(167 days)
Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) 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 acuty.
Toric
Innova Vision Toric (Etafilcon A) 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 -10.00 diopters.
Multifocal
Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in 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 (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves 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 -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) 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 Hydrogel (Etafficon A) 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 Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.
The properties of the lens are:
Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Sphere Power: -20.00 D to +20.00 D in 0.25 D steps
Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps
Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps
Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps
Specific Gravity: 0.98 to 1.12
Refractive Index: 1.400 plus or minus 0.005
Visible Light Transmittance: > 95%
UVA (315 nm380 nm) Absorbance < 30%315 nm) Absorbance < 5%
UVB (285 nm
Surface Character: Hydrophilic
Water Content: 58% plus or minus 2%
Oxygen Permeability: 24 times 10 to the power of -11 (cm squared dot ml O2)/(sec dot ml dot mmHg) plus 20%
The provided text describes the regulatory submission for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954). The submission demonstrates substantial equivalence to predicate and reference devices, primarily through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative format for all aspects. Instead, it states that "All the test results met the requirements of product specification" and "The results complied with the testing guidance." It provides specific performance characteristics for the subject device and compares them to predicate and reference devices, asserting non-significant differences.
Based on the "Description of the Device" and the comparison tables, here's a summary of performance characteristics presented as implicit acceptance criteria and reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens) |
|---|---|
| Geometric Parameters | |
| Chord Diameter | 13.00 mm to 15.00 mm |
| Center Thickness | 0.080 mm to 0.580 mm |
| Base Curve | 8.0 mm to 9.8 mm |
| Power Range (Sphere) | -20.00 D to +20.00 D in 0.25 D steps |
| Power Range (Cylinder, Toric) | -0.25 D to -2.25 D in 0.25 D steps |
| Cylinder Axis (Toric) | 10° to 180° in 10° steps |
| Multifocal Power | +0.25 D to +4.00 D in 0.25 D steps |
| Material Properties | |
| Specific Gravity | 0.98 to 1.12 |
| Refractive Index | 1.400 ± 0.005 |
| Visible Light Transmittance | > 95% |
| UVA (315 nm~380 nm) Absorbance | < 30% |
| UVB (285 nm~315 nm) Absorbance | < 5% |
| Surface Character | Hydrophilic |
| Water Content | 58% ± 2% |
| Oxygen Permeability | 24 × 10⁻¹¹ (cm²•ml O₂)/(sec•ml•mmHg) ± 20% |
| Biocompatibility | Complies with ISO 10993-1, -5, -10, -11, -12, -23, and ASTM F750-87 requirements. |
| Sterilization & Shelf Life | Complies with ISO 11138-1, -3, ISO 11137-1, -2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2, and ASTM F2338-09 requirements. |
| Other Performance Tests | Complies with ISO 18369-4, ISO 18369-3, ASTM D882-18, and ASTM D1708-18 requirements (e.g., Tensile Strength, Extractables, pH Value, Osmolality, Lens Compatibility with Multi-Purpose Solution). |
The document notes that no specifications were significantly different between the subject, predicate, and reference devices, and that differences in material properties (water content, oxygen permeability, refractive index) were "not significantly different and meets the requirements." The production method (cast-molded vs. spin-casting) was deemed "Equivalent" because "the performance of the device are not affected and meet the requirements."
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing."
Therefore, there is no "test set" in the context of human clinical data, nor is there information about data provenance (e.g., country of origin, retrospective/prospective) because such data was not utilized. The non-clinical tests would have involved specific numbers of contact lenses or samples of materials, but these specific sample sizes are not detailed in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test data or human ground truth assessment was performed for the substantial equivalence determination.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test data requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a contact lens and does not involve AI assistance or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" implicitly refers to recognized consensus standards and established product specifications (e.g., ISO, ASTM standards, and Innova Vision's own product requirements). The reported performance meeting these standards and specifications serves as the "ground truth" for non-clinical aspects.
8. The sample size for the training set
Not applicable. This device is a contact lens; it does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm was used.
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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 acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
March 13, 2023
Innova Vision Inc. Kari Huang Engineer 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu. 300091 TWN
Re: K222954
Trade/Device Name: Innova Vision Hydrogel (Etafilcon A) 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: January 6, 2023 Received: February 3, 2023
Dear Kari 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.
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
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(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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).
Sincerelv.
