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

Device Description

A sterile, isotonic solution that contains Poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution are primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices (specifically, Bausch and Lomb ReNu Multipurpose Solution). This means the device must perform as safely and effectively as the predicate device. The summary doesn't explicitly state quantitative acceptance criteria for each test in a pass/fail format with specific numerical thresholds. Instead, it reports outcomes which, upon review, were deemed to meet the substantial equivalence standard.

Aspect of Performance	Acceptance Criteria (Implied by Substantial Equivalence and Regulatory Requirements)	Reported Device Performance
Solution Compatibility	No significant differences in lens parameters after simulated use (cleaning, rinsing, disinfecting, storing).	No differences in lens parameters found after 30 cycles of simulated use.
Cleaning Effectiveness	Demonstrate efficacy as a daily cleaner.	Efficacy shown by determining critical micelle concentration.
Agar Overlay Cytotoxicity	Non-cytotoxic.	All test lens types were noncytotoxic.
Systemic Toxicity	No difference from control animals; pass test requirements.	No difference from control animals (saline injection). Passed test.
Acute Oral Toxicity	No clinical signs of toxicity; pass test requirements.	No clinical signs of toxicity from test initiation to Day 14. Passed test.
Acute Ocular Irritation	No evidence of ocular irritation compared to control.	No differences between test and control eyes; no evidence of ocular irritation. Meets requirements.
USP Class VI Testing (Bottle)	Test extract showed no evidence of cell lysis/toxicity (Cytotoxicity); no mortality or significant systemic toxicity (Systemic Toxicity); no significant irritation (Ocular Irritation).	Saline test extract not cytotoxic and passed. Each test article extract met systemic toxicity requirements. No significant ocular irritation in test or control eye.
Sterility	Meet sterility testing requirements.	Passed requirements of sterility testing.
Preservative Efficacy	Meet requirements of modified preservative efficacy test with rechallenge.	Passed requirements of the modified preservative efficacy test with rechallenge.
Disinfection Efficacy	Meet requirements of stand-alone disinfection test (obviating multi-item testing).	Passed requirements of the stand-alone disinfection test.
Stability	Maintain efficacy and safety over intended shelf-life.	Currently passed stability testing corresponding to 11 months shelf-life (ongoing).
Clinical Study - Adverse Reactions	Incidence of adverse reactions comparable to or better than controls.	One case of mild conjunctivitis and one case of marginal keratitis; both resolved with no permanent sequelae (considered acceptable given the study size and comparison to controls).
Clinical Study - Slit Lamp Findings (No Findings)	Percentage of "no findings" comparable to or better than controls.	Test: 79.1%; Multipurpose Control: 57.5%; Peroxide Control: 67.0%. (Higher "no findings" in test group indicates better performance).
Clinical Study - Symptoms (None)	Percentage of "no symptoms" comparable to or better than controls.	Test: 83.7%; Multipurpose Control: 79.6%; Peroxide Control: 85.3%. (Comparable to controls).
Clinical Study - Visual Acuity	Appropriate acuity achieved by a high percentage of eyes, comparable to controls.	Test: 97.1%; Multipurpose Control: 98.4%; Peroxide Control: 100%. (Comparable to controls).
Clinical Study - Wear Time	Wear time remains essentially unchanged.	Wear time remained essentially unchanged over six months.
Clinical Study - Lens Cleanliness	High percentage of clinically clean lenses, comparable to controls.	Test: 97.6%; Multipurpose Control: 92.7%; Peroxide Control: 93.8%. (Better than or comparable to controls).

2. Sample Sizes and Data Provenance

Test Set (Clinical Trial):
- Test Group: 246 subjects
- Control Group: 117 subjects (59 using a commercially available multipurpose solution, 58 using a commercially available two-step peroxide system).
- Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. However, the submitter's address is in the UK and the official agent is in the US, suggesting a potential international or multi-site study, but no definitive statement is made. The study is prospective as it involved tracking subjects using the product over a period of at least three months.
Test Set (Toxicological & Microbiological):
- Agar Overlay Cytotoxicity: Representative lenses from all four groups of soft (hydrophilic) lens types.
- Systemic Toxicity: Healthy mice, 50ml/kg body weight. (Specific number of mice not given).
- Acute Oral Toxicity: Healthy rats, 5ml/kg body weight. (Specific number of rats not given).
- Acute Ocular Irritation: Three rabbits.
- USP Class VI Testing: Not specified, but involved extracts from bottles.
- Sterility, Preservative Efficacy, Disinfection Efficacy: Not specified, but likely involved laboratory samples and standardized media.

