The AEROSOLV UNPRESERVED BUFFERED SALINE SOLUTION is indicated for the rinsing of soft contact lenses after cleaning, dissolving of the Sauflon AEROTAB Disinfecting Tablet to make the disinfecting/ storage solution, and rinsing of the soft contact lenses prior to insertion onto the eye.

The SAUFLON Barrel Lens Case is to be used with the AEROSOLV UNPRESERVED BUFFERED SALINE SOLUTION and Sauflon AEROTAB Disinfecting Tablets as the lens case for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses .

The SAUFLON barrel lens case may also be used as the lens case for storage of soft (hydrophilic) contact lenses during chemical disinfection only. DO NOT USE WITH HEAT OR HYDROGEN PEROXIDE SYSTEMS.

Device Description

The Sauflon Aerotab Disinfecting Tablet contains halazone (4-carboxyphenyl N-chloro sulphonamide) as the active ingredient, with an effervescent base of adipic acid and anhydrous sodium carbonate. There is no preservative in the tablet. AEROSOLV Unpreserved Buffered Saline Solution is a sterile, aqueous, isotonic solution of sodium chloride buffered with boric acid and sodium borate.

The Sauflon AEROTAB disinfecting system was shown to be compatible with clear (untinted) soft (hydrophilic) contact lenses .

AI/ML Overview

The Sauflon AEROTAB Disinfecting System (composed of the Sauflon AEROTAB Disinfecting Tablet, AEROSOLV Unpreserved Buffered Saline Solution, and Sauflon Barrel Lens Case) was evaluated through several studies to meet its acceptance criteria for chemical disinfection and storage of soft (hydrophilic) contact lenses.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Microbiology	Meets Stand-Alone Procedure for Disinfecting Products requirements	Efficacy maintained throughout labeled shelf-life	Microbiology
Clinical Safety (Adverse Reactions)	No adverse reactions	No adverse reactions observed	Clinical Trial
Clinical Safety (Ocular Findings)	Acceptable percentage of "no positive slit lamp findings"	90% of eye examinations showed no positive slit lamp findings (compared to 67% for peroxide control)	Clinical Trial
Clinical Safety (Symptoms)	Acceptable percentage of "no symptoms reported"	81% of visits reported no symptoms (compared to 85% for peroxide control, considered not significantly different)	Clinical Trial
Clinical Efficacy (Visual Acuity)	Appropriate visual acuity (within 2 Snellen lines of original best corrected acuity)	95% of test eyes achieved appropriate visual acuity	Clinical Trial
Clinical Efficacy (Lens Cleanliness)	Acceptable percentage of "clinically clean" lenses	93% of test lenses were clinically clean at scheduled visits	Clinical Trial
Toxicology (Cytotoxicity)	No cytotoxicity	No cytotoxicity reported for lenses disinfected for 30 cycles	Toxicology
Toxicology (Ocular Irritation)	No ocular irritation	No ocular irritation reported for lenses disinfected for 30 cycles	Toxicology
Toxicity (Lens Case Components)	Compliance with USP XXIII for Plastics for Ophthalmic Products	Components passed USP XXIII requirements	Toxicology
Lenses Compatibility	Compatibility with clear (untinted) soft (hydrophilic) contact lenses	Shown to be compatible	Product Description

2. Sample Size Used for the Test Set and Data Provenance

Clinical Trial: 334 subjects (276 test, 58 control). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. However, the study involved a "6 month clinical trial," which typically implies a prospective design.
Toxicology: Hydrophilic lenses representative of all four groups were disinfected for 30 cycles. The exact number of lenses is not specified.
Microbiology: Not specified, but the "Stand-Alone Procedure for Disinfecting Products" would involve specific laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The provided text does not specify the number or qualifications of experts used to establish the ground truth for the test set. For the clinical trial, "no positive slit lamp findings" and "clinically clean" lenses likely involved evaluations by ophthalmologists or optometrists, but their specific qualifications or number are not detailed.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned. The clinical trial compared the Sauflon AEROTAB Disinfecting Tablet system to a "commercial peroxide disinfecting system," which is a comparison of two different disinfecting methods, not an AI assistance study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a chemical disinfecting system, not an AI algorithm. Therefore, the concept of an "algorithm only without human-in-the-loop performance" does not apply. The clinical and microbiological studies represent the "standalone" performance of the disinfecting system itself.

7. The Type of Ground Truth Used

Clinical Trial: The ground truth for the clinical trial would be a combination of:
- Expert Clinical Assessment: Slit lamp findings, visual acuity measurements (likely by trained professionals), and assessment of lens cleanliness.
- Patient-Reported Outcomes: Symptoms reported by subjects.
Toxicology: Expert assessment of cytotoxicity and ocular irritation (e.g., cell viability assays, animal models or in-vitro tests for ocular irritation).
Microbiology: Laboratory testing according to the "Stand-Alone Procedure for Disinfecting Products," which would have defined metrics for microbial kill.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device (disinfecting system), not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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SEP | 4 1955

K991125

510(K) SUMMARY FOR FREEDOM OF INFORMATION

SAUFLON AEROTAB DISINFECTING SYSTEM FOR SOFT (HYDROPHILIC) CONTACT LENSES

Sauflon Pharmaceuticals, Ltd 1. Submitted by: 49-53 York St Twickenham, Middlesex TW1 3LP United Kingdom
- John M. Szabocsik, Ph.D. Contact Person: Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 TEL: 312-553-0828

July 16, 1999 2. Date Prepared

Sauflon AEROTAB Disinfecting System: 3. Common/Usual Sauflon AEROTAB Disinfecting Tablet with Name AEROSOLV Unpreserved Buffered Saline Solution and Sauflon Barrel Lens Case
Sauflon AEROTAB Disinfecting System: 4. Trade/ Sauflon AEROTAB Disinfecting Tablet with Proprietary AEROSOLV Unpreserved Buffered Saline Solution and Sauflon Barrel Lens Case
Class II (Performance Standards) 21 CFR 5. FDA 886.5928 Soft (hydrophilic) contact lens Classification disinfecting tablet with saline and lens case. Sauflon AEROTAB Disinfecting System: Product code 86LPN
1. Substantial This product is substantially equivalence equivalent to PD 1343 Disinfecting Tablet with Unisol®, approved PMA 8890059.