J Angelo Green -S
Image /page/1/Picture/6 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in a light blue color and is displayed on a white background. The letters "FDA" are large and bold.
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
510(k) Number (if known) K222954
Device Name
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) 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 acuty.
Toric
Innova Vision Toric (Etafilcon A) 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 -10.00 diopters.
Multifocal
Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in 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 (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves 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 -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) 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 Hydrogel (Etafficon A) 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 Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
5.1 Type of Submission: Traditional
5.2 Date of Summary: 03/03/2023
5.3 Submitter: Innova Vision Inc.
Address: 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park 300091, Taiwan Phone: +886-3-5927299 Contact: Kari Huang (karihuang@innovavision.com.tw)
5.4 Identification of the Device:
| Proprietary/Trade name: | Innova Vision Hydrogel (Etafilcon A) Soft |
|---|---|
| (Hydrophilic) Contact Lens | |
| Classification Product Code: | LPL |
| Subsequent Product Code: | MVN |
| Regulation Number: | 886.5925 |
| Regulation Description: | Soft (hydrophilic) contact lens |
| Review Panel: | Ophthalmic |
| Device Class: | II |
| Basis for the Submissions | New Device |
5.5 Identification of the Predicate Device:
| Predicate Device Name: | Discon Plus (Etafilcon A) Contact Lensvisibility tint with UV blocker |
|---|---|
| Applicant: | Innova Vision Inc. |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
| Device Class: | II |
| 510(k) Number: | K083288 |
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5.6 Identification of the Reference Device:
| Reference Device Name: | Innova Vision Hydrogel (Hioxifilcon A)Soft (Hydrophilic) Contact Lens |
|---|---|
| Applicant: | Innova Vision Inc. |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
| Device Class: | II |
| 510(k) Number: | K213119 |
5.7 Indications for Use / Intended Use of the Device
Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) 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 (Etafilcon A) 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 -10.00 diopters.
Multifocal
Innova Vision Multifocal (Etafilcon A) 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.
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Multifocal Toric
Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic 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 -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) 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 Hydrogel (Etafilcon A) 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 Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
5.8 Description of the Device
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an
{7}------------------------------------------------
additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.
The properties of the lens are:
| ● | Chord Diameter: | 13.00 mm to 15.00 mm |
|---|---|---|
| ● | Center Thickness | 0.080 mm to 0.580 mm |
| ● | Base Curve: | 8.0 mm to 9.8 mm |
| ● | Power Range | |
| Sphere Power: | -20.00 D to +20.00 D in 0.25 D steps | |
| Cylinder Power (Toric): | -0.25 D to -2.25 D in 0.25 D steps | |
| Cylinder Axis (Toric): | 10° to 180° in 10° steps | |
| Multifocal Power: | +0.25 D to +4.00 D in 0.25 D steps | |
| ● | Specific Gravity: | 0.98 to 1.12 |
| ● | Refractive Index: | 1.400 ± 0.005 |
| ● | Visible Light Transmittance: | > 95% |
| ● | UVA (315 nm~380 nm) Absorbance | < 30% |
| ● | UVB (285 nm~315 nm) Absorbance | < 5% |
| ● | Surface Character: | Hydrophilic |
| ● | Water Content: | 58% ± 2% |
| ● | Oxygen Permeability: | 24 × 10-11 (cm²•ml O2)/(sec•ml•mmHg)+ 20% |
Non-clinical Testing 5.9
A series of non-clinical safety and performance studies were conducted on the subject device. The following tests and studies were according to the FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. All the test results met the requirements of products specification.
- . Sterilization validation and Shelf life Test results demonstrated that subject device complies with ISO 11138-1,
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ISO 11138-3, ISO 11137-1, ISO 11137-2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2 and ASTM F2338-09 requirements.
-
. Biocompatibility
Test results demonstrated that subject device complies with ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-23, ISO 10993-10, ISO 10993-11 and ASTM F750-87 requirements. -
. Performance
- Geometric Parameters
- Luminous Transmittance
- Refractive Index ।
- Water Content ।
- । Oxygen Permeability
- Extractables ।
- Tensile Strength ।
- pH Value Determination -
- Osmolality Determination ।
- Specific Gravity -
- Lens Compatibility with Multi-Purpose Solution
Test results demonstrated that subject device complies with ISO 18369-4, ISO 18369-3, ASTM D882-18 and ASTM D1708-18 requirements.
5.10 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing.
