(98 days)
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.
The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.
The provided text is a 510(k) summary for a contact lens care product, not a medical device that utilizes AI or algorithmic performance for diagnostics or treatment. Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI-specific metrics (like MRMC studies or standalone algorithm performance) is not applicable to this document.
The document discusses the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to a predicate device based on pre-clinical and clinical studies submitted previously (K003345 and K013512). It confirms its intended use for cleaning, disinfecting, daily protein removal, and storing soft contact lenses.
Without details from the referenced prior submissions (K003345 and K013512), it's impossible to extract specific acceptance criteria, reported performance, or study methodologies that traditionally apply to AI-driven medical devices.
Summary of inapplicable questions:
- 1. A table of acceptance criteria and the reported device performance: Not provided. This document describes a chemical solution, not a performance-based diagnostic device.
- 2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned (K003345, K013512) are for the chemical solution's safety and effectiveness.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to microbiological efficacy or clinical outcomes, not expert image interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
- 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 (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but would likely involve microbiological challenge tests and clinical trial outcomes for safety/efficacy in contact lens care.
- 8. The sample size for the training set: Not applicable. There is no "training set" for this type of product.
- 9. How the ground truth for the training set was established: Not applicable.
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510(k) SUMMARY
In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.
510(k) SUMMARY FOR AOSEPT Clear Care Cleaning and Disinfecting Solution
1. Submitter Information
CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdley Telephone No: 678-415-3897
2. Device Name
Classification Name: Soft (hydrophilic) Contact Lens Solution AOSEPT Clear Care Cleaning and Disinfecting Solution Proprietary Name:
ന് Predicate Devices
Allergan Ultracare Disinfecting Solution/Neutralizer
4. Description of the Devices
The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.
5. Indications for Use
AOSeptClear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Description of Safety and Substantial Equivalence 6.
A series of preclinical and clinical studies were completed on this product and were previously submitted under submission K003345 and K013512.
7. Substantial Equivalence
AOSept Clear Care Cleaning and Disinfection Solution is substantially equivalent to currently marketed AOSept Clear Care Cleaning and Disinfection Solution in cleaning, disinfecting, daily protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2002
CIBA Vision Corp. c/o Steven Dowdley, RAC 11460 Johns Creek Parkway Duluth, GA 30097-1556
Re: K022687
Trade/Device Name: AOSEPT Clear Care Cleaning and Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL Dated: October 4, 2002 Received: October 7, 2002
Dear Mr. Dowdley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Steven Dowdley, RAC
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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PART III. INDICATIONS FOR USE STATEMENT ME CORRECT CONTRACT
510(k) Number: This is a new 510 (k) Notification. (Number to be assigned) AOSEPT Clear Care Cleaning and Disinfecting Solution Device Name:
Indications for Use:
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ☐ or over-the-counter: ☑
Off ് Vision of Ophthalmic Ear, Nose and Throat Dev
Nose and Throat
510(k) Number K022687
§ 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.”