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 recommended by your eye care practitioner.

Device Description

The AOSept Clear Care Cleanir, 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 solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.

AI/ML Overview

Here's an analysis of the provided text regarding the AOSEPT Clear Care Cleaning and Disinfecting Solution, focusing on acceptance criteria and supporting studies:

This document primarily describes the substantial equivalence of a contact lens cleaning solution to existing products, rather than a medical device employing AI or complex algorithms. Therefore, many of the standard questions regarding AI device evaluation (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not directly applicable.

However, I can extract the relevant information from the provided text in the requested format where possible, and indicate when information is not applicable or not provided for this type of product.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Measurement	Predicate Device (Control) Performance	AOSEPT Clear Care Performance (Results)	Met Criteria?
Microbiology	Stand-alone disinfection efficacy	Not specified (implied by predicate)	Meets FDA 5/1/1997 Guidance criteria	Yes
Cleaning (Protein Removal)	Daily protein removal	ReNu Multiplus, OptiFree Express	Substantially equivalent	Yes
Clinical Performance (Subjective)	Insertion comfort (preference)	Bausch & Lomb ReNu Multi-Plus	Statistically significant improvement	Yes
	Overall dryness (preference)	Bausch & Lomb ReNu Multi-Plus	Statistically significant improvement	Yes
	Lens cleanliness (preference)	Bausch & Lomb ReNu Multi-Plus	Statistically significant improvement	Yes
	All subjective ratings	Bausch & Lomb ReNu Multi-Plus	Statistically significant improvement	Yes
	All subjective preference rankings	Bausch & Lomb ReNu Multi-Plus	Statistically significant improvement	Yes
Clinical Performance (Objective)	Front surface wetting (investigator observation)	Bausch & Lomb ReNu Multi-Plus	Similar	Yes
	Lens deposits (investigator appraisal)	Bausch & Lomb ReNu Multi-Plus	No statistically significant difference	Yes
	Objective dark-field image analysis (90 days)	Bausch & Lomb ReNu Multi-Plus	No statistically significant difference; clinically acceptable cleanliness	Yes
Safety	Clinical acceptability (no-rub regimen for >1 month worn lenses)	Bausch & Lomb ReNu Multi-Plus (rub regimen)	Clinically acceptable and similar	Yes

2. Sample size used for the test set and the data provenance:

Sample Size (Clinical Evaluation): Not explicitly stated as a number of participants. It mentions "Study participants were all randomized."
Data Provenance: Prospective, randomized, single masked, contralateral trial. No country of origin is explicitly stated, but the submitter information is from Duluth, Georgia, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this device (contact lens solution). The "ground truth" for clinical efficacy and safety was established through participant feedback, investigator observations, and objective measurements (dark-field image analysis). "Investigators" observed front surface wetting and appraised lens deposits, but their number and specific qualifications (e.g., ophthalmologist, optometrist) are not detailed.

4. Adjudication method for the test set:

Not applicable as this is not an image-based or diagnostic device requiring expert adjudication. The study used a "single masked" design, where participants were masked to which eye received the test vs. control product.

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 diagnostic device. The study compared two contact lens care solutions.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithmic device. The "standalone" term is used in the context of microbiology testing, referring to the solution's ability to disinfect by itself, without a separate cleaning step. The text notes: "These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."

7. The type of ground truth used:

Performance (Microbiology): Compliance with FDA guidance for disinfection efficacy.
Performance (Cleaning): Objectively measured protein removal, and dark-field image analysis of lenses for cleanliness.
Clinical Efficacy/Safety: Subjective feedback (insertion comfort, dryness, cleanliness, overall preference) from study participants and objective observations/appraisals by investigators.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

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.

SUMMARY OF SAFETY AND EFFECTIVENESS 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 Proprietary Name: AOSEPT Clear Care Cleaning and Disinfecting Solution

3. Predicate Devices

Bausch & Lomb ReNu MultiPlus Mulit-Purpose Solution

র্ব -Description of the Devices

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.

6. Description of Safety and Substantial Equivalence

Cleaning Studies

Previous studies have demonstrated the cleaning capacity of AOSEPT Clear Care Cleaning and Disinfecting Solution (K003345) with soft contact lenses. The study previously submitted and reviewed demonstrated that AOSept Clear Care was substantially equivalent to the ReNu Multiplus and OptiFree Express in terms of daily protein removal.

Microbiology

A series of studies were completed to demonstrate the microbiological efficacy of AOSEPT Clear Care. These studies were previously submitted under 510(k) K003345. These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of

{1}------------------------------------------------

the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

Clinical Evaluation Summary:

Overview

A three-month prospective, randomized, single masked, contralateral trial was preformed. Study participants were all randomized for which eye used the test and which eye used the control product. The control used in the study was Bausch & Lomb ReNu Multi-Plus Multi-Purpose solution. The regimen followed by the participants was the manufacturer's instructions for the eye using the control product (including rub and rinse) and the instructions provided for the eye using the test product (no rub/no rinse). The contra-lateral design and inclusion criteria optimize sensitivity in comparing the products.

Statistically significant differences in favor of AOSept Clear Care were found for insertion comfort and overall dryness. Statistically significant preference differences in those who expressed a preference in favor of AOSept Clear Care were also found for insertion comfort, dryness and lens cleanliness. Statistically significant differences (at the 0.01 or greater level) in favor of AOSept Clear Care were also found for all subjective ratings. Statistically significant differences (0.01 or greater) in favor of AOSept Clear Care were found for all subjective preference rankings.

Front surface wetting of the lenses was observed by the investigators and was found to be similar between the two lens groups. In addition, there were no statistically significant differences in investigator appraisal of lens deposits, front surface wetting and objective dark-field image analysis of lenses worn for 90 days. Both the test and control product provided clinically acceptable lens cleanliness when used according to their directions for use as measured by dark filed image analysis of the returned lenses.

The safety of AOSept Clear Care used without a rub (for lenses worn greater than onemonth), is clinically acceptable and similar to the Bausch & Lomb ReNu Multi-Purpose Solution used according to its approval labeling, which requires a digital rubbing step.

7. Substantial Equivalence

AOSept Clear Care Cleaning and Disinfection Solution is substantially equivalent to the Bausch & Lomb ReNu Multi-Purpose Solution in cleaning, disinfecting, daily protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The system was also shown to be substantially equivalent to the ReNu Multiplus Solution in daily removal of protein.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized eagle emblem, consisting of three curved lines representing the eagle's wings and body. The emblem is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Mr. Steven Dowdley, RAC Regulatory Specialist Global Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097

Re: K013512

Trade/Device Name: AOSEPT Clear Cleaning and Disinfecting Solution (No Rub Regimen for soft contact lenses worn more than 30 days) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: October 16, 2001 Received: October 22, 2001

Dear Mr. Dowdley:

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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter hit and my of substantial equivalence of your device of your device to a legally premated notificate 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 additionally 21 011 594-4613. 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

{4}------------------------------------------------

PART III. INDICATIONS FOR USE STATEMENT

510(k) Number:	This is a new 510 (k) Notification. (Number to be assigned)
Device Name:	AOSEPT Clear Care Cleaning and Disinfecting Solution

Indications for Use:

Indications for Use.
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning. AUSEPT Clear Care Cleaning and Disinlecting Goldion is indisated for as a recommended by your eye care practitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	or over-the-counter:
-------------------	-----------------------------------------------------------------------------------

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devices

510(k) Number	K013572
---------------	---------

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.”