CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

K990011 · Continental Soft Lens, Inc. · LPL · May 11, 1999 · Ophthalmic

Device Facts

• Record ID: K990011
• Device Name: CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
• Applicant: Continental Soft Lens, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Device Story

Continental 45 Toric is a soft (hydrophilic) contact lens composed of hefilcon A. Designed for daily wear to correct refractive ametropia, including myopia, hyperopia, and astigmatism, in both aphakic and non-aphakic patients. The lens is intended for use in non-diseased eyes. Maintenance requires disinfection via heat or chemical systems. The device is prescribed by eye care professionals to improve patient vision.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device characteristics.

Technological Characteristics

Material: hefilcon A (hydrophilic polymer). Type: Soft contact lens. Intended for daily wear. Compatible with heat or chemical disinfection systems.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1999

Mr. Kim McQuarrie, President Continental Soft Lens, Inc. 10 Glenview Drive Littleton, CO 80123

Re: K990011

Trade Name: Continental 45 Toric (hefilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: April 19, 1999 Received: April 21, 1999

Dear Mr. McQuarrie:

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 - Mr. Kim McQuarrie, President

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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510 (k) K990011 Continental 45 Toric

April 19, 1999

## INDICATIONS FOR USE

The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over the Counter Use

Myra Smith

Division Sign-Off)
Division of Ophthalmic Devices

K990011 «k) Number __

(Optional Format 1-2-96)