K Number

Device Name

PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS

Manufacturer

WESLEY JESSEN CORP.

Date Cleared

2000-03-20

(88 days)

Product Code

LPL

Regulation Number

886.5925

Intended Use

Spherical: ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. Toric: ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear. The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process. Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

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

K965052, P850057

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes standard contact lenses manufactured through lathing and tinting processes. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is indicated for the correction of visual acuity by a physical means (lenses), not for treating a disease or condition. It helps correct vision, which is a functional improvement rather than a therapeutic intervention in the medical sense.

Diagnostic

These contact lenses are indicated for the correction of visual acuity, meaning they treat an existing condition rather than diagnose one. The text describes their physical properties and how they are manufactured, and their purpose is to improve vision for people with nearsightedness, farsightedness, or astigmatism.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical contact lens made of a hydrophilic copolymer, which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
Device Function: The ProSoft contact lenses are designed to be worn on the eye to correct vision (myopia, hyperopia, astigmatism). They are a medical device, but they do not analyze biological samples in vitro.
Intended Use: The intended use clearly states correction of visual acuity in persons with non-diseased eyes. This is a direct treatment/correction of a physical condition (refractive error), not a diagnostic test.
Device Description: The description focuses on the material and manufacturing process of the lens itself, not on any analytical or diagnostic capabilities.
Performance Studies: The performance studies focus on the physical properties, toxicology, and compatibility of the lens with care regimens, all related to its function as a contact lens worn on the eye. There are no studies related to analyzing biological samples.

Therefore, based on the provided information, the ProSoft contact lenses are a medical device for vision correction, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Spherical

ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

Toric

ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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

86 LPL

Device Description

Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process.

Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

eye care practitioner

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)

Comparison of physical and mechanical properties to the current lathed DuraSoft 3 UV lenses. Measured properties show equivalence.
Preclinical studies for toxicology on ProSoft with CTL tinting process using Vat Green #1:
a. Cytotoxicity: No evidence of causing cell lysis or toxicity. Met USP requirements.
b. Systemic Injection: No mortality or evidence of systemic toxicity from extracts. Each extract met USP requirements.
c. Ocular irritation: SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.
Residual Analysis: No dye extractables detected in lens extracts.
Lens Compatibility with Recommended Lens Care Regimen: Parameters within manufacturing tolerances after 30 cycles in ReNu Multipurpose System. Tint color still evident.
Light Transmittance: No significant difference between UV light transmittance before and after cycling.
Microbiology: Not required due to identical manufacturing, packaging, and sterilization processes as predicate device.

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.

K965052, P850057

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

MAR 200 zuuu

Image /page/0/Picture/1 description: The image shows a sequence of characters, which appear to be handwritten. The sequence is "K994335". The characters are bold and dark, contrasting with the white background. The style of the characters suggests a casual or informal writing style.

SECTION VI

Summary of 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 F. Foos
Vice President, Scientific Affairs
Phone: (847) 294-3306
Fax: (847) 294-3853 |
| 2. Name of the Device: | |
| Common Name: | Daily wear soft (hydrophilic) contact lens |
| Trade Name: | ProSoft (phemfilcon A) |
| Device Classification: | As per 21 CFR Section 886.5925. S
(hydrophilic) daily wear contact lenses
classified as a Class II device. |
| Classification Number: | LPL; Ophthalmic Devices Panel |

B. Indications for use:

Spherical

Toric

Soft are

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

C. Description of device:

Physical and Mechanical Properties

The ProSoft contact lenses were compared to the current lathed DuraSoft 3 UV lenses for physical and mechanical properties. The measured properties show that the lathed lenses are equivalent to predicate lenses.

Toxicology

The safety of phemfilcon A is well established (PMA P830037). The preclinical studies on ProSoft with the CTL tinting process using Vat Green #1 were conducted to assure that the safety of this material, phemfilcon A, has not been altered by these changes. The studies are summarized below:

a. Cytotoxicity:

The negative controls and positive controls performed as anticipated. Under the condition of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the USP.

b. Systemic Injection:

Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the USP requirements.

C. Ocular irritation:

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

Under the conditions of this study, the SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants to the ocular tissue of the rabbit.

Residual Analysis:

Samples of lenses were extracted in saline and the extracts analyzed to determine if dye extractables from the material would be detected. There were no dye extractables detected.

Lens Compatibility with the Recommended Lens Care Regimen

Any changes in parameters through 30 cycles were within manufacturing tolerances. Cycling in the ReNu Multipurpose System® did not adversely affect measured lens parameters relative to the uncycled control lenses. Tint color was still evident after 30 cycles.

Light Transmittance:

The ultraviolet spectra of cycled lenses was individually measured before and after cvcling. All variances were within the experimental tolerance. It can be considered that there was no significant difference between the light transmittance before and after cycling.

Microbiology:

Lens manufacturing, packaging and sterilization are identical to the sterilization described for the predicate device, DuraSoft 3 UV, therefore sterilization validation is not required.

D. Conclusion:

ProSoft (phemfilcon A) contact lenses are substantially equivalent to marketed DuraSoft® 3UV lenses of the same material as approved under 510(k) premarket notification, K965052, and the tinting process is substantially equivalent to the approved process for CustomEyes (bufilcon A) contact lenses under PMA P850057.

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2000

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

Re: K994335

Trade Name: ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: December 21, 1999

Received: December 23, 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 .

Page 2 - Mr. Joseph F. 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

INDICATIONS STATEMENT

K994335 510(k) Number (if known)

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Device Name: Contact Lenses for Daily Wear

Indications for Use:

Spherical

Toric

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Conference of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Counter

(Division Sign-Off)
Division of Ophthalmic Devices

00011