AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AOSEPT Clear Care Cleaning and Disinfecting Solution, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Device Performance (AOSept Clear Care)
Compatibility	Optical Parameters (Paraperm EW RGP Lenses - Power, Base Curve, Diameter)	Maintained within specifications after 30 cycles
	Physical Parameters (Paraperm EW RGP Lenses - Visual appearance, % transmittance, microscope)	Maintained within specifications after 30 cycles
	Optical Parameters (Fluoroperm 30 RGP Lenses - Power, Base Curve, Diameter)	Maintained within specifications after 30 cycles
	Physical Parameters (Fluoroperm 30 RGP Lenses - Visual appearance, % transmittance, microscope)	Maintained within specifications after 30 cycles
	Compatibility with Focus Lens Drops (lubricating/rewetting)	Successfully demonstrated compatibility
	Compatibility with Aquify Lens Drops (lubricating/rewetting)	Successfully demonstrated compatibility
Microbiology	ISO 14729 (FDA 510(k)) Stand Alone Test	Provides effective disinfection based on criteria
	ISO 14729 (FDA 510(k)) Regimen Test	Provides effective disinfection based on criteria
Biocompatibility	FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance for Contact Lens Care Products	Meets guidelines; non-toxic and biocompatible (from previous studies)
Clinical Effectiveness (RGP Lenses)	Lenses "clean" after 1-month wear	91% reported none or slightly deposited
	Subject reporting lens needs cleaning at follow-up 2	7% reported lenses needed cleaning
	Usage of lubricating drops prior to insertion every day	29% of AOSept Clear Care users
	Comfort grading (0-10 scale) at Follow-up 2	Reported high ( > 8.5)
	(Comparative with Aquify vs. Focus Clerz)	Aquify users showed higher comfort, fewer lens deposits, better wettability

2. Sample Sizes and Data Provenance

Test Set (Clinical Study for RGP Lenses): The text states, "Two thirds of subjects used the AOSept Clear Care, while and one-third used the control solution." The total number of subjects is not specified, only the ratio.
Data Provenance: The RGP lens clinical study was a "one-month prospective randomized trial." The country of origin of the data is not explicitly stated, but the submission is from CIBA Vision Corporation in Duluth, Georgia, USA, suggesting the study was likely conducted in the USA.
Other Studies (Compatibility, Microbiology, Biocompatibility): Sample sizes for these preclinical studies are not provided in this summary. The summary mentions these were "previously conducted" and "reviewed by FDA under two 510(k), K013512 and K003345."

3. Number of Experts and Qualifications for Ground Truth

This submission does not detail the use of experts to establish ground truth in the typical sense of a diagnostic medical device's performance claims.

For the clinical study, a "one-month prospective randomized, trial" was conducted. The "ground truth" for clinical effectiveness (e.g., lens cleanliness, comfort) would be based on subject reporting and potentially investigator observations. The qualifications of the clinical investigators are not specified.
For pre-clinical tests (Microbiology, Compatibility, Biocompatibility), the "ground truth" is defined by standardized test methods (e.g., ISO 14729) and regulatory guidelines (e.g., FDA guidance documents, GLP regulations). Performance against these standards serves as the benchmark, rather than expert consensus on individual cases.

4. Adjudication Method

No specific adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the device (contact lens solution) and the types of studies performed (compatibility, microbiology, clinical trial for lens care). Clinical endpoints like "lens cleanliness" and "comfort" are typically assessed by the subject or clinical investigator, not through a multi-expert adjudication of a diagnostic finding.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This device is a contact lens care solution, and its evaluation methodologies do not involve MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Not applicable/done in the context of an algorithm. This product is a chemical solution. The "standalone performance" is demonstrated by the various in vitro and in vivo tests, such as the ISO 14729 Stand Alone Test and Regimen Test for antimicrobial activity, which evaluate the solution's properties independent of human interaction during the test itself, but these tests are not for an AI algorithm.

7. Type of Ground Truth Used

Compatibility: Ground truth is established by objective measurements against pre-defined specifications (e.g., optical power, diameter, visual appearance, % transmittance) and compliance with regulatory guidelines.
Microbiology: Ground truth is established by adherence to in vitro antimicrobial efficacy standards as defined by ISO 14729 and FDA 510(k) performance criteria for contact lens disinfecting solutions, measured by reductions in microbial populations.
Biocompatibility: Ground truth is established by meeting the guidelines set forth in FDA guidance documents and demonstrating non-toxicity and biocompatibility through standard tests.
Clinical: Ground truth for effectiveness with RGP lenses is based on observed clinical outcomes and subject-reported data (e.g., lens cleanliness scores, comfort ratings, need for rewetting drops).

