Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.

The Preference® standard, CooperHT™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity.

The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of -20.00 to +12.00.

Device Description

All tetrafilcon A Soft (hydrophilic Contact Lenses are hemispherical shells and are available as a spherical or astigmatic lens. When place on the cornea, the hydrated lens acts as a refracting medium to focus light rays on the retina.

The lens material is a hydrophilic random terpolymer of 2-hydroxyethyl methacrylate, N-vinylpyrrolidone and methylmethacrylate joined in a three dimensional network of terpolymer chains by divinylbenzene cross links.

When produced with a handling tint, the dye C.I. Reactive Blue 163 is chemically bound to the polymer to impart a light blue tint on the lens. The handling tint increases the visibility of the lens when not worn on the eye.

AI/ML Overview

This document describes a 510(k) submission for CooperVision's tetrafilcon A soft contact lenses. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the tinting process from post-hydration to in-monomer.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantified table format for each performance metric. Instead, it states that "Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses." The reported performance is then compared to these established guidelines or the predicate device.

However, we can infer the tested parameters and the general conclusion of equivalence.

Parameter Tested	Implicit Acceptance Criteria	Reported Device Performance (In-monomer tinted lenses)
Water Content	Equivalent to predicate device / within established guidelines for daily wear lenses	Tested and found to be equivalent to the predicate post-hydration tinted lenses.
Light Transmittance	Equivalent to predicate device / within established guidelines for daily wear lenses	Tested and found to be equivalent to the predicate post-hydration tinted lenses.
Refractive Index	Equivalent to predicate device / within established guidelines for daily wear lenses	Tested and found to be equivalent to the predicate post-hydration tinted lenses.
Mechanical Properties	Equivalent to predicate device / within established guidelines for daily wear lenses	Tested and found to be equivalent to the predicate post-hydration tinted lenses.
Toxicity (Cytotoxicity)	Acceptable levels (as per established standards)	Passed
Toxicity (Ocular Irritation Study)	Acceptable levels (as per established standards)	Passed
Toxicity (Acute Systemic Study)	Acceptable levels (as per established standards)	Passed
Design	Same as predicate device	The in-monomer tinted lenses have the same design as the predicate post-hydration tinted lenses.
Indication for Use	Same as predicate device	The in-monomer tinted lenses have the same indication for use as the predicate post-hydration tinted lenses.
Directions for Use	Same as predicate device	The in-monomer tinted lenses have the same directions for use as the predicate post-hydration tinted lenses.

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

The document does not specify the exact sample sizes (number of lenses or patients) used for each physical, chemical, and toxicity test. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. It only mentions that the testing was "performed on the lenses made by Aspect using an in-monomer tint."

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

This information is not applicable to this submission. The study described focuses on non-clinical, laboratory-based physical, chemical, and toxicity testing of contact lenses, not on interpreting images or patient conditions where expert consensus would be required for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this involves laboratory testing against established physical/chemical properties and toxicity standards, not clinical adjudication of patient data or images.

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 510(k) submission for a medical device (contact lenses), not an artificial intelligence (AI) or software product. Therefore, no MRMC study to compare human readers with and without AI assistance was performed or described.

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 the physical and chemical tests (water content, light transmittance, refractive index, mechanical properties) would be the established scientific and engineering standards for contact lens materials and manufacturing, often defined in ISO standards or recognized industry guidelines, or by direct comparison to data from the predicate device. For toxicity studies, the ground truth would be pre-defined safety thresholds and biological response criteria as outlined in relevant regulatory guidelines for medical device biocompatibility (e.g., ISO 10993 series).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning model that requires a training set. The "study" described is a series of non-clinical, laboratory-based tests.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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3/15/99

K 990606

510(K) Summary

Submitter

's Name:	CooperVision, Inc.
	711 North Road
	Scottsville, NY 14546
	Phone: (716) 385-6810
	FAX: (716) 889-5688

1. Contact person:
  Bonnie Tsymbal Phone: (716) 264-3210 FAX:

3. Date Summary Prepared:

4. Name of Device:

Trade Name:	Preference® standardPreference® ToricCooper HT™Cooper Toric™CV 43™Vantage™Vantage™ Accents
Common Name:	Soft Contact Lens
Classification Code:	86LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
5. Legally Marketed Device:	Same as Trade Name

6. Description of Device:

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510(k) Summary (continued)

7. Intended Use:

Tetrafilcon A lenses are intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in not-aphakic persons with non-diseased eyes.

8. Technological Characteristics:

The technological characteristics of tetrafilcon A lenses manufactured with a in-monomer tint are the same as the predicate device tinted after hydration.

9. Summary of Non-Clinical Tests:

Physical and chemical testing was performed on the lenses made by Aspect using an in-monomer tint as called for in the May 1994 Premarket Notification (510(k) Guidance Document for Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by Cytotoxicity, Ocular Irritation Study and Acute Systemic Study.

10. Conclusion:

The determination of substantial equivalence is based in the results if non-clinical testing. Review of all test data demonstrates that tetrafilcon A lenses manufactured at Aspect Vision, Ltd. with an in-monomer tint, are equivalent to the predicated post-hydration tinted lenses. The in-monomer tinted lenses have the same design, indication and directions for use. CooperVision, Inc. concludes, therefore, that the in-monomer tinted lenses are substantially equivalent to the post-hydration tinted lenses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features a stylized human figure with three lines extending upwards, resembling a bird in flight. The emblem is a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ms. Bonnie Tsymbal Regulatory Associate COOPERVISION, Inc. 711 North Road Scottsville, New York 14546

Re: K990606

Trade Name: The Preference ® Standard, CooperClear ™, CV43 ™, Vantage ® and Vantage ® Accents, (tetrafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (Spherical and Toric, Clear and Handling Tint with In- Monomer-Tinting Process, Cast-molded) Regulatory Class: II Product Code: 86 LPL Dated: February 22, 1999 Received: February 23, 1999

Dear Ms. Tsymbal:

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. Bonnie Tsymbal

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 Roerl 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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Image /page/4/Picture/0 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the wordmark is a black square containing a white stylized eye shape.

711 North Road Scottsville New York 14546 (716) 385-6810 Fax (716) 889-5688

Indications for Use Statement

K990666 510(k) Number:

Device Name:

Preference® standard Preference Toric™ Cooper Toric™ CooperHTTM CV 43mm Vantage® Vantage® Accents

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

Eis
(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number K990606

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.