(420 days)
The Hydron ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters.
Eyecare practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
The ActiFresh 400 soft contact lens is a hemispherical shell manufactured of a high water content (73%), polymerised material of n-vinyl pyrrolidone (nVP) and methy methacrylate (MMA) and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eye. A UV filter has been incorporated into the lens material. The lens is visibility tinted with a minute amount of poly (2-hydroxyethyl methacrylate and Reactive Blue Dye #4 copolymer. The lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness) and hyperopia (farsightedness). The lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. The lens is designed with a spherical lenticulated front surface and spherical bicurve back surface. The lens is manufactured by cast molding.
The provided document describes the ActiFresh™ 400 Soft (hydrophilic) Contact Lens and its application for 510(k) clearance, asserting substantial equivalence to the predicate device, Hydron Omniflex SofBlue. The document does not describe acceptance criteria in the typical sense of a table with specific thresholds for performance metrics. Instead, it presents a comparative study against a predicate device and notes the absence of adverse events and comparability of clinical findings.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a table format with numerical thresholds for clinical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (Hydron Omniflex SofBlue) through a combination of non-clinical (physical, chemical, mechanical properties, toxicology, microbiology, stability) and clinical studies. The "acceptance criteria" are implicitly met if the ActiFresh 400 performs comparably to the predicate device and does not raise new questions of safety or effectiveness.
Here's a summary of the comparative performance as presented, alongside the predicate device, which can be interpreted as demonstrating "meeting acceptance criteria" by being comparable:
| Property | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (ActiFresh 400) | Predicate Device Performance (Omniflex SofBlue) |
|---|---|---|---|
| Non-Clinical | |||
| USAN | lidofilcon A | lidofilcon A | lidofilcon A |
| Monomers | nVP, MMA | nVP, MMA | nVP, MMA |
| Manufacturing Process | - (Different permitted if equivalent performance) | Cast Molding | Lathe-cut |
| Diameter (mm) | 14.3 | 14.3 | 14.3 |
| Center Thickness (mm) | 0.12 | 0.12 | 0.12 |
| Base Curves (mm) | - (Within specified range) | 8.4, 8.8 | 8.10 to 9.30 |
| Refractive Index | Comparable | $1.37 \pm 0.0003$ | $1.39 \pm 0.0007$ |
| Water Content (%) | Comparable | $73 \pm 0.3$ | $69 \pm 0.5$ |
| Oxygen Permeability (Dk) | Comparable | $28 \times 10^{-11}$ | $24 \pm 2.7 \times 10^{-11}$ |
| Light Transmittance | Comparable | $94.11\pm14.68%$ | $95.24\pm3.42%$ |
| Modulus (N/mm²) | Comparable | $0.31 \pm 0.04$ | $0.52 \pm 0.065$ |
| Tensile Strength (N/mm²) | Comparable | $0.48 \pm 0.14$ | $1.01\pm0.338$ |
| Elongation at Break (%) | Comparable | $126 \pm 27$ | $213\pm63$ |
| Toxicology | Non-toxic (according to ISO standards) | All results provide reasonable assurance of non-toxicity | Not explicitly stated but assumed for predicate |
| Microbiology | Sterilizable to SAL of 10⁻⁶ | Efficacy of sterilization checked, bioburden |
§ 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.