NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR by SOFTFOCAL COMPANY, INC.

The NuSoft Spherical (ocufilcon B) Soft 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 nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.

The NuSoft Toric (ocufilcon B) Soft 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 myopic or hyperopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.

The NuSoft Aspherical (ocufilcon B) Soft 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 myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D that does not interfere with visual acuity.

The NuSoft Bifocal (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with non-diseased eves that are myopic, or hyperopic, and/or presbyopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.

NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.

Device Description

NuSoft (ocufilcon B) Spherical, Toric, Aspherical and Bifocal Soft Contact Lenses for Daily Wear (lathe-cut, clear or visibility tinted)

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for Softfocal Company, Inc.'s NuSoft contact lenses. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include details on performance metrics, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2003

Robert B. Mandell, O.D. President Softfocal Company, Inc. 69 Sullivan Drive Moraga, CA 94556

Re: K023791

Trade/Device Name: NuSoft (ocufilcon B) Spherical, Toric, Aspherical and Bifocal Soft Contact Lenses for Daily Wear (lathe-cut, clear or visibility tinted) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 8, 2002 Received: November 13, 2002

Dear Dr. Mandell:

We have reviewed your Section 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, 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 (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 - Dr. Robert B. Mandell

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 may be obtained 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. Ralph 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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Softfocal Company, Inc. 510(k) Premarket Notification NuSoft Spherical, NuSoft Toric, NuSoft Aspheric , NuSoft Bifocal (ocufilcon B) Soft Contact Lens for Daily Wear (lathe-cut, clear or tinted)

INDICATIONS FOR USE STATEMENT

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Device Name: Re:510(k) Application – NuSoft Spherical, NuSoft Toric, NuSoft Aspherical and NuSoft Bifocal (ocufilcon B) Soft Contact Lens for Daily Wear (lathe-cut, clear or tinted) (ocufilcon B) Soft Contact Lenses (Clear & Tinted, Lathe-cut)

INDICATIONS FOR USE:

NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.