(68 days)
The Paragon Lens Vial is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.
The Paragon Lens Vial is indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection.
Not Found
The provided text is a 510(k) summary for the Paragon Lens Vial, a contact lens case. It is for chemical disinfection and storage of rigid gas permeable and hard contact lenses. The submission refers to toxicology testing performed to support the premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the format requested.
The document is a regulatory approval letter and 510(k) summary, which typically outlines the device, its intended use, and its substantial equivalence to a predicate device. While toxicology testing is mentioned, the specifics of an "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes, expert involvement, and ground truth are not present.
Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not contained within the provided text.
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DEC 2 2 1999
510(k) Summary
| Submitter | Company Name:Address:Phone:Registration: | Paragon Vision Sciences945 East Impala Ave., Mesa, AZ 85204480-892-7602 Fax: 480-892-3226Owner Operator # 9024618 |
|---|---|---|
| Manufacturer | Company Name:Address:Phone:Registration: | Paragon Vision Sciences945 East Impala Ave., Mesa, AZ 85204480-892-7602 Fax: 480-892-3226Site Registration #2020433 |
| Official Correspondent | William E. Meyers, Ph.D. | |
| Company Name:Address:Phone: | Paragon Vision Sciences945 East Impala Ave., Mesa, AZ 85204480-507-7606 Fax: 480-892-322 | |
| Reason for 510(k) | New Device | |
| Date of submission | October 12, 1999 | |
| Device Identification | Trade Name:Common Name:Classification Name:Reference: | Paragon Lens VialContact Lens CaseSoft (hydrophilic) contact lens solution, contact lens caseSoft (hydrophilic) contact lens solution (21CFR 886.5928)Also see "GUIDANCE FOR INDUSTRY- PREMARKETNOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR CONTACTLENS CARE PRODUCTS, May 1,1997. |
| Indication for use | The Paragon Lens Vial is indicated for the chemical disinfection and storage ofRigid Gas Permeable and Hard contact lenses. | |
| Equivalence | The Paragon Lens Vial is substantially equivalent to the Paragon Contact Lens Casemarketed by Paragon Vision Sciences which is presently approved and marketedunder 510k # K974635. | |
| Toxicology Testing | In support of the premarket notification information the following is submitted.1. Eye Irritation Test2. Cytotoxicity Test3. Systemic Injection Test |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with wavy lines below them, possibly representing water or movement.
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 (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
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.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”