Horizon™ 49 (hioxifilcon B) Spherical, Horizon™ 49 (hioxifilcon B) Toric, Horizon™ 49 (hioxifilcon B) Bi-con, Horizon™ 49 (hioxifileon B) Bi-con Toric, Horizon™ 49 (hioxifilcon B) Progressive, Horizon™ 49 (hioxifilcon B) Progressive Toric for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes.

The lenses may be disinfected using chemical systems only.

Device Description

The Westcon Horizon™ 49 (hioxifilcon B) soft contact lenses for daily wear that are manufactured from hioxifilcon B 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 and notaphakic persons with non-diseased eyes.

The Westcon Horizon™ 49 (hioxifilcon B) is a lathe-cut soft lens. In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. In the hydrated state, the Westcon Horizon™ 49 (hioxifilcon B), when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

The progressive optics in the Horizon™ 49 progressive designs utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.

AI/ML Overview

Here's an analysis of the provided information, describing the acceptance criteria and the study used to demonstrate compliance for the Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens for Daily Wear.

Acceptance Criteria and Device Performance for Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens

Based on the provided K080686 510(k) Summary, the device demonstrates substantial equivalence to "Horizon™59 (hioxifilcon A)" (K043540) and "Benz-G 3X (hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear in Clear and with a Blue Visibility Tint" (K964528).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on the physical properties of the lens material (hioxifilcon B), which are intrinsic to the device's design and manufacturing rather than directly reported "performance" in a clinical study sense beyond basic material specifications. The acceptance criteria here are implicitly those that define the material characteristics to ensure safety and effectiveness, similar to the predicate devices.

Acceptance Criteria (Implicit from Material Specifications)	Reported Device Performance (Westcon Horizon™ 49)
Refractive Index (Hydrated)	1.425
Light Transmission (Clear)	Greater than 95% T
Light Transmission (Tinted)	Greater than 95% T
Water Content	48 %
Specific Gravity (Hydrated)	1.136
Oxygen Permeability ($D_k$)	$15 X 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg @35°C), (revised Fatt method)
Lens Material Composition	52% hioxifilcon B, 48% water (by weight)
Co-polymer components	2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (GMA)
Color additive (if tinted)	Phthalocyanato (2) - (copper) (legally marketed)

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

The 510(k) summary does not describe a specific clinical "test set" or a prospective clinical study directly conducted for the Westcon Horizon™ 49 device to establish its performance. Instead, it relies on the concept of substantial equivalence to predicate devices.

The key statement is under "VI. Pre-Clinical Performance Data":
"Pre-clinical performance data can be referenced for hioxifilcon B in Benz Research and Development's 510(k) K964528."

This indicates that the performance and safety of the hioxifilcon B material have been previously established through studies submitted for the predicate device K964528. Therefore, the "test set" for the material characteristics would be from the studies referenced in K964528. The current submission (K080686) does not provide details on the sample size or provenance of that prior data.

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

Given that this 510(k) relies on substantial equivalence and references pre-clinical data from a predicate device (K964528) for the material, there is no mention of experts establishing a ground truth for a test set in the context of the K080686 submission itself. The data for material characteristics (e.g., refractive index, water content) are typically derived from laboratory measurements and standardized testing, not expert consensus on clinical outcomes in this specific submission's context.

4. Adjudication Method for the Test Set

As no specific "test set" for evaluating performance in a clinical trial is described for this 510(k) (K080686), there is no adjudication method explicitly stated. The process relies on comparing the device's design, materials, and intended use to those of legally marketed predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for the Westcon Horizon™ 49 device as described in this 510(k) summary. These types of studies are typically for devices that aid human readers in interpretation (e.g., AI for medical imaging), which is not relevant for a soft contact lens.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done or is not applicable to a soft contact lens, which is a physical medical device rather than an algorithm or software.

7. The Type of Ground Truth Used

For the material properties listed, the "ground truth" would be established through laboratory measurements and standardized analytical testing (e.g., measuring refractive index, water content, oxygen permeability as per established industry and regulatory methods).

