(303 days)
The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
The ChromaGen v2.0 Color Discrimination Enhancement filters are designed specifically to improve discrimination between colors that are normally confused by people with protan or deutan (red-green) color vision deficiencies. The ChromaGen v20 Color Discrimination Enhancement Soft Contact Lenses are a range of soft contact lenses with precision tinted pupils of varying hue and saturation which, when used monocular and binocularly, have been shown to be of use in patients with defective color vision. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This device in not a cure for color vision deficiencies or colorblindness. The ChromaGen v2.0 Color Discrimination Enhancement 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 manufacturing 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 on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted to the eyecare professional instructions. The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethy) methacrylate). The reactive color additives that may be used either alone or in combination 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 v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
The provided text is a 510(k) summary for the "ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens". It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria and a detailed study report for the device itself.
Therefore, much of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a performance study) is not available in the provided document.
The document primarily describes the device's characteristics and compares them to predicate devices, focusing on materials, manufacturing, intended use, and general safety aspects (like color additives). It does not contain a study designed to quantify the "enhancement of color discrimination" with specific metrics against defined acceptance criteria.
However, I can extract the available information:
- Device Name: ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens
- Intended Use: To enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.
Not Applicable/Not Provided due to the nature of the 510(k) summary:
- A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for substantial equivalence, not a performance study against acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or study data is presented to evaluate clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical performance study is detailed with a test set and ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool; it's a contact lens.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study for color discrimination enhancement is described with a ground truth methodology. The document mentions improvement in discrimination based on the design of the filters and previous device history.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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OCT 2 0 2000
510 (k): SUMMARY OF SAFETY AND EFFECTIVENESS
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.
K994320 The assigned 510(k) number is:
Applicant information:
| Date Prepared: | October 1, 2000 |
|---|---|
| Name: | Cantor & Silver Limited |
| Address | Market PlaceBrackley NorthantsEngland NN13 7DP |
| Contact Person: | Mr. David CantorManaging Director/President |
| Phone Number:Fax: | 011 44 1280 702002011 44 1280 703003 |
| USA Consultant: | Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Cantor & Silver, Inc.623 Glacier DriveGrand Junction, CO 81503(970) 243-5490Fax #: (970) 243-5501 E-mail: mdalsing@gj.net |
Device Infor
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL, NCZ |
| Trade Name: | ChromaGen v2.0 Haploscopic System &Color Discrimination Enhancement Soft ContactLens |
| Classification Name: | Lens, Soft Contact, Daily Wear |
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SUMMARY BASIS for Substantial Equivalence ~
Substantially Equivalent Devices:
The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are substantially equivalent to the "X-Chrom" RED Tinted PMMA Contact Lens" and the Cantor & Silver "CANTOR & SILVER 5X Tinted", the predicate devices.
NOTE: The "X-Chrom" RED Tinted lens is classified as a pre-amendment device.
Device Descriptive Characteristics:
The ChromaGen v2.0 Color Discrimination Enhancement filters are designed specifically to improve discrimination between colors that are normally confused by people with protan or deutan (red-green) color vision deficiencies
The ChromaGen v20 Color Discrimination Enhancement Soft Contact Lenses are a range of soft contact lenses with precision tinted pupils of varying hue and saturation which, when used monocular and binocularly, have been shown to be of use in patients with defective color vision. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This device in not a cure for color vision deficiencies or colorblindness.
The ChromaGen v2.0 Color Discrimination Enhancement 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 manufacturing 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 on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted to the eyecare professional instructions.
The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethy) methacrylate). The reactive color additives that may be used either alone or in combination 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 v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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PRECAUTION FOR CHROMAGEN LENSES
Special precaution for ChromaGen practitioners regarding the possible alterations in spatial perception.
