The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of vision acuity in aphakic and for not-aphakic person with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. Additional information is available in the Wearing Schedule Section of the package insert, patient instruction and fitting quide. The lenses may be disinfected using a chemical disinfection system.

Device Description

The DuraSoft® 3 UV (pherical and Optifit Toric hydrophilic contact lenses in Clear, Colors, Complements and Handling Tint are hemispherical shells of the lens material (phemfilcon A). A hydrophilic copolymer of 2-hydroxyethy) methacrylate and 2-ethoxyethyl methacrylate.

The DuraSoft® 3 UV Optifit Toric Contact lenses and DuraSoft® 3 UV (phemfilcon A) Spherical Contact Lenses are made by adding the UV absorber and carbazole violet in-monomer tint to the monomer mixture. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configuration.

AI/ML Overview

The provided document is a 510(k) summary for contact lenses and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the way typically expected for medical devices involving algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, based on the content available, here's a breakdown interpreting the request in the context of this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with quantitative targets for performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" are implied to be that the new device's physical, optical, and chemical properties, as well as final lens specifications, are identical or equivalent to those of the previously approved predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Physical properties are identical to the original opaque tint process.	Demonstrated in pre-clinical toxicology and compatibility studies.
Optical properties are identical to the original opaque tint process.	Demonstrated in pre-clinical toxicology and compatibility studies.
Chemical properties are identical to the original opaque tint process.	Demonstrated in pre-clinical toxicology and compatibility studies.
Final lens specifications are equivalent to lenses approved for the opaque tinting process.	Demonstrated in pre-clinical toxicology and compatibility studies.

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

The document refers to "pre-clinical toxicology and compatibility studies." It does not specify the sample size for these studies, nor does it provide information about data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The studies were pre-clinical toxicology and compatibility studies, which typically involve laboratory testing and not human expert-driven ground truth establishment in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the "test set" in this context refers to pre-clinical testing, not human-read diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/not provided. The device is a contact lens, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. The device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the pre-clinical studies would be established through scientific measurement and analysis of the physical, optical, and chemical properties of the contact lens material and the finished lenses, compared to established benchmarks or the predicate device. This is a scientific and laboratory-based ground truth, not expert consensus or pathology in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of contact lens material and design testing.

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

This information is not applicable/not provided as there is no training set for this device.

Study Proving the Device Meets the Acceptance Criteria:

The document states: "A thorough series of pre-clinical toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint are identical to the original opaque tint process and the final lens specifications are equivalent to the lenses approved for the opaque tinting process."

This statement is the summary of the study proving substantial equivalence. The details of these "pre-clinical toxicology and compatibility studies" (e.g., specific tests, methodologies, results, sample sizes) are not included in this 510(k) summary, but are referred to as the evidence for meeting the implicit acceptance criteria of identity/equivalence. The outcome is that the FDA determined the device to be "substantially equivalent" to predicate devices.

Summary

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DEC 2 2 1998

SECTION VI

510 (k) Summary Safety and Effectiveness

A. General Information

1. Name and Address of Applicant:

Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018

Contact Person:

Joseph Foos Vice President Scientific Affairs Phone: (847) 294-3306 Fax: (847) 294-3853

2. Name of the Device:

Trade Name:

DuraSoft® 3 UV (phemfilcon A) Optifit Toric Clear, Handling Tint, Colors and Complements Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear.

DuraSoft® 3 UV (phemfilcon A) Spherical Clear, Handling Tint, Colors and Complements Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear.

Soft (Hydrophilic) Contact Lenses for Daily Classification Name: Wear.

D® 3 UV Optifit Toric. Common Name: D® 3 UV Spherical.

DuraSoft® 3 UV (phemfilcon A) Optifit Toric Proprietary Name: (Hydrophilic) Contact Lenses.

DuraSoft® 3 UV (phemfilcon A) Spherical (Hydrophilic) Contact Lenses.

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B. Indication for use:

C. Description of device:

D. Substantial Equivalence/Safety & Effectiveness:

DuraSoft® 3UV (with carbazole violet in-monomer tint) Optifit Toric and Spherical Soft (Hydrophilic) Contact Lenses are substantially equivalent to previously marketed DuraSoft® 3UV lenses of the same material (phemfilcon A) as approved under 510(k) premarket notification, K965052 for daily wear and PMA 830037/S40 for extended wear.

Carbazole violet has been listed as a color additive under 21 CFR 73.3107 approved October 21, 1988 (53 FR 41322) as part of an approval of the sponsors opaque series of tints under P830037/S19 approved November 30, 1988.

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The opaque series of tints was approved as a surface entrapment tinting process of which carbazole violet was a part. In this supplement the addition of carbazole violet is intended to be incorporated as an in-monomer tint by entrapment. The violet pigment will be incorporated under the Handling Tint program of tints which follows the approval of DuraSoft® 3 Spherical and Toric Soft Hydrophilic Lenses for Extended Wear as approved under P830037/S21 on October 27, 1987.

Please note that the tint as referenced is a listed tint, has been approved as an opaque surface tint with an amount which exceeds the amount of tint required to be incorporated into the monomer mix as a handling tint.

E. Conclusion

A thorough series of pre-clinical toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint are identical to the original opaque tint process and the final lens specifications are equivalent to the lenses approved for the opaque tinting process.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1998

Mr. Joseph Foos Vice President, Scientific Affairs Wesley - Jessen Corporation 333 E. Howard Avenue Des Plaines, IL 60018-5903

Re: K982344/S1

Trade Name: DuraSoft @ 3 UV (phemfilcon A) Spherical and OptiFit ® Toric Clear, Handling Tint, Color and Color Complements Soft (Hydrophilic) Contact Lenses for Daily Wear ( lathe cut with carbazole violet in monomer tint) Regulatory Class: II Product Code: 86 LPL Dated: October 20, 1998 Received: October 21, 1998

Dear Mr. Foos:

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 (OS) 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 - Mr. Joseph Foos Vice President

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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INDICATIONS STATEMENT

510(k) Number (if known)

Device Name:

DuraSoft® 3 UV (phemfilcon A) Optifit Toric and Spherical Clear, Handling Tint, Colors and Complements Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear

Indication for Use:

The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.

The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint hydrophilic contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Conference of CDRH, Office of Device Evaluation (ODE)
Ming-Chuen Shir
	(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use		OR	Over-The Counter
510(k) Number

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.