I. INDICATIONS FOR USE

The SAUFLON AEROTAB DISINFECTING SYSTEM is indicated for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses.

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K991125, FOI pg 2

The SAUFLON barrel lens case may also be used as the lens case for storage of soft (hydrophilic) contact lenses during chemical disinfection only. DO NOT USE WITH HEAT OR HYDROGEN PEROXIDE SYSTEMS.

PRODUCT DESCRIPTION AND CHEMISTRY II.

Sauflon AEROTAB Disinfecting System

The Sauflon AEROTAB disinfecting system was shown to be compatible with clear (untinted) soft (hydrophilic) contact lenses .

III. TOXICOLOGY

Hydrophilic lenses representative of all four groups disinfected for 30 cycles with the Sauflon AEROTAB Disinfecting System showed no cytotoxicity and no ocular irritation.

All toxicology concerning the AEROSOLV Unpreserved Buffered Saline Solution is contained in P850074 and its supplements.

The components of the lens case have passed the requirements for Plastics for Ophthalmic Products (USP XXIII).

MICROBIOLOGY IV.

The Sauflon AEROTAB Disinfecting Tablet is a nonsterile tablet, and the system contains no preservative. The Sauflon AEROTAB Disinfecting System meets the requirements of the Stand-Alone Procedure for Disinfecting Products, and maintains efficacy throughout the labeled shelf-life.

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K991125, FOI pg 3

All microbiology concerning the AEROSOLV Unpreserved Buffered Saline Solution is contained in P850074 and its supplements.

V. CLINICAL STUDIES

A. AEROTAB Disinfecting Tablet

A 6 month clinical trial of 334 subjects (276 test, 58 control) compared the safety and efficacy of the Sauflon AEROTAB Disinfecting Tablet when used with commercially available saline, daily cleaners and wetting solutions to that of a commercial peroxide disinfecting system.

There were no adverse reactions with the Sauflon AEROTAB Disinfecting System, and there were no positive slit lamp findings at 90% of the eye examinations, compared to 67% with no findings with peroxide. No symptoms were reported at 81% of visits, compared to 85% in the peroxide controls, a difference considered not significantly different. The most common symptoms were lens awareness and discomfort in both test and control groups. Appropriate visual acuity (within 2 Snellen lines of original best corrected acuity) was obtained by 95% of the test eyes and all of the control eyes. Wear time was not affected by the care regimen. Evaluation of lens cleanliness showed 93% of test lenses and 94% of control lenses were clinically clean at scheduled visits. There were no significant gender differences in the findings.

All clinical information concerning the AEROSOLV Unpreserved Buffered Saline Solution is contained in P850074 and its supplements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

Sauflon Pharmaceuticals, Ltd. c/o John Szabocsik, Ph.D. Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, Illinois 60601

Re: K991125

Trade Name: Sauflon Aerotab Disinfecting System (Sauflon Aerotab Disinfecting Tablet, Aerosolv Unpreserved Buffered Saline Solution, Sauflon Barrel Leng Case)

Regulatory Class: II Product Code: 86 LPN, 86 LRX Dated: July 19, 1999 Received: July 30, 1999

Dear Dr. Szabocsik:

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 - John Szabocsik, Ph.D.

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,

Afrez L. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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់

510(k) NUMBER (IF KNOWN) K991125

SAUFLON AEROTAB DISINFECTING SYSTEM DEVICE NAME (SAUFLON AEROTAB DISINFECTING TABLET, AEROSOLV UNPRESERVED BUFFERED SALINE, SAUFLON BARREL LENS CASE)

INDICATIONS FOR USE

The preservative-free SAUFLON AEROTAB DISINFECTING SYSTEM is indicated for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(Optional Format 1-2-96)

Myra Smith

(Division Jivision of Ophthalmic Devices 510(k) Number

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510(k) NUMBER (IF KNOWN) K991125

AEROSOLV UNPRESERVED BUFFERED SALINE DEVICE NAME

INDICATIONS FOR USE

The AEROSOLV UNPRESERVED BUFFERED SALINE is indicated for the rinsing of soft contact lenses after cleaning, dissolving of the AEROTAB tablet to make the disinfecting/ storage solution, and rinsing of the soft contact lenses prior to insertion onto the eye.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use

(Optional Format 1-2-96)

Myra Smith

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K991125

してこ

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510(k) NUMBER (IF KNOWN) K991125

SAUFLON BARREL LENS CASE DEVICE NAME

INDICATIONS FOR USE

The SAUFLON Barrel Lens Case is to be used with the AEROSOLV UNPRESERVED BUFFERED SALINE and Sauflon AEROTAB Disinfecting Tablets as the lens case for chemical disinfection and storage of clear, untinted soft (hydrophilic) contact lenses.

The SAUFLON Barrel Lens Case may also be used as the lens case for storage of soft (hydrophilic) contact lenses during chemical disinfection only. DO NOT USE WITH HEAT OR HYDROGEN PEROXIDE SYSTEMS.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use X _

(Optional Format 1-2-96)

Myra Smith

Division of Ophthalmic Devices 510(k) Number_ K 9911 2 5

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.”