SAUFLON FLAT COLOURED LENS CASE

K052809 · Sauflon Pharmaceuticals, Ltd. · LRX · Nov 2, 2005 · Ophthalmic

Device Facts

• Record ID: K052809
• Device Name: SAUFLON FLAT COLOURED LENS CASE
• Applicant: Sauflon Pharmaceuticals, Ltd.
• Product Code: LRX · Ophthalmic
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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

Device Story

Moulded plastic flat-style contact lens case with screw-top lids; used for storage of soft, hard, and rigid gas permeable contact lenses during chemical disinfection. Device is a passive storage container; no electronic or mechanical components. Used by contact lens wearers for lens maintenance. Benefits include providing a container for chemical disinfection of lenses.

Clinical Evidence

Bench testing only. Cytotoxicity, systemic toxicity, and ocular irritation studies were performed. Results showed no evidence of cellular or systemic toxicity or ocular irritation.

Technological Characteristics

Moulded plastic, flat-style case with screw-top lids. Passive device; no energy source, connectivity, or software.

Indications for Use

Indicated for storage of soft (hydrophilic), hard, and rigid gas permeable (RGP) contact lenses during chemical disinfection. Contraindicated for heat disinfection.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Bausch and Lomb Lens Case

Submission Summary (Full Text)

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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 Street<br>Twickenham<br>Middlesex<br>TW1 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 [phone]. 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 [phone] or [phone] 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)

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ాం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<br>(RGP) contact lenses during chemical disinfection only. Not<br>to be used for heat disinfection. |

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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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