(203 days)
The OxyPure Color Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
The OxyPure Color Silicone Hydrogel Soft Contact Lenses is a daily wear lens in spherical design. It may be prescribed as daily wear. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. A benzotriazole UV absorbing monomer is used to block UV radiation. OxyPure Color Silicone Hydrogel Soft Contact Lenses contain a pigmented area that will alter or enhance the appearance of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phythalocyanine green and carbazole violet. Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
This document is a 510(k) premarket notification for the OxyPure Color Silicone Hydrogel Soft Contact Lenses. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device. Therefore, much of the requested information regarding acceptance criteria, study sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable or available in this specific document.
Here's a breakdown of the available information related to acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of clearly defined acceptance criteria and reported device performance for a new study, this document provides a comparison table between the new device (OxyPure Color Silicone Hydrogel Soft Contact Lenses) and its predicate device (VISCO SOFT CONTACT LENS K141348). The "Result of Comparison" column essentially indicates whether the new device meets the performance characteristics of the predicate (implied acceptance) or if there's a difference.
| Category | OxyPure Color Silicone Hydrogel Soft Contact Lenses (New device) | VISCO SOFT CONTACT LENS (K141348) | Result of Comparison |
|---|---|---|---|
| Physical/Material Properties | |||
| USAN Name | Olifilcon A | Olifilcon A | Same |
| FDA Category (Group) | Group 1 Non-ionic, Low water | Group 1 Non-ionic, Low water | Same |
| Water Content | 47% | 47% | Same |
| Light Transmittance | >94% | >94% | Same |
| Refractive Index | 1.410 (hydrated) | 1.410 (hydrated) | Same |
| Oxygen Permeability (DK, 35°C) | 150 (Fatt method) | 150 (Fatt method) | Same |
| Leachability | no leachable monomers and addictive residues | no leachable monomers and addictive residues | Same |
| Mechanical Properties | |||
| Tensile strength (Mpa) | 0.78±0.2 | 0.5±0.2 | Different |
| Modulus (Mpa) | 0.60 ± 0.1 | 0.60±0.1 | Same |
| Elongation at break (%) | 195 ± 20% | 100± 20% | Different |
| Toughness (J/m3) | 0.87±0.05 | 0.25±0.05 | Different |
| Design/Manufacturing | |||
| Manufacturing Method | Cast Molded | Cast Molded | Same |
| Tint process | Pad printing | No Pad Printing | Different |
| Print Zone | Corresponds to the iris | N/A | Different |
| Location of printing | embedded between HEMA (Sandwich Process) | embedded between HEMA (Sandwich Process) | Same |
| Lens Design | Spherical | Spherical | Same |
| Diameter Range | 13 to 15 mm | 13 to 15 mm | Same |
| Power Range | - 20.00D to +20.00D in 0.25 steps | - 20.00D to +20.00D in 0.25 steps | Same |
| Center Thickness | 0.08mm @ -3.00D (Varies with Power) | 0.08mm @ -3.00D (Varies with Power) | Same |
| Base Curve | 8.0 mm to 9.2 mm | 8.0 mm to 9.2 mm | Same |
| Blue handling tint | No | Yes, reactive Blue19 | Different |
| Color Additives in dye | Iron oxide, Titanium dioxide, Phthalocyanine green, Carbazole violet | Reactive Blue19 | Different |
| Packaging/Sterilization | |||
| Single Use | No, Frequent/ Planned Replacement | No, Frequent/ Planned Replacement | Same |
| Packaging | Blister Pack | Blister Pack | Same |
| Packaging Solution | sterile isotonic Borate buffered saline | sterile isotonic phosphate buffered saline | Same |
| Sterilization method | Steam | Steam | Same |
| Shelf Life | 5 years | 5 years | Same |
| Sterility of Device | SAL= 10-6 | SAL= 10-6 | Same |
The document states: "The differences between those two devices are mechanical properties and color additives, but other reference devices have same technical characteristic as new devices to support the substantial equivalence." This implies that while the values might be numerically different for some mechanical properties and the color additives differ, these differences are not considered to raise new questions of safety or effectiveness because they align with established characteristics of other marketed devices. The acceptance criteria essentially appear to be "comparable to the predicate device or other legally marketed devices, with no new questions of safety or effectiveness raised by differences."
