(228 days)
Sphere/Asphere
Innova Vision Sphere and Asphere (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon 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.
Multifocal Toric
Innova Vision Multifocal Toric (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (59% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization. Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for handling and contains 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 50% in the UVA region.
The document describes the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens and its substantial equivalence determination, rather than a study proving the device meets specific acceptance criteria in a clinical trial setting. The substantial equivalence relies on non-clinical testing and comparison to predicate devices.
Here's an analysis of the provided information, framed to address your request for acceptance criteria and study details:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the typical quantitative sense for a clinical study with primary endpoints. Instead, it demonstrates compliance with recognized standards and similarity to predicate devices. The "reported device performance" is primarily the physical and chemical properties of the lens and the results of non-clinical tests meeting specific standard requirements.
| Characteristic / Test | Acceptance Criteria (Standard/Predicate Equivalence) | Reported Device Performance (Innova Vision Hydrogel) |
|---|---|---|
| Material | Hioxifilcon A (Same as predicates) | Hioxifilcon A (random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization, tinted with Reactive Blue 19, contains UV blocking additive 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate) |
| Water Content | 59% ± 2% (Same as predicates) | 59% ± 2% |
| Oxygen Permeability | $20.76 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mm Hg)$ (Predicate Clalen 58), $25 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mmHg)$ (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement" | $25 \times 10^{-11} (cm^2/s)/(ml O_2/[ml \cdot mmHg]) \pm 20%$ |
| Refractive Index | 1.403 (hydrated) (Predicate Clalen 58), 1.404 (hydrated) (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement" | $1.400 \pm 0.005$ |
| UVB Absorbance | < 5% average transmittance (specified for the device) | > 95% (meaning < 5% transmittance) |
| UVA Absorbance | < 50% average transmittance (specified for the device) | > 50% (meaning < 50% transmittance) |
| Visible Light Transmittance | N/A (not explicitly stated for predicates, but generally accepted to be high for clear lenses) | > 95% |
| Sterilization Validation & Shelf Life | Compliance with ISO 11138-1, -3, ISO 11137-1, -2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2, ASTM F2338-09 requirements. | All test results met the requirements of product specification. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -12, -10, -11 and ASTM F750-87 requirements. | All test results met the requirements of product specification. |
| Performance (Oxygen Permeability, Tensile Strength, Refractive Index, Water Content, Specific Gravity, Extractables, Luminous Transmittance, Lens Compatibility with Multi-Purpose Solution, Osmolality Determination, pH Value Determination, Geometric Parameters) | Compliance with ISO 18369-4, ASTM D882-18, ASTM D1708-18, and ISO 18369-3 requirements. | All test results met the requirements of product specification. |
| Indications for Use | Substantially equivalent to predicate and reference devices, with "few different wordings [that] do not affect the equivalence." | See detailed indications on page 2, 5, 6, 10, 11, and 12 for Sphere/Asphere, Toric, Multifocal, and Multifocal Toric lenses. Powers from -20.00 to +20.00 diopters, astigmatic correction up to -10.00 diopters, add powers up to +4.00 diopters. Frequent/planned replacement wear or single-use disposable wear. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable. This submission relies on non-clinical testing (e.g., laboratory tests on lens samples) and a comparison to predicate devices, not a clinical "test set" of patients.
- Data Provenance: The tests were conducted internally by Innova Vision Inc. or contracted labs on samples of the device. The data is based on these non-clinical tests. The country of origin of the data is implicit to be Taiwan, where Innova Vision Inc. is located. It is prospective data in the sense that the tests were specifically performed for this 510(k) submission, but it's not "prospective clinical trial data."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical test set was used, there was no ground truth for patient outcomes established by experts. Ground truth for the non-clinical tests would be the measurement standards themselves and the validation of the testing methodologies.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set or adjudication of patient outcomes was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is for image-based diagnostic devices comparing human readers' performance with and without AI assistance. This device is a contact lens and does not involve AI or diagnostic imaging.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.
7. Type of Ground Truth Used:
- The "ground truth" for this submission are the international and national standards for contact lens materials, manufacturing, biocompatibility, and performance, as well as the established safety and effectiveness profiles of the chosen predicate devices. The properties of the Innova Vision lens are compared to these established benchmarks and to the predicate devices. For example, oxygen permeability and refractive index values are compared to the predicate's values, and non-clinical tests conform to ISO and ASTM standards.
8. Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI models with a "training set." The device is a physical product.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary:
This 510(k) submission (K213119) for the Innova Vision Hydrogel Contact Lens is a Traditional 510(k) based on demonstrating substantial equivalence to existing legally marketed predicate devices (Clalen 58 and UNICON Hydrogel lenses). The "acceptance criteria" are compliance with established regulatory standards and the demonstration that the device's physical, chemical, and performance characteristics are either identical or not significantly different from the predicate devices. The "study" that proves this is a series of non-clinical laboratory tests performed on the contact lens samples, rather than a clinical trial with human subjects.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2022
Innova Vision Inc. Kari Huang Official Correspondent 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu, 300091 Taiwan
Re: K213119
Trade/Device Name: Innova Vision Hydrogel (Hioxifilcon 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: April 1, 2022 Received: April 4, 2022
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213119
Device Name
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere/Asphere
Innova Vision Sphere and Asphere (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon A) 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 -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon 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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Traditional 510(k) 510(k) Summary
510(k) SUMMARY
- 1 Type of Submission: Traditional
- 2 Date of Summary: 09/17/2021
- 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)
4 Identification of the Device:
| Proprietary/Trade name: | Innova Vision Hydrogel (Hioxifilcon 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 Identification of the Predicate Device:
| Predicate Device Name: | Clalen 58 (hioxifilcon A) Soft (hydrophilic) |
|---|---|
| Contact Lens for Daily Wear | |
| Applicant: | Interojo, Inc. |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
| Device Class: | II |
| 510(k) Number: | K153766 |
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Traditional 510(k) 510(k) Summary
| 6 Identification of the Reference Device: | |
|---|---|
| Reference Device Name: | UNICON Hydrogel (Hioxifilcon A) Soft(Hydrophilic) Contact Lens |
| Applicant: | UNICON Optical CO.,LTD |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |
| Device Class: | II |
| 510(k) Number: | K191929 |
7 Indications for Use / Intended Use of the Device
Sphere/Asphere
Innova Vision Sphere and Asphere (Hioxifilcon 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 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 (Hioxifilcon 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 (Hioxifilcon 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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Traditional 510(k) 510(k) Summary
Multifocal Toric
Innova Vision Multifocal Toric (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon 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 (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
8 Description of the Device
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (59% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization. Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for handling and contains 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 50% in the UVA region.
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Traditional 510(k) 510(k) Summary
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 0.25D steps | |
| ● | Specific Gravity: | 0.98 to 1.12 |
| ● | Refractive Index: | 1.400 ± 0.005 |
| ● | Visible Light Transmittance: | > 95% |
| ● | UVA (315 nm~380 nm) Absorbance | > 50% |
| ● | UVB (285 nm~315 nm) Absorbance | > 95% |
| ● | Surface Character: | Hydrophilic |
| ● | Water Content: | 59% ± 2% |
| ● | Oxygen Permeability: | 25 × 10-11(cm²/s)/(ml O2/[ml•mmHg]) ±20% |
9 Non-clinical Testing
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, 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.
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Traditional 510(k) 510(k) Summary
-
. Biocompatibility
Test results demonstrated that subject device complies with ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-10, ISO 10993-11 and ASTM F750-87 requirements. -
. Performance
- Oxygen Permeability -
- Tensile Strength -
- Refractive Index -
- Water Content -
- Specific Gravity -
- Extractables -
- Luminous Transmittance -
- Lens Compatibility with Multi-Purpose Solution -
- Osmolality Determination -
- pH Value Determination -
- Geometric Parameters -
Test results demonstrated that subject device complies with ISO 18369-4, ASTM D882-18. ASTM D1708-18 and ISO 18369-3 requirements.
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.
