Search Results
Found 1 results
510(k) Data Aggregation
(132 days)
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The POLYVUE (polymacon) Soft (hydrophilic) Contact Lens is available clear or tinted for visibility using phthalocyanine blue. The POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens contains a unique tinted pattern to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Phthalocyanine blue, Phthalocyanine green, Titanium dioxide, Iron Oxide, Reactive black 5, Carbazole violet.
When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material-in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses are manufactured in an aspheric design configuration.
This document describes a 510(k) premarket notification for POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lenses. The information primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain the details typically associated with the acceptance criteria and study proving performance for an AI-powered medical device, such as a multi-reader multi-case (MRMC) study or ground truth establishment by experts.
Therefore, many of the requested sections about AI device performance metrics, expert adjudication, and large-scale clinical studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted and how it relates to proving the device meets acceptance criteria, followed by a note on the information that is not present:
A. Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document primarily evaluates the contact lenses against established standards and predicate devices for their physical, chemical, and biological properties. The acceptance criteria are implicit in the "Performance Data" section, where "results support the claim that the ... Contact Lenses are substantially equivalent to the currently marketed predicate device."
| Acceptance Criteria Category (Implicit) | Specific Test/Property | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility/Safety | In-Vitro Cytotoxicity (ISO 10993-5) | Finished lenses extracts are non-toxic. |
| Sensitization (ISO 10993-10) | Lens extracts do not cause sensitization. | |
| Acute Ocular Irritation (ISO 10993-10) | Finished lens extracts were non-irritating. | |
| Systemic Toxicity (ISO 10993-11) | Finished lenses meet the requirements of the systemic injection test and are considered non-toxic. | |
| Product Stability | Shelf Life (Stability, Sterility, Package Integrity) | Data supports substantial equivalence over the duration of the labeled expiration date. |
| Physical/Chemical Properties | Refractive Index | 1.440 (hydrated) ±0.005 |
| Water Content | 38% ±2% | |
| Oxygen Permeability (x 10^-11 (cm²/sec)(mlO2)/(ml x mmHg)) | 8.9 (range given as 10.26 ±20% for subject device, 8.9 ±20% for primary predicate) - "demonstrate consistency of the material properties between the POLYVUE and POLYVUE COLOR (polymacon) contact lenses and the predicate device." | |
| Light Transmission - Clear (@ 380-780nm) | 95% ±5% | |
| Light Transmission - Tinted (@ 380-780nm) | 95% ±5% (This may be a typo as colored lenses usually have lower light transmission, but this is what is stated in the table). The text states "Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens." | |
| Tensile Strength, Modulus, Elongation to Break, Specific Gravity, Polymerization Residuals | Results demonstrate consistency of the material properties between the subject contact lenses and the predicate device. | |
| Manufacturing Tolerances (ISO 18369-2:2017) | Chord Diameter | 11.00 mm to 15.00 mm; Tolerance: ±0.20 mm |
| Center Thickness | 0.05 mm to 0.15 mm; Tolerance: When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | |
| Base Curve | 7.00 mm to 10.0 mm; Tolerance: ±0.20 mm | |
| Back Vertex Power (F'v) | +10.00 D to -20.00D (in 0.25D steps); Tolerance: When 0.00 1.50 D → ± 5° | |
| Surface Appearance | Lenses should be clear with no surface defect. |
B. Sample Size and Data Provenance for the Test Set:
- Sample Size: Not explicitly stated for each non-clinical test, but typically these tests involve a representative sample size to meet the statistical requirements of the relevant ISO standards (e.g., ISO 10993 series and ISO 18369-2:2017).
- Data Provenance: The submitter is INTEROJO INC. based in PYONGTAEK-CITY Gyeonggi, SOUTH KOREA. The testing was conducted in accordance with GLP (Good Laboratory Practice) regulations, implying established quality control over the testing process. The original source of the raw materials (polymacon) isn't specified, but the testing would have been on the finished product. The data is retrospective in the sense that it was collected as part of the submission process, not from an ongoing clinical trial.
C. Number of Experts and Qualifications for Ground Truth for the Test Set:
- Not Applicable. This document is for a contact lens, not an AI-powered diagnostic device. Ground truth for non-clinical testing of material properties, biocompatibility, and manufacturing tolerances is established through standardized laboratory procedures and measurements, not by human experts interpreting images or clinical data.
D. Adjudication Method for the Test Set:
- Not Applicable. As above, no human interpretation requiring adjudication is involved in the non-clinical tests described.
E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not an AI-powered device. The document explicitly states: "Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously."
F. Standalone (Algorithm Only) Performance:
- Not Applicable. This is not an AI-powered device.
G. Type of Ground Truth Used:
- Laboratory Measurements and Compliance with Standards/Predicate Devices: The "ground truth" for the non-clinical tests is established by adhering to validated methods described in ISO standards (e.g., ISO 10993 for biocompatibility, ISO 18369-2 for optical properties and specifications) and comparing results to the properties of the legally marketed predicate devices.
H. Sample Size for the Training Set:
- Not Applicable. This is not an AI-powered device requiring a training set.
I. How the Ground Truth for the Training Set was Established:
- Not Applicable. This is not an AI-powered device requiring a training set.
Ask a specific question about this device
Page 1 of 1