Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eve, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Leo Toric Colors (methafilcon A) 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 nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia an extreme photophobia.

When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.

When prescribed for Disposable Wear, the wearing time prescribed by the eve care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

Device Description

The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic lenses. The lens material, methafilcon A, is a random co-polymer of hydroxyethylmethacrylate and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. The lenses are made by modifying the uncolored methafilcon A base lens by affixing colorants on that portion of the front surface that corresponds to the iris. The colorants Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 are listed in 21 CFR Part 73.

AI/ML Overview

The provided 510(k) summary for the "Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses" explicitly states that clinical studies were not deemed necessary to establish the safety and efficacy of the device. This determination was based on the device's substantial equivalence to two predicate devices:

Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164 and K973063)
Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lens (K001090)

As a result, no specific acceptance criteria or performance numbers for the device itself are described in the context of a dedicated study. Instead, the focus is on demonstrating equivalence to already approved devices.

However, the document does describe preclinical testing to support safety.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was conducted for the subject device to establish specific performance metrics, there's no direct "acceptance criteria" table with performance numbers. Instead, the acceptance criteria were met by demonstrating equivalence in material, physical, optical, and chemical properties, and acceptable preclinical safety.

Aspect	Acceptance Criteria (Demonstrated Equivalence / Preclinical Safety)	Reported Device Performance
Material Equivalence	The material (methafilcon A, Group 4, high water ionic polymer) must be equivalent to predicate devices (Frequency 55 and Frequency Colors).	Material is Methafilcon A.
Physical/Optical Equivalence	Parameters like water content, light transmittance, Dk (oxygen permeability), index of refraction, and power ranges must be equivalent to predicate devices.	Water Content: 55%Light Transmittance: >90.0%Dk (35°): 15.04Index of Refraction: 1.41Powers: -20.00 to +20.00D
Chemical Equivalence	Colorants must be listed in 21 CFR Part 73 and have demonstrated non-leachability.	Colorants: Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 (all listed in 21 CFR Part 73).Leachability Study: Undetectable levels (<1ppm) of dye observed in extraction solution after two weeks at 37°C in saline.
Biocompatibility/Toxicity	Must be non-toxic, with no ocular irritation, cytotoxicity, or systemic toxicity.	Toxicology testing (Ocular Irritation, Cytotoxicity, Systemic Toxicity) demonstrated the lens is non-toxic.
Manufacturing Method	Acceptable manufacturing method (Molded or FIPS II)	Molded or FIPS II
Tint Process	Acceptable tint process (Ink jetting post lens forming)	Ink jetting post lens forming
Clinical Efficacy/Safety	Determination of substantial equivalence to predicate devices (Frequency 55 and Frequency Colors & Expressions), implying that no new safety or effectiveness questions are raised. Clinical studies not deemed necessary. No specific performance numbers are evaluated, as the safety and efficacy are inferred from the predicate devices plus demonstrated material and chemical safety of the colorants.	Not applicable - clinical studies were not performed for the subject device based on substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set was used for the subject device to establish efficacy/safety. Preclinical tests (toxicology, leachability) were performed.
Data Provenance: The preclinical data would have been generated at the manufacturer's facility or a contracted lab. The document does not specify country of origin for this data but states the submitter is CooperVision Manufacturing, Ltd. in the UK. The data type for preclinical tests is experimental/bench testing, not retrospective or prospective human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No clinical test set required expert ground truth establishment for the subject device.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No. No human-reader study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not applicable. This device is a contact lens, not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the preclinical safety assessment, the "ground truth" was established by laboratory measurements and scientific standards for biocompatibility (toxicity testing) and chemical stability (leachability study) as per applicable regulations and guidance documents for medical devices. For substantial equivalence, the "ground truth" is the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. No AI algorithm or clinical training dataset was used.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. No training set was used.

Summary

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Goper Vision P

Leo Colors Methafilcon A

510(k) Summary

Premarket Notification

Ko41138

1. SUBMITTER:

Submitted on Behalf of:

Company Name:
I Address:
I Phone:
Fax:

2. CONTACT PERSON:

Company Name:
E Address:
트 Phone:
트 Fax:

Bonnie Tsymbal

April 28, 2004

Unit 2. South Point

011 44 2380 605200 011 44 2380 605299

Hamble SO3 4RF Southampton UK

CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688

CooperVision Manufacturing, Ltd.