2. Sample size used for the test set and the data provenance
The document explicitly states: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This indicates that there was no specific "test set" of patients or data collected for a clinical study with this device. The data provenance would be from laboratory bench testing (non-clinical tests) and comparison to the predicate device's characteristics, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study with a test set requiring expert ground truth was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication was conducted.
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, not an AI-powered diagnostic tool, and no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" refers to established scientific and engineering standards and validated test methods. These include:
- ISO18369-3: Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
- ISO18369-4: Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
- ISO18369-2: Ophthalmic optics - Contact lenses - Part 2: Tolerances
- ISO11986: Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for etermination of preservation uptake and release
- ISO11987: Ophthalmic optics -- Contact lenses and contact lens care products --Determination of physical compatibility of contact lens care products with contact lenses
- ISO17665-2: Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
- ISO17665-1: Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO11980: Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations (though a clinical study was not used for this submission, compliance with this standard for potential future studies is implied).
- ASTM D792-13: Standard Test Methods For Density And Specific Gravity (Relative Density) Of Plastics By Displacement. (Materials)
- ISO10993-1, -5, -10, -11: For Biocompatibility.
The "ground truth" for the device's properties is established through these standardized measurement methods, with the results compared to the known and acceptable properties of the predicate device and other legally marketed devices.
8. The sample size for the training set
Not applicable, as no AI/algorithm training set was used.
9. How the ground truth for the training set was established
Not applicable, as no AI/algorithm training set was used.
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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.
December 5, 2017
Visco Vision Inc. Evan Huang Director of Global QA No. 1. Xingve St.. Guishan Dist.. Taoyuan City, 33341 TW
Re: K171447
Trade/Device Name: OxyPure Color Silicone Hydrogel Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 23, 2017 Received: October 31, 2017
Dear Evan 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. 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.
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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171447
Device Name
OxyPure Color Silicone Hydrogel Soft Contact Lenses
Indications for Use (Describe)
The OxyPure Color Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Company Name: | Visco Vision Inc |
|---|---|
| Company Address: | No. 1, Xingye St., Guishan Dist.,Taoyuan City, 33341, TAIWAN |
| Telephone: | +886-3-359-6868 |
| Fax: | +886-3-349-0202 |
| Contact Person: | Evan Huang |
| Summary Preparation Date: | 2017.4.17 |
| Trade Name: | OxyPure Color Silicone Hydrogel Soft Contact Lenses |
|---|---|
| Classification | Soft (hydrophilic) contact lens. |
| Name: Regulation | 886.5925 |
| Number: Product | LPL, MVN |
| Code: Device | Class 2 |
| Class: Panel: | Ophthalmic |
PREDICATE DEVICE:
K141348, VISCO SOFT CONTACT LENS
Device Description
The OxyPure Color Silicone Hydrogel Soft Contact Lenses is a daily wear lens in spherical design. It may be prescribed as daily wear. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. A benzotriazole UV absorbing monomer is used to block UV radiation. OxyPure Color Silicone Hydrogel Soft Contact Lenses contain a pigmented area that will alter or enhance the appearance of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phythalocyanine green and carbazole violet. Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date. Intended Use:
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The OxyPure Color Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.
