(91 days)
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye.
Replacement schedules may vary from patient to patient, and should be decided by eye care professionals in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care professionals. The lens may be disinfected using a chemical disinfection system.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is a hemispherical flexible shell which may cover a portion of the cornea and a portion of the adjacent sclera. It consists of a polymer of Hydroxyethyl Methacrylate (HEMA) and Ethylene Glycol Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted in the monomer with Phthalocyanine Blue Dye 246 (1, 4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone), which conforms to 21 CFR Part 73.3106. Finished lenses are subsequently tinted to achieve different colors using color additives that conform to 21 CFR Part 73.3121.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is designed to aid visual performance in athletic settings. MAXSIGHT (polymacon) Sport-Tinted Contact lenses enhance contrast in a wide range of outdoor light conditions. This allows athletes to see created objects with greater clarity than with the naked eye.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is manufactured with the following dimensions:
Diameter: 13.5 to 15.5 mm
Center Thickness: 0.06 to 0.175mm
Base Curve: 8.4-9.0mm
Powers (Spherical): +20.00D to -20.00D
The physical / optical properties of the lens are:
Specific Gravity: 1.13
Refractive Index: 1.43
Light Transmittance: ≥30%
UV Absorption: >95%
UVA absorption: >95%
UVB absorption: >95%
Water Content: 38.6%
Oxygen Permeability (Dk): 8.4x10-11[cm³O2 (STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method)
Each MAXSIGHT (polymacon) Sport-Tinted Contact Lens is supplied in a plastic blister container with sterile saline solution. The lid of the container is marked with the lens power, diameter, manufacturing lot number, and expiration date.
The provided text describes a 510(k) premarket notification for the MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens, which seeks substantial equivalence to a predicate device. This type of submission focuses on demonstrating safety and effectiveness through equivalence to an existing legally marketed device, rather than through a comprehensive clinical trial with specific performance acceptance criteria and a detailed study design as might be seen for a novel device.
The document does not contain explicit acceptance criteria for device performance in a clinical study or a study proving that such criteria were met. Instead, it focuses on non-clinical laboratory testing to demonstrate safety and physicochemical equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study sample sizes, expert involvement, and ground truth are not applicable or not provided in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated as "acceptance criteria" for a primary performance study. The document reports physicochemical properties and their equivalence to a predicate device and the untinted base lens, as well as toxicology and biocompatibility test results demonstrating safety.
| Property/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Physicochemical Properties | Equivalent to Bausch & Lomb NaturalTint® (polymacon) Contact Lens | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the predicate device. |
| Equivalent to base lens prior to tinting | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the base lens prior to tinting. | |
| Specific Gravity | (Not explicitly stated as criterion, but a property) | 1.13 |
| Refractive Index | (Not explicitly stated as criterion, but a property) | 1.43 |
| Light Transmittance | (Not explicitly stated as criterion, but a property) | ≥30% |
| UV Absorption (UVA, UVB) | (Not explicitly stated as criterion, but a property) | >95% (for both UVA and UVB) |
| Water Content | (Not explicitly stated as criterion, but a property) | 38.6% |
| Oxygen Permeability (Dk) | (Not explicitly stated as criterion, but a property) | 8.4x10⁻¹¹ [cm³O₂(STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method) |
| Toxicology & Biocompatibility | No detectable monomer components, cross-linker, initiator, or diluent in extracts; dye extracts |
§ 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.