For the overall safety and effectiveness assertion, the "ground truth" relies on the established safety and effectiveness of the predicate devices (K043540 and K964528), specifically the hioxifilcon B material, as proven in their own submissions.

8. The Sample Size for the Training Set

There is no mention of a "training set" in this 510(k) submission. This term typically applies to machine learning or AI-based devices. For a physical medical device like a contact lens, the development process involves material formulation, manufacturing, and testing, not a "training set" in the computational sense.

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

As there is no "training set" mentioned, this question is not applicable.

Summary

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K080686

APR 2 2 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens for Daily Wear

510(k) Summary Page 1 of 3

I. Submitter Information

510(k) Owner:	Westcon Contact Lens Company.611 Eisenhauer StreetGrand Junction, CO 81505
510(k) Preparer &Contact Person:	Kevin RandallGlobalReg™ Compliance Associates, Inc581 Whiles CourtErie, CO 80516-7225Phone: 303-828-0844Fax: 303-828-0835Email:kevin@globalregcompliance.com www.globalregcompliance.com
Date SummaryPrepared:	February 29, 2008

II. Name of Device

Trade Name: Westcon Horizon™ 49 (hioxifilcon B) *
キ Common Name: Daily Wear Soft Contact Lens
- Classification Name: Lenses, Soft Contact, Daily Wear
- USAN (generic name): (hioxifilcon B)

Predicate Devices III.

Subject Device	Predicate Device(s)
Westcon Horizon™ 49 (hioxifilcon B)	Horizon™59 (hioxifilcon A)(K043540)Benz-G 3X (hioxifilcon B) Sphericaland Toric Soft (Hydrophilic) ContactLenses for Daily Wear in Clear andwith a Blue Visibility Tint(K964528)

Device Description & Technological Characteristics IV.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens for Daily Wear

510(k) Summary Page 2 of 3

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 and notaphakic persons with non-diseased eyes.

The non-ionic lens material, hioxifilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The Westcon Horizon™ 49 (hioxifilcon B) is made out of hioxifilcon B and is available in clear and with a blue visibility-handling tint, phthalocyanato (2) -(copper). This is a legally marketed color additive for which FDA has previously reviewed the toxicology/biocompatibility profile [see the Toxicology / Biocompatibility section of this submission for further data regarding phthalocyanato (2) - (copper)].

Horizon™ 49 (hioxifilcon B) Spherical, Horizon™ 49 (hioxifilcon B) Toric, Horizon™ 49 (hioxifilcon B) Bi-con, Horizon™ 49 (hioxifilcon B) Bi-con Toric, Horizon™ 49 (hioxifilcon B) Progressive, Horizon™ 49 (hioxifilcon B) Progressive Toric for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and notaphakic persons with non-diseased eyes.

Refractive Index	1.425 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	48 %
Specific Gravity	1.136 (hydrated)
Oxygen Permeability	$15 X 10^{-11}$ (cm2/sec) (ml O2/ml x mm Hg@35°C), (revised Fatt method).

The physical properties of the hioxifileon B lens are:

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Westcon Horizon™ 49 (hioxifilcon B) Soft Contact Lens for Daily Wear

510(k) Summary Page 3 of 3

V. Intended Use

The lenses may be disinfected using chemical systems only.

VI. Pre-Clinical Performance Data

Pre-clinical performance data can be referenced for hioxifilcon B in Benz Research and Development's 510(k) K964528.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 22 2008

Westcon Contact Lens Company c/o Kevin Randall GlobalReg™ Compliance Associates, Inc. 581 Whiles Court Erie, CO 80516-7225

Re: K080686

Trade/Device Name: Westcon Horizon™ 49 (hioxifilcon B) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 31, 2008 Received: March 11, 2008

Dear Mr. Randall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to 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 (OS) 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 - Kevin Randall

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Egleston, und

Malvina B. Eydelman, M. 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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Page of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Westcon Horizon™ 49 (hioxifilcon B)

Indications For Use:

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)

(Division Sign-Off)	Division of Ophthalmic Ear,Nose and Throat Devises
510(k) Number	K080686
Prescription Use	X
OR
Over-The-Counter Use

(Optional Format 1-2-96)

A-2

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.