5.11 Substantial Equivalence Determination
The Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main
{9}------------------------------------------------
materials, and safety and performance claims to the cleared device, Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker (K083288) and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
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| Item | Subject Device | Predicate Device | Reference Device | Substantial Equivalence Discussion |
|---|---|---|---|---|
| Manufacturer | Innova Vision Inc. | Innova Vision Inc. | Innova Vision Inc. | |
| Trade Name | Innova Vision Hydrogel(Etafilcon A) Soft (Hydrophilic)Contact Lens | Discon Plus (Etafilcon A)Contact Lens visibility tintwith UV blocker | Innova Vision Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | Substantial Equivalence Discussion |
| 510(k) No. | (to be assigned) | K083288 | K213119 | |
| Indications For Use | Sphere/AsphereInnova Vision Sphere andAsphere (Etafilcon A) SoftContact lenses are indicated forthe correction of ametropia(myopia and hyperopia) inaphakic and non-aphakic personswith non-diseased eyes inpowers from -20.00 to +20.00diopters. The lenses may beworn by persons who exhibitastigmatism of 2.00 diopters orless that does not interfere withvisual acuity.ToricInnova Vision Toric (Etafilcon | Sphere/AsphereDiscon Plus (Etafilcon A)Contact Lens visibility tint withUV blocker is indicated for dailywear for the correction ofrefractive ametropia innot-aphakic persons withnon-diseased eyes that aremyopic or hyperopic and mayexhibit refractive astigmatism upto 2.00 diopters that does notinterfere with visual acuity.Eye care practitioners mayprescribe the lenses for eithersingle-use daily disposable wearor frequent/planned replacementwear with cleaning, rinsing, | Sphere/AsphereInnova Vision Sphere andAsphere (Hioxifilcon A) SoftContact lenses are indicated forthe correction of ametropia(myopia and hyperopia) inaphakic and non-aphakic personswith non-diseased eyes inpowers from -20.00 to +20.00diopters. The lenses may beworn by persons who exhibitastigmatism of 2.00 diopters orless that does not interfere withvisual acuity.ToricInnova Vision Toric (Hioxifilcon | EquivalentThe main indication is thesame, and the few differentwordings do not affect theequivalence. |
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| A) Soft Contact lenses areindicated for the correction ofametropia (myopia or hyperopiawith astigmatism) in aphakic andnon-aphakic persons withnon-diseased eyes in powersfrom -20.00 to +20.00 dioptersand astigmatic corrections from-0.25 to -10.00 diopters.MultifocalInnova Vision Multifocal(Etafilcon A) Soft Contact lensesare indicated for the correctionof refractive ametropia (myopiaand hyperopia) and emmetropiawith presbyopia in aphakic andnon-aphakic persons withnon-diseased eyes in powersfrom -20.00 to +20.00 dioptersand with add powers from +0.25to +4.00 diopters. The lensesmay be worn by persons whoexhibit astigmatism of 2.00 | disinfection and scheduledreplacement as prescribed by theeyecare professional. Whenprescribed for frequent/plannedreplacement wear, the lens maybe disinfected using a chemical(not heat) disinfection system.Disposable Wear:Eyecare practitioners mayprescribe any of the above lensesfor single use daily disposablewear. When Prescribed for dailydisposable wear the lens is to bediscarded after each removal. | A) Soft Contact lenses areindicated for the correction ofametropia (myopia or hyperopiawith astigmatism) in aphakic andnon-aphakic persons withnon-diseased eyes in powersfrom -20.00 to +20.00 dioptersand astigmatic corrections from-0.25 to -10.00 diopters.MultifocalInnova Vision Multifocal(Hioxifilcon A) Soft Contactlenses are indicated for thecorrection of refractiveametropia (myopia andhyperopia) and emmetropia withpresbyopia in aphakic andnon-aphakic persons withnon-diseased eyes in powersfrom -20.00 to +20.00 dioptersand with add powers from +0.25to +4.00 diopters. The lensesmay be worn by persons who |
|---|---|---|
