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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance criteria for a novel device. Therefore, the "acceptance criteria" discussed are primarily about meeting the safety and effectiveness standards implied by the predicate devices and general regulatory requirements for contact lenses.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Safety & Biocompatibility	- Dye Leachability: Lenses demonstrated "not susceptible to the migration of color from the lenses."- Toxicology Testing: Passed Acute Eye Irritation, Cytotoxicity, and Systemic Toxicity tests, demonstrating they are "non-toxic."
Structural Integrity (Pigment Incorporation)	- Interface Bonding: Tests "verified the integrity of the interface bonding of the sandwich-configuration of the lenses."- Surface Smoothness: Due to pigment incorporation method, "the internal and external lens surface remains smooth." (Implied safety - no irritation from pigment contact)
Substantial Equivalence to Predicate Devices (Key Properties)	- Material: Polymacon, nonionic polymer, 38% water content (matches Aspect Vision Natural Touch).- Light Transmission: > 95% (Comparable to predicate devices: Natural Touch > 97%, Ciba Vision Illusions 75.6 to 98%).- Dk (Oxygen Permeability): 9 (Comparable to predicate devices: Natural Touch 8 x 10⁻¹¹, Ciba Vision Illusions 9).- Refractive Index: 1.43 (hydrated) (Comparable to predicate devices: Natural Touch 1.44, Ciba Vision Illusions 1.43).- Powers: +20 to -20 (Broader range than some predicates, but within general contact lens capabilities).
Intended Use Compatibility	- Indicated for daily wear, ocular masking, correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons, and occlusive therapy. (Supported by material safety and comparison to predicates with similar uses).
Disinfection Compatibility	- May be disinfected using chemical disinfection systems. (Implied capability based on material and comparison to predicates).

Study Details

The document describes performance testing rather than a full "study" in the sense of a clinical trial with a defined test set and ground truth established by experts.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests (dye leachability, toxicology, interface bonding). The document refers to "tests were conducted," implying a sufficient number of samples were used to generate reliable results for these specific engineering/material property evaluations.
- Data Provenance: Not explicitly stated. Given it's a submission by Contact Color Srl in Italy, the testing was likely conducted in Europe or at laboratories contracted by the manufacturer. It is retrospective data, meaning it was collected prior to this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to the performance testing described. The tests are material property and safety evaluations (e.g., chemical leachability, cytotoxicity assays), not diagnostic or clinical accuracy studies that would require expert human interpretation for ground truth. The "ground truth" for these tests would be objective scientific measurements against established laboratory standards or protocols.
Adjudication method for the test set:
- Not applicable. As explained above, these are objective laboratory tests, not subjective interpretations requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an AI-powered diagnostic or assistive technology. Such a study would be irrelevant to its intended use and regulatory pathway.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (contact lens), not an algorithm.
The type of ground truth used:
- For the described performance tests (dye leachability, toxicology, interface bonding), the "ground truth" is based on objective laboratory measurements and validated scientific protocols for material safety and integrity, as well as adherence to recognized standards for biocompatibility testing. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for these specific tests.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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K0//893

DEC 0 6 2001

510(k) Summary as required by 21 CFR 807.92(c)

1. Submitted by:	Mr. Paolo CocianiContact Color SrlVia Ludovico di Monreale, 3600152 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.

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

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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 VisionNatural Touch(polymacon) Soft(hydrophilic)Contact Lens	Ciba VisionIllusions (tefilcon)Soft (hydrophilic)Contact Lenses
Indications for use	Daily wear in aphakic and notaphakic persons	Daily wear in notaphakic persons	Daily wear in notaphakic 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 uponover-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, titaniumdioxide, and iron oxides	Chromium-cobalt-aluminum oxide.titanium oxide andiron oxides	Opaque pigmentsare titanium dioxide,carmine, mica
Tint process	Incorporation of color, appliedby hand, between polymerlayers using FDA-cleared lensblanks; no over-tinting	Two stage print padprinting, pre-lensforming	Incorporation ofcolor betweenpolymer layers; thenlenses are"over-tinted"

CONTACT COLOR Srl

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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.

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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.

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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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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)

Over-The-Counter Use

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.