| Category | OxyPure Color SiliconeHydrogel Soft ContactLensesNew device | VISCO SOFTCONTACT LENSK141348 | Result ofComparasion |
|---|---|---|---|
| Applicant | Visco Vision Inc | Visco Vision Inc | Same |
| Classification | class II | class II | Same |
| Regulationnumber | 886.5925 | 886.5925 | Same |
| Product code | LPL, MVN | LPL, MVN | Same |
| Indication | Daily Wear or DailyDisposable, Soft(hydrophilic) Contact Lensfor Myopia, Hyperopia, | Daily Wear or DailyDisposable, Soft(hydrophilic) Contact Lensfor Myopia | Same |
| Intended use | The OxyPure Color SphericalSilicone Hydrogel SoftContact Lenses are indicatedas daily wear single use softcontact lens for the correctionof refractive ametropia(myopia and hyperopia) inphakic or aphakic personswith non-diseased eyes who | The VISCO Soft(Hydrophilic) ContactLenses is indicated fordaily wear for thecorrection of refractiveametropia (myopia andhyperopia) in phakic oraphakic persons withnon-diseased eyes who | Same |
| Category | OxyPure Color SiliconeHydrogel Soft ContactLensesNew device | VISCO SOFTCONTACT LENSK141348 | Result ofComparasion |
| exhibit refractive astigmatismof 1.00D or less where theastigmatism does not interferewith visual acuity. | exhibit refractiveastigmatism of 2.00D orless where the astigmatismdoes not interfere withvisual acuity. Eyecarepractitioners may prescribethe lens for eithersingle-use disposablewear, or forfrequent/plannedreplacement wear, withcleaning, disinfection, andscheduled replacement.When prescribed forfrequent replacement, thelens may be disinfectedusing a chemicaldisinfection system only.The VISCO Soft(Hydrophilic) ContactLenses help protect againsttransmission of harmfulUV radiation to the corneaand into the eye. | ||
| Eyecare practitioners mayprescribe the lens for eithersingle-use disposable wear, orfor frequent/plannedreplacement wear, withcleaning, disinfection, andscheduled replacement. Whenprescribed for frequentreplacement, the lens may bedisinfected using a chemicaldisinfection system only. | |||
| USAN Name | Olifilcon A | Olifilcon A | Same |
| FDA Category(Group) | Group 1Non-ionic, Low water | Group 1Non-ionic, Low water | Same |
| ManufacturingMethod | Cast Molded | Cast Molded | Same |
| Tint process | Pad printing | No Pad Printing | Different |
| Print Zone | Corresponds to the iris | N/A | Different |
| Category | OxyPure Color SiliconeHydrogel Soft ContactLensesNew device | VISCO SOFTCONTACT LENSK141348 | Result ofComparasion |
| Location ofprinting | embedded between HEMA(Sandwich Process) | embedded between HEMA(Sandwich Process) | Same |
| Lens Design | Spherical | Spherical | Same |
| Water Content | 47% | 47% | Same |
| LightTransmittance | >94% | >94% | Same |
| Refractive Index | 1.410 (hydrated) | 1.410 (hydrated) | Same |
| OxygenPermeability(DK, 35°C) | 150(Fatt method) | 150(Fatt method) | Same |
| Diameter Range | 13 to 15 mm | 13 to 15 mm | Same |
| Power Range | - 20.00D to +20.00D in 0.25steps | - 20.00D to +20.00D in0.25 steps | Same |
| CenterThickness | 0.08mm @ -3.00D (Varieswith Power) | 0.08mm @ -3.00D (Varieswith Power) | Same |
| Base Curve | 8.0 mm to 9.2 mm | 8.0 mm to 9.2 mm | Same |
| Blue handlingtint | No | Yes, reactive Blue19 | Different |
| Color Additivesin dye | ● Iron oxide● Titanium dioxide● Phthalocyanine green● Carbazole violet | Reactive Blue19 | Different |
| Leachability | no leachable monomers andaddictive residues | no leachable monomersand addictive residues | Same |
| Single Use | No, Frequent/ PlannedReplacement | No, Frequent/ PlannedReplacement | Same |
| Packaging | Blister Pack | Blister Pack | Same |
| PackagingSolution | sterile isotonic Boratebuffered saline | sterile isotonic phosphatebuffered saline | Same |
| Sterilizationmethod | Steam | Steam | Same |
| Category | OxyPure Color SiliconeHydrogel Soft ContactLensesNew device | VISCO SOFTCONTACT LENSK141348 | Result ofComparasion |
| Shelf Life | 5 years | 5 years | Same |
| Sterility ofDevice | SAL= 10-6 | SAL= 10-6 | Same |
| Tensile strength(Mpa) | 0.78±0.2 | 0.5±0.2 | Different |