Patients using the darker shades of tint in their ChromaGen lenses may experience some or all of the following:
- reduced low contrast acuity, -
- reduced illumination at night, -
- distortions in distance perception of moving objects or while driving, »
- distortions of apparent velocity. -
Thus, wearing these darker lenses may make driving difficult, especially at night, or under foggy, misty, or other adverse conditions.
INDICATIONS FOR USE STATEMENT
The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
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SUBSTANTIAL EQUIVALENCE TABLE
The following table summarizes Cantor & Silver Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.
| Characteristic | ChromaGen V2.0 | X-CHROM LENS(pre-amendment device) | Cantor & Silver5X Prosthetic | |
|---|---|---|---|---|
| 1.) | INDICATIONfor USE | The ChromaGen v2.0Haploscopic System & ColorDiscrimination EnhancementSoft Contact Lenses areindicated for daily wear toenhance color discrimination inpatients with protan or deutan(red-green) color visiondeficiencies. The lens may alsobe prescribed for the correctionof refractive ametropia (myopia,hyperopia and astigmatism) inaphakic and not aphakic personswith non-diseased eyes. Thelenses are disinfected using ahydrogen peroxide lens caresystem only and are available ina frequent replacement program. | Correction of color-blindness particularlyred-green color blindness.NOTE: Not regulated (pre-amendmentdevice) | The Cantor & Silver 5XProsthetic Tinted Soft ContactLenses are indicated for dailywear to enhance or alter theapparent eye color, includingocular masking, either in sightedor non-sighted eyes that require aprosthetic contact lens forcosmetic management ofconditions such as corneal, iris orlens abnormalities. The lensmay also be prescribed for thecorrection of refractive ametropia(myopia, hyperopia andastigmatism) in aphakic and notaphakic persons or for occlusivetherapy for conditions such asdiplopia, amblyopia or extremephotophobia. The lenses aredisinfected using a hydrogenperoxide lens care system onlyand are available in a frequentreplacement program. |
| 2.) | ProductionMethod | Lathe-Cut | Lathe-cut | Lathe-cut |
| 3.) | Contact LensMaterial | hydrophilic | PMMA | hydrophilic |
| 3.) | FDA ListedColor Additives | The reactive colored additivesconsist of reactive black 5,reactive blue 4, reactive blue 19,reactive 21, reactive blue 163,reactive yellow 15, reactiveyellow 86, reactive orange 78,reactive red 11 and reactive red180. | Not Available | The reactive colored additivesconsist of reactive black 5,reactive blue 4, reactive blue 19,reactive 21, reactive blue 163,reactive yellow 15, reactiveyellow 86, reactive orange 78,reactive red 11 and reactive red180. |
| 4.) | Color AdditiveCharacteristics | The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics arenot altered by the lens coloringprocess. | 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 arenot altered by the lens coloringprocess. |
| 5.) | Use andrestrictions | The color additives listed abovemay be used to color contactlenses in amounts not to exceedthe minimum reasonablyrequired to accomplish theintended prosthetic effect. | Not Available | The color additives listed abovemay be used to color contactlenses in amounts not to exceedthe minimum reasonablyrequired to accomplish theintended prosthetic effect. |
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2000
Mr. Martin Dalsing Consultant for Cantor & Silver Limited c/o Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K994320 Trade Name: The ChromaGeny20 Haploscopic System & Color Discrimination Enhancement Soft Lenses Regulatory Class: II Product Code: 86 NCZ Dated: August 21, 2000 Received: August 24, 2000
Dear Mr. Dalsing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Martin Dalsing
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noctication " THE I Dr I milling sification 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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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INDICATIONS FOR USE STATEMENT
Device Name:
ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens
INDICATIONS FOR USE:
The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-The lens may also be prescribed for the correction of refractive green) color vision deficiencies. green) color vision deliciences. - The tenism) in aphakic and not aphakic persons with non-diseased antenopia (nyopia, ifyoropa and mings.hudrogen peroxide lens care system only and are available in a frequent replacement program.
(PLEASE DO OT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heve Hilmanto
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K994370
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.