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 SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the SAUFLON Flat Coloured Contact Lens Cases, focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Type)	Reported Device Performance
Cytotoxicity	No evidence of cellular toxicity
Systemic Toxicity	No evidence of systemic toxicity
Ocular Irritation	No evidence of ocular irritation

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

The 510(k) summary does not specify the sample sizes used for the cytotoxicity, systemic toxicity, or ocular irritation studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, given that Sauflon Pharmaceuticals Ltd. is based in the UK, it's reasonable to infer the studies likely involved testing done in the UK or under UK/European standards at the time, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The 510(k) summary does not mention the use of experts to establish ground truth for the test set. The reported performance is based on the laboratory study results (cytotoxicity, systemic toxicity, ocular irritation). These types of studies typically involve scientific methodologies and instrumentation rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The testing performed (cytotoxicity, systemic toxicity, ocular irritation) are laboratory-based studies that produce objective results, not requiring an adjudication process commonly used for subjective interpretation tasks (e.g., image reading).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, often clinical imaging, to assess reader performance with and without AI assistance. The Sauflon contact lens case is a physical medical device, not an AI-powered diagnostic tool.

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

This question is not applicable. The Sauflon Flat Coloured Lens Case is a physical product for storing contact lenses during chemical disinfection. It does not involve an algorithm or AI functionality, so the concept of standalone performance (algorithm-only) does not apply. The "standalone" performance here relates to the inherent safety and effectiveness of the material and design as tested in the mentioned studies.

7. The Type of Ground Truth Used

For the studies mentioned:

Cytotoxicity: The ground truth would be established through laboratory assays (e.g., cell viability, cell proliferation) comparing the device's extract/material exposure to control substances, with scientific criteria defining what constitutes cellular toxicity.
Systemic Toxicity: The ground truth would be established through animal models (e.g., using extracts of the material) with predetermined endpoints and measurements to assess systemic adverse effects, using established toxicological protocols.
Ocular Irritation: The ground truth would be established through in-vitro or in-vivo testing (e.g., using extracts applied directly to ocular tissues or cell lines, or in animal models) using established protocols to evaluate irritating effects on the eye.

The ground truth in all these cases is based on objective scientific/laboratory measurements and established biological assays/protocols, rather than expert consensus, pathology, or outcomes data in the context of clinical trials.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical contact lens case, not an AI/machine learning model that requires a training set. The safety and effectiveness were demonstrated through direct testing of the device's materials, not through a learning algorithm.

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

This question is not applicable, as there is no training set for this device.

Summary

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SAUFLON FLAT COLOURED CONTACT LENS CASES 510(k)

Image /page/0/Picture/2 description: The image shows a logo for a company called "SAUFLON PHARMACEUTIC LIMITED". The logo consists of a stylized eye symbol on the left, followed by the company name in a simple, sans-serif font. The eye symbol is made up of concentric shapes, creating a modern and abstract design. The text is stacked in three lines, with "SAUFLON" on the top, "PHARMACEUTIC" in the middle, and "LIMITED" on the bottom.

510(k) Summary

SUBMITTER INFORMATION:

Company Name:	Sauflon Pharmaceuticals Ltd.
Address:	49 - 53 York StreetTwickenhamMiddlesexTW1 3LP
Phone:	020 8322 4200
Fax:	020 8891 2833
Official Correspondent	Miss Azitta Jadalizadeh
DATE PREPARED:	30th September 2005
Trade Name:	SAUFLON Flat Coloured Lens Case
Common Name:	Contact Lens Case
Classification:	CLASS II (21 CFR 886.5925)

DEVICE DESCRIPTION

The SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.

INTENDED USE

The SAUFLON Coloured Flat 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 Flat Coloured 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 Coloured Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation.

SUBSTANTIAL EQUIVALENCE:

The SAUFLON Flat Coloured contact lens cases are substantially equivalent in terms of indications 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 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 a stylized image of an eagle with three human profiles incorporated into its design.

NOV - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sauflon Pharmaceuticals, Ltd. c/o Azitta Jadalizadeh 49-53 York Street Twickenham, Middlesex TW1 3LP UK

Re: K052809

Trade/Device Name: Sauflon Flat Colored Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: September 30, 2005 Received: October 4, 2005

Dear Ms. Jadalizadeh:

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 (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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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) 827-8910. 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/industry/support/index.html.

Sincerely yours.

David M. Whipple

David M. Whipple Acting 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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Image /page/3/Picture/0 description: The image shows a logo with a stylized eye-shaped symbol on the left and the text "SAUFLON PHARMACEUTICALS LIMITED" on the right. The eye-shaped symbol is made up of curved lines and a solid black circle in the center. The text is stacked in three lines, with "SAUFLON" on the top line, "PHARMACEUTICALS" on the second line, and "LIMITED" on the bottom line. The text is in a simple, sans-serif font.

SAUFLON FLAT COLOURED CONTACT LENS CASE 510(k)

ాంభేష . . . .

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K052809
Device Name:	SAUFLON Flat Coloured Lens Case
Indications For Use:	Storage of soft (hydrophilic), hard and rigid gas permeable(RGP) contact lenses during chemical disinfection only. Notto be used for heat disinfection.

(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	X
(Division Sign-Off) /Division of Ophthalmic Ear, Nose and Throat Devises			gs
510(k) Number	K052809

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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.”