Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

Device Description

The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.

AI/ML Overview

This document describes a 510(k) submission for Sauflon Contact Lens Cases and focuses on their substantial equivalence to a predicate device rather than a study with acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria, study details, and expert ground truth is not explicitly available in this type of submission.

However, I can extract the information relevant to the safety and effectiveness assessment conducted:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a contact lens case, the "acceptance criteria" are not reported as specific numerical thresholds for performance metrics. Instead, "acceptance" is implicitly defined by demonstrating that the device is substantially equivalent to a predicate device, particularly regarding safety aspects. The reported "performance" is the successful completion of safety studies without adverse findings.

Acceptance Criteria (Implicit)	Reported Device Performance
No evidence of cellular toxicity (Cytotoxicity)	Results of testing show no evidence of cellular toxicity.
No evidence of systemic toxicity	Results of testing show no evidence of systemic toxicity.
No evidence of ocular irritation	Results of testing show no evidence of ocular irritation.
Substantial equivalence in indications for use to predicate device	The SAUFLON contact lens cases are substantially equivalent in terms of indication for use (storage of contact lenses during chemical disinfection) to the Bausch and Lomb Lens Case.
Substantial equivalence in safety to predicate device	Demonstrated through the absence of toxicity and irritation, showing similar safety profile to the predicate.
Substantial equivalence in effectiveness to predicate device	Demonstrated through similar design and intended function for chemical disinfection, implying similar effectiveness in maintaining lens hygiene as the predicate.

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

Sample size for test set: Not explicitly stated in terms of number of units or biological samples used for the cytotoxicity, systemic toxicity, and ocular irritation studies.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is typically detailed in the full study reports, not the 510(k) summary.

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

Number of experts: Not applicable/not stated. The safety studies (cytotoxicity, systemic toxicity, ocular irritation) would be assessed by trained toxicologists and histopathologists, but a "ground truth" derived from expert consensus in the diagnostic sense is not relevant here.

4. Adjudication method for the test set:

Adjudication method: Not applicable/not stated. The results of the toxicology studies would be interpreted by specific scientific methods rather than through an adjudication process among multiple experts as typically seen in clinical diagnostic studies.

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:

MRMC study: No, this type of study is not relevant for a contact lens case. MRMC studies are typically for diagnostic AI systems that assist human readers in interpreting medical images or data.

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

Standalone performance: No, this is not a diagnostic algorithm. The "device" is a physical product (contact lens case), not software or AI.

7. The type of ground truth used:

Type of ground truth: For the safety studies (cytotoxicity, systemic toxicity, ocular irritation), the "ground truth" would be established by scientific methods and measurements (e.g., cell viability assays, histopathological examination, irritation scoring) against established toxicity standards and biological responses. It's objective scientific criteria rather than "expert consensus" or "pathology" in a diagnostic imaging context.

8. The sample size for the training set:

Sample size for training set: Not applicable. This device is not an AI/ML product that requires a "training set."

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

Ground truth for training set: Not applicable.

Summary

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FEB - 2 2004

510(k) Summary

K033656

SUBMITTER INFORMATION:

Company Name:	Sauflon Pharmaceuticals Ltd.
Address:	49 – 53 York StreetTwickenhamMiddlesexTW1 3LP
Phone:	020 8322 4200
Fax:	020 8891 3001
Official Correspondent	Dr Ligia Delacruz
DATE PREPARED:	14th November 2003
DEVICE NAME:
Trade Name:	SAUFLON Flat Lens CaseSAUFLON 2003 Barrel Lens Case
Common Name:	Contact Lens Case
Classification:	CLASS II (21 CFR 886.5925)

DEVICE DESCRIPTION

INTENDED USE

The SAUFLON Flat and Barrel Lens Case are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection.

PREDICATE DEVICE

The Bausch and Lomb Lens Case was selected as the predicate device for the SAUFLON contact lens cases.

SUMMARY OF SAFETY AND EFFECTIVENESS

Cytotoxicity, systemic toxicity and ocular irritation studies were performed to assess the safety and effectiveness of the SAUFLON Flat and Barrel Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation.

SUBSTANTIAL EQUIVALENCE:

The SAUFLON contact lens cases are substantially equivalent in terms of indication for use, safety and effectiveness to the Bausch and Lomb Lens Case.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

KEA Plastics Ltd. c/o Dr. Ligia Delacruz Sauflon Pharmaceuticals Ltd. 49-53 York Street Twickenham, Middlesex TW1 3LP United Kindom

Re: K033656

Trade/Device Name: SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: November 14, 2003 Received: November 21, 2003

Dear Dr. 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 adultcration.

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 requrements, 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 (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.

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Pagc 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.

Ahalye 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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SAUFLON CONTACT LENS CASES 510(k)

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K033686

Device Name:

SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case

Indications For Use:

Prescription Use

Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

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

Harvel W. Brown, Ph.D.

Concur(Since Sion Sign Off)Office of Device Evaluation (ODE) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K033656

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

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.”