PARAGON LENS CARRIER

K993486 · Paragon Vision Sciences · LRX · Dec 22, 1999 · Ophthalmic

Device Facts

• Record ID: K993486
• Device Name: PARAGON LENS CARRIER
• 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 Carrier is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.

Device Story

Paragon Lens Carrier is a contact lens case used for storage and chemical disinfection of rigid gas permeable and hard contact lenses. The device is intended for use by contact lens wearers. It functions as a container to hold lenses while they are submerged in a chemical disinfection solution. The device supports patient eye health by providing a dedicated vessel for the disinfection process, reducing the risk of contamination. No electronic, software, or algorithmic components are involved.

Clinical Evidence

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

Technological Characteristics

Contact lens case for storage and chemical disinfection. Materials were subjected to systemic injection, eye irritation, and cytotoxicity testing to ensure safety for ocular contact.

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

• Paragon Contact Lens Case (K974635)

Submission Summary (Full Text)

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020-222 19:48

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## 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<br>Fax: [phone]<br>Owner Operator # 9024618 |
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| Manufacturer | Company Name:<br>Address:<br>Phone:<br>Registration: | Paragon Vision Sciences<br>945 East Impala Ave., Mesa, AZ 85204<br>480-892-7602<br>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<br>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 Carrier<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 Carrier is indicated for the chemical disinfection and storage of<br>Rigid Gas Permeable and Hard contact lenses. | |
| Equivalence | The Paragon Lens Carrier is substantially equivalent to the Paragon Contact Lens<br>Case 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. | |
| | 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

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: K993486 Trade Name: Paragon ® Lens Carrier 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

510(k) Number (if known):

Device Name: Paragon Lens Carrier

Indications For Use: The Paragon Lens Carrier 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)

Mrs. Smith

Division of 510(k) Number