PARAGON LENS CARE

K974635 · Paragon Vision Sciences · LRX · Feb 4, 1998 · Ophthalmic

Device Facts

• Record ID: K974635
• Device Name: PARAGON LENS CARE
• Applicant: Paragon Vision Sciences
• Product Code: LRX · Ophthalmic
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The Paragon Contact Lens Case is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.

Device Story

Paragon Contact Lens Case is a storage container for rigid gas permeable and hard contact lenses. Device facilitates chemical disinfection process by holding lenses in solution. Used by patients in home setting. Device provides physical housing for lenses during disinfection; no active electronic or mechanical components.

Clinical Evidence

No clinical data. Evidence consists of bench testing: systemic injection test, eye irritation test, and cytotoxicity test.

Technological Characteristics

Contact lens storage case. Materials evaluated via systemic injection, eye irritation, and cytotoxicity testing. No electronic components or software.

Indications for Use

Indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection.

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.”

Predicate Devices

• Boston Contact Lens Case (K962512)

Submission Summary (Full Text)

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510(k) Summary

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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K914635'. The characters are rendered in a bold, sans-serif font, giving them a clear and distinct appearance. The sequence appears to be a code or identifier, possibly a serial number or product code.

| Submitter: | Company Name: Paragon Vision Sciences<br>Address: 945 East Impala Ave.<br>Phone: [phone], Fax: [phone]<br>Registration: Owner Operator # 9024618<br>FEB - 4 1998 |
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| Manufacturer: | Company Name: Paragon Vision Sciences<br>Address: 945 East Impala Ave. Mesa AZ 85204<br>Phone: [phone], Fax: [phone]<br>Registration. Site Registration #2020433 |
| Official Correspondent: | William E. Meyers, Ph.D.<br>% Paragon Vision Sciences<br>Address: 945 East Impala Ave. Mesa AZ 85204<br>Phone: [phone], Fax: [phone] |
| Reason for 510(k): | New Device |
| Date of submission | 12/9/97 |
| Device Identification: | Trade Name: Paragon Contact Lens Case<br>Common Name: Contact lens Case<br>Classification Name: Contact Lens Case |
| Indication for use: | The Paragon Contact Lens Case is indicated for the chemical disinfection and<br>storage of Rigid Gas Permeable and Hard contact lenses. |
| Equivalence: | The Paragon Contact Lens Case is substantially equivalent to the Boston Contact<br>Lens Case marketed by Polymer Technology, Division of Wilmington Partners which<br>is presently approved and marketed under premarket notification k962512. |
| Toxicology Testing: | In support of the premarket notification information from the following<br>was submitted:<br>1. Systemic Injection Test<br>2. Eye Irritation Test<br>3. Cytotoxicity test |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

William E. Meyers, Ph.D. Vice President, Science & Technology Paragon Vision Sciences 945 East Impala Ave. Mesa, AZ 85204

FEB - 4 1998

Re: K974635 Trade Name: Paragon Contact Lens Case Regulatory Class: Unclassified Product Code: 86 LRX Dated: December 9, 1997 Received: December 12, 1997

Dear Dr. Meyers:

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 - William E. Meyers, Ph.D.

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 Statement

510(k) Number (if known): K974635

Device Name: Paragon Contact Lens Case

Indications For Use: The Paragon Contact Lens Case is indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection

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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