K Number

Device Name

WESTCON HORIZON 49% (HIOXIFILCON B)

Manufacturer

WESTCON CONTACT LENS CO.

Date Cleared

2008-04-22

(42 days)

Product Code

LPL

Regulation Number

886.5925

Intended Use

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 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). 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K043540, K964528

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard soft contact lens and its material properties. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia), which is a corrective function and not a treatment or therapy for a disease.

Diagnostic

Explanation: The device is described as a soft contact lens intended for the correction of refractive ametropia. It acts as a refracting medium to focus light rays on the retina and does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly describes a physical contact lens made from a specific material (hioxifilcon B) and manufactured through a lathe-cutting process. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the Horizon™ 49 contact lenses are designed to be placed on the corneal surface of the eye to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia). They act as a refracting medium to focus light on the retina.
No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient.

Therefore, the Horizon™ 49 contact lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 not-aphakic persons with non-diseased eyes.

The lenses may be disinfected using chemical systems only.

Product codes (comma separated list FDA assigned to the subject device)

LPL

Device Description

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)].

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eye / corneal surface of the eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K043540, K964528

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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 Street
Grand Junction, CO 81505 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Preparer &
Contact Person: | Kevin Randall
GlobalReg™ Compliance Associates, Inc
581 Whiles Court
Erie, CO 80516-7225
Phone: 303-828-0844
Fax: 303-828-0835
Email:kevin@globalregcompliance.com
www.globalregcompliance.com |
| Date Summary
Prepared: | 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) Spherical
and Toric Soft (Hydrophilic) Contact
Lenses for Daily Wear in Clear and
with a Blue Visibility Tint
(K964528)

Device Description & Technological Characteristics IV.

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.

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:

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.

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.

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

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