1. DATE SUMMARY PREPARED:

4. DEVICE IDENTIFICATION:

프 Trade Name:
Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lens
I Common Name: Hydrophilic Soft Contact Lens
I Classification
트 Device Classification:

Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)

5. DEVICE DESCRIPTION:

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Chemical Name	CI Number	CFR#
Titanium dioxide	77891	73.3126
Poly (hydroxyethyl methacrylate)-dyecopolymer	C.I. Reactive Blue 21	73.3121
Poly (hydroxyethyl methacrylate)-dyecopolymer	C.I. Reactive Red 180	73.3121
Poly (hydroxyethyl methacrylate)-dyecopolymer	C.I. Reactive Yellow 15	73.3121
Poly (hydroxyethyl methacrylate)-dyecopolymer	C.I. Reactive Black 5	73.3121

6. INTENDED USE

1. Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eve, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
1. Leo Toric Colors (methafilcon A) 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 nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia an extreme photophobia.

Frequent/Planned Replacement Wear

Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eve care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

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7. PREDICATE DEVICE:

The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear manufactured by Cooper\ision Manufacturing Ltd. Is equivalent to the Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164) and Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear (K001090)

As the methafilcon A base lens is produced at the same manufacturing facility as the Frequency 55, Frequency Colors and Expressions, the physical, optical and chemical properties are the same. They are all in Lens Group 4, high water ionic polymer as established by FDA and located in the May 1994 Guidance Document for Daily Wear Contact Lenses.

	Leo ColorsSubject Device	Frequency 55Predicate DeviceK971164	Frequency ColorsPredicate DeviceK001090
Material	Methafilcon A	Equivalent	Equivalent
MaterialClassification	Hydrophilic lens, Group 4	Equivalent	Equivalent
Indication for use	Daily WearMyopia, hyperopia andastigmatism	Daily WearMyopia and hyperopia	Daily WearMyopia, hyperopia andastigmatism
Water Content	55%	Equivalent	Equivalent
Light transmittance	>90.0%	Equivalent	Equivalent
Dk (35°)	15.04	Equivalent	Equivalent
Index of Refraction	1.41	Equivalent	Equivalent
Powers	-20.00 to +20.00D	Equivalent	Equivalent
Colorants	Titanium DioxideCI Reactive Blue 21CI Reactive Red 180CI Reactive Yellow 15CI Reactive Black 5.	CI Reactive Blue 4	Carbozale violetchromim oxide greendihydrodinaphto browndihydrodioxo yellowphthalocyanine greeniron oxide rediron oxide browniron oxide blackphthalocyanine blueand titanium dioxide
Tint Process	Ink jettingpost lens forming.	In-monomer tint	Pad printingpost lens forming
ManufacturingMethod	Molded or FIPS II	Molded	Molded or FIPS II

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PRECLINICAL INFORMATION 8.

The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.

A leachability study was conducted to assess the color fastness of the listed dyes used to tint the Leo Colors. Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. The study demonstrates that after two weeks of extraction at 37°C in saline, undetectable levels (<1ppm) of dye were observed in the extraction solution.

The physical, optical and chemical properties of the subject lens are equivalent to the predicate device.

ഗ CLINICAL DATA

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. This determination was based on the following:

. The Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses were demonstrated to be substantially equivalent to the predicate Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164) and (K973063)
. The Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses were demonstrated to be substantially equivalent to the predicate Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lens (K001090).

10. CONCLUSION

The information provided in this 510(k) established that the Leo Colors. Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses is equivalent in optical, chemical and physical properties of the predicate device and does not raise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Cooper Vision c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs 711 North Road Scottsville, NY 14546

Re: K041138

Trade/Device Name: Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL; MVN Dated: April 29, 2004 Received: May 3, 2004

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bated in the 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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Page 2 - Ms. Bonnie Tsymbal

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Levy 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

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for CooperVision. The logo is in black and white and features the company name in a stylized font. To the right of the name is a square with a circle inside.

Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688

Indication for Use Statement

Device Name:

Leo Colors (methafilcon A) Soft (hydrophilic) Contact Lenses Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses

Indication for Use:

Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses l. are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eves that require a prosthetic contact lens for the management of conditions such as 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 with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia. amblyopia or extreme photophobia.
Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to 2. enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal. iris or lens abnormalities. 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 eves. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia.

Frequent/Planned Replacement Wear

Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fis 6

510(k) Number K041138

Prescription Use
(Per 21 CFR 801.109) ✓

AND/OR

Over-The-Counter

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.