(267 days)
OPTI-FREE® EXPRESS® LENS DROPS may be used to lubricate and rewet daily, extended wear and disposable soft (hydrophilic) contact lenses as follows:
- Moistening lenses as needed during the day to reduce discomfort. .
- Moistening extended wear lenses prior to retiring at night and upon . awakening.
OPTI-FREE EXPRESS Lens Drops is a sterile, buffered, isotonic, aqueous solution that contains a citrate buffer and sodium chloride with edetate disodium 0.05% and Polyguad® (polyguaternium-1) 0.001% as preservatives and Clens® ~ 100.
The provided text describes a 510(k) submission for OPTI-FREE® EXPRESS® Lens Drops, which is a contact lens rewetting solution. The submission focuses on demonstrating substantial equivalence to a previously approved device. While it mentions safety and effectiveness studies, the level of detail provided is insufficient to fully answer all aspects of your request as it pertains to acceptance criteria and a structured study demonstrating all specifics.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or precise performance metrics in a readily table format. Instead, it refers to compliance with FDA guidelines for contact lens solutions and demonstration of "safety and effectiveness."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Microbiological Safety and Effectiveness: Compliance with FDA guidelines for contact lens solutions. | "Results of all tests were in compliance with the FDA testing guidelines." |
| Toxicological Safety: No hazard to consumers under recommended use or accidental/intentional misuse. | "OPTI-FREE EXPRESS Lens Drops has been shown to be safe in comprehensive toxicology studies. OPTI-FREE EXPRESS Lens Drops should not present a hazard to the consumer when used under the recommended treatment regimen for soft (hydrophilic) contact lenses, or under conditions of accidental or intentional misuse." |
| Clinical Safety and Efficacy: Safe and effective, and reduction in lens lysozyme levels. | "These clinical studies demonstrate that OPTI-FREE EXPRESS Lens Drops is safe and effective and also significantly reduce lens lysozyme levels on soft contact lenses when used as indicated." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document only states "Studies were conducted to clinically evaluate the safety and efficacy..." without giving numbers of participants or lenses.
- Data Provenance: Not explicitly stated. However, given it's an FDA submission, the studies would typically be conducted according to US regulatory standards. It's likely prospective for clinical studies, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This type of study is highly unlikely for a rewetting solution for contact lenses. MRMC studies are typically used for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated for its impact on their performance. The provided device is a liquid solution for lens care.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- This concept is not applicable to a contact lens rewetting solution. The device itself is the product, not an algorithm that operates independently. Its "performance" is assessed through its chemical and biological effects on lenses and eyes, and its clinical impact on users.
7. Type of Ground Truth Used:
Based on the nature of the studies mentioned:
- Microbiological tests: Likely laboratory assays and challenge tests with defined microbial strains.
- Toxicology studies: Likely animal models and/or in vitro cell culture tests, following established toxicology protocols.
- Clinical studies: Likely relied on patient-reported outcomes (e.g., discomfort, satisfaction) and potentially objective clinical assessments by ophthalmologists or optometrists (e.g., ocular health, lens deposition). The mention of "lens lysozyme levels" suggests quantitative biochemical analysis from lenses.
8. Sample Size for the Training Set:
- Not applicable/Not specified. For a chemical product like this, there isn't a "training set" in the context of an AI/machine learning algorithm. The "development" would involve formulation and laboratory testing leading to the product and subsequent clinical validation, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of AI. The "ground truth" for the product's development and validation would be derived from scientific principles, laboratory testing standards, and clinical study endpoints.
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SEP 1 6 1999
510(K) SUMMARY
Submitted by:
Ralph H. Larsen Manager, Requlatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4702 (Phone) (817) 551-4630 (Fax)
Device Name:
| Common Name:and the first of the state of the program and the first of the programment of the first of the first of the first of the first of the first of the first of the first of the f | Contact Lens Care Rewetting Solution | |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------- | -- |
OPTI-FREE® EXPRESS® Lens Drops Proprietary Name:
Indications for Use:
OPTI-FREE® EXPRESS® LENS DROPS may be used to lubricate and rewet daily, extended wear and disposable soft (hydrophilic) contact lenses as follows:
- Moistening lenses as needed during the day to reduce discomfort. .
- Moistening extended wear lenses prior to retiring at night and upon . awakening.
Description:
OPTI-FREE EXPRESS Lens Drops is a sterile, buffered, isotonic, aqueous solution that contains a citrate buffer and sodium chloride with edetate disodium 0.05% and Polyguad® (polyguaternium-1) 0.001% as preservatives and Clens® ~ 100.
Substantial Equivalence:
OPTI-FREE EXPRESS Lens Drops is substantially equivalent, in terms of its actions and indications for use, to OPTI-FREE Rewetting Drops approved under PMA 830034/S16. OPTI-FREE EXPRESS Lens Drops meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.
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Safety and Effectiveness:
A. Non-Clinical Data
OPTI-FREE EXPRESS Lens Drops was evaluated for microbiological safety and effectiveness using the FDA guidelines for contact lens solutions. Results of all tests were in compliance with the FDA testing guidelines
OPTI-FREE EXPRESS Lens Drops has been shown to be safe in comprehensive toxicology studies. OPTI-FREE EXPRESS Lens Drops should not present a hazard to the consumer when used under the recommended treatment regimen for soft (hydrophilic) contact lenses, or under conditions of accidental or intentional misuse.
B. Clinical
Studies were conducted to clinically evaluate the safety and efficacy of OPTI-FREE EXPRESS Lens Drops These clinical studies demonstrate that OPTI-FREE EXPRESS Lens Drops is safe and effective and also significantly reduce lens lysozyme levels on soft contact lenses when used as indicated.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1999
Mr. Ralph H. Larsen, RAC Manager, Regulatory Affairs Alcon Laboratories 6201 South Freeway Fort Worth, Texas 76134-2099
Re: K984573 Trade Name: OPTI-FREE® EXPRESS® Lens Drops Regulatory Class: II Product Code: 86 LPN Dated: July 14, 1999 Received: July 15, 1999
Dear Mr. Larsen:
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 - Mr. Ralph H. Larsen, RAC
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Alver L. 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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510(k) Number (if known): K984573
Device Name: OPTI-FREE® EXPRESS® Lens Drops
Indications for Use:
OPTI-FREE® EXPRESS® LENS DROPS may be used to lubricate and rewet daily, extended wear and disposable soft (hydrophilic) contact lenses as follows:
- Moistening lenses as needed during the day to reduce discomfort. .
- Moistening extended wear lenses prior to retiring at night and upon awakening.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K 984573
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use X
§ 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.”