(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.
§ 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.