(149 days)
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilis contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
(Hioxifilcon B)
Refractive Index: 1.51 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.137 (hydrated)
Oxygen Permeability: 16.40 X 10 to the power of -11 (cm squared/sec) (ml O sub 2/ml x hPa @ 35 degrees C), (revised Fatt method)
This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This process does not involve extensive clinical trials with acceptance criteria, ground truth, or statistical analyses in the same way a PMA (Premarket Approval) would.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this type of submission.
Instead, the submission focuses on demonstrating substantial equivalence based on material properties, intended use, and design similarity to existing predicate devices.
Here's what the document does provide, structured to address relevant aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the new device's properties to existing, legally marketed predicate devices to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate Device Values) | RevitalEyes (New Device) Reported Performance |
|---|---|---|
| Intended Use | Corrective ametropia in non-diseased eyes; management of surgically altered corneas (FlexLens), or correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes with myopia or hyperopia (METRO-G). | Indicated for daily wear and may be prescribed in non-diseased eyes that require soft contact lens for management of surgically altered corneas following LASIK, PRK or RK surgery. |
| Functionality | Act as a refractive medium to focus light rays on the retina. | Same as predicate device. |
| Indications | Daily wear, soft (hydrophilic) contact lens. | Same as predicate device. |
| Production Method | Lathe-cut. | Same as predicate device (Lathe-cut). |
| FDA Group # | Group # 1 |
§ 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.