(68 days)
No
The 510(k) summary describes a contact lens case for disinfection and storage, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The predicate device is also a contact lens case.
No
The device is indicated for chemical disinfection and storage of contact lenses, not for treating any medical condition.
No
Explanation: The device is indicated for chemical disinfection and storage of contact lenses, which are functions related to maintenance and care, not diagnosis of a condition or disease.
No
The device is described as a "Lens Carrier" and is indicated for the "chemical disinfection and storage" of contact lenses, which strongly suggests a physical container, not software. The predicate device is also a "Contact Lens Case," further supporting this interpretation.
Based on the provided information, the Paragon Lens Carrier is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the chemical disinfection and storage of contact lenses. This is a device used with a medical device (contact lenses) but does not perform a diagnostic test on a biological sample from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect specific substances
The device is a container for contact lenses and is used in conjunction with chemical disinfectants, which are separate products. Its function is storage and facilitating disinfection, not diagnosis.
N/A
Intended Use / Indications for Use
The Paragon Lens Carrier is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.
The Paragon Lens Carrier is indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection.
Product codes
LRX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '9', another '9', then '3', '4', '8', and ends with '6'. The characters are written in a bold, sans-serif font.
510(k) Summary
| Submitter | Company Name:
Address:
Phone:
Registration: | Paragon Vision Sciences
945 East Impala Ave., Mesa, AZ 85204
480-892-7602
Fax: 480-892-3226
Owner Operator # 9024618 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Company Name:
Address:
Phone:
Registration: | Paragon Vision Sciences
945 East Impala Ave., Mesa, AZ 85204
480-892-7602
Fax: 480-892-3226
Site Registration #2020433 |
| Official Correspondent | | William E. Meyers, Ph.D. |
| | Company Name:
Address:
Phone: | Paragon Vision Sciences
945 East Impala Ave., Mesa, AZ 85204
480-507-7606
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 Carrier
Contact Lens Case
Soft (hydrophilic) contact lens solution, contact lens case
Soft (hydrophilic) contact lens solution (21CFR 886.5928)
Also see "GUIDANCE FOR INDUSTRY- PREMARKET
NOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR CONTACT
LENS CARE PRODUCTS, May 1,1997. |
| Indication for use | The Paragon Lens Carrier is indicated for the chemical disinfection and storage of
Rigid Gas Permeable and Hard contact lenses. | |
| Equivalence | The Paragon Lens Carrier is substantially equivalent to the Paragon Contact Lens
Case marketed by Paragon Vision Sciences which is presently approved and marketed
under 510k # K974635. | |
| Toxicology Testing | In support of the premarket notification information the following is submitted. | |
| | 1. Systemic Injection Test
2. Eye Irritation Test
3. Cytotoxicity Test | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
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 (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
3
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