5925) | Soft (hydrophilic) Contact Lens (21CFR 886.5925) | Soft (hydrophilic) Contact Lens(21 CFR 886.5925) |
| FDA Group | FDA Group V | FDA Group V | FDA Group II |
| Production Method | Fully molded | Fully molded | Fully molded |
| USAN name | inifilcon A | senofilcon C | hioxifilcon A |
| Water Content (%) | 40±2% | 41±2% | 59±2% |
| Oxygen Permeabilityx 10-11 (cm2/sec)(mlO2)/(ml x mmHg @35°C)) (revised Fatt method) | 100 | 103 | 25 |
| Refractive Index(hydrated) | 1.410 | 1.420 | 1.400 |
| UV Blocker | Yes - benzotriazole | Yes - benzotriazole | Yes - benzotriazole |
| Manufacturing | Cast-Molded | Cast-Molded | Cast-Molded |
| Color | Blue Handling TintC.I. Reactive Blue No. 19 | Blue Handling TintReactive Blue Dye #4 | Blue Handling TintC.I. Reactive Blue No. 19 |
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The following matrix compares the indications for use of the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens with the predicate device.
| Indications for Use | |
|---|---|
| InnovaVisionSiliconeHydrogel(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 by personswho 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 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, disinfectionand scheduled replacement or for single-use disposable wear. | |
| When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) SiliconeHydrogel Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time thelens is removed. The contact lens is to be discarded after the recommended wearing period asprescribed by the Eye Care Professional. When prescribed for frequent/planned replacementwear, the lenses may be disinfected using a chemical disinfection only. | |
| When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone HydrogelSoft (Hydrophilic) Contact Lens is to be discarded after each removal. |
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| Johnson &JohnsonVision CareAcuvue Vita(K160212) | ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for dailywear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic oraphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – TORIC is indicated for dailywear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic oraphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – MULTIFOCAL is indicated fordaily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/orpresbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D ofADD power and may have 0.75D or less of astigmatism.ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – MULTIFOCAL-TORIC isindicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopiaand/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes whomay need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.These lenses contain a UV Blocker to help protect against transmission of harmful UVradiation to the cornea and into the eye.Eye Care Professionals may prescribe the lenses either for daily disposable wear orfrequent/planned replacement wear with cleaning, disinfection and scheduled replacement.When prescribed for daily disposable wear, lenses should be discarded upon removal. Whenprescribed for frequent/planned replacement wear, the lenses may be disinfected using achemical disinfection system only. The contact lens is to be discarded after the recommendedwearing period as prescribed by the Eye Care Professional. |
|---|---|
| InnovaVisionHydrogel(K213119) | Same as the subject device |
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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 Soft (Hydrophilic) Contact Lens. The results support the claim that the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the currently marketed predicate device. 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 are considered not acutely systemically toxic.
- · 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.
- · Skin Sensitization Study (Maximization Test): The skin sensitization study was conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
- · 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in accordance with ISO 9394 on the finished lenses, and the contact lenses produced no ocular irritation.
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens uses identical packaging materials and storage solution as the predicate device cleared under K213119. Cytotoxicity, systemic toxicity, and acute ocular irritation studies for the final packaging are referenced in K213119.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Soft (Hydrophilic) Contact Lens with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed following the methodology described in ISO 11981:2017, Ophthalmic optics -Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses.
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Preservative Uptake and Release
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses were analyzed for uptake and release of preservatives found in lens care products. Testing was conducted according to ISO 11986:2017, Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release. Uptake and release profiles of inifilcon A contact lenses for polyaminopropyl biguanide (PAPB) and Polyquaternium-1 (PQ-1) demonstrate sub-detection limit amounts of release at each time point evaluated.
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 Soft (Hydrophilic) Contact Lens and the predicate device.
Clinical Testing
A single-masked, bilateral, multi-center, randomized concurrent-control study with 91-day treatment follow-up was completed. One hundred eighteen (118) subjects were enrolled in the study-of which 59 subjects wore the test lenses (Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses) and 59 subjects wore the control lenses (Acuvue Vita (senofilcon C) Monthly Contact Lens). One hundred and five (105) of the 118 enrolled subjects completed the study (54 completed in the test arm and 51 completed in the control arm). There were 80 females and 38 males in the study (1:0.48 ratio female: male). The average age of the subjects was 32.92 years in the test group and 33.51 years in the control group). No serious adverse events were reported. The study results establish substantially equivalent clinical performance between the test (Innova Vision Silocone Hydrogel) and control (Acuvue Vita) lenses with respect to biomicroscopy findings, symptoms or vision safety measures; therefore, this clinical investigation supports the claim of substantial equivalence between the two lens types with regard to clinical safety and effectiveness.
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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 Soft (Hydrophilic) Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions 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.
§ 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.