(77 days)
No
The device description focuses on physical coatings and filters on spectacle lenses, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The "Intended Use / Indications for Use" section states that the device is "Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism)," "Prescribed as a colored filter to aid individuals who experience reading discomfort," and "Prescribed to enhance color discrimination," all of which describe therapeutic interventions.
No
The device is described as prescription spectacles with special coatings to correct refractive ametropia, aid reading discomfort, and enhance color discrimination. It serves as a therapeutic or assistive device, not one for diagnosing medical conditions.
No
The device description explicitly states it is "prescription spectacles that have been precision coated with varying hue and saturation filters," indicating a physical hardware component (spectacle lenses with coatings).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device is described as "prescription spectacles that have been precision coated with varying hue and saturation filters." It is a physical device worn by the patient.
- Intended Use: The intended uses are for correcting refractive errors, aiding reading discomfort, and enhancing color discrimination. These are all related to visual perception and correction, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing performed on bodily fluids or tissues.
Therefore, the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses fall under the category of a medical device, specifically an ophthalmic device, rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NJH, HQG, NAI
Device Description
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5844 Prescription spectacle lens.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
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: | |
| Address | Cantor & Nissel Limited |
| 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 I |
| Regulation Number: | 886.5844 |
| Product Code: | NJH, HQG, NAI |
| Trade Name: | ChromaGen v3.0 Reading Aid & Color Discrimination |
| Enhancement Spectacle Lenses | |
| Reason for 510(k) submission: | Expanded Device classification to K994320 & K012132 |
| Classification Name: | Prescription Spectacle lens |
1
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.
2
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,
Spectacle Lenses (subject
device) | ChromaGen Reading Aid, Soft
Contact Lenses (predicate
device) | ChromaGen Color
Discrimination Enhancement,
Soft Contact Lenses (predicate
device) |
|-----|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INDICATION
for USE | The ChromaGen v1.0 Reading Aid & Color
Discrimination, Spectacle Lenses are
prescription spectacle lenses that are
indicated for the correction of refractive
ametropia (myopia, hyperopia and
astigmatism) in aphakic and not-aphakic
persons. The Chroma Gen V3.0 Reading Aid
spectacle 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 ChromaGen V3.0 Color
Discrimination Enhancement spectacle
lenses may also be prescribed to enhance
color discrimination in patients with protan
or deutan (red-green) color vision
deficiencies. | The ChromaGen v1.0 Reading Aid Soft
Contact Lenses are indicated for daily wear
as an aid for patients who experience visual
discomfort when reading. 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. These
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. | The ChromaGen v2.0 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 any
hydrogen peroxide lens care system or the
PuriLens system, and are available in a
frequent replacement program. |
| 2.) | Efficacy | Substantially Equivalent, Clinical
study (reference K994320 &
K012132) | Established, Clinical study
K012132 | Established, Clinical study
K994320 |
| 3.) | Device
Classification | Class I | Class II | Class II |
| 4.) | Device type | Spectacle Lens | Soft Contact Lens | Soft Contact Lens |
Table of Substantial Equivalence
3
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.
4
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 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
5
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)
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 | or | Over-The-Counter Use _____ | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)