| diopters or less that does notinterfere with visual acuity.Multifocal ToricInnova Vision Multifocal Toric(Etafilcon A) Soft Contact lensesare indicated for the opticcorrection of distance and nearvision in presbyopic phakic oraphakic persons withnon-diseased eyes in powers of-20.00 to +20.00 diopters withadd powers from +0.25 to +4.00diopters and astigmatismcorrections from -0.25 to -10.00diopters.Eye Care Practitioners mayprescribe the Innova Vision(Etafilcon A) Soft (Hydrophilic)Contact Lenses forfrequent/planned replacementwear, with cleaning, disinfectionand scheduled replacement or forsingle-use disposable wear. | exhibit astigmatism of 2.00diopters or less that does notinterfere with visual acuity.Multifocal ToricInnova Vision Multifocal Toric(Hioxifilcon A) Soft Contactlenses are indicated for the opticcorrection of distance and nearvision in presbyopic phakic oraphakic persons withnon-diseased eyes in powers of-20.00 to +20.00 diopters withadd powers from +0.25 to +4.00diopters and astigmatismcorrections from -0.25 to -10.00diopters.Eye Care Practitioners mayprescribe the Innova VisionHydrogel (Hioxifilcon A) Soft(Hydrophilic) Contact lenses forfrequent/planned replacementwear, with cleaning, disinfectionand scheduled replacement or for | |
| When prescribed forfrequent/planned replacement,the Innova Vision (Etafilcon A)Soft (Hydrophilic) Contact Lensis to be cleaned, rinsed anddisinfected each time the lens isremoved. The contact lens is tobe discarded after therecommended wearing period asprescribed by the Eye CareProfessional. When prescribedfor frequent/planned replacementwear, the lenses may bedisinfected using a chemicaldisinfection only.When prescribed for single-usedisposable wear, Innova Vision(Etafilcon A) Soft (Hydrophilic)Contact Lens is to be discardedafter each removal. | single-use disposable wear.When prescribed forfrequent/planned replacement,the Innova Vision Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens is tobe cleaned, rinsed anddisinfected each time the lens isremoved. The contact lens is tobe discarded after therecommended wearing period asprescribed by the Eye CareProfessional. When prescribedfor frequent/planned replacementwear, the lenses may bedisinfected using a chemicaldisinfection only.When prescribed for single-usedisposable wear, Innova VisionHydrogel (Hioxifilcon A) Soft(Hydrophilic) Contact Lens is tobe discarded after each removal. |
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| Item | Subject device | Predicate device | Reference device | Substantial EquivalenceDiscussion |
|---|---|---|---|---|
| Manufacturer | Innova Vision Inc. | Innova Vision Inc. | Innova Vision Inc. | |
| Trade Name | Innova Vision Hydrogel(Etafilcon A) Soft (Hydrophilic)Contact Lens | Discon Plus (Etafilcon A)Contact Lens visibility tintwith UV blocker | Innova Vision Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | |
| 510(k) No. | (to be assigned) | K083288 | K213119 | |
| Type of Use | Prescription Use | Prescription Use | Prescription Use | Same |
| UV blocking | Yes | Yes | Yes | Same |
| ProductionMethod | Cast-molded | Spin-casting | Cast-molded | EquivalentDifferent but theperformance of the deviceare not affected and meetthe requirements. Thereforeit would not affect theequivalence. |
| USAN Name | Etafilcon A | Etafilcon A | Hioxifilcon A | SameThe material USAN nameEtafilcon A, is the same asthe predicate deviceK083288. |
| Water Content | $58 \pm 2%$ | 58% | $59 \pm 2%$ | EquivalentNot significantly differentand meets the requirements |
| therefore it would not affectthe equivalence. | ||||
| OxygenPermeability | $24 × 10^{-11}(cm^2•ml O_2)/(sec•ml•mmHg) ± 20%$ | $24 × 10^{-11}(cm^2/sec) (mlO_2/ml-mmHg)$ | $25 × 10^{-11}(cm^2/s) (mlO_2/[ml*mmHg]) ± 20%$ | EquivalentNot significantly differentand meets the requirement;therefore it would not affectthe equivalence. |
| RefractiveIndex | 1.400 ± 0.005 | 1.40 | 1.400 ± 0.005 | EquivalentNot significantly differentand meets the requirement;therefore it would not affectthe equivalence. |
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5.12 Similarity and Difference
The Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is compared with Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens. The subject device has same intended use and technology/mechanism of action, and similar safety and performance as the predicate device and reference device. No specifications are significantly different between these three devices.
Furthermore, the subject device has undergone other safety and performance tests, and the results complied with the testing guidance. Therefore, any differences between the subject device, the predicate device and reference device are insignificant and do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device and reference device in intended use, design and performance claims.
5.13 Conclusion
After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is substantially equivalent to the predicate device and reference device.
§ 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.