(171 days)
K001089, PMA #810005/S25
No
The description focuses on the material composition and manufacturing process of the contact lenses, with no mention of AI or ML technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the lenses may be used for "occlusive therapy for conditions such as diplopia or extreme photophobia," which is a therapeutic application. Additionally, it mentions correction of refractive ametropia.
No
The device, Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses, are indicated for enhancing or altering the apparent color of the eye, correction of refractive ametropia, or occlusive therapy. It does not provide any diagnostic functions.
No
The device description clearly states that the device is a physical contact lens made of polymacon, a hydrophilic polymer, with an opaque pigment incorporated. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Contact Color COSMETICA contact lenses are placed on the eye to alter its appearance, correct vision, or provide therapeutic occlusion. They do not perform any diagnostic tests on bodily samples.
- Intended Use: The intended use clearly states the purpose is to "enhance or alter the apparent color of the eye," "correct refractive ametropia," or for "occlusive therapy." These are not diagnostic purposes.
- Device Description: The description focuses on the material composition and manufacturing process of the lens itself, not on any diagnostic testing capabilities.
- Performance Studies: The performance studies mentioned are related to the safety and integrity of the lens material and construction (dye leachability, toxicology, bonding integrity), not to the accuracy of any diagnostic test.
Therefore, based on the provided information, the Contact Color COSMETICA contact lens is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.
Product codes
LPL
Device Description
Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are daily wear soft contact lenses for use in enhancing or altering the apparent color of the eye for prosthetic and theatrical use. The lenses used to produce Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are Benz 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear) supplied by Benz Research & Development of Sarasota, Florida. These lenses have received FDA premarket clearance (K961103). The Benz 38 lens material is polymacon, which in the hydrated state consists of 62% hydrophilic polymer of 2-hydroxyethylmethacrylate (2-HEMA) and 38% water. The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are made by incorporating by hand an opaque pigment in an iris pattern between two layers of the polymacon polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses were subjected to dye leachability testing and toxicology testing, including Acute Eye Irritation, Cytotoxicity, and Systemic Toxicity. The results of these tests demonstrated that the lenses are not susceptible to the migration of color from the lenses and that they are non-toxic. In addition, tests were conducted that verified the integrity of the interface bonding of the sandwich-configuration of the lenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001089, PMA #810005/S25
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K0//893
DEC 0 6 2001
510(k) Summary as required by 21 CFR 807.92(c)
| 1. Submitted by: | Mr. Paolo Cociani
Contact Color Srl
Via Ludovico di Monreale, 36
00152 Rome, Italy |
|-------------------------|---------------------------------------------------------------------------------------------|
| Telephone: | +39 06 581 6689 |
| Fax: | +39 06 583 31099 |
| Date Summary prepared: | 19 November 2001 |
| 2. Device Name: | |
|---|---|
| Common Name: | Contact lens |
| Proprietary Name: | Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses |
| Classification Name: | Lenses, soft contact, daily wear |
Predicate Devices: 3.
Natural Touch (polymacon) Soft (hydrophilic) Contact Lens 510(k) number: K001089 Aspect Vision Care Ltd. Unit 2, South Point Hamble SO3 4RF Southampton, United Kingdom
Ciba Vision Illusions (tefilcon) Soft (hydrophilic) Contact Lenses PMA #810005/S25 Ciba Vision 11460 Johns Creek Parkway Duluth, Georgia 30097, USA
Description of Device: 4.
Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are daily wear soft contact lenses for use in enhancing or altering the apparent color of the eye for prosthetic and theatrical use. The lenses used to produce Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are Benz 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear) supplied by Benz Research & Development of Sarasota, Florida. These lenses have received FDA premarket clearance (K961103). The Benz 38 lens material is polymacon, which in the hydrated state consists of 62% hydrophilic polymer of 2-hydroxyethylmethacrylate (2-HEMA) and 38% water. The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are made by incorporating by hand an opaque pigment in an iris pattern between two layers of the polymacon polymer.
Intended Use Statement: ર.
The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in
CONTACT COLOR Srl
Fage 1 of 3
1
sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.
Comparison with Predicate Devices: ર્ણ.
Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are substantially equivalent to the Aspect Vision Natural Touch (polymacon) Soft (hydrophilic) Contact Lens in that the hydrophilic material used is the same, which is 38% water content Polymacon, a nonionic polymer. They are also both daily wear contact lenses.