11 Substantial Equivalence Determination
The Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main materials, and safety and performance claims to the cleared device, Clalen 58 (hioxifilcon A)
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Traditional 510(k) 510(k) Summary
Soft (hydrophilic) Contact Lens For Daily Wear (K153766) and UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K191929). 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. | Interojo, Inc. | UNICON Optical CO.,LTD | |
| Trade Name | Innova Vision Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | Clalen 58 (hioxifilcon A) Soft(hydrophilic) Contact Lens forDaily Wear | UNICON Hydrogel (HioxifilconA) Soft (Hydrophilic) ContactLens | Substantial EquivalenceDiscussion |
| 510(k) No. | (to be assigned) | K153766 | K191929 | |
| Indications ForUse | 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 | The Clalen 58 (hioxifilcon A)Spherical Soft Contact Lensesfor daily wear are indicated forthe correction of refractive errorin aphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopia. Thelens may be worn by personswho exhibit refractiveastigmatism of 0.75 diopters orless where the astigmatism doesnot interfere with visual acuity.The lens is available clear ortinted for visibility and handling.The Clalen 58 (hioxifilcon A)Toric Soft Contact Lens for daily | The Unicon Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens isindicated for the correction ofametropia (myopia andhyperopia) in aphakic andnon-aphakic persons withnon-diseased eyes and 6.00diopters (D) or less ofastigmatism.Eye Care Professionals mayprescribe the lenses either forsingle-use disposable wear orfrequent/planned replacementwear with cleaning, disinfectionand scheduled replacement. | EquivalentThe main indication is thesame, and the few differentwordings do not affect theequivalence. |
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Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
Traditional 510(k) 510(k) Summary
| 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 | wear are indicated for thecorrection of refractive error inaphakic persons withnon-diseased eyes with myopiaor hyperopia and/or possessrefractive astigmatism notexceeding 5.00 diopters. Thelens is available clear or tintedfor visibility and handling.The Clalen 58 (hioxifilcon A)Multifocal Soft Contact Lensesfor daily wear are indicated forthe correction of refractive errorin aphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopia. Thelens may be worn by presbyopicpersons requiring an add powerranging from +1.25D to +2.50D,and who exhibit refractiveastigmatism of 0.75 diopters orless where the astigmatism doesnot interfere with visual acuity. | When prescribed for dailydisposable wear, the lens is to bediscarded after each removal.When prescribed forfrequent/planned replacement,the lens may be cleaned anddisinfected using a chemicaldisinfection system only. |
|---|---|---|
| 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 | The lens is available clear ortinted for visibility and handling.The Clalen 58 (hioxifilcon A))Toric-Multifocal Soft ContactLenses for daily wear areindicated for the correction ofrefractive error in aphakic andnot aphakic persons withnondiseasedeyes with myopia or hyperopia,possesses refractive astigmatismnot exceeding 5.00 diopters. Thelens may be worn by presbyopicpersons requiring an add powerranging from +1.25D to +2.50D.The lens is available clear ortinted for visibility and handling.Daily wear replacementschedules may vary from patientto patient and should be decidedby eyecare practitioners inconsultation with their patients. | |
| 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. | Frequent/Planned ReplacementWear:Eyecare practitioners mayprescribe any of the above lensesfor frequent/planned replacementwear, with cleaning disinfectionand scheduled replacement.When prescribed forfrequent/planned replacementwear, the lens may be disinfectedusing a chemical disinfectingsystem.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. |
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Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
Traditional 510(k) 510(k) Summary
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Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
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Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
Traditional 510(k) 510(k) Summary
| Item | Subject device | Predicate device | Reference device | Substantial EquivalenceDiscussion |
|---|---|---|---|---|
| Manufacturer | Innova Vision Inc. | Interojo, Inc. | UNICON Optical CO.,LTD | |
| Trade Name | Innova Vision Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | Clalen 58 (hioxifilcon A) Soft(hydrophilic) Contact Lens ForDaily Wear | UNICON Hydrogel(Hioxifilcon A) Soft(Hydrophilic) Contact Lens | |
| 510(k) No. | (to be assigned) | K153766 | K191929 | |
| Type of Use | Prescription Use | Prescription Use | Prescription Use | Same |
| UV blocking | Yes | Yes | Yes | Same |
| ProductionMethod | Cast-molded | Fully molded | Cast-molded | Same |
| USAN Name | Hioxifilcon A | Hioxifilcon A | Hioxifilcon A | Same |
| Water Content | 59 ± 2% | 59 ± 2% | 59 ± 2% | Same |
| OxygenPermeability | $25 × 10-11(cm²/s)/(mlO²/[ml•mmHg]) ± 20%$ | $20.76 × 10-11(cm²/sec) (mlO2/mlx mm Hg)$ | $25 × 10-11(cm²/sec)(mlO2/ml*mmHg)$ | EquivalentNot significantly differentand meets the requirement;therefore it would not affectthe equivalence. |
| RefractiveIndex | 1.400 ± 0.05 | 1.403 (hydrated) | 1.404 (hydrated) | EquivalentNot significantly differentand meets the requirement;therefore it would not affectthe equivalence. |
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Traditional 510(k) 510(k) Summary
12 Similarity and Difference
The Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is compared with Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear and UNICON 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.
13 Conclusion
After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the Innova Vision Hydrogel (Hioxifilcon 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.