FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.

Device Description

The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively. The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.

AI/ML Overview

The provided text is a 510(k) Summary for the FreshLook® Bifocal UV-absorbing Contact Lenses. It details the device's characteristics and its equivalence to a predicate device but does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document states, "Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review," and refers to this PMA Supplement for "technological device characteriatios" and "manufacturing." This suggests that the detailed study data regarding acceptance criteria and performance might be located in the referenced PMA Supplement, which is not part of the provided text.

Therefore, for the FreshLook® Bifocal UV-absorbing Contact Lenses, based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided document. The document lists physical properties but not against specific acceptance criteria in a performance study context.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not available in the provided document. As this is a physical contact lens, expert adjudication in the manner of diagnostic AI is not directly applicable. However, clinical trial data would involve ophthalmologists or optometrists, but details are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not available in the provided document.

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:

This information is not applicable as the device is a contact lens and not an AI-powered diagnostic tool involving human readers.

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

This information is not applicable as the device is a contact lens and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not available in the provided document. For contact lenses, "ground truth" would typically refer to established clinical endpoints and measurements (e.g., visual acuity, comfort, fit, physiological response of the eye), but no details of such studies are included here.

8. The sample size for the training set:

This information is not applicable as the device is a physical contact lens, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

This information is not applicable as the device is a physical contact lens, not an AI model.

Summary of available information from the document:

The 510(k) summary focuses on the device's description, its intended use, and its substantial equivalence to a predicate device (FreshLook® UV). It details the physical properties and range of parameters for the contact lenses. The approval letter confirms that the device is "substantially equivalent" to legally marketed devices, allowing it to proceed to market. The basis for this equivalence and any specific performance studies with acceptance criteria appear to be contained in the referenced PMA Supplement P830037/S042, which is not provided in this text.

Summary

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K991550

SECTION III

510(k) Summary

FreshLook® Bifocal UV-absorbing Contact Lenses

A. Product Summary

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 (847) 294-3853 Fax:

2. Name of the Device:

Classification Name:

Trade Name:

FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear

Soft (Hydrophilic) Contact Lenses for Daily Wear.

FreshLook® Bifocal UV-absorbing (phemfilcon A)

Spherical Soft (Hydrophilic) Contact Lenses.

FreshLook® Bifocal Common Name:

Proprietary Name:

Facility Registration Number:

1422160

1. Identification of predicate device:
  FreshLook® UV (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses. FreshLook® Bifocal is an alternate design to the currently marketed FreshLook® UV (phemfilcon A) Contact Lenses.

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4. Description of device:

The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.

The FreshLook® Bifocal lenses are available in the following parameter range:

Chord Diameter:	12.0 to 15.0 mm
Base Curve:	7.80 to 9.00 mm
Distance Power Zone:	5 mm (colors)
Distance Power Zone:	5 mm to 9 mm (Handling Tint - varies with power)
Increments:	0.25 D
Center Thickness:	0.08 to 0.56 mm (Varies with power)
Distance Powers:	-20.00 D to +20.00 D
Bifocal Add Powers:	+0.50 D to +3.00 D
Near Power Zone:	1.00 to 3.80 mm
Progressive Power Zone:	1.40 to 4.80 mm

The physical properties of the FreshLook® Bifocal UV-absorbing lens are identical to the FreshLook® UV lens and are as follows:

Physical Property	FreshLook® Bifocal UV
Specific Gravity	1.152
Refractive Index	1.411 @ 25°C
Light Transmittance	95% (minimum)
Surface Character	Hydrophilic
Water Content	55%
Oxygen Permeability (Dk)	$16.1 x 10^{-11}$ ml O2 cm2 / sec ml mmHg
Oxygen Transmissibility* (Dk/L)	$20 x 10^{-9}$ ml O2 cm / sec ml mmHg

10° ml O₂ cm / sec ml mmHg at 35°C (Dr. Irving Fatt Method)

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Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review,

8. Statement of Intended Use

Fresh Look Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual aculty and prosbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does net interfere with visual acuity. The lons ranges in power from -20.00 to +20.00 not their ore tor daily war.
display for daily war.
display for daily war.
The for daily war.

The letters may be prescribed for Daily Wear to agraduic or not appartic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning. disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disingles chemical disinfection system.

FreshLook Lenses with UV-absorbing monomer help protect against transmission of hannful UV radiation to the comes and into the eye.

C. Technological Characteristics of the Device and Comparison

Reference PMA Supplement P830037/S042 for technological device characteriatios. of the FreshLook® Bifocal UV-absorbing Spherical (phemfijcon A) Soft (Hydrophille) Contact Lenses submitted to the agency for Real Time Review.

D. Device Manufacturing Section

Reference PMA Supplement P830037/S042 for the manufacturing of the Freah Look® Bifocal UV-absorbing Spherical (phermflicon A) Soft (Hydrophillic) Contact Lenses. All device manufacturing information submitted to the FDA In the PMA Supplement P830037/S042 Real Time Review is applicable to this submission.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

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

Re: K991550

Trade Name: FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: May 3, 1999 Received: May 4, 1999

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 (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 - Mr. Joseph Foos

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 STATEMENT

510(k) Number (if known)

Device Name:

FreshLook® Bifocal UV-absorbing (phomfilcon A) Molded Spherical Handling Tint and Colors Soft (Hvdrophille) Contact Lenses for nondiseased presbyopic eves Dally Wear

Indication for Use:

Spherical

FreshLook® Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.

Toric

Fresh Look Toric (chemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 dioptors.

Bifocal

Pres

FrashLook® Bifocal UV-absorbing Sphenical (phemfilcon A) Soft (Hydrophille) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. · - - ·· · . .. .. -- · - ----

FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.

(PLEASE DO NOT WRITTERE (OWLTHIS I INE CONTINUE ON ANOTHER PAGE IF NEEDED) Conference of CORH, Office of Device Eveluation (ODE)

cription Use	OR	Over-The Counter
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(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number	K991550
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(((33

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.