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.

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.

AI/ML Overview

Acceptance Criteria and Study for ChromaGen v3.0 Reading Aid Soft Contact Lens

This response details the acceptance criteria and the study conducted to demonstrate the effectiveness of the ChromaGen v3.0 Reading Aid Soft Contact Lens, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Metric
Subjective preference for ChromaGen lenses over placebo lenses	72.5% of subjects preferred ChromaGen lenses to placebo lenses (29 out of 40 subjects who expressed an opinion)	Percentage
Improved "ease of reading" with ChromaGen lenses compared to placebo lenses	Median "ease of reading" grading was 7.0 for ChromaGen lenses vs. 4.5 for placebo lenses (on a scale from -10 to +10)	Median Score
Statistical significance of improved "ease of reading"	p-value < 0.001 (Wilcoxon analysis)	p-value

2. Sample Size and Data Provenance

Sample Size for Test Set: 47 subjects completed the study. (53 subjects initially entered, but 6 were excluded from the analysis for not providing an opinion on lens preference)
Data Provenance: The document does not explicitly state the country of origin. The study was conducted by Cantor & Nissel Limited, an English company, implying the data likely originated from the UK. The study was prospective, as it involved recruiting subjects and conducting new tests.

3. Number and Qualifications of Experts for Ground Truth

The study did not use experts to establish ground truth in the traditional sense of diagnostic accuracy.
The ground truth was based on the subjective experience of the participants, who were asked to grade their own "ease of reading" and express their preference between lenses.

4. Adjudication Method

None. There was no adjudication method described. The outcome was based on individual subjective reports from the participants.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the subjective experience of individual users with and without the device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The ChromaGen v3.0 Reading Aid Soft Contact Lens is a physical device (tinted contact lens), not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

Subjective Patient Self-Report / Patient Reported Outcomes (PROs): The ground truth was based on the participants' subjective grading of "ease of reading" and their expressed preference between the ChromaGen lenses and placebo lenses.

8. Sample Size for Training Set

Not applicable. This device is a physical product (tinted contact lens) and does not involve a "training set" in the context of machine learning or algorithms. The clinical study evaluated the device's performance in a test set of patients.

9. How Ground Truth for Training Set Was Established

Not applicable, as there was no training set for this device.

Summary

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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 PlaceBrackley NorthantsEngland NN13 7DP
Contact Person:	Mr. David CantorManaging 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

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Substantially Equivalent Devices:

The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are substantially equivalent to the following legally marketed devices:

1. 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:

INDICATIONS FOR USE:

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.

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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<0.001)."

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Table of Substantial Equivalence

	Characteristic	ChromaGenReading Aid lenses(subject device)	Cantor & NisselChromaGen ColorDiscrimination lenses(K994320)(predicate device)	Cantor & NisselTinted lenses(K990757 )(predicate device)
1.)	INDICATIONfor USE	The ChromaGen V3.0 Reading AidSoft Contact Lenses are indicated fordaily wear for the correction ofrefractive ametropia (myopia,hyperopia and astigmatism) in aphakicand not-aphakic persons with non-diseased eyes. Theses lenses may alsobe prescribed as a colored filter to aidindividuals who experience readingdiscomfort not related to binocularvision problems or uncorrectedrefractive error. The lenses aredisinfected using a hydrogen peroxidelens care system only and are availablein a frequent replacement program.	The ChromaGen V2.0 ColorDiscrimination Enhancement SoftContact Lenses are indicated for dailywear to enhance color discrimination inpatients with protan or deutan (red-green) color vision deficiencies. Thelens may also be prescribed for thecorrection of refractive ametropia(myopia, hyperopia and astigmatism)in aphakic and not aphakic personswith non-diseased eyes. The lenses aredisinfected using a hydrogen peroxidelens care system only and are availablein a frequent replacement program.	The Cantor & Nissel 5X Tinted SoftContact Lenses are indicated for dailywear to enhance or alter the apparenteye color, including ocular masking,either in sighted or non-sighted eyes.The lens may also be prescribed for thecorrection of refractive ametropia(myopia, hyperopia and astigmatism)in aphakic and not aphakic persons.The lenses are disinfected using ahydrogen peroxide lens care systemonly and are available in a frequentreplacement program.
2.)	Efficacy	Established, Clinicalstudy	Established, Clinicalstudy	Established Pre-clinicalstudies
3.)	Device	Colored Filter ContactLens (lathe-cut)	Colored Filter ContactLens (lathe-cut)	Colored Filter ContactLens (lathe-cut)
4.)	Device Material	Soft Contact Lens(hydrophilic)	Soft Contact Lens(hydrophilic)	Soft Contact Lens(hydrophilic)
5.)	FDA ListedColor Additives	The reactive colored additives consistof reactive black 5, reactive blue 4,reactive blue 19, reactive 21, reactiveblue 163, reactive yellow 15, reactiveyellow 86, reactive orange 78, reactivered 11 and reactive red 180.	The reactive colored additives consistof reactive black 5, reactive blue 4,reactive blue 19, reactive 21, reactiveblue 163, reactive yellow 15, reactiveyellow 86, reactive orange 78, reactivered 11 and reactive red 180.	The reactive colored additives consistof reactive black 5, reactive blue 4,reactive blue 19, reactive 21, reactiveblue 163, reactive yellow 15, reactiveyellow 86, reactive orange 78, reactivered 11 and reactive red 180.
6.)	Color AdditiveCharacteristics	The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics are notaltered by the lens coloring process.	The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics are notaltered by the lens coloring process.	The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics are notaltered by the lens coloring process.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 9 2002

Cantor & Nissel, Ltd. c/o Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K012132/S002

Trade/Device Name: ChromaGen.js , Reading Aid Soft Contact Lens Regulation Number: 886.5925 Regulation Name: Soft (hydrophilic) contact Lens Regulatory Class: Class II Product Code: NIC; LPL Dated: April 9, 2002 Received: April 16, 2002

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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K012i32

INDICATIONS FOR USE STATEMENT

ChromaGen v3.0 Reading Aid, Soft Contact Lens Device Name:

INDICATIONS FOR USE:

(PLEASE DO OT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Khur Wakunta

Division Sian-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number K012132

Prescription Use (Per 21 CFR 801.109) or

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.