PARAGON LENS VIAL

K993487 · Paragon Vision Sciences · LRX · Dec 22, 1999 · Ophthalmic

Device Facts

• Record ID: K993487
• Device Name: PARAGON LENS VIAL
• Applicant: Paragon Vision Sciences
• Product Code: LRX · Ophthalmic
• Decision Date: Dec 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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

Device Story

Paragon Lens Vial is a contact lens case used for the chemical disinfection and storage of rigid gas permeable and hard contact lenses. The device serves as a container for the lens and disinfection solution. It is intended for use by contact lens wearers to maintain lens hygiene and storage. The device is a simple mechanical container with no electronic or software components.

Clinical Evidence

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

Technological Characteristics

Contact lens case for chemical disinfection and storage. Mechanical device; no energy source, connectivity, or software. Materials evaluated via biocompatibility testing (eye irritation, cytotoxicity, systemic injection).

Indications for Use

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

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

• Paragon Contact Lens Case (K974635)

Submission Summary (Full Text)

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DEC 2 2 1999

K993487

## 510(k) Summary

| Submitter | Company Name:<br>Address:<br>Phone:<br>Registration: | Paragon Vision Sciences<br>945 East Impala Ave., Mesa, AZ 85204<br>480-892-7602 Fax: [phone]<br>Owner Operator # 9024618 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Company Name:<br>Address:<br>Phone:<br>Registration: | Paragon Vision Sciences<br>945 East Impala Ave., Mesa, AZ 85204<br>480-892-7602 Fax: [phone]<br>Site Registration #2020433 |
| Official Correspondent | William E. Meyers, Ph.D. | |
| | Company Name:<br>Address:<br>Phone: | Paragon Vision Sciences<br>945 East Impala Ave., Mesa, AZ 85204<br>480-507-7606 Fax: [phone] |
| Reason for 510(k) | New Device | |
| Date of submission | October 12, 1999 | |
| Device Identification | Trade Name:<br>Common Name:<br>Classification Name:<br>Reference: | Paragon Lens Vial<br>Contact Lens Case<br>Soft (hydrophilic) contact lens solution, contact lens case<br>Soft (hydrophilic) contact lens solution (21CFR 886.5928)<br>Also see "GUIDANCE FOR INDUSTRY- PREMARKET<br>NOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR CONTACT<br>LENS CARE PRODUCTS, May 1,1997. |
| Indication for use | The Paragon Lens Vial is indicated for the chemical disinfection and storage of<br>Rigid Gas Permeable and Hard contact lenses. | |
| Equivalence | The Paragon Lens Vial is substantially equivalent to the Paragon Contact Lens Case<br>marketed by Paragon Vision Sciences which is presently approved and marketed<br>under 510k # K974635. | |
| Toxicology Testing | In support of the premarket notification information the following is submitted.<br>1. Eye Irritation Test<br>2. Cytotoxicity Test<br>3. Systemic Injection Test | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1999

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

Re: K993487 Trade Name: Paragon ® Lens Vial Regulatory Class: Unclassified Product Code: 86 LRX Dated: October 12, 1999 Received: October 15, 1999

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. 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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Indications Statement

K993487 510(k) Number (if known):

Paragon Lens Vial Device Name:

Indications For Use: The Paragon

Indications For Use: The Paragon Lens Vial 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)

Prescription Use_

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Myra Smith
Radiological Health

Enclosure