(54 days)
Not Found
No
The 510(k) summary describes a contact lens case for disinfection and storage, with no mention of AI or ML capabilities. The performance studies listed are standard toxicology tests for material safety.
No.
The device is indicated for chemical disinfection and storage of contact lenses, which does not constitute a therapeutic function.
No
Explanation: The device is a contact lens case used for disinfection and storage, not for diagnosing any medical condition.
No
The device is described as a "Contact Lens Case," which is a physical hardware product used for storing and disinfecting contact lenses. The summary details toxicology testing relevant to a physical material in contact with the eye, not software performance.
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 physical process applied to a medical device (contact lenses), not a test performed on a biological sample from a human body to diagnose a condition.
- Device Description: The device is a contact lens case, which is a container for storing and treating contact lenses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed are toxicology tests, which assess the safety of the materials in contact with the eye and the disinfection process, not the diagnostic accuracy of a test.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Paragon Contact Lens Case does not fit this description.
N/A
Intended Use / Indications for Use
The Paragon Contact Lens Case is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.
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)
Not Found
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
510(k) Summary
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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K914635'. The characters are rendered in a bold, sans-serif font, giving them a clear and distinct appearance. The sequence appears to be a code or identifier, possibly a serial number or product code.
| Submitter: | Company Name: Paragon Vision Sciences
Address: 945 East Impala Ave.
Phone: 602-892-7602, Fax: 602-892-3226
Registration: Owner Operator # 9024618
FEB - 4 1998 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Company Name: Paragon Vision Sciences
Address: 945 East Impala Ave. Mesa AZ 85204
Phone: 602-892-7602, Fax: 602-892-3226
Registration. Site Registration #2020433 |
| Official Correspondent: | William E. Meyers, Ph.D.
% Paragon Vision Sciences
Address: 945 East Impala Ave. Mesa AZ 85204
Phone: 602-507-7606, Fax: 602-892-322 |
| Reason for 510(k): | New Device |
| Date of submission | 12/9/97 |
| Device Identification: | Trade Name: Paragon Contact Lens Case
Common Name: Contact lens Case
Classification Name: Contact Lens Case |
| Indication for use: | The Paragon Contact Lens Case is indicated for the chemical disinfection and
storage of Rigid Gas Permeable and Hard contact lenses. |
| Equivalence: | The Paragon Contact Lens Case is substantially equivalent to the Boston Contact
Lens Case marketed by Polymer Technology, Division of Wilmington Partners which
is presently approved and marketed under premarket notification K962512. |
| Toxicology Testing: | In support of the premarket notification information from the following
was submitted:
- Systemic Injection Test
- Eye Irritation Test
- Cytotoxicity test |
. . . . . . .
:
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William E. Meyers, Ph.D. Vice President, Science & Technology Paragon Vision Sciences 945 East Impala Ave. Mesa, AZ 85204
FEB - 4 1998
Re: K974635 Trade Name: Paragon Contact Lens Case Regulatory Class: Unclassified Product Code: 86 LRX Dated: December 9, 1997 Received: December 12, 1997
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 Roerl 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): K974635
Device Name: Paragon Contact Lens Case
Indications For Use: The Paragon Contact Lens Case 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)
Ming-chuer Shut
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