Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only.

The Horizon 38 (polymacon) (polymacon), Horizon 38 (polymacon) Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) in aphakic or not-aphakic persons with nondiseased eyes.

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat o chemical disinfecting system.

Device Description

The soft contact lenses that are manufactured from W-55 and W-38 lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eves.

Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 55 (methafilcon A) Contact Lens and Horizon 38 (polymacon) contact lens. The tinting process alters or changes the lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors.

The Horizon Enhanced lenses are available in shades of the following: blue, green, brown and aqua.

Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.

AI/ML Overview

The provided document describes a 510(k) submission for various contact lenses. It does not contain a study comparing the device's performance against acceptance criteria in the manner expected for diagnostic or AI-driven medical devices. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared contact lenses and addresses the safety and effectiveness of adding color enhancement to the existing lens designs.

Therefore, many of the questions regarding acceptance criteria, study design, expert involvement, and statistical measures cannot be answered from the provided text, as these types of studies were not presented for this submission. The submission is primarily focused on safety and technological characteristics, especially for the new color-enhanced versions, and references prior 510(k) clearances for the core lens designs.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit table of acceptance criteria and device performance is provided in the document in the context of a comparative clinical study for efficacy. The "performance" described relates to the safety and physical characteristics of the lenses.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
No identifiable evidence of tint pigment leaching.	Showed no identifiable evidence.
No evidence of cellular toxicity.	Test results showed no evidence.
No evidence of systemic toxicity.	Test results showed no evidence.
No evidence of ocular irritation.	Test results showed no evidence.
Physical/Optical Characteristics remain same.	Remains the same as clear version.
No changes to validated microbiology process.	No changes.
Spectra measurement remains same after cleaning/disinfecting cycles.	Remained the same.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The studies mentioned (leachability, toxicology, microbiology, compatibility) are laboratory tests, not clinical performance tests with a "test set" of patient data in the typical sense.
Data Provenance: Not specified. These are laboratory studies.
Retrospective or Prospective: These appear to be laboratory studies conducted specifically for this submission, implying they are prospective for the aspects tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission doesn't involve establishing ground truth from expert assessments of images or patient outcomes for a diagnostic device. The "ground truth" for the tests performed would be the results of the laboratory assays themselves and comparisons to established safety thresholds.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication method described as this is not a study involving expert readers or interpretation of results that would require adjudication.

5. 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

Not applicable. This is a contact lens submission, not an AI-driven diagnostic device. No MRMC study was conducted.

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

Not applicable. This is a contact lens submission, not an AI-driven diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the studies performed would be:

Leachability: Chemical analysis results (absence of tint pigment in leachate).
Toxicology: In vitro (cytotoxicity) and in vivo (systemic toxicity, ocular irritation) laboratory assay results compared to control or safety thresholds.
Microbiology/Compatibility: Laboratory measurements comparing pre- and post-processing characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The submission demonstrates the safety and effectiveness of the color-enhanced versions of the contact lenses by showing they are substantially equivalent to their clear counterparts (K992010 and K963837) and do not raise new questions of safety or effectiveness. The core lenses themselves are already FDA-approved.

The studies performed for the color-enhanced lenses, as described in the "Summary of Safety and Effectiveness 6.0" and "7.0 Technical Summaries" sections, include:

Leachability Studies: Showed "no identifiable evidence of tint pigment leaching." This addresses a critical safety concern for color additives in contact with the eye.
Toxicology Studies: Included cytotoxicity, systemic toxicity, and ocular irritation studies. Results showed "no evidence of cellular or systemic toxicity, or ocular irritation." This confirms the biological safety of the materials, including the color additives.
Physical/Optical Characteristics Review: Concluded that the "color-enhanced version remains the same as the clear version." This indicates no significant alteration to the lens's fundamental optical properties or fit due to the color.
Microbiology Review: Stated that "There will be no changes to the validated process in 510(k) K954524," implying the sterilization and manufacturing processes for the color-enhanced lenses are consistent with previously validated methods, maintaining sterility.
Compatibility Studies: Indicated that "The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement." This demonstrates that the color-enhanced lenses hold up to standard care routines without degradation.
Shelf-life Study: Was started and would be completed later, based on relevant guidance documents. This is an ongoing study to confirm the stability of the lenses over time.

Conclusion: The submission relies on these laboratory and characteristic studies to support the claim that adding color enhancement does not negatively impact the safety and effectiveness established for the predicate clear lenses. The FDA's final decision letter (K031774) confirms that the device is "substantially equivalent" for the stated indications based on this presented data.

Summary

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Traditional 510(k)-Submission

K 03174

1.0 Name and address of submitter	Westcon Contact Lens Company, Inc.611 Eisenhauer StreetGrand Junction, CO. 81503
Contact Person	Carol Noble970-245-3845
Fax	970-245-4516
Date Prepared	1/23/04

8.0 Summary of Safety and Effectiveness#### 2.0 Name of Device

Trade Name: �

Horizon 55 (methafilcon A), Horizon 55 (methafficon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric.

Horizon 38 (polymacon), Horizon 38 (polymacon) Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

Common Name: Daily Wear Soft Contact Lens �
Generic (USAN) Name: Methafilcon A � Polymacon
Classification Name: Soft Hydrophilic Contact Lens �

3.0 Indications

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only.

{1}------------------------------------------------

Summary of Safety and Effectiveness 8.0

4.0 Device Description

The Horizon Enhanced lenses are available in shades of the following: blue, green, brown and aqua.

5.0 Substantially Equivalent To:

Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K992010 and 510(k) K963837.