In contrast to the method of mixing the pigment with the polymer, which is used for the Natural Touch Soft Contact Lens, the color added to Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses is hand-painted on an inner lens surface and incorporated between two layers of polymacon polymer and therefore does not come into contact with the surface of the eye. This method of incorporating pigment between two polymer layers is similar to that described for the Ciba Vision Illusions contact lenses, which have received premarket approval from FDA.
Because of the incorporation of the pigment between two polymer layers, the internal and external lens surface remains smooth.
| Characteristic | Contact Color COSMETICA
(Polymacon) soft
(hydrophilic) contact lenses | Aspect Vision
Natural Touch
(polymacon) Soft
(hydrophilic)
Contact Lens | Ciba Vision
Illusions (tefilcon)
Soft (hydrophilic)
Contact Lenses |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for use | Daily wear in aphakic and not
aphakic persons | Daily wear in not
aphakic persons | Daily wear in not
aphakic persons |
| Material | Polymacon (Benz 38 lenses) | Polymacon | Tefilcon |
| Material type | Nonionic polymer | Nonionic polymer | Nonionic polymer |
| Water content | 38% | 38% | 37.5% |
| Light transmission | > 95% | > 97% | 75.6 to 98%.
depending upon
over-tint |
| Dk (35°C) | 9 | 8 x 1011 | 9 |
| Refractive index | 1.43 (hydrated) | 1.44 (hydrated) | 1.43 |
| Powers | +20 to -20 | +6.00 to -10.00 | +4 to -10 |
| Pigments | Ultramarine blue, titanium
dioxide, and iron oxides | Chromium-cobalt-
aluminum oxide.
titanium oxide and
iron oxides | Opaque pigments
are titanium dioxide,
carmine, mica |
| Tint process | Incorporation of color, applied
by hand, between polymer
layers using FDA-cleared lens
blanks; no over-tinting | Two stage print pad
printing, pre-lens
forming | Incorporation of
color between
polymer layers; then
lenses are
"over-tinted" |
CONTACT COLOR Srl
2
In consideration of the requirements of section 510(k) of the Federal Food Drug and Cosmetic Act, the Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are substantially equivalent in terms of their safety and effectiveness to the Natural Touch (polymacon) Soft (hydrophilic) Contact Lens and the Ciba Vision Illusions (tefikon) Soft (hydrophilic) Contact Lenses.
Performance Testing: 7.
Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses were subjected to dye leachability testing and toxicology testing, including Acute Eye Irritation, Cytotoxicity, and Systemic Toxicity. The results of these tests demonstrated that the lenses are not susceptible to the migration of color from the lenses and that they are non-toxic. In addition, tests were conducted that verified the integrity of the interface bonding of the sandwich-configuration of the lenses.
8. Conclusion:
Based on the analysis of the comparison in section 6 above and the performance evaluation results contained in section 7, Contact Color Srl has concluded that Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are safe, effective, and perform as well as the legally marketed devices identified in section 3 above.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with two intertwined snakes and a pair of wings at the top. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Mr. Paolo Cociani Managing Director Contact Color SrL Via L. di Monreale, 36 00152 Rome, Italy
Re: K011893
Roll Device Name: Contact Color COSMETICA (polymacon) Soft (hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 26, 2001 Received: October 29, 2001
Dear Mr. Cociani:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becaon 910(x) healthcantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Medical Doviet Federal Food, Drug, and Cosmetic Act (Act). The program therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the dovice, basyes to equirements for annual registration, listing of devices, controls provisions or the rice networks and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major regulations (Frenarket Approval), it may be sacyce to an a federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Madical 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 mispections, the Food and Dright may result in regulatory action. In addition, FDA may publish comply with the Griff Togalaten and June in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promanter nombouts of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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
5
510(k) Number: [not known]
Device Name: Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses
Indications for Use:
The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated The Collact Color COUND From (1 Corporent color of the eye, including ocular masking, for daily wear to clinance of ares that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may management of conditions outh as coof as refractive ametropia (myopia and hyperopia) in also be presertood for the eersons or for occlusive therapy for conditions such as diplopia, aphakit and not appliakte persons in The lens may be disinfected using chemical disinfection systems.
Concurrence of CDRH Office of Device Evaluation Division of Reproductive, Abdominal, ENT, and Radiological Devices
E.C.
(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use (Per 21CFR 801.109)
OR
Over-The-Counter Use