8. Sample Size for the Training Set

Not applicable. This product is a chemical solution, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML algorithm, there is no training set or associated ground truth establishment process.

Summary

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K023455

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

Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Steven Dowdlev Telephone No: 678-415-3897

Device Name

Classification Name: Rigid gas permeable contact lens solution Proprietary Name: AOSEPT Clear Care Cleaning and Disinfecting Solution

Predicate Devices

SOLO-Care™Brand Hard Solution

Description

Indications for Use

Description of Safety and Substantial Equivalence

A series of preclinical studies were previously conducted and reviewed by FDA to assess and demonstrate the safety and effectiveness of AOSept Clear Care with soft hydrophilic lenses. These studies were previously reviewed under two 510(k), K013512 and K003345. All toxicology and microbiological tests were conducted in accordance with GLP regulations. All other testing was conducted in accordance with and in conformance to applicable device regulations. The results further demonstrated that the solution is non-toxic and biocompatible.

The results sumerized below demonstrate that AOSept Clear Care is substantially equivalent to SOLO-Care Hard for cleaning, rinsing, disinfecting and storing rigid permeable (fluoro silicone acrylate and silicone acrylate lenses.

Compatibility

A study was conducted to verify the optical and physical parameters of Paraperm EW (Group II) and Fluoroperm 30 (Group III) hydrophobic contact lenses remain within specifications when used with AOSept Clear Care after 30 cycles. Paraperm EW (Group II) and Fluoroperm 30 (Group III) hydrophobic contact lenses were shown to be

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compatible with AOSept Clear Care in terms of optical (power, base curve and diameter) and physical (visual appearance, % transmittance and microscope) properties

In addition, a compatibility study was successfully conducted to demonstrate the compatibility of AOSept Clear Care when used in conjunction with Focus Lens Drops and Aquify Lens Drops.

Microbiology

The antimicrobial activity of AOSept Clear Care was previously evaluated by the ISO 14729 (FDA 510(k)) Stand Alone Test and Regimen Test procedure for disinfection of contact lenses. The results, as previously reviewed under K013512 and K003345. demonstrated that AOSept Clear Care provides effective disinfection of contact lenses based on ISO 14729 and the FDA 510(k) performance criteria for contact lens disinfecting solutions.

Biocompatibility

AOSept Clear Care meets the guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance for Contact Lens Care Products. In addition, compatibility was demonstrated with AOSept Clear Care and two currently marketed lubricating/rewetting drops (Focus Lens Drops and Aquify Comfort Drops),

Clinical

A one-month prospective randomized, trial consisting of a baseline visit and two follow-up visits were conducted with AOSept Clear Care. Subjects were randomized into two treatment groups according to which were to use the test and which were to use the control solution. Two thirds of subjects used the AOSept Clear Care, while and one-third used the control solution.

The data supports that AOSept Clear Care is an effective lens care system for rigid gas permeable lenses. The data also support that lenses treated AOSept Clear Care were clean after 1-month wear: 91% none or slightly deposited and 7% reporting lens needs cleaning at follow-up 2 visit. In addition, only 29% of the AOSept Clear Care users used lubricating drops prior to insertion every day and comfort was graded high (>8.5 [0-10 scale] at Follow-up 2). Subjects using the Aquify lubricating system showed higher comfort, fewer lens deposits and better lens wettability than those subjects using Focus Clerz.

In conclusion, the data supports that AOSept Clear Care is clinically acceptable as a care system for RGP lenses and is substantially equivalent to SOLO-Care Hard.

Substantial Equivalence

AOSept Clear Care Cleaning and Disinfection Solution is substantially equivalent to the SOLO-Care Hard Solution in cleaning, disinfecting, daily protein removal and storing of rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three lines forming the body and two curved lines at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2003

CIBA VisionCorporation C/O Steven Dowdley, RAC 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K023455

Trade/Device Name: AOSEPT Clear Care Cleaning and Disinfecting Solution Regulation Number: 21 CFR 886.5928, 21 CFR 886.5918 Regulation Name: Soft contact lens care products, Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LPN, MRC Dated: January 22, 2003 Received: January 29, 2003

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, 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 (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 – Mr. Steven Dowdley

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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

Enclosure

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PART III. INDICATIONS FOR USE STATEMENT

K023455

This is a new 510 (k) Notification. (Number to be assigned) 510(k) Number:

AOSEPT Clear Care Cleaning and Disinfecting Solution Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

or over-the-counter:

unter:

Kaiser Waibant

Nos

510(k) Number K023455

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”