The Horizon 55 Westint and Horizon 55 (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia.

Device Description

W-55 (methafilcon A) clear or tinted lens blanks are a hydrophilic polymer of 2hydroxyethy methacrylate crossed linked with ethyleneglycol dimethacrylate. The lens consists of 45% methafilcon and 55% water by weight when immersed in buffered saline solution. When the lens blank is tinted blue, up to .8 % of the color additive Copper Phthalocyanine Blue Pigment will be added to the MA. The color additive conforms to 21 CFR Part 74.3045.

The soft contact lenses that are manufactured from W-55 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (multifocal). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated.

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 Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

AI/ML Overview

This document describes a 510(k) submission for a modification to an approved device, specifically adding a visibility tint to contact lens blanks and the resulting contact lenses. It is not an AI/ML device, so it doesn't contain information typically found in studies for AI/ML devices, such as sample sizes for test/training sets, expert ground truth, or MRMC studies. The "study" here refers to the testing conducted to ensure the safety and effectiveness of the tinted lenses compared to the already approved clear lenses.

Here's an analysis based on the provided text, focusing on the established safety and effectiveness of the modified device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate device K954524)	Reported Device Performance (for tinted lenses)	Study/Section
Safety:
No identifiable evidence of tint pigment leaching	No identifiable evidence of tint pigment leaching	6.0 Summary of Safety and Effectiveness
No cellular or systemic toxicity	No evidence of cellular or systemic toxicity	7.1 Toxicology
No ocular irritation	No evidence of ocular irritation	7.1 Toxicology
Biocompatibility (cytotoxicity, systemic toxicity, ocular irritation)	Passed (No evidence)	7.1 Toxicology
Effectiveness/Performance:
Light transmittance within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Refractive index within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Water content within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Linear expansion within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Radial expansion within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Tensile strength within limits	Equivalent to 510(k) K954524 (clear lenses)	7.2 Physical/Optical Characteristics
Manufacturing process validated	No changes to validated process in 510(k) K954524	7.3 Microbiology
Compatibility (e.g., lens durability over wear cycles)	Within normal limits after 30 cycles	7.4 Compatibility
Shelf life (with 10-year expiration)	Shelf life studies started for tinted lenses, will be completed later. No change to 10-year expiration for button.	7.5 Shelf Life

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

Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many tinted lenses were tested for each characteristic. It refers to "samples of tinted lenses" (e.g., in Toxicology and Physical/Optical Characteristics sections). For compatibility, it states "all lenses were within normal limits" after 30 cycles, implying a sample was used but no number is given.
Data Provenance: The studies were conducted by Westcon Contact Lens Company, Inc. (the submitter). The country of origin is not explicitly stated but implies internal studies based in the US (Grand Junction, CO). The studies are retrospective in the sense that they are comparing the newly tinted lenses against previously established data for the clear lenses (predicate device K954524), and are prospective in that new testing was performed on the tinted lenses.

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

This is not applicable as the device is a medical device (contact lens) and not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" here is objective physical and chemical measurements (e.g., light transmittance, toxicity tests).

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML device. The "adjudication" is based on laboratory test results meeting established scientific and regulatory standards.

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, not an AI/ML system that would assist human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness relies on objective scientific, chemical, and physical measurements and toxicological assessments. This includes:
- Chemical analysis for pigment leaching.
- Biological assays for cytotoxicity, systemic toxicity, and ocular irritation.
- Physical measurements for light transmittance, refractive index, water content, linear expansion, radial expansion, and tensile strength.
- Compatibility testing (e.g., durability cycles).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The "training" for this device would be the extensive research, development, and testing conducted on the original clear lens (K954524) to establish its safety and effectiveness.

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

Not applicable. As above, this is a physical medical device. The "ground truth" for the original clear lens was established through:
- "Non-clinical studies" for the clear lenses run in 1995 (referenced in 7.4 Compatibility).
- Extensive toxicology, physical/optical characteristics, and microbiology studies conducted for the original 510(k) K954524.
- These studies would have involved scientific methods, laboratory tests, and adherence to relevant standards and guidance documents (e.g., "Shelf Life of Medical Devices-April 1991 and Premarket Notification Guidance Document for Daily Wear Contact Lenses-May 1994" mentioned in 7.5 Shelf Life).

