(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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Cal Bionics. The logo consists of a stylized letter C that is thick and black. Below the C is the text "Cal Bionics" in a simple, sans-serif font.
NOV 29 1996
K962911
Summary of Safety and Effectiveness for Contact Lens with Color Additive.
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. Since 1984, it has been a widely employed polymer in the contact lens industry. There are many FDA approved manufacturers of soft contact lenses from this material.
Cal Bionics, Inc. received FDA Approval for our daily wear and extended wear soft contact lenses in 1986. In the ten years that our FDA approved daily wear and extended wear lenses have been distributed, there have been no reported adverse reactions or significant complaints. Cal Bionics, Inc. manufactures the contact lens blanks which are then supplied to our FDA approved Alternate Manufacturing Sites where the blanks are lathe cut into finished soft contact lenses.
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. 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 cleaning regimens already approved by the FDA for our clear lenses will apply to the tinted lenses. The parameters and indications for the tinted lenses are exactly the same as those approved by the FDA for our clear lenses.
It is believed that the addition of an FDA approved colorant, in concentrations approved by the FDA, to an FDA approved polymer will produce tinted lens blanks which will produce the safest of conditions when manufactured into soft (hydrophilic) contact lenses following these designs and parameters already approved by the FDA.
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
§ 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.