(228 days)
No
The summary describes standard contact lenses and their material properties, with no mention of AI, ML, or any computational processing of data for diagnosis, treatment, or device function.
No.
The contact lenses are indicated for the correction of ametropia (myopia and hyperopia), astigmatism, and presbyopia, which are refractive errors, not diseases or therapeutic conditions.
No
The device is a contact lens intended for correction of ametropia, not for diagnosis of a condition. Its purpose is to correct refractive errors, not to identify or measure them for diagnostic purposes.
No
The device is a physical contact lens, not software. The description details the material composition and manufacturing method of the lens.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the contact lenses are for the correction of ametropia (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the material and manufacturing of a contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) or to provide information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LPL, MVN
Device Description
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 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%
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 |
5
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.
6
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.
7
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.
8
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)
9
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.
10
| 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 for | ||||
| Daily Wear | UNICON Hydrogel (Hioxifilcon | |||
| A) Soft (Hydrophilic) Contact | ||||
| Lens | Substantial Equivalence | |||
| Discussion | ||||
| 510(k) No. | (to be assigned) | K153766 | K191929 | |
| Indications For | ||||
| Use | 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 | The Clalen 58 (hioxifilcon A) | |||
| Spherical Soft Contact Lenses | ||||
| for daily wear are indicated for | ||||
| the correction of refractive error | ||||
| in aphakic and not aphakic | ||||
| persons with non-diseased eyes | ||||
| with myopia or hyperopia. The | ||||
| lens may be worn by persons | ||||
| who exhibit refractive | ||||
| astigmatism of 0.75 diopters or | ||||
| less where the astigmatism does | ||||
| not interfere with visual acuity. | ||||
| The lens is available clear or | ||||
| tinted for visibility and handling. | ||||
| The Clalen 58 (hioxifilcon A) | ||||
| Toric Soft Contact Lens for daily | The Unicon Hydrogel | |||
| (Hioxifilcon A) Soft | ||||
| (Hydrophilic) Contact Lens is | ||||
| indicated for the correction of | ||||
| ametropia (myopia and | ||||
| hyperopia) in aphakic and | ||||
| non-aphakic persons with | ||||
| non-diseased eyes and 6.00 | ||||
| diopters (D) or less of | ||||
| astigmatism. | ||||
| Eye Care Professionals may | ||||
| prescribe the lenses either for | ||||
| single-use disposable wear or | ||||
| frequent/planned replacement | ||||
| wear with cleaning, disinfection | ||||
| and scheduled replacement. | Equivalent | |||
| The main indication is the | ||||
| same, and the few different | ||||
| wordings do not affect the | ||||
| equivalence. |
11
Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
Traditional 510(k) 510(k) Summary
| 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 | wear are indicated for the
correction of refractive error in
aphakic persons with
non-diseased eyes with myopia
or hyperopia and/or possess
refractive astigmatism not
exceeding 5.00 diopters. The
lens is available clear or tinted
for visibility and handling.
The Clalen 58 (hioxifilcon A)
Multifocal Soft Contact Lenses
for daily wear are indicated for
the correction of refractive error
in aphakic and not aphakic
persons with non-diseased eyes
with myopia or hyperopia. The
lens may be worn by presbyopic
persons requiring an add power
ranging from +1.25D to +2.50D,
and who exhibit refractive
astigmatism of 0.75 diopters or
less where the astigmatism does
not interfere with visual acuity. | When prescribed for daily
disposable wear, the lens is to be
discarded after each removal.
When prescribed for
frequent/planned replacement,
the lens may be cleaned and
disinfected using a chemical
disinfection system only. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The lens is available clear or
tinted for visibility and handling.
The Clalen 58 (hioxifilcon A))
Toric-Multifocal Soft Contact
Lenses for daily wear are
indicated for the correction of
refractive error in aphakic and
not aphakic persons with
nondiseased
eyes with myopia or hyperopia,
possesses refractive astigmatism
not exceeding 5.00 diopters. The
lens may be worn by presbyopic
persons requiring an add power
ranging from +1.25D to +2.50D.
The lens is available clear or
tinted for visibility and handling.
Daily wear replacement
schedules may vary from patient
to patient and should be decided
by eyecare practitioners in
consultation with their patients. | |
| 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. | Frequent/Planned Replacement
Wear:
Eyecare practitioners may
prescribe any of the above lenses
for frequent/planned replacement
wear, with cleaning disinfection
and scheduled replacement.
When prescribed for
frequent/planned replacement
wear, the lens may be disinfected
using a chemical disinfecting
system.
Disposable Wear:
Eyecare practitioners may
prescribe any of the above lenses
for single use daily disposable
wear. When Prescribed for daily
disposable wear the lens is to be
discarded after each removal. | |
12
Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
Traditional 510(k) 510(k) Summary
13
Innova Vision Innova Vision Hydrogel (Hioxifilcon A) Soft
(Hydrophilic) Contact Lens
14
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 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 For
Daily 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 |
| Production
Method | 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 |
| Oxygen
Permeability | $25 × 10-11(cm²/s)/(mlO²/[ml•mmHg]) ± 20%$ | $20.76 × 10-11(cm²/sec) (mlO2/mlx mm Hg)$ | $25 × 10-11(cm²/sec)(mlO2/ml*mmHg)$ | Equivalent
Not significantly different
and meets the requirement;
therefore it would not affect
the equivalence. |
| Refractive
Index | 1.400 ± 0.05 | 1.403 (hydrated) | 1.404 (hydrated) | Equivalent
Not significantly different
and meets the requirement;
therefore it would not affect
the equivalence. |
15
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.