Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

Device Description

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.

AI/ML Overview

This document discusses the K982988 submission for the Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses. The submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than providing extensive de novo clinical trial data.

Therefore, the typical structure for a detailed acceptance criteria breakdown, including specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies associated with new clinical studies for device performance, does not directly apply in the same manner as it would for a PMA (Premarket Approval) or de novo submission requiring extensive new clinical efficacy and safety data.

Instead, the core of this submission revolves around demonstrating that the "Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material" (as stated in Section D). The key point of the K982988 submission is the modification of labeling and indications for use, not a fundamental change in the device itself or its core performance characteristics.

Here's an analysis based on the provided text, addressing your questions where possible within the context of a 510(k) for labeling changes:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for labeling modifications of an already marketed and substantially equivalent device, the acceptance criteria are not explicitly defined in terms of new performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and justifying the updated labeling.

However, the previous approvals (PMA P940013 and 510(k) K961299) would have established performance criteria for the device's physical, optical, chemical, biocompatible, and microbiological properties, as well as clinical safety and effectiveness for its original indications. The current submission relies on these prior approvals.

Criteria Category / Performance Metric	Acceptance Criteria (Implicit from Predicate Device)	Reported Device Performance (Implicit from Predicate Device)
Physical Properties	Meets established standards for contact lenses (e.g., diameter, base curve, center thickness)	Device is identical to previously approved Precision UV™ lenses.
Optical Properties	Provides specified visual acuity correction (myopia/hyperopia, ≤2.00D corneal astigmatism).	Device is identical to previously approved Precision UV™ lenses.
Material Properties (Chemical/Biocompatibility)	Material (vasurfilcon A: 74% water, 26% copolymer) is safe and biocompatible.	Device is identical to previously approved Precision UV™ lenses.
Microbiological Safety	Sterile and resistant to microbial growth.	Device is identical to previously approved Precision UV™ lenses.
Clinical Safety & Effectiveness	Safe and effective for daily wear, single-use, or frequent replacement with specified disinfecting systems.	Device is identical to previously approved Precision UV™ lenses, supported by prior PMA P940013 and 510(k) K961299.
UV Protection (New indication focus)	Helps protect against transmission of harmful UV radiation to the cornea and into the eye.	This is an added claim, supported by "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.)" not new device performance data.
Indications for Use	Correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00D or less of corneal astigmatism.	Device meets these specifications.
Wear Modalities	Suitable for daily wear, single-use disposable wear, or frequent replacement wear with approved disinfection systems.	Device meets these specifications.

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

The document explicitly states: "There were no changes to the lens material or design; however, the associated labeling and indications were changed." This implies that no new clinical test set was used to prove the device's fundamental performance for this specific 510(k) submission. Instead, the submission relies on the existing data and approvals for the predicate device.

The basis for the new labeling claims (specifically UV protection) is described as "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6". This indicates that the support for the UV claim comes from existing scientific literature and non-clinical data, rather than a new primary clinical trial. Therefore, specific sample sizes and provenance for a "test set" demonstrating the device's primary clinical performance for this submission are not provided because the device itself hasn't changed.

For the original PMA P940013 and 510(k) K961299, clinical trials would have been conducted with specific sample sizes, and the provenance would likely be multi-center clinical studies, typically prospective. However, these details are not provided in this excerpt.

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

Not applicable for this 510(k) submission as no new clinical test set requiring expert adjudication for ground truth was conducted for the device's core performance. The "experts" involved are likely the regulatory reviewers at the FDA and potentially the internal scientific/medical team at Wesley Jessen, who evaluated the referenced literature for the UV claims.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set requiring adjudication was conducted for this 510(k).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI system is evaluated for its assistance. A contact lens is a therapeutic/corrective device, not an interpretative one in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. There is no "algorithm" or AI component to this contact lens.

7. Type of Ground Truth Used:

For the original device approvals (PMA P940013 and 510(k) K961299), the ground truth for clinical safety and effectiveness would have been based on:

Clinical outcomes data: Measured visual acuity, comfort, adverse event rates, biomicroscopic findings, etc., observed in human subjects.
Physical/Chemical/Optical standards: Compliance with established laboratory tests for lens properties.

For the new UV claim in this 510(k) K982988, the "ground truth" for the claim's validity is derived from:

Referenced literature: Epidemiological studies, non-clinical research reports, studies on the nature of UV energy. This implies a scientific consensus on the effects of UV radiation and the ability of certain materials to block it, rather than new primary data from this specific device.

8. Sample Size for the Training Set:

Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI.

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

Not applicable.

Summary

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K982988

6 1999 JAN

Attachment C

Summary of Safety and Effectiveness

A. General Information

Name and Address of Applicant: 1.
Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018

Contact Person:

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

1. Name of the Device:
  Proprietarv Name:

Precision UVTM (vasurfilcon A)

1. Identification of Predicate Device: Same as above

B. Indication for use:

C. Description of device:

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Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are currently marketed domestically and internationally by Wesley Jessen Corporation under PMA P940013. Previously, they were marketed by Pilkington Barnes Hind under Allergan Medical Optic's PMA P790020.

D. Substantial Equivalence/Safety & Effectiveness:

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed
Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material as under 510(k) premarket notification, K961299, and PMA P940013 for all properties (physical, optical, chemical, biocompatible, microbiological, and clinical). There were no changes to the lens material or design; however, the associated labeling and indications were changed.

E. Summary:

Wesley Jessen considers the study, data and referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6, evidence supporting the additional intended use and associated modified labeling.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 1999

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

K982988 Re:

Trade Name: Precision UV™ (vasurfilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted) (Labeling modifications) Regulatory Class: II Product Code: LPL Dated: November 20, 1998 Received: November 23, 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 legally marketed predicate 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.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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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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Attachment B

INDICATIONS STATEMENT

510(k) Number (if known): K982988

Device Name:

Precision UVTM clear and tinted (74% water) Daily Wear Soft Contact Lans

Indication for Use:

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eves that are myopic or hyperopic and may have 2,00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lanses help protect against transmission of harmful UV radiation to the comea and into the eve.

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

Prescription Use

Over-The Counter

Kaver Warburton
(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982988

000052

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.