CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION

K994021 · Strieter Clinical Research Laboratories, Inc. · LYL · Feb 22, 2000 · Ophthalmic

Device Facts

• Record ID: K994021
• Device Name: CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
• Applicant: Strieter Clinical Research Laboratories, Inc.
• Product Code: LYL · Ophthalmic
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.

Device Story

ContaClair Multi-Purpose Solution is a chemical lens care product for soft (hydrophilic) and RGP contact lenses. It performs cleaning, rinsing, disinfecting, protein removal, and storage functions. Intended for patient self-use in a chemical (non-heat) regimen as directed by a practitioner. The solution maintains lens hygiene and comfort for contact lens wearers.

Technological Characteristics

Multi-purpose chemical solution for contact lens care. Formulated for cleaning, rinsing, disinfecting, protein removal, and storage. Compatible with soft (hydrophilic) and RGP lenses. Non-heat chemical disinfection process.

Indications for Use

Indicated for cleaning, rinsing, disinfecting, protein removal, and storage of daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses. For use in chemical (not heat) lens care regimens.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 2 2000

Dr. James F. Strieter Strieter Clinical Research Laboratories, Inc. 724 St. Louis Rd. Collinsville, IL 62234

Re: K994021 Trade Name: ContaClair® Multi-Purpose Solution(add protein removal indication) Regulatory Class: II Product Code: 86 LYL Dated: December 17, 1999 Received: December 28, 1999

Dear Dr. Strieter:

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 - Dr. James F. Strieter

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 Roerl 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 for ContaClair

(99402)

## INDICATIONS (uses):

ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.

**Over-the-Counter Use**

Artects

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number上994021