Summary of Safety and Effectiveness 6.0

The Horizon lenses were subjected to leachability studies and showed no identifiable evidence of tint pigment leaching.

7.0 Technical Summaries

7.1 Toxicology:
Cytotoxicity, systemic toxicity and ocular irritation studies were. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.

{2}------------------------------------------------

Summary of Safety and Effectiveness 8.0

7.2 Physical/Optical Characteristics

The color-enhanced version remains the same as the clear version 510(k) K992010 and 510(k) K963837.

7.3 Microbiology
There will be no changes to the validated process in 510(k) K954524
7.4 Compatibility
The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement.
The shelf life study has been started on color-enhanced lenses and will be 7.5 completed later this year. The procedure is based on the guidance documents Shelf Life of Medical Devices-April 1991 and Premarket Notification Guidance Document for Daily Wear Contact Lenses-May 1994.
The packaging remains the same as 510(k) K954524 and 510(k) K963837.

8.0 Conclusion

In conclusion, it is Westcon's conviction that the data submitted shows that by adding the color-enhancement tint to the surface of the contact lens does not raise different questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three horizontal lines above it, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2, 0 2004

Westcon Contact Lens Company, Inc. c/o Carol Noble 611 Eisenhauer Street Grand Junction, CO 81505

K031774 Re:

K031774
Trade/Device Name: Horizon 55 (methafilcon A) and Horizon 55 Westint Spherical, Soft Toric, Bi-con (toric), Progressive (toric), Horizon 38 (polymacon), Toric, Bi-con (toric), Frogressive (2006), and Westhin 38 Soft Toric Westint Contact Lenses

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 20, 2004 Received: January 21, 2004

Dear Ms. Noble:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premantially equivalent (for the indications
referenced above and have determined the device is subserverketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally inanced peofical Device Amendments, or to
commerce prior to May 28, 1976, the chactment date of the Federal Food. Drug. commerce prior to May 28, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance whil as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assessions of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general conversions of the Act. T You may, therefore, market the uevice, subject to annual registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act morade requirembitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to such additional controls. Existing major regalato 899. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of I ederal Regardine, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issuales of a subscuration with other requirements of the Act
that FDA has made a determination that your device of onemage - Your must that FDA has made a decemination that your areas over Federal agencies. You must or any Federal statules and regulations adminited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the (21 CFR Part 807); labeling (21 CFR Pair 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and 11 CFR 1000 (10 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Carol Noble

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 halph 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

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT 5.0

Device Name:

Horizon 55 (methafilcon A) (spherical), Horizon 55 (methafilcon A) soft Toric, Horizon Horizon 55 (methafilcon A) (Splericas), riorizon 55 (x) Bi-con Torizon 55 (methafilcon A) Bi-con, Horizon 3.5 (inchianton 55 (methaticon A) Westint (spherical),
Progressive, Horizon Progressive Toric, Horizon 55 (methafilon, A) Westint Bi-Progressive, Horizon Progressive Toric, Horizon 55 (methafileon A) Westint Bi-Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A)
con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon wa Torie con, Horizon 35 (methafileon A) Wostint Brook Schrist
Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric

Horizon 38 (polymacon), Horizon 38 (polymacon), Westint (polymacon),
1988), e de la mark (polymacon), and explos Westing (polymacon), Horizon 38 (polymacon) (polymacon), Horizon 30 (polymator)
Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

Indication of Use:

ion of Use:
Horizon 55 (methafilcon A), Horizon 55 (methafileon A) Provinsiya Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A), Horizon (nethan (nethafiloon A) Progressive, Horizon (nethafileon A)
Horizon 55 (methafilcon A) Bi-con Toric, Horizon (netharinol), Horizon (neth Horizon 55 (methafilcon A) Blecon 10ffc, Horizon (inchination A) Hosint St (methafileon A) Westint
Progressive Toric, Horizon 55 (methatilcon A) Westint (spierical), Horizon Progressive Torizon 55 (methafilcon A) Westint Di-con, Horizon 55 (methafilcon A) Westint Bi-con Toric,
soft Toric, Horizon 55 (methafilcon A) Westint Di-con, Horizon 55 (met soft Toric, Horizon 55 (methanicon A) Westin, Horizon So (Methafile, Mestint Progressive Toric are
Horizon (methafilcon A) Westint Progressive, Horizon (methafileon Averopic, Horizon (methafilcon A) Westint Progressive, Frontzon (memained). Ay wordt reggion and the mand of the matism and
indicated for daily wear for the correction of refractive an indicated for daily wear for the correctors with nondiseased eyes.
presbyopia) in aphakic or not-aphakic persons with more to aphance or a

presbyopia) in aphakic or not-aplakit persons with notabled of your alter the apparent eye color.
The color-enhanced version is indicated for daily wear to enhance or alter t The color-chianced versioned using chemical systems only.

The Horizon 38 (polymacon), Horizon 38 (polymacon), Westint (polymacon), Westhin 38 Soft Torio The Horizon 38 (polymacon), Horizon 38 (polymacon) are indicated for daily wear for the correction
(polymacon) and Westhin 38 Soft Toric Westtingstign in ankric nersons with (polymacon) and Westhin 38 Soft Toric Westfilt (porymation) in aphakic or not-aphakic persons with nondiseased eyes.

nondiseased eyes.
The color-enhanced version is indicated for daily wear to enter the apparent eye color. The apparent The color-enhanced version is indicated for ually wear to child in upplied by the problems.
color-chhanced lenses can be chemically disinfected only. The clear lenses may be or chemical disinfecting system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use

signature

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

510(k) Number K031774

Page 11 of 115

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.