PARAGON LENS CARE

• K Number: K974635
• Device Name: PARAGON LENS CARE
• Manufacturer: PARAGON VISION SCIENCES
• Date Cleared: 1998-02-04 ( 54 days)
• Product Code: LRX
• Regulation Number: 886.5928
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: k962512
• Predicate For: K060036 , K974649 , K983382 , K992844 , K993486 , K993487

Intended Use

The Paragon Contact Lens Case is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.

Device Description

Trade Name: Paragon Contact Lens Case
Common Name: Contact lens Case
Classification Name: Contact Lens Case

AI/ML Overview

The provided text is a 510(k) summary for a contact lens case, which is a physical medical device, not a software algorithm. Therefore, the questions regarding acceptance criteria and studies for a device meeting those criteria, particularly those related to AI/algorithm performance, ground truth, expert consensus, and sample sizes for training/test sets, are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and includes information about toxicology testing for the materials used in the contact lens case.

Here's a breakdown of what is available in the provided text, related to the nature of the device:

1. Acceptance Criteria and Reported Device Performance: Not applicable in the context of an algorithm. For a physical device like a contact lens case, acceptance criteria typically involve material biocompatibility, structural integrity, and effective containment/disinfection properties. The document mentions Toxicology Testing as follows:

   • Systemic Injection Test
   • Eye Irritation Test
   • Cytotoxicity test
     No specific quantitative "performance" metrics for these tests are provided in the summary, just that information from these tests was submitted in support of the premarket notification.

2. Sample size used for the test set and the data provenance: Not applicable. Toxicology testing usually involves in-vitro or animal studies, not "test sets" of data in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This pertains to AI-assisted reading, which is not relevant for a contact lens case.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable. For toxicology, the "ground truth" would be the observed biological response to the materials.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In essence, the provided document is a regulatory submission for a physical medical device (contact lens case) and does not contain information relevant to the performance evaluation of an AI or algorithmic device as requested by your prompt.

Summary

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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 SciencesAddress: 945 East Impala Ave.Phone: [phone], Fax: [phone]Registration: Owner Operator # 9024618FEB - 4 1998
Manufacturer:	Company Name: Paragon Vision SciencesAddress: 945 East Impala Ave. Mesa AZ 85204Phone: [phone], Fax: [phone]Registration. Site Registration #2020433
Official Correspondent:	William E. Meyers, Ph.D.% Paragon Vision SciencesAddress: 945 East Impala Ave. Mesa AZ 85204Phone: [phone], Fax: [phone]
Reason for 510(k):	New Device
Date of submission	12/9/97
Device Identification:	Trade Name: Paragon Contact Lens CaseCommon Name: Contact lens CaseClassification Name: Contact Lens Case
Indication for use:	The Paragon Contact Lens Case is indicated for the chemical disinfection andstorage of Rigid Gas Permeable and Hard contact lenses.
Equivalence:	The Paragon Contact Lens Case is substantially equivalent to the Boston ContactLens Case marketed by Polymer Technology, Division of Wilmington Partners whichis presently approved and marketed under premarket notification K962512.
Toxicology Testing:	In support of the premarket notification information from the followingwas submitted:1. Systemic Injection Test2. Eye Irritation Test3. Cytotoxicity test

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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.

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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 Roerl 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): 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)

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Prescription Use	OR Over-The Counter Use	✓
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Regulation Number and Section

§ 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.”