3. Number of Experts and Qualifications for Ground Truth

Clinical Study: The clinical trial involved 12 investigators. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not specified in the provided summary. They reported symptoms, problems, complaints, and performed slit lamp examinations.
Toxicological/Microbiological Studies: Not applicable in the same sense as clinical ground truth. These are laboratory tests with objective endpoints.

4. Adjudication Method for the Test Set

Clinical Study: The summary does not describe a formal adjudication method for the clinical observations (slit lamp findings, symptoms). The data appears to be collected directly by the 12 investigators. However, the "Analysis of the discontinuations among the various groups...showed that the differences in the incidence of discontinuations for cause...were not statistically significant," suggesting a statistical comparison was performed.
Laboratory Tests: Not applicable, as these are objective laboratory measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The clinical study was a comparison of a single product (Sauflon Multipurpose Solution) against two control product types, as used by subjects under the supervision of investigators. It was not a study evaluating human readers' diagnostic accuracy with or without AI assistance.

6. Standalone Performance

Yes, standalone (algorithm only without human-in-the-loop performance) was implicitly done for the toxicological and microbiological tests. The solution itself was tested for its inherent properties (cytotoxicity, systemic toxicity, ocular irritation, sterility, preservative efficacy, disinfection efficacy, stability) independent of human interpretation of its effects on patients in the clinical study.

7. Type of Ground Truth Used

Clinical Study: The "ground truth" for the clinical study was based on clinical observations and reported symptoms by human subjects and medical personnel (the 12 investigators). This includes slit lamp findings, adverse reactions, and subjective reports of discomfort or issues. Comparison was made to control groups using established products, indicating a comparative clinical "truth."
Toxicological & Microbiological Tests: The ground truth for these tests was based on standardized, objective laboratory assays with predefined endpoints and pass/fail criteria (e.g., absence of cell lysis, no difference from control animals, reduction in microbial count).

8. Sample Size for the Training Set

Training Set (for the reported clinical trial) NA: There is no explicit mention of a separate "training set" for the clinical study or any AI/algorithmic development. The clinical trial described in the submission served as the primary validation study for human use. The toxicological and microbiological studies would have been performed on laboratory samples, not human "training sets." This product is a chemical solution, not an AI/ML-driven device, so the concept of a "training set" for an algorithm as typically understood in AI is not directly applicable here. The product's formulation and design may have been informed by prior R&D data, but that's distinct from an AI training set.

9. How Ground Truth for Training Set Was Established

As the device is a contact lens solution and not an AI or algorithm, the concept of a "training set" with established ground truth in the AI context does not directly apply. The formulation of the solution would have been developed based on chemical principles, known antimicrobial agents, surfactants, and buffers, guided by an understanding of ocular compatibility and cleaning efficacy. The various laboratory tests (cytotoxicity, microbiology, etc.) serve more as validation steps for the R&D, rather than "ground truth establishment" for an AI model.

Summary

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K974485

510 (k) Summary

SAUFLON MULTIPURPOSE SOFT (HYDROPHILIC) CONTACT LENS SOLUTION FEB 2 4 1998

l. Submitted by: Sauflon Pharmaceuticals, Ltd 49-53 York St Twickenham, UK TW1 3LP
Contact : John M. Szabocsik, Ph.D. Official agent Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 (312) 553-0828
1. Date prepared: February 9, 1998
1. Device: Common Name Multipurpose Contact Lens Solution Trade Name Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution
1. Classification Class II (Performance Standards) 21 CFR 886.5928 Soft (hydrophilic) contact lens solution
1. Substantial This product is substantially equivalent equivalence to the currently marketed Bausch and Lomb ReNu Multipurpose Solution.
1. Device A sterile, isotonic solution that description contains Poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.
1. Intended use The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by the eye care practitioner.
1. Comparison to predicate devices: see following table

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212 581 2611 11 12815942942942 MAY 15 '98 13:38 FR SZABOCSIK & ASSEC.

K974485 Summary

SUBSTANTIAL EQUIVALENCE COMPARISON

F. 23709

SAUFLON	BAUSCH & LOMB
MULTIPURPOSE	ReNu
SOFT (HYDROPHILIC)	ALL-IN-ONE
CONTACT LENS SOLUTION

SALT	NaCl	NaCl
CHELATOR	Edetatedisodium	Edetatedisodium
BUFFER	Phosphate	Borate
SURFACTANT	Poloxamer	Poloxamine
ANTIMICROBIAL	Polyhexanide(0.0001% w/v)	Polyhexanide(0.00005% w/v)
WATER	qs	qs
OTHER	SterileIsotonic	SterileIsotonic

Introduction

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is a solution intended to be used as a daily cleaner, rinsing agent, disinfecting and storage solution, and wetting/rewetting solution prior to lenses being placed on the eye, in the care of soft (hydrophilic) lenses. It is comparable to currently marketed multipurpose solutions such as ReNu, Complete and Solocare.

