(128 days)
We now intend to add a "visibility tint" to our daily wear lenses so that they can be seen more easily while being handled for cleaning.
The parameters and indications for the tinted lenses are exactly the same as those approved by the FDA for our clear lenses.
The material from which the lens will be manufactured is FDA approved methafilcon-A. When fully hydrated, the material has a 55% water content. This high water content soft (hydrophilic) contact lens material has been tested for performance, comfort and oxygen transmissibility.
We intend to add to our contact lens blanks a small amount of a colorant approved by the FDA for use in contact lenses. The concentration of the colorant is within the range approved by the FDA for use of this colorant in lenses. The colorant concentration is so low that the finished contact lens appears to have just a very faint blue-green tint when held against a white background. The very faint tint of this lens does not change the apparent color of the wearer's eye.
The processes and equipment used to manufacture the "visibility tint" blanks and lenses are identical to those used for our clear daily wear blanks and lenses. The addition of the colorant does not affect the material in any way except for the addition of a faint color.
The provided document is a summary of safety and effectiveness for a contact lens with a color additive, submitted in 1996 for FDA approval (K962911). It is not a detailed study report that would typically contain acceptance criteria, primary study data, or details about ground truth establishment.
Therefore, I cannot provide the requested information as it is not present in the given text.
The document primarily states:
- The lens material (methafilcon-A) is FDA-approved and has a 55% water content.
- Cal Bionics, Inc. already had FDA approval for daily and extended wear lenses made from this material since 1986, with no reported adverse reactions or significant complaints.
- The "new" approval is for a "visibility tint" using an FDA-approved colorant at an FDA-approved concentration.
- The manufacturing processes, equipment, parameters, and indications are identical to their previously approved clear lenses.
- The tint is very faint and does not change the wearer's eye color.
This document describes a pre-market notification (510(k)) where the manufacturer is arguing "substantial equivalence" to an already approved device. This process typically relies on demonstrating that the new device (with the tint) is as safe and effective as a legally marketed predicate device (their clear lenses), rather than conducting new, large-scale clinical trials with specific statistical endpoints and acceptance criteria as would be required for a novel device.
To answer your questions, one would need access to the original FDA approval documents for the predicate device (Cal Bionics' clear contact lenses from 1986) or a more detailed submission report for K962911 that elaborated on performance testing. The current text only states that the material "has been tested for performance, comfort and oxygen transmissibility" but provides no specific data, acceptance criteria, or study design details.
§ 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.