Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Toric, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, 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 eve color.

The lenses may be disinfected using chemical systems only.

Device Description

The soft contact lenses that are manufactured from Hioxifilcon A 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 eyes.

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 59 Oasis (hioxifilcon A) 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 irris. 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 59 Oasis (hioxifilcon A) 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

This document is a 510(k) premarket notification for a contact lens, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence of the "Horizon 59 Oasis (hioxifilcon A)" contact lens to a previously approved device. The "studies" mentioned are related to the physical, optical, and biological safety of the contact lens material and design, not the performance of an AI/ML algorithm.

Here's a breakdown of why each requested point is not applicable:

A table of acceptance criteria and the reported device performance: Not applicable. This device is a contact lens, not an AI/ML device with performance metrics like sensitivity, specificity, etc. The document assesses physical characteristics (light transmittance, expansion) and safety (leachability, toxicity).
Sample size used for the test set and the data provenance: Not applicable. No test set for an algorithm is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm. The safety and equivalence are determined through laboratory testing and comparison to a predicate device.
Adjudication method: Not applicable. No expert adjudication is described in the context of an AI/ML device.
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 not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a contact lens, not an algorithm.
The type of ground truth used: Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The 'truth' for a contact lens involves meeting material specifications, biological safety standards, and functional requirements.
The sample size for the training set: Not applicable. There is no AI/ML model to train.
How the ground truth for the training set was established: Not applicable. No training set or ground truth for an algorithm is discussed.

Instead, the document describes the following for the contact lens:

Acceptance Criteria/Performance Parameters (Implied):
- Leachability: No identifiable evidence of tint pigment leaching.
- Toxicology: No evidence of cellular or systemic toxicity, or ocular irritation (cytotoxicity, systemic toxicity, ocular irritation studies conducted).
- Physical/Optical Characteristics: Equivalent to predicate device (K031774) in light transmittance, linear expansion, and radial expansion.
- Microbiology: No changes to validated process in 510(k) K954524.
- Compatibility: Spectra measurement after cleaning/disinfecting cycles remained the same as before.
- Shelf Life: Study started and to be completed in 2005.
Study That Proves the Device Meets the Criteria:
- Leachability studies were conducted.
- Cytotoxicity, systemic toxicity, and ocular irritation studies were conducted.
- Light transmittance, linear expansion, and radial expansion studies were conducted, and data was compared to the predicate device K031774.
- Compatibility studies were conducted (spectra measurement after cleaning/disinfecting cycles).
- Shelf life study initiated.

The primary method to "prove" the device meets acceptance criteria in this 510(k) is by demonstrating substantial equivalence to an existing FDA-approved predicate device (Westcon's own K031774 for the clear lens, and K954524 for manufacturing process and packaging). The studies mentioned above support this claim of equivalence and safety.

Summary

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K043540

Traditional 510(k)-Submission

8.0 Summary of Safety and Effectiveness

Westcon Contact Lens Company, Inc. Name and 611 Eisenhauer Street address of submitter Grand Junction, CO. 81503

Contact Person Carol Noble 970-245-3845 970-245-4516 Fax

Date Prepared 12/20/04

2.0 Name of Device

1.0

� Trade Name: Horizon 59 Oasis (hioxifilcon A)
Common Name: Daily Wear Soft Contact Lens �
Generic (USAN) Name: Hioxifilcon A �
Classification Name: Soft Hydrophilic Contact Lens �

3.0 Indications

Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Toric, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Toric are indicated for daily wear for the correction of refractive amettropia (myopia, hyperopic, 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 eve color.

The lenses may be disinfected using chemical systems only.

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Summary of Safety and Effectiveness 8.0

Device Description 4.0

The Horizon 59 Oasis (hioxifilcon A) lenses are available in shades of the following: blue, green, brown and aqua.

Substantially Equivalent To: 5.0

Westcon will be claiming equivalency to our own that is currently FDA approved in 510(k) K031774.

Summary of Safety and Effectiveness 6.0

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

Technical Summaries 7.0

7.1 Toxicology:

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

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Summary of Safety and Effectiveness 8.0

Physical/Optical Characteristics 7.2
Light transmittance, linear expansion and radial expansion were determined. A comparison of data from these studies showed that the Horizon 59 Oasis (hioxifilcon A) is equivalent in physical and optical characteristics as 510(k) K031774.
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 in 2005 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.

Conclusion 8.0

In conclusion, it is Westcon's conviction that the data submitted shows the Horizon 59 Oasis (hioxifilcon A) contact lens does not raise different questions of safety and effectiveness.

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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 consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2005

Westcon Contact Lens Co., Inc. c/o Ms. Carol Noble 611 Eisenhauer St. Grand Junction, CO 81505

Re: K043540

K043540
Trade/Device Name: Horizon 59 Oasis (Hioxifilcon A) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Daily Wear Soft Contact Lens Regulatory Class: Class II Product Code: LPL Dated: December 20, 2004 Received: December 22, 2004

Dear Ms. Noble:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 91007 personalially equivalent (for the indications for referenced above and nave decemined are est a vices marketed in interstate connection use stated in the encrosure/ to regally mail. of the Medical Device Amendments, or to devices that prior in May 26, 1770, the endemon and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with are market approval application (PMA). You may. Act (Act) that do not require approval of a preneral controls provisions of the Act. The general therefore, market the device, subject to the generals for annual registration, listing of devices, good controls provisions of the neving and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (see ao roy into existing major regulations affecting your device can be Illia be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Cours ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat 1 DX 3 isoualise of addition of the requirements of the Act or that FDA nade a decemination administered by other Federal agencies. You music comply with ally roderal statutes and regulations but not limited to: registration and listing - (21 CFR Part an the Act 3 requirements, meriding, e...
807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the 807), labeling (21 OF R Part 820); goods and if applicable, the electronic product quality Systems (QB) issons (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. 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,

Ahalgi 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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INDICATIONS FOR USE STATEMENT 5.0

Device Name:

Indication of Use:

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eve color.

The lenses may be disinfected using chemical systems only.

(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 _________________________________________________________________________________________________________________________________________________________

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

510(k) Number K043540

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.