(68 days)
Not Found
No
The 510(k) summary describes a contact lens storage and disinfection vial, a purely mechanical device, and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is indicated for chemical disinfection and storage of contact lenses, not for treating any medical condition.
No
The device is indicated for chemical disinfection and storage of contact lenses, which are maintenance and hygiene functions, not diagnostic.
No
The 510(k) summary describes a "Lens Vial" which is a physical container for contact lenses, not a software application. The predicate device is also a "Contact Lens Case".
Based on the provided information, this device 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 process applied to a medical device (contact lenses) outside of the body, not a diagnostic test performed on a biological sample to determine a medical condition.
- Device Description: While the description is "Not Found," the intended use clearly defines the function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a container for contact lenses during a disinfection process, which falls under the category of a medical device accessory or a device used in the care of another medical device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
86 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Toxicology Testing:
- Eye Irritation Test
- Cytotoxicity Test
- Systemic Injection Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
DEC 2 2 1999
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 Vial
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 Vial is indicated for the chemical disinfection and storage of
Rigid Gas Permeable and Hard contact lenses. | |
| Equivalence | The Paragon Lens Vial 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.
- Eye Irritation Test
- Cytotoxicity Test
- Systemic Injection Test | |
1
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 .
2
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
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