Summary

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JUN 2 9 1999

Special 510(k)-Modification to an approved device 510 (k) 954524

510 (k) Safety and Effectiveness Summary 8.0

Westcon Contact Lens Company, Inc. 1.0 Name and 611 Eisenhauer Street address of Grand Junction, CO. 81503 submitter
Contact Person Carol Noble 970-245-3845 970-245-4516 Fax

ર્ભ રાતેત્વેત Date Prepared

2.0 Name of Device

Trade Name: �
W-55 (methafilcon A) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (tinted).
Common Name: Daily Wear Soft Contact Lens �
Generic (USAN) Name: Methafilcon A �
Classification Name: Soft Hydrophilic Contact Lens �

3.0 Indications

Horizon 55 Soft (methafilcon A) Spherical (hydrophilic) contact lenses in clear or with blue visibility tint are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes myopic, hyperopic. The spherical lenses are being applied from +20.00 to -20.00 diopters and masking up to 1.50 diopters of astigmatism where it does not interfere with visual acuiity.

Horizon 55 Soft (methafilcon A) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes that are myonic, hyperopic or astigmatic. The toric lenses are being applied for spherical powers from +20.00 to -20.00 diopters and masking up to 10.00 diopters of astigmatism where it does not interfere with visual acuity.

Horizon 55 Bi-con (methafilcon A) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes myopic, hyperopic and are presbyopic. The spherical lenses are being applied from +20.00 to -20.00 diopters and masking up to 1.00 diopters of astigmatism where it does not interfere with visual acuiity.

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Special 510(k)-Modification to an approved device 510 (k) 954524

510 (k) Safety and Effectiveness Summary 8.0

Horizon 55 Bi-con (methafilcon A) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with non-diseased eyes myopic, hyperopic posses refractive astigmatism not exceeding 4.00 diopters and are presbyopic . The spherical lenses are being applied from +20.00 diopters and masking up to 10.00 diopters of astigmatism where it does not interfere with visual acuiity.

Device Description 4.0

5.0 Substantially Equivalent To:

Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K954524

6.0 Summary of Safety and Effectiveness

W-55 (methafilcon A) lens blank with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.

7.0 Technical Summaries

7.1 Toxicology:

Cytotoxicity, systemic toxicity and ocular irritation studies were conducted with samples of tinted lenses. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.

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Special 510(k)-Modification to an approved device 510 (k) 954524

510 (k) Safety and Effectiveness Summary 8.0

7.2 Physical/Optical Characteristics

Light transmittance, refractive index, water content, linear expansion, radial expansion and tensile strength were determined in samples of tinted lenses. A comparison of data from this study showed that the tinted lenses were equivalent in physical and optical characteristics as 510(k) K954524

7.3 Microbiology
There will be no changes to the validated process in 510(k) K954524
7.4 Compatibility
Westcon ran non-clinical studies for the clear lenses in 1995 in 510(k) K954524 and for the visibility-tinted lenses in 1998 (submitted with this notification). At the end of the 30 cycles all lenses were within normal limits.
7.5 Shelf Life
The shelf life studies have been started on visibility tinted lenses and will be 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.

Westcon will utilize a 10-year expiration date on the actual button as in 510(k) K954524.

8.0 Conclusion

In conclusion, it is Westcons conviction that the data submitted shows that by adding the tint 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 features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

Ms. Carol Noble Management Representative Westcon Contact Lens Company, Inc. 611 Eisenhauer Street Grand Junction, Co 81505

K992010 Re:

Trade Name: W-55 (methafilcon A) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (tinted) Regulatory Class: II Product Code: 86 LPL Dated: June 9, 1999 Received: June 15, 1999

Dear Ms. Noble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carol Noble

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 5.0

Device Name:

Horizon 55 Soft and Horizon 55 Westint (methafilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens.

W-55 (methafilcon A) lens blanks, clear or tinted.

Indication of Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use

Einar W. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K992010

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.