(128 days)
Not Found
Not Found
No
The 510(k) summary describes a contact lens with a visibility tint, focusing on material properties and manufacturing processes. There is no mention of AI or ML technology.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a contact lens with a visibility tint, which serves no therapeutic purpose but aids in handling the lens.
No
The device described is a contact lens with a visibility tint, which is a therapeutic device intended for vision correction and handling ease, not for diagnosing medical conditions.
No
The device described is a contact lens, which is a physical medical device made of material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device described is a contact lens with a visibility tint. Its purpose is to aid in handling during cleaning.
- Intended Use: The intended use is for daily wear and the parameters and indications are the same as approved clear lenses. There is no mention of using the lens to analyze a specimen from the human body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
The addition of a visibility tint to a contact lens for easier handling does not change its fundamental purpose from a medical device (correcting vision or for cosmetic use) to an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
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. The device is a daily wear contact lens with a "visibility tint" (faint blue-green tint) added using a small amount of an FDA-approved colorant. The concentration of the colorant is low and does not change the apparent color of the wearer's eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.