Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.

AI/ML Overview

In the provided text, the device in question is "Sauflon Multipurpose Solution". The purpose of the 510(k) submission is to add the indication for use with Silicone Hydrogel Lenses, with the predicate device being Aquify Multi-Purpose Disinfecting Solution.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome	Reported Device Performance (Sauflon Multipurpose Solution)
Silicone Hydrogel Lens Compatibility	Compatibility with currently marketed Silicone Hydrogel lenses	"The results of these studies confirm that the Sauflon Multipurpose Solution is compatible with Silicone Hydrogel lenses." Specifically, it is compatible with "4 representative marketed silicone hydrogel lenses."
Toxicology	Non-toxic in cytotoxicity, systemic toxicity and ocular irritation testing	"Sauflon Multipurpose Solution was shown to be non-toxic in all cytotoxicity, systemic toxicity and ocular irritation testing."
Microbiology	Meet requirements for disinfection efficacy and preservative efficacy	"The Sauflon Multipurpose Solution met the requirements of this testing."
Clinical Safety & Acceptability	Safety and acceptability comparable to predicate device (Aquify Multi-Purpose Solution) for intended use	"The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use."
Overall Equivalence	Substantially equivalent to Aquify Multi-Purpose Disinfecting Solution	"The data provided in this 510k submission concludes that Sauflon Multipurpose Solution for use in soft contact lenses including silicone hydrogel lenses is substantially equivalent to the Aquify Multi-Purpose Disinfecting Solution."

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Clinical Trial: Circa 250 subjects.
- Data Provenance: Not explicitly stated, but the submission is from a UK company, making it plausible the study was conducted there or internationally. The text does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
- Silicone Hydrogel Lens Compatibility: Tested with "4 representative marketed silicone hydrogel lenses."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The clinical study compares the new solution to a predicate device, focusing on safety and acceptability based on subject outcomes and observations, rather than expert interpretation of data points.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The clinical trial focused on safety and acceptability, which typically involves collection of adverse events, comfort scores, and other objective measures, rather than subjective adjudication by multiple experts.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not applicable to a contact lens solution.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a contact lens solution, not an algorithm. The "standalone" performance would refer to the chemical properties and biological effects of the solution, which were tested in pre-clinical (toxicology, microbiology) and clinical studies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For pre-clinical studies (toxicology, microbiology, lens compatibility): The "ground truth" was established by objective laboratory test results against predefined standards (e.g., cytotoxicity assays, microbial kill rates, material compatibility assessments).
- For clinical studies: The "ground truth" for safety and acceptability was established through clinical observations, reported adverse events, comfort questionnaires, and other objective measures from the 250 subjects, compared against the predicate device. This falls under outcomes data or clinical endpoints.
The sample size for the training set:
- Not applicable. This is a contact lens solution, not an AI/machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as no training set was used.

Summary

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SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

510(k) SUMMARY

MAY 1 5 2013

SAUFLON MULTIPURPOSE SOLUTION

Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner. The Sauflon Multipurpose Solution is identical to that cleared in K974485 and K030278. The purpose of this submission is to add the indication for use with Silicone Hydrogel Lenses.

1. Submitted by:	Sauflon Pharmaceuticals Ltd49-53 York StreetTwickenhamTW1 3LPUK
Official correspondent:	Christopher Smejkal (BSc, PhD)Strategic Technical Projects Manager+44 (0) 20 8322 4233chrissmejkal@sauflon.co.uk
2. Device name
Common Name:	Multipurpose Solution

Proprietary Name: Sauflon Multipurpose Solution

Classification: Class II (Performance Standards) 21 CFR 886.5928 Soft (hydrophilic) contact lens solution

1. Substantial The product is substantial equivalent to the currently marketed Aquify Multipurpose Disinfecting Solution Equivalence: (K050250/K033608)
1. Device Description: Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.

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K130734
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SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

1. Indications for use: Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner

7. Pre-clinical Testing

Silicone Hydrogel lens compatibility

A series of compatibility studies were conducted assessing the Sauflon Multipurpose Solution with currently marketed Silicone Hydrogel lenses. The results of these studies confirm that the Sauflon Multipurpose Solution is compatible with Silicone Hydrogel lenses.

Toxicology

Sauflon Multipurpose Solution was shown to be non-toxic in all cytotoxicity, systemic toxicity and ocular irritation testing.

