ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER by VISTAKON

The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. ACUVUE® 2 COLOURS contact lenses are available in 0.00D for those patients who do not need vision correction but desire the cosmetic benefits of opaque or enhancer cosmetic contact lenses.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Device Description

The device description is identical to that cleared under K010114 and K024177.

AI/ML Overview

The provided 510(k) summary for the ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft Hydrophilic Contact Lens with UV Blocker does not describe any acceptance criteria or the results of a study to prove the device meets such criteria related to AI or algorithm performance.

Instead, this submission is for a medical device (contact lens) where the manufacturer states that no clinical studies were required to demonstrate the safety and effectiveness of the device. This is because the device is deemed "substantially equivalent" to a predicate device already cleared by the FDA (K024177 and K010114).

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies for an AI/algorithm is not applicable based on the provided document.

The document focuses on non-clinical studies typically required for contact lenses, such as:

Toxicology: USP Ocular Irritation, USP Systemic Toxicity, In-Vitro Cytotoxicity
Chemistry/Leachables: Formulation and Process, Physical and Mechanical Properties, Leachable Monomer and Additives

The conclusion is that the modified contact lens is substantially equivalent to the previously cleared predicate device, meaning it has the same intended use and technological characteristics, and thus does not require new clinical data to prove safety and effectiveness.

Summary

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FEB - 4 2004

Ko33969

510(k) Summary

Date	December 19, 2003
Name andAddress ofManufacturer	VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.,7500 Centurion Parkway, Suite 100Jacksonville, FL 32256
	Contact: Annette M. HillringPhone: (904) 443-1808Fax: (904) 443-1424Email: ahillring@visus.jnj.com
Identification ofDevice	Trade Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) SoftHydrophilic Contact Lens with UV Blocker
	Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear)
	Classification: 21 CFR 886.5923 Class II
PredicateDevice	ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft Hydrophilic ContactLens with UV Blocker cleared via 510(k)s K024177 on January 22, 2003, andK010114 on April 11, 2001
DeviceDescription	The device description is identical to that cleared under K010114 andK024177.
Intended Use	The intended use is identical to that cleared under K010114 and K024177.
TechnologicalCharacteristics	The technological characteristics are identical to those cleared under K010114and K024177.
	Continued on next page

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510(k) Summary, Continued

Non-ClinicalStudies	As recommended in the Premarket Notification 510(k) Guidance Documenfor Daily Wear Contact Lenses, May 1994, the following tests wereconducted:
	A. Toxicology USP Ocular Irritation USP Systemic Toxicity In-Vitro Cytotoxicity B. Chemistry/Leachables Formulation and Process Physical and Mechanical Properties Leachable Monomer and Additives
Clinical Studies	No clinical studies were required to demonstrate the safety and effectivenessof the subject device.
Conclusions	The modified ACUVUE® 2 COLOURSTM Brand (etafilcon A) SoftHydrophilic Contact Lens with UV Blocker is substantially equivalent to theACUVUE® 2 COLOURSTM Brand (etafilcon A) Soft Hydrophilic ContactLens with UV Blocker most recently cleared via 510(k) K024177 on January22, 2003.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Ms. Annette M. Hillring Regulatory Affairs Consultant VISTAKON Division of Johnson and Johnson Vision Care, Inc. 7500 Centurion Parkway Suite 100 Jacksonsville, FL 32256

Re: K033969

Trade/Device Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: December 19, 2003 Reccived: December 22, 2003

Dear Ms. Hillring:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Ilsting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Annette M. Hillring

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalyn Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

510(k) Number (if known):

ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft Hydrophilic Contact Device Name: Lens with UV Blocker

Indications For Use:

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off
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Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K033969

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.