(304 days)
No
The device description and performance studies focus on the physical properties of tinted contact lenses and subjective patient feedback, with no mention of AI or ML algorithms for analysis or decision-making.
Yes
The device is indicated to "aid individuals who experience reading discomfort". This addresses a medical condition (reading discomfort) and aids in its alleviation, which is a therapeutic function.
No.
The document indicates that the ChromaGen v3.0 Reading Aid Soft Contact Lenses are used for correction and as a colored filter to aid reading discomfort, not for diagnosing a condition. Its use to determine which color filters provide the 'least distortion' is part of selecting the appropriate corrective lens, not diagnosing a disease.
No
The device is described as soft contact lenses with precision tinted hues and saturation, which are physical objects made of material and color additives. The description details the manufacturing process and the physical properties of the lenses, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for the correction of refractive errors (myopia, hyperopia, astigmatism) and as a colored filter to aid in reading discomfort. These are related to vision correction and visual aids, not the diagnosis of a disease or condition.
- Device Description: The device is a soft contact lens with a tint. It modifies how light enters the eye to potentially improve reading comfort. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Claims: The documentation does not mention any claims related to diagnosing a disease, condition, or state of health. The study focuses on subjective improvement in reading comfort.
- Predicate Devices: The predicate devices listed are also tinted contact lenses, which are not typically classified as IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.
Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Product codes
NIC, LPL
Device Description
The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the encoufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.
The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used in and paragraph with (pation are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
9 to 40
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The ChromaGen Reading Aid, Soft Contact Lens are lenses that have the pupil area tinted with one of a variety of colors. A clinical study was carried out to evaluate these colored lenses as an aid for patients who ewxperience visual discomfort while reading. Fifty-three subjects who had reading difficulties entered into the study. They ranged in age from 9 to 40. (Patients were selected from those responding to press coverage.) Subjects were excluded if their own eyecare professional indicated that they had any underlying optometric cause for reading difficulties. Forty-seven subjects completed the study.
Subjects were tested to determine which color filters from the ChromaGen diagnostic set gave the least distortion or made the print "easiest to read" (subjectiviely). The study used placebo lenses, which were clear (light handling tint) contact lenses that the patients were told had been specially treated to make the color invisible to the naked eye. Patients were given various short paragraphs to read aloud. These consisted of simple words placed in random order (not sentences). Each patient read some of these paragraphs: (1) without lenses (2) with ChromaGen lenses, and (3) with placebo contact lenses. The order of lens use was randomized. Subjects were asked to grade the subjective improvement in "ease of reading" and were asked which type of leas they preferred. Of the 40 subjects who espressed an opinion, 29 (72.5 per cent) preferred ChromaGen lenses to the placebo lenses. Six subjects chose not to give a response and 1 rated the two lenses equal. The median "ease of reading" grading (scale from -10 to +10) was 7.0 for the ChromaGen lenses and was 4.5 for the placebo lenses. Analysis of these results (Wilcoxon) shows that ChromaGen lenses were rated very significantly more highly than the placebo lenses (p
§ 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
MAY 0 9 2002
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K012132 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
| Date Prepared: | April 12, 2001 |
|---|---|
| Name: | Cantor & Nissel Limited |
| Address | Market Place |
| Brackley Northants | |
| England NN13 7DP | |
| Contact Person: | Mr. David Cantor |
| Managing Director | |
| USA Consultant: | Martin Dalsing, |
| Medvice Consulting, Inc. | |
| Consultant and US Agent for Cantor & Nissel, Ltd. | |
| 623 Glacier Drive | |
| Grand Junction, CO 81503 | |
| (970) 243-5490 | |
| Fax #: (970) 243-5501 E-mail: mdalsing@FDApproval.com |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | 886,5925 |
Trade Name:
Reason for 510(k) submission:
Classification Name:
ChromaGen v3.0 Reading Aid Soft Contact Lens
Expanded Indication to K990757, K994320
Lens, Soft Contact, Daily Wear
1
Substantially Equivalent Devices:
The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are substantially equivalent to the following legally marketed devices:
-
- Cantor & Nissel "CANTOR & NISSEL 5X Tinted", tinted contact lens Re: K990757
- Cantor & Nissel "ChromaGen v2.0 Color Discrimination Enhancement, Soft Contact Lenses" 2. tinted contact lens Re: K994320
Device Descriptive Characteristics:
The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the encoufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.
The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used in and paragraph with (pation are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
INDICATIONS FOR USE:
The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.
Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disiofected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
2
Preclinical Studies
The biocompatibility testing, compatibility testing, physical parameters of the lens can be referenced in K990757 & K994320.
Clinical Testing
The ChromaGen Reading Aid, Soft Contact Lens are lenses that have the pupil area tinted with one of a variety of colors. A clinical study was carried out to evaluate these colored lenses as an aid for patients who ewxperience visual discomfort while reading. Fifty-three subjects who had reading difficulties entered into the study. They ranged in age from 9 to 40. (Patients were selected from those responding to press coverage.) Subjects were excluded if their own eyecare professional indicated that they had any underlying optometric cause for reading difficulties. Forty-seven subjects completed the study.
Subjects were tested to determine which color filters from the ChromaGen diagnostic set gave the least distortion or made the print "easiest to read" (subjectiviely). The study used placebo lenses, which were clear (light handling tint) contact lenses that the patients were told had been specially treated to make the color invisible to the naked eye. Patients were given various short paragraphs to read aloud. These consisted of simple words placed in random order (not sentences). Each patient read some of these paragraphs: (1) without lenses (2) with ChromaGen lenses, and (3) with placebo contact lenses. The order of lens use was randomized. Subjects were asked to grade the subjective improvement in "ease of reading" and were asked which type of leas they preferred. Of the 40 subjects who espressed an opinion, 29 (72.5 per cent) preferred ChromaGen lenses to the placebo lenses. Six subjects chose not to give a response and 1 rated the two lenses equal. The median "ease of reading" grading (scale from -10 to +10) was 7.0 for the ChromaGen lenses and was 4.5 for the placebo lenses. Analysis of these results (Wilcoxon) shows that ChromaGen lenses were rated very significantly more highly than the placebo lenses (p