The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.

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

Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

Device Description

The device description does not change from that cleared under K983912.

AI/ML Overview

The provided 510(k) submission (K991163) for the VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses does not describe a study involving acceptance criteria and device performance in the typical sense of a new medical device efficacy study. Instead, this submission is a labeling modification for an already cleared device (K983912).

Therefore, the following information is largely not applicable or directly extractable from the provided text, as the focus is on the equivalence of the device and its existing data to support new indications, rather than a de novo study demonstrating meeting new acceptance criteria.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of acceptance criteria or new device performance data. The core of this 510(k) is that the device material and manufacturing process are unchanged from a previously cleared device (K983912). The only new "performance" mentioned relates to UV blocking, which was also established in a prior submission or existing data.

UV Blocking:
- UVA: 95%
- UVB: 99.9%
- Acceptance Criteria for UV Blocking: Not explicitly stated in this document, but implied to be met based on the reported values. Generally, contact lenses classified as UV-blocking must meet certain FDA-defined percentages for UVA and UVB absorption.

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

Test Set Description: Not applicable, as no new clinical or non-clinical studies were conducted specifically for this 510(k) to establish performance against new acceptance criteria.
Data Provenance: The submission explicitly states: "There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K983912 supports the clinical safety of the subject device." This means any performance data supporting the indications would stem from studies related to K983912. The provenance for those original studies is not detailed in this document.

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

Not applicable, as no new test set was created for a study mentioned in this 510(k). The clinical safety is supported by prior data.

4. Adjudication Method for the Test Set

Not applicable, as no new test set was created for a study mentioned in this 510(k).

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

No MRMC study was done. This device is a contact lens, and the 510(k) is for an expanded indication statement, not for an AI diagnostic or interpretive device. Therefore, a human reader improvement effect size is not relevant.

6. Standalone Performance Study (Algorithm Only)

No standalone performance study was done. This device is a contact lens. The concept of an "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

For the original submission (K983912) that established the safety and efficacy of the lens material, the "ground truth" would have likely been based on clinical outcomes data from human subjects wearing the contact lenses (e.g., visual acuity, comfort, adverse events, fit characteristics, etc.) as evaluated by optometrists or ophthalmologists.
For the UV blocking claim, the ground truth would be based on laboratory measurements of UV transmission through the lens material.

8. Sample Size for the Training Set

Not applicable. This 510(k) is not for a machine learning or AI device that requires a training set. The clinical data from K983912 would have involved a cohort of human subjects. The details of that sample size are not in this document.

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

Not applicable, as there is no "training set" in the context of this 510(k). For the original clinical data from K983912, the ground truth would have been established by clinical investigators (eye care professionals) assessing patient outcomes and device performance against defined endpoints in clinical trials.

Summary

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K991163

Summary of 510(k) Submission

Name andaddress ofsubmitter	Vistakon, Johnson & Johnson Vision Products, Inc.4500 Salisbury Road, Suite 300Jacksonville, Florida 32216Contact: Martine D. MartinoPhone: (904) 443-1808Date of Original: April 22, 1999Date Modified: May 26, 1999
Identification ofdevice	The trade name is VISTAKON (lenefilcon A) soft (hydrophilic) contactlenses, clear and visibility tint, with UV blocker, for daily wear The common or usual name is Soft (hydrophilic) Contact Lens (dailywear). The FDA Classification is Class II.
Predicatedevices	The predicate device is VISTAKON (lenefilcon A) soft (hydrophilic) contactlenses, clear and visibility tint, with UV blocker, for daily wear covered underK983912.
Description ofdevice	The device description does not change from that cleared under K983912.

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Summary of 510(k) Submission, Continued

The reason for the 510(k) is to add the following Indications Statement (see Intended use bold text) for VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses, clear and visibility tint, with UV blocker, for daily wear. The revised Indications Statement is included with this 510(k): The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism. The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism. The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. VISTAKON UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

Continued on next page

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Summary of 510(k) Submission, Continued

Characteristics	The characteristics do not change. They are the same as previously submittedin K983912.
Non-clinicalstudies	Non-clinical studies (microbiology, toxicology, chemistry, shelf-life, andleachability) on the lens material were not conducted because the lensmaterial, lenefilcon A, does not change. Non-clinical studies were conducted to support the following modifiedActions in the labeling. The average UV blocking for VISTAKON (lenefilcon A) ContactLenses with UV Blocker for UVA is 95% and for UVB is 99.9%.
Clinical studies	This 510(k) describes a labeling modification: an additional IndicationsStatement. There is no change in lens material, the manufacturing process,nor the parameters and properties, therefore, the clinical data previouslysubmitted in K983912 supports the clinical safety of the subject device.
Conclusionsdrawn fromstudies	Additional studies were not conducted, therefore, the conclusions drawn fromstudies previously submitted in K983912 support the non-clinical and clinicalsafety of the subject device.

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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 stylized depiction of an eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 1699

Ms. Martin D. Martino Regulatory Affairs Specialist Vistakon Johnson & Johnson Vision Products, Inc. 4500 Salisbury Road Suite 300 Jacksonville, FL 32216

Re: K991163

Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tint, with UV Blocker, for daily Wear

Regulatory Class: II Product Code: 86 LPL Dated: April 6, 1999 Received: April 7, 1999

Dear Ms. Martino:

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

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Page 2 - Ms. Martin D. Martino

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

K991163 510(k) Number:

VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Device Name: Tint with UV Blocker

The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

VISTAKON UV Blocking 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
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number	K991163
Prescription Use
	OR Over the Counter

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.