Microbiology

A series of microbiological studies were conducted to demonstrate the disinfection efficacy, preservative efficacy and thus safety of the Sauflon Multipurpose Solution. The Sauflon Multipurpose Solution met the requirements of this testing.

8. Clinical Studies

A clinical trial of circa 250 subjects, using the Sauflon Multipurpose Solution with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi- Purpose Solution. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.

9. Technological Characteristics

The sponsor considers Sauflon Multipurpose Solution to be substantially equivalent to the current marketed product Aquify Multi- Purpose Solution. The following table shows a comparison of the Sauflon Multipurpose Solution to the predicate device, Aquify.

Sauflon Multipurpose solution is also identical to the currently marketed Sauflon Multipurpose solution which has already been previously reviewed by the FDA under 510(k)'s K974485 and K030278. The purpose of this submission is to add the indication for use with Silicone Hydrogel Lenses.

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K130734
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SAUFLON MULTIPURPOSE SOLUTION 510(k) Date of Revision 15th May 2013

Indications for use	SAUFLON MULTIPURPOSESOLUTION	AQUIFY MULTI-PURPOSESOLUTION
	Sauflon Multipurpose Solution isindicated for use in the dailycleaning, rinsing, chemical (not heat)disinfection, removal of proteins,storage and conditioning of soft(hydrophilic) contact lenses(including Silicone Hydrogel Lenses)replaced in 30 days or less, asrecommended by the eye carepractitioner.	Aquify Multi-Purpose Solution isindicated for use in the dailycleaning, rinsing, chemical (not heat)disinfection, removal of proteins,storage and conditioning of soft(hydrophilic) contact lenses(including Silicone Hydrogel Lenses)replaced in 30 days or less, asrecommended by the eye carepractitioner.
Product description
	Sauflon Multipurpose Solution is asterile, isotonic solution that containspoloxamer 188, sodium phosphatebuffer, sodium chloride, anddisodium edetate; preserved withpolyhexanide 0.0001%. Contains nochlorohexidine or thimerosal.	Aquify Multi-Purpose Solution is asterile, aqueous solution that containssorbitol, tromethamine, pluronicF127, sodium phosphate dihydrogen,Dexpant 5 (dexpanthenol) andedetate disodium dihydrate;preserved with polyhexanide0.0001%. Contains nochlorohexidine or thimerosal.
Product Characteristics
Active ingredient/preservative	Polyhexamethylene biguanide	Polyhexamethylene biguanide
Chelating agent	Disodium edetate	edetate disodium dihydrate
Tonicity agent	Sodium Chloride	Sorbitol
Surfactant cleaner	Poloxamer 188	Pluronic F127
Lubricant	N/A	N/A
Sterility	Sterile	Sterile
Performance
Compatibility	Compatible with soft (hydrophilic)contact lenses, groups 1 and 4 as per510(k) K974485/ K030278 and with4 representative marketed siliconehydrogel lenses.	Compatible with soft (hydrophilic)contact lenses and silicone hydrogellenses.
Clinical	Substantially equivalent to Aquify
Toxicology	Non-toxic in all cytotoxicity andocular irritation tests.

Conclusions 10.

The data provided in this 510k submission concludes that Sauflon Multipurpose Solution for use in soft contact lenses including silicone hydrogel lenses is substantially equivalent to the Aquify Multi-Purpose Disinfecting Solution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wings or feathers.

May 15. 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sauflon Pharmaceuticals Ltd % Dr. Christopher Smeikal Strategic Technical Projects Manager 49-53 York Street Twickenham, Middlesex TW1 3LP England

Re: K130734

Trade/Device Name: Sauflon Multipurpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: March 25, 2013 Received: March 29, 2013

Dear Dr. Smejkal:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Dr. Christopher Smeikal

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia YAlexander -S

for Malvina B. Eydelman, 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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SAUFLON MULTIPURPOSE SOLUTION 510(k)

INDICATIONS FOR USE

510(k) Number (if known):	K130734
Device Name:	Sauflon Multipurpose Solution
Indications For Use:	Sauflon Multipurpose Solution is indicated for use inthe daily cleaning, rinsing, disinfection, removal ofproteins, storage and conditioning of soft (hydrophilic)contact lenses including silicone hydrogel lenses, asrecommended by the eye care practitioner

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ಳ

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

Concurrence of the CDRH, Office of Device Evaluation (ODE)

J Angelo Green హెక్టార్లు
2013.05.14 16:06:18 04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number_

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.”