The ACUVUE 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 ACUVUE 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 ACUVUE 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 ACUVUE 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 10.00 D of astigmatism or less.

ACUVUE 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 K991134.

AI/ML Overview

The provided 510(k) submission (K994324) for the ACUVUE (etafilcon A) soft contact lenses is a labeling modification submission, not a submission for a new device requiring a comprehensive performance study against acceptance criteria.

The purpose of this 510(k) is to revise the wear schedule in the labeling to include a statement about the reduced risk of giant papillary conjunctivitis (GPC) with frequent replacement.

Therefore, many of the typical elements of a performance study required for novel device clearance are not present or applicable in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present a table of acceptance criteria or new device performance data in the way a new device would. The core claim is a labeling modification supported by existing clinical literature, not new performance metrics for the device itself.

The "acceptance criteria" in this context would be the FDA's acceptance of the scientific literature supporting the labeling change.

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

Test Set (for the labeling claim): The submission states that the labeling modification is supported by "clinical studies published in the July 1999 CLAO Journal (see Attachment A)." Attachment A is not provided in the document. Therefore, the sample size and data provenance of these specific studies are not detailed in this 510(k) submission.
Data Provenance: The document does not specify the country of origin of the data mentioned in the CLAO Journal. It states the studies were "published," implying they are retrospective in terms of this 510(k) submission.

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

This information is not provided in the 510(k) submission. As the evidence relies on published clinical studies, the details about expert involvement in establishing ground truth would typically be found within those external publications, not in this regulatory submission.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) submission for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done, nor would it be relevant for a contact lens labeling modification based on GPC risk. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices.

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

N/A. This device is a contact lens; there is no algorithm or human-in-the-loop performance component.

7. The Type of Ground Truth Used

The "ground truth" for the labeling modification regarding reduced GPC risk would be derived from the clinical outcomes data reported in the published studies cited (July 1999 CLAO Journal). This would include observations and diagnoses of GPC in patients using contact lenses with different replacement schedules.

8. The Sample Size for the Training Set

N/A. This device is a contact lens. There is no training set in the context of machine learning or algorithms. The "training data" for general contact lens safety and efficacy would have been the extensive clinical trials conducted for the original device clearance (K991134).

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

N/A. See point 8. The ground truth for the original ACUVUE lens (K991134) would have been established through standard clinical trial methodologies, including patient examinations, objective measurements, and subjective patient feedback, reviewed and interpreted by qualified clinicians, to demonstrate the lens's safety and effectiveness for its intended use.

Summary

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FEB 2 3 2000

Summary of 510(k) Submission

K 994324

Name andaddress ofsubmitter	Vistakon, Johnson & Johnson Vision Products, Inc.7500 Centurion ParkwayJacksonville, Florida 32256Contact: Sharon BriggsPhone: (904) 443-1471Date Prepared: December 21, 1999
Identification ofdevice	The trade name is ACUVUE (etafilcon A) soft (hydrophilic) contact lenses, clear and visibility tinted, with UV blocker, for daily wear The common or usual name is Soft (hydrophilic) Contact Lens (daily wear). The FDA Classification is Class II.
Predicatedevices	The predicate device is ACUVUE (etafilcon A) soft (hydrophilic) contact lenses, clear and visibility tinted, with UV blocker, for daily wear covered under K991134.
Description ofdevice	The device description does not change from that cleared under K991134.
	Continued on next page

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Summary of 510(k) Submission, Continued

Indications forUse
	The ACUVUE Contact Lens (spherical) is indicated for daily wear forthe correction of refractive ametropia (myopia and hyperopia) inaphakic or non-aphakic persons with non-diseased eyes who may have1.00 D or less of astigmatism.
	The ACUVUE BIFOCAL Contact Lens is indicated for daily wear forthe correction of distance and near vision in presbyopic, aphakic ornon-aphakic persons with non-diseased eyes who may have 0.75 D orless of astigmatism.
	The ACUVUE TORIC Contact Lens is indicated for daily wear forthe correction of visual acuity in aphakic or non-aphakic persons withnon-diseased eyes that are hyperopic or myopic and may have 10.00 Dor less of astigmatism.
	The ACUVUE TORIC BIFOCAL Contact Lens is indicated for dailywear for the correction of distance and near vision in presbyopicaphakic or non-phakic persons with non-diseased eyes who may have10.00 D of astigmatism or less.
	ACUVUE Contact Lenses help protect against transmission ofharmful UV radiation to the cornea and into the eye.
	Eye care practitioners may prescribe the lens for either single-usedisposable wear or for frequent/planned replacement wear, withcleaning, disinfection and scheduled replacement. When prescribedfor frequent/planned replacement wear, the lens may be disinfectedusing a chemical disinfection system only.

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Summary of 510(k) Submission, Continued

Reason for510(k)	The reason for the 510(k) is to revise the "Wear Schedule" in the DraftPackage Insert, and the "Introduction" statements in the Draft PatientInstruction Guides (Disposable and Frequent Replacement) for ACUVUE(etafilcon A) soft (hydrophilic) contact lenses, clear and visibility tinted, withUV blocker, for daily wear to include the following statement:When ACUVUE UV Blocking Contact Lenses are replaced at intervalsranging from 1 day to 2 weeks, the risk of developing giant papillaryconjunctivitis may be reduced .
Characteristics	The characteristics do not change. They are the same as previously submittedin K991134.
Non-clinicalstudies	Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, andleachability) on the lens material were not conducted because the lensmaterial, etafilcon A, does not change.
Clinical studies	This 510(k) describes a labeling modification which is supported by clinicalstudies published in the July 1999 CLAO Journal (see Attachment A). Thereis no change in lens material, the manufacturing process, nor the parametersand properties, therefore, the clinical data previously submitted in K991134supports the clinical safety of the subject device.
Conclusionsdrawn fromstudies	Additional studies were not conducted, therefore, the conclusions drawn fromstudies previously submitted in K991134 support the non-clinical and clinicalsafety of the subject device. The clinical studies published in the July 1999CLAO Journal support the labeling modification that is the subject of this510(k).

For the disposable patient guide, the statement is revised to: "When ACUVUE UV Blocking Contact Lenses are replaced daily, the risk of developing giant papillary conjunctivitis may be reduced."

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2000

Ms. Sharon A. Briggs Manager, Regulatory Submissions VISTAKON™ 7500 Centurion Parkway Jacksonville, FL 32256

Re: K994324 Trade Name: ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Tinted with UV blocker Regulatory Class: II -ﺴﻬ Product Code: 86 LPL Dated: December 21, 1999 Received: December 22, 1999

Dear Ms. Briggs:

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 - Ms. Sharon A. Briggs

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,

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

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): j( 99 4 32 4

ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Device Name: Tinted with UV blocker

Indication for Use:

ACUVUE 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)

Prescription Use		OR	Over the Counter
	antist(Division Sign-Off)Division of Ophthalmic Devices
	510(k) Number上9 94324

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.