The Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner

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. Sauflon Multipurpose Solution remains unchanged from the previously approved product in K974485, except for the revised directions for use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sauflon Multipurpose Solution, based on the provided text:

Important Note: The provided document is a 510(k) summary for a multipurpose solution, which is a chemical product, not a medical device in the typical sense of AI-powered diagnostic or therapeutic tools. Therefore, many of the requested categories (like "Number of experts," "MRMC study," "AI assistance," "Standalone performance," "Training set sample size," etc.) are not applicable to this type of submission. The information provided focuses on the safety and efficacy of the solution itself and its comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (Summary from Text)
Solution Compatibility	Compatibility with contact lenses.	"Details... contained in K974485." (Not explicitly stated in K030278, but referenced as already met).
Toxicology	Non-toxic for ophthalmic use.	"Toxicological testing... contained in K974485." (Not explicitly stated in K030278, but referenced as already met).
Container Material	Meet USP<661> for ophthalmic containers.	"Sauflon Multipurpose solution container components meet the requirements of the USP<661>... confirmed by... cytotoxicity, occular irritancy, and systemic toxicity tests."
Sterility	Sterile.	"Meets the requirements of sterility testing as per K974485." (Not explicitly stated in K030278, but referenced as already met).
Preservative Efficacy	Effective at preserving the solution.	"Meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K974485."(Not explicitly stated in K030278, but referenced as already met).
Disinfection Efficacy	Effective at disinfecting contact lenses.	"Meets the requirements of both the stand-alone with organic load disinfection test and the regimen test."
Clinical Safety & Acceptability	Safe and acceptable for use by contact lens wearers; equivalent to predicate.	"A clinical trial of 3 months usage... by 50 subjects... showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device."

Study Details for Clinical Safety & Acceptability (as applicable for this product)

Since this is a solution, not a device with AI, the "test set" and "ground truth" concepts are interpreted differently. For the clinical study, the "test set" refers to the subjects using the product, and "ground truth" is established through clinical observations of safety and acceptability.

2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Clinical Study): 50 subjects using Sauflon Multipurpose Solution.
- Control Group: 21 control subjects using AMO Complete Brand Multi-Purpose Solution - No Rub.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data beyond the submission being from "Twickenham, Middlesex TW1 3LP United Kingdom". The study is prospective, as it describes a 3-month usage period.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not explicitly stated. The "ground truth" for a contact lens solution clinical study would typically involve clinical assessments by eye care practitioners or other medical professionals monitoring the subjects for adverse events, comfort, and other relevant outcomes. The document indicates the product is for use "as recommended by the eye care practitioner," implying expert involvement in monitoring but doesn't specify how many or their qualifications for establishing study "ground truth."
4. Adjudication Method for the Test Set:
- Not described in the provided text. For a clinical study of this nature, adjudication of adverse events or safety concerns would typically be part of the protocol, but the method is not detailed here.
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:
- No, this was not done. This type of study is relevant for diagnostic imaging AI devices, not for contact lens care solutions.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this was not done. This concept is only applicable to AI/algorithm-based devices. The "standalone" tests for this product were laboratory tests for sterility, preservative efficacy, and disinfection efficacy (as listed in section 7 of the 510(k) summary).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
- For the clinical study, the ground truth was based on clinical observations and subjective feedback from subjects regarding safety and acceptability over a 3-month period, likely assessed against outcomes data such as adverse event rates, comfort scores, and overall satisfaction, compared to the predicate device.
- For the pre-clinical (laboratory) tests (sterility, efficacy, etc.), the "ground truth" was established by defined laboratory standards and measurement protocols (e.g., USP<661> requirements, specific disinfection test standards).
8. The Sample Size for the Training Set:
- Not applicable. This product is a chemical solution, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an AI model.

Summary

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SAUFLON MULTIPURPOSE SOLUTION 510(k)

7.0

510(k) SUMMARY

SAUFLON MULTIPURPOSE SOLUTION

1.	Submitted by:	Sauflon Pharmaceuticals Ltd 49-53 York Street Twickenham TW1 3LP UK
	Official correspondent:	Ligia Delacruz, PhD Regulatory Affairs Manager
2.	Device name
	Common Name:	Multipurpose Solution
	Proprietary Name:	Sauflon Multipurpose Solution
3.	Classification:	Class II (Performance Standards) 21 CFR 886.5928 Soft (hydrophilic) contact lens solution
4.	Substantial Equivalence:	The product is substantially equivalent to the currently marketed Complete Brand Multi-Purpose Solution - No Rub
	5. 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.
		Sauflon Multipurpose Solution remains unchanged from the previously approved product in K974485, except for the revised directions for use.
6. Intended use:		The Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage and soft (hydrophilic) contact lenses, as recommended by the eye care practitioner

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7. Pre-clinical Testing

Solution compatibility

Details of the compatibility study on the Sauflon Multipurpose Solution are contained in K974485

Toxicology

The toxicological testing of Sauflon Multipurpose Solution is contained in K974485

SAUFLON MULTIPURPOSE SOLUTION CONTAINER

The Sauflon Multipurpose solution container components meet the requirements of the USP<661> for containers and closures for ophthalmic preparations, and it has been confirmed by the appropriate tests (i.e the cytotoxicity, occular irritancy, and systemic toxicity tests).

Microbiology

Sterility

The Sauflon Multipurpose Solution meets the requirements of sterility testing as per K974485.

Preservative efficacy

The Sauflon Multipurpose Solution meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K974485.

Disinfection Efficacy

The Sauflon Multipurpose Solution meets the requirements of both the stand-alone with organic load disinfection test and the regimen test.

Clinical Studies 8.

A clinical trial of 3 months usage of the Sauflon Multipurpose Solution by 50 subjects, wearing soft (hydrophilic) contact lenses of either group II and IV, compared to 21 control subjects using to the AMO Complete Brand Multi-Purpose Solution - No Rub, showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.

9. Conclusions

The Sauflon Multipurpose Solution for use in a no rub regimen for lenses replaced in 30 days or less is substantially equivalent to the AMO Complete Brand Multi-Purpose Solution - No Rub.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.

Public Health Service

JUL 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sauflon Pharmaceuticals Ltd. c/o Dr. Ligia Delacruz Regulatory Affairs Manager 49-53 York St. Twickenham. Middlesex TW1 3LP United Kingdom

Re: K030278

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: June 11, 2003 Received: June 13, 2003

Dear Dr. Ligia Delacruz:

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 (OS) 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 - Dr. Ligia Delacruz

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 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. Levy 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Indications For Use:

Sauflon Multipurpose Solution

hipe Smith

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K030278

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

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter

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.”