| Modulus (Mpa) | 0.60 ± 0.1 | 0.60±0.1 | Same |
| Elongation atbreak (%) | 195 ± 20% | 100± 20% | Different |
| Toughness(J/m3) | 0.87±0.05 | 0.25±0.05 | Different |
| Compliance standard | |||
| Biocompatibility | ISO10993-1 | ISO10993-1 | Same |
| ISO10993-5 | ISO10993-5 | ||
| ISO10993-10 | ISO10993-10 | ||
| ISO10993-11 | ISO10993-11 | ||
| Sterilization andShelf life | ISO 17665-1 | ISO 17665-1 | Same |
| ISO11737-1 | ISO11737-1 | ||
| ISO 11987 | ISO 11987 | ||
| performance | ISO18369-3 | ISO18369-3 | Same |
| ISO18369-4 | ISO18369-4 | ||
| ISO11986 | ISO11986 | ||
| ASTM D792-13 | ASTM D792-13 |
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Image /page/5/Picture/0 description: The image shows the logo for VISCO, a company that specializes in silicone hydrogel. The word "VISCO" is written in large, bold, blue letters. Below the company name is the tagline "The Silicone Hydrogel Expert" in a smaller, gray font.
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Image /page/6/Picture/0 description: The image contains the word "VISCO" in large, bold, blue letters. Below that, in smaller, gray letters, is the phrase "The Silicone Hydrogel Expert". The text is centered and the background is white.
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Image /page/7/Picture/0 description: The image shows the logo for VISCO. The logo is in blue and gray. The text below the logo says "The Silicone Hydrogel Expert".
Substantial Equivalence Comparison
The OxyPure Color Silicone Hydrogel Soft Contact Lenses, and the VISCO SOFT CONTACT LENS have same indication, intended use, classification name/ product code, lens design, lens materials/packaging materials and saline, manufacturing and sterilization method, tint process, perfomance parameter ranges, physical properties, mechanical properties, biocompatibility and shelf life. The differences between those two devices are mechanical properties and color additives, but other reference devices have same technical characteristic as new devices to support the substantial equivalence.
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Non-clinical tests
The safety tests, such as biocompatibility have been performed and meet the requirement of following FDA Recognized Consensus Standards.
Regarding the performance, the bench tests were performed in accordance with following FDA Recognized Consensus Standards. All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device.
- ISO18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
- ISO18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of ● contact lens materials
- ISO18369-2 Ophthalmic optics - Contact lenses - Part 2: Tolerances
- ISO11986 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for etermination of preservation uptake and release
- ISO11987 Ophthalmic optics -- Contact lenses and contact lens care products --Determination of physical compatibility of contact lens care products with contact lenses
- ISO17665-2 terilization Of Health Care Products - Moist Heat - Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
- ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO11980 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
- ASTM D792-13 Standard Test Methods For Density And Specific Gravity (Relative ● Density) Of Plastics By Displacement. (Materials)
Clinical study
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
Conclusions:
OxyPure Color Silicone Hydrogel Soft Contact Lenses has the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, OxyPure Color Silicone Hydrogel Soft Contact Lenses is substantially equivalent to the predicate devices with respect to its intended use, technological
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Image /page/9/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word, in smaller, gray letters, is the phrase "The Silicone Hydrogel Expert". The text is centered and the background is white.
characteristics and performance characteristics.
§ 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.