Contained in this submission are comparisons of the product to the predicate device, information on the chemistry and manufacturing, results of toxicological and microbiological tests, and the report of a clinical trial of 246 subjects, who have used the product over a period of at least three months. Details are included in the appropriate sections.

I. Chemistry

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. It contains no chlorhexidine or thimerosal.

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K974485 Summary

A. Solution compatibility

The compatibility of the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution was demonstrated by cycling lenses through 30 cycles of simulated use, using the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution for cleaning, rinsing, disinfecting and storing. Parameters of lenses were measured before and after the 30 cycles, and no differences were found.

B. Cleaning effectiveness

The efficacy of the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution as a daily cleaner was shown by determining the critical micelle concentration.

II. Toxicology

The toxicological testing is summarized below, and reports are attached. The solution was shown to be non-toxic in all tests. Additional toxicity testing (cytotoxicity, systemic toxicity and ocular irritation)
was done to verify the safety of the solution in the contract manufacturer's bottle.

A. Agar Overlay Cytotoxicity:

Representative lenses from all four groups of soft (hydrophilic) lens types were exposed to the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution for 24 hours, then tested in a direct contact cytotoxicity assay. All test lens types were noncytotoxic.

B. Systemic toxicity:

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution was evaluated for systemic toxicity by intraperitoneal (ip) injection in healthy mice, 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals injected with saline. The solution passed the test requirements, that there be no difference between the response of test and control animals.

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P. 25729

K974485 Summary

C. Acute Oral toxicity

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution was evaluated for acute oral toxicity by intubation in healthy rats, 5ml/kg body The animals were observed immediately after weight. intubation, after 2 and 4 hours, then daily for fourteen days. The animals were weighed prior to intubation, at 7 days, and at 14 days. All animals showed no clinical signs of toxicity from test initiation to Day 14, therefore the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution passed the test requirements of no acute oral toxicity.

Acute Ocular irritation: D.

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution was instilled directly into one eye of each of three rabbits, the other eye receiving sterile water as a control. Examinations over 72 hours showed no differences between test and control eyes, with no evidence of ocular irritation with either the test or control solutions. The Sauflon Multipurpose solution therefore meets the requirements of the acute ocular irritation test.

Full USP Class VI Testing of Sauflon Multipurpose 12 . Soft (hydrophilic) Contact Lens Solution in bottles manufactured of high density polyethylene.

1. Cytotoxicity test :
  Under the conditions of this study, the saline test extract showed no evidence of causing cell lysis or toxicity. The negative controls, reagent controls, and the positive controls performed as anticipated. The saline test extract was not cytotoxic and passed this test.
1. Systemic Toxicity Test: Under the conditions of this study, there was no mortality or evidence of significant systemic toxicity from the Each test article extract met the extracts. requirements of this test.
1. Ocular Irritation Study: Under the conditions of this study, there was no evidence of significant irritation in the test or control eye of any rabbit. The saline and cottonseed oil test article extracts would not be considered irritants to the ocular tissue of the rabbits.

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K974485 Summary

III. Microbiology

Sterility A.

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution passed the requirements of sterility testing.

Preservative efficacy B.

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution passed the requirements of the modified preservative efficacy test with rechallenge at 14 days.

Disinfection Efficacy C.

The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution passed the requirements of the stand-alone disinfection test, obviating the requirements for the multi-item testing.

D. Stability

Stability testing is in progress; the solution has currently passed stability testing corresponding to a shelf-life of 11 months.

IV. Clinical Studies

A clinical trial of 6 months usage of the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution by 246 subjects, wearing representative lenses from all groups of soft (hydrophilic) contact lenses, compared to 117 control subjects using currently marketed care products, showed that the product is substantially equivalent to those current solutions.

Twelve (12) investigators enrolled a total of 246 test subjects. The control group included 59 subjects using a commercially available multipurpose solution and 58 using a commercially available two-step peroxide system. The age range was from 12 to 73, 70.4% female and 29.6% male. Analysis of the discontinuations among the various groups, test vs control, female vs male, showed that the differences in the incidence of discontinuations for cause (stain, discomfort, etc) were not statistically significant.

