CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS

K022373 · Cantor & Nissel , Ltd. · NJH · Oct 7, 2002 · Ophthalmic

Device Facts

• Record ID: K022373
• Device Name: CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
• Applicant: Cantor & Nissel , Ltd.
• Product Code: NJH · Ophthalmic
• Decision Date: Oct 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5844
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

Device Story

ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lenses are prescription spectacle lenses featuring precision-applied hue and saturation filter coatings. Designed for binocular use, these lenses function as colored filters to mitigate reading discomfort and improve color discrimination for patients with red-green color vision deficiencies. The coating process is applied to standard prescription lenses without altering their optical or performance characteristics. The device is used in a clinical or optical setting, prescribed by eye care professionals to address specific visual symptoms. By filtering light through specific hues, the lenses aim to enhance visual comfort and color perception, providing a non-invasive alternative to contact lens-based versions of the same technology.

Clinical Evidence

No new clinical data provided. Efficacy established via reference to clinical studies conducted for predicate devices K994320 and K012132.

Technological Characteristics

Prescription spectacle lenses with precision-applied hue and saturation filter coatings. Designed for binocular use. Coating process does not alter optical performance of the base lens. Class I device.

Indications for Use

Indicated for aphakic and non-aphakic patients requiring refractive correction (myopia, hyperopia, astigmatism), individuals experiencing reading discomfort unrelated to binocular vision or refractive error, and patients with protan or deutan (red-green) color vision deficiencies.

Regulatory Classification

Identification

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

Predicate Devices

• ChromaGen v3.0 Reading Aid, Soft Contact Lenses (K012132)
• ChromaGen v20 Color Discrimination Enhancement, Soft Contact Lenses (K994320)

Submission Summary (Full Text)

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# 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.

KO22373 The assigned 510(k) number is:

# Applicant information:

| Date Prepared: | June 27, 2002 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name:<br>Address | Cantor & Nissel Limited<br>Market Place<br>Brackley Northants<br>England NN13 7DP |
| Contact Person: | Mr. David Cantor<br>Managing Director |
| USA Consultant: | Martin Dalsing,<br>Medvice Consulting, Inc.<br>Consultant and US Agent for Cantor & Nissel, Ltd.<br>623 Glacier Drive<br>Grand Junction, CO 81503<br>[phone]<br>Fax #: [phone] E-mail: [e-mail] |
| Device Information: | |
| Device Classification: | Class I |
| Regulation Number: | 886.5844 |
| Product Code: | NJH, HQG, NAI |
| Trade Name: | ChromaGen v3.0 Reading Aid & Color Discrimination<br>Enhancement Spectacle Lenses |
| Reason for 510(k) submission: | Expanded Device classification to K994320 & K012132 |
| Classification Name: | Prescription Spectacle lens |

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# Substantially Equivalent Device:

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are substantially equivalent to the following legally marketed devices:

Cantor & Nissel "ChromaGen v3.0 Reading Aid, Soft Contact Lenses" A tinted contact lens Re: K012132

Cantor & Nissel "ChromaGen v20 Color Discrimination Enhancement, Soft Contact Lenses" A tinted contact lens Re: K994320

### Device Descriptive Characteristics:

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

# INDICATIONS FOR USE:

Prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

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#### Summary Basis for Substantial equivalence

ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses to ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Contact Lenses:

ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacle lenses coated/tinted to the exact same spectacle light transmittance as the predicate device soft contact lens. Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132.

| | Characteristic | ChromaGen Reading Aid,<br>Spectacle Lenses (subject<br>device) | ChromaGen Reading Aid, Soft<br>Contact Lenses (predicate<br>device) | ChromaGen Color<br>Discrimination Enhancement,<br>Soft Contact Lenses (predicate<br>device) |
|-----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INDICATION<br>for USE | The ChromaGen v1.0 Reading Aid & Color<br>Discrimination, Spectacle Lenses are<br>prescription spectacle lenses that are<br>indicated for the correction of refractive<br>ametropia (myopia, hyperopia and<br>astigmatism) in aphakic and not-aphakic<br>persons. The Chroma Gen V3.0 Reading Aid<br>spectacle lenses may also be prescribed as a<br>colored filter to aid individuals who<br>experience reading discomfort not related to<br>binocular vision problems or uncorrected<br>refractive error. The ChromaGen V3.0 Color<br>Discrimination Enhancement spectacle<br>lenses may also be prescribed to enhance<br>color discrimination in patients with protan<br>or deutan (red-green) color vision<br>deficiencies. | The ChromaGen v1.0 Reading Aid Soft<br>Contact Lenses are indicated for daily wear<br>as an aid for patients who experience visual<br>discomfort when reading. The lens may also<br>be prescribed for the correction of refractive<br>ametropia (myopia, hyperopia and<br>astigmatism) in aphakic and not-aphakic<br>persons with non-diseased eyes. These<br>lenses may also be prescribed as a colored<br>filter to aid individuals who experience<br>reading discomfort not related to binocular<br>vision problems or uncorrected refractive<br>error. The lenses are disinfected using a<br>hydrogen peroxide lens care system only and<br>are available in a frequent replacement<br>program. | The ChromaGen v2.0 Color Discrimination<br>Enhancement Soft Contact Lenses are<br>indicated for daily wear to enhance color<br>discrimination in patients with protan or<br>deutan (red-green) color vision deficiencies.<br>The lens may also be prescribed for the<br>correction of refractive ametropia (myopia,<br>hyperopia and astigmatism) in aphakic and<br>not aphakic persons with non-diseased eyes.<br>The lenses are disinfected using any<br>hydrogen peroxide lens care system or the<br>PuriLens system, and are available in a<br>frequent replacement program. |
| 2.) | Efficacy | Substantially Equivalent, Clinical<br>study (reference K994320 &<br>K012132) | Established, Clinical study<br>K012132 | Established, Clinical study<br>K994320 |
| 3.) | Device<br>Classification | Class I | Class II | Class II |
| 4.) | Device type | Spectacle Lens | Soft Contact Lens | Soft Contact Lens |

#### Table of Substantial Equivalence

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD - 20850

OCT 07 2002

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

Re: K022373

> Trade Name: ChromaGen v3 . Reading Aid & Color Discrimination Enhancement Spectacle Lenses Classification Regulation Number: 886.5844 Regulation Name: Prescription Spectacle lens Regulatory Class: I Product Code: NJH, HQG, NAI Dated: June 27, 2002 Received: July 22, 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address littp://www.fda.gov/cdrlv/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 v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses

# INDICATIONS FOR USE:

Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) |
|-----------------------------|
| Division of Ophthalmic Ear, |
| Nose and Throat Devises |

| 510(k) Number | K022373 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div> <img alt="Check Mark" src="check_mark.png"/> </div> | or | Over-The-Counter Use _____ |
|----------------------|-----------------------------------------------------------|----|----------------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)