(459 days)
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the lens is to be discarded after each removal.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.
This document is a 510(k) Pre-Market Notification for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable in the way they would be for an AI/ML medical device.
However, I can extract information related to the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to established standards and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or target performance manner as one might expect for a diagnostic or AI device. Instead, it compares the subject device's characteristics to those of its predicate devices, implying that similarity or equivalence to the predicate's performance across these characteristics is the "acceptance criterion" for substantial equivalence.
| Characteristic | Acceptance Criterion (Implied: Similar to Predicate) | Reported Subject Device Performance | Predicate Device 1 (K150630) Performance | Predicate Device 2 (K211448) Performance |
|---|---|---|---|---|
| Material USAN Name | Polymacon (same as Predicate 1) | Polymacon | Polymacon | Etafilcon A |
| Manufacturing Method | Cast Molded (same as Predicate 1 & 2) | Cast Molded | Same | Same |
| Sterilization | Moist Heat (Steam) in Validated Autoclave (same as Predicate 1 & 2) | Moist Heat (Steam) in Validated Autoclave | Same | Same |
| Packaging | Blister pack (same as Predicate 1 & 2) | Blister pack | Same | Same |
| Water Content | 38 % (same as Predicate 1) | 38 % | 38 % | 58% |
| Tint | C.I. Reactive Blue #4 (same as Predicate 1) | C.I. Reactive Blue #4 | Same | Reactive Blue 19 |
| Packaging Solution | Similar to predicate packaging solutions or established safe solutions. | A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution. | Phosphate buffered saline solution containing sodium hyaluronate and trehalose. | Sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin. |
| Base Curve | Range of 7.50 ~ 9.00 mm (similar to Predicate 1, or appropriate for contact lenses) | 7.85 ~ 10.00 mm | 7.50 ~ 9.00 mm | N/A (Predicate 2 provides a wider range of lens types, base curve is not explicitly listed in table for this predicate) |
| Diameter | Range of 12.0 ~ 15.0 mm (similar to Predicate 1) | 12.0 ~ 15.0 mm | Same | N/A (Predicate 2 provides a wider range of lens types, diameter is not explicitly listed in table for this predicate) |
| Center Thickness (Eye Secret 38 UV lens) | 0.04 ~ 0.14 mm (similar to Predicate 1) | 0.06 ~ 0.13 mm | 0.04 ~ 0.14 mm | N/A |
| Center Thickness (Air Light 38 UV lens) | Not explicitly compared but within acceptable range for contact lenses. | 0.03 mm | N/A | N/A |
| Refractive Index | 1.440 ± 0.005 $n_d$ (same as Predicate 1) | 1.440 ± 0.005 $n_d$ | Same | 1.402 $n_d$ |
| Oxygen Permeability (Dk) | 13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg) (same as Predicate 1) | 13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg) | Same | 19.73 x 10-11 (cm2/sec)(ml O2/ml x mmHg) |
| Light Transmittance | 95 ± 5 % (similar to Predicate 1 and >95% for Predicate 2) | 95 ± 5 % | Same | > 95% |
| UV-A Transmittance (Eye Secret 38 UV lens) |
§ 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.