(1) Adverse Reactions

The only adverse events in the test population were one case of mild conjunctivitis and one case of marginal keratitis; both cases resolved with no permanent sequelae.

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MAY 15 195 1.54 SE 58 52 52 52 6 6 8 500 500 100 500 1000 1000 1000 1000 1000

K974485 Summary

(2) Slit Lamp Findings:

Table A compares the incidence of slit lamp findings in the investigational group and the two control groups.

TABLE A

SLIT LAMP FINDINGS

FINDING	TEST	CONTROLS
		MULTIPURPOSE	PEROXIDE
NO FINDINGSa	79.1	57.5	67.0
EDEMAb	0.2	0.8	0.6
NEOVASCULAR	3.4	6.4	9.3
STAINING	2.9	15.9	8.9
HYPEREMIA	10.8	12.5	6.0
PALPEBRAL	11.1	26.4	18.3
OTHER	0.6	0.9	0.4

마 Percent of eyes examined with no findings, regularly scheduled visits only

b Percent of eyes with finding, regularly scheduled visits only
(3) Symptoms, Problems and Complaints:

Symptoms, problems and complaints were reported by the investigators at each visit. Discomfort, burning, lens awareness, variable vision and need for cleaning were the most frequently reported symptoms among all subjects. Table B compares the incidence of selected symptoms in the three groups (test, multipurpose and peroxide controls).

TABLE B

SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS

SYMPTOM	TEST	CONTROLS
NONEa	83.7	MULTIPURPOSE	PEROXIDE
		79.6	85.3
DISCOMFORTb	2.9	3.5	3.6
PAIN, BURNING	2.0	2.9	2.7
VARIABLE VISION	1.5	4.5	1.6
LENS AWARENESS	4.0	3.3	3.9
NEED FOR CLEANING	1.8	5.2	1.8

e Percent of eyes examined with no findings, regularly scheduled visits only D

Percent of eyes with finding, regularly scheduled visits only

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J.C. G. D. C. C. C. - - - - - - - - - - - - - - - - - - -MAY 15 TEE 1.3:35 FR 52-50000K & F5500.

K974485 Summary

Visual Acuity: ( 4 )

The appropriate acuity was achieved by 97.1% of the test eyes, 98.4% of the multipurpose control, and 100% of the peroxide control eyes.

Wear Time: ( 2 )

Wear time remained essentially unchanged over the six months of the study.

( 6) Lens Cleanliness:

Overall, the reports of the lens cleanliness evaluation showed that 97.6% of test lenses, 92.7% of the multipurpose and 93.8% of the peroxide were clinically clean at scheduled visits.

(7) Gender Analysis:

The overall test population was 68.7% female, 31.3% male, and the visit distribution over the study was 67.7% female, 32.3% male. Overall, there were no slit lamp findings at 79% of the visits; among females, at 76.9%, among males at 83.9% of the visits. For symptoms, there were no symptoms reported at 84% of the visits; among females, no symptoms were reported at 83%, among males, at 86%. There is no significant difference in the findings, and no further analysis was warranted.

OVERALL CONCLUSION OF THE CLINICAL STUDY:

The data of the clinical trial confirm that Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is substantially equivalent to other currently marketed cleaning, rinsing, disinfecting and storage products, specifically Bausch & Lomb Multipurpose solution, when used according to the manufacturer's instructions.

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Image /page/7/Picture/1 description: The image shows a partial view of a document or logo. On the left, there's a circular emblem with a textured or patterned fill, possibly representing a seal or official mark. Adjacent to the emblem, vertically aligned text reads 'DEPARTMENT OF HEALTH'. Above the text and emblem, there are three stylized, curved lines, possibly part of a larger design or logo element.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1998

John M. Szabocsik, Ph.D. Official Correspondent for Sauflon Pharmaceuticals, Inc. 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K974485

Trade Name: Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution Regulatory Class: II Product Code: 86 LPN Dated: November 24, 1997 Received: November 26, 1997

Image /page/7/Picture/8 description: The image shows a black circle on a white background. The circle is not perfectly solid, as there are some white specks and lines within it, giving it a slightly textured appearance. The circle is positioned towards the left side of the image, leaving a larger white space on the right.

Dear Mr. 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 M. Szabocsik, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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 device, 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 toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,
Alolph L. Rosenthal

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

Enclosure

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510 (k) NUMBER (IF KNOWN) K974485

DEVICE NAME SAUFLON MULTIPURPOSE SOFT (HYDROPHILIC) CONTACT LENS SOLUTION

INDICATIONS FOR USE

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

Ming-Chen-Shu 28

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CPR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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.”