(273 days)
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated 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.
The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) with isotonic buffered saline solution.
The provided text is a 510(k) Summary for the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens. It outlines the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, but it explicitly states that no clinical study was conducted to prove the device meets acceptance criteria. Therefore, most of the requested information regarding a study, sample sizes, experts, adjudication, MRMC, and standalone performance cannot be provided as they are not applicable to this submission.
However, based on the provided "Technological characteristic" and "Performance Data" sections, we can infer some aspects of what would typically be considered "acceptance criteria" for a contact lens and how its performance was assessed non-clinically.
Here's a breakdown of the requested information, adapted to what is available in the text:
1. Table of acceptance criteria and the reported device performance:
Since no clinical study was performed with explicit acceptance criteria and corresponding performance metrics from that study, I will extract relevant technical specifications of the HydroSens A lens from the "Technological characteristic" and "Performance Data" sections, along with performance from non-clinical physiochemical studies. These values represent the device's intended performance.
| Criterion (Inferred from Technological Characteristics & Performance Data) | Acceptance Criteria (Implied / Design Specification) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|---|
| Dimensional Characteristics: | ||
| Diameter Range | 13.0 to 15.0 mm, ±0.2mm | Stated as design specification |
| Base Curve | 8.0 to 9.2 mm, ±0.2mm | Stated as design specification |
| Center Thickness (-3.00D) | 0.08 mm, ± [0.010 mm + 0.10 tc] | Stated as design specification |
| Power Range (for | FL | ≤ 10.00 D) |
| Power Range (for 10.00 D |
§ 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.