SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

K013649 · Sauflon Pharmaceuticals, Ltd. · LPL · Dec 26, 2001 · Ophthalmic

Device Facts

• Record ID: K013649
• Device Name: SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Sauflon Pharmaceuticals, Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Device Story

Hemispherical flexible soft contact lens; made of methafilcon A (hydrophilic polymer of HEMA and methacrylic acid cross-linked with ethyleneglycol dimethacrylate); 55% water content. Features aquamarine visibility tint and benzophenone UV-absorbing monomer to block UV radiation. Used by eyecare practitioners to correct refractive ametropia in patients. Lens covers cornea and portion of adjacent sclera. Daily wear modality; compatible with chemical or hydrogen peroxide disinfection systems. Benefits patient by providing vision correction while reducing UV exposure.

Clinical Evidence

Bench testing only. Toxicology testing (cytotoxicity, acute systemic toxicity, acute ocular irritation) demonstrated non-toxic and non-irritating properties. Residual monomer and color leachability testing showed no significant levels of leachable substances. Physical, optical, and chemical properties compared to predicate.

Technological Characteristics

Material: Methafilcon A (HEMA/methacrylic acid/ethyleneglycol dimethacrylate). Water content: 55%. Refractive index: 1.40. Oxygen permeability (Dk): 22.0 x 10^-11 (cm²/sec)(ml O₂/ml x mmHg) at 35°C. UV-blocking: Benzophenone monomer. Form factor: Hemispherical flexible shell. Manufacturing: Cast moulding. Sterilization: Parametric release.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (up to 2.00 D) in aphakic and non-aphakic persons with non-diseased eyes.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens (K973063)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for SAUFLON PHARMACEUTICALS LIMITED. The logo consists of a stylized eye-shaped symbol on the left, followed by the company name in a simple, sans-serif font. The word "SAUFLON" is on the top line, "PHARMACEUTICALS" is on the second line, and "LIMITED" is on the third line.

K013649

#### 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 3001 |
| Contact Person: | Dr Ligia Delacruz |
| DATE SUMMARY PREPARED: | 31st October 2001 |
| DEVICE NAME: | |
| Trade Name: | SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility<br>Tinted Contact Lens for Daily Wear |
| Common Name: | Contact Lens |
| Classification: | CLASS II (21 CFR 886.5925)<br>SOFT (HYDROPHILIC) CONTACT LENS |

# SUBSTANTIAL EQUIVALENCE:

SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear are substantially equivalent to FREQUENCY 55 (methafilcon A) Hydrophilic Contact wear are substantially over (clear and tinted) that received market clearance pursuant to K973063, currently marketed in the USA.

# DESCRIPTION of the DEVICE:

The SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear is available as a single vision lens in an aquamarine visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the Inns consists of 45.0% HEMA and 55.0% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with: Reactive Blue No. 4 and Reactive Yellow Dye # 86. A benzophenone UV absorbing monomer is used to block UV radiation.

The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380mm.

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Image /page/1/Picture/0 description: The image shows the logo for Sauflon Pharmaceuticals Limited. The logo consists of a stylized eye on the left and the company name on the right. The eye is a black and white graphic, and the company name is written in a simple, sans-serif font.

The SAUFLON 55 UV Contact Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

| • | Chord Diameter:<br>Centre Thickness:<br>Base Curve:<br>Powers: | 14.0mm to 15.0mm<br>0.03mm to 0.40mm<br>8.40mm to 9.30mm<br>-20.00 Diopters to<br>+20.00Diopters |
|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| • | The physical/optical properties of the lens<br>are: | |
| • | Refractive Index:<br>%Transmittance @ 590nm<br>% Transmittance @ 280-315nm<br>% Transmittance @ 316-380nm<br>Surface Character:<br>Water Content:<br>Specific Gravity<br>Oxygen Permeability (Dk):<br>(Fatt Method for determination of oxygen permeability) | 1.40<br>94.61<br>9.41<br>36.00<br>Hydrophilic<br>55%<br>1.09<br>$22.0 \times 10^{-11}$ (cm²/sec) (ml<br>O₂/ml x mm Hg) at 35°C |

# COMPARISON OF PHYSICAL / OPTICAL PROPERTIES

| PARAMETER | SAUFLON 55UV<br>(methafilcon A) Soft<br>(Hydrophilic) Visibility<br>Tinted Contact Lens for<br>Daily Wear | FREQUENCY 55<br>Hydrophilic Contact Lens<br>for Daily Wear (clear and<br>tinted) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Material | Methafilcon A | Methafilcon A |
| Indication for Use | Myopia, Hyperopia and<br>Astigmatism | Myopia, Hyperopia and<br>Astigmatism |
| Water Content | 55% | 55% |
| % Transmittance @590nm | 94.61% | 95.47% |
| %Transmittance @280-315nm | 9.41% | 82.47% |
| % Transmittance @316-<br>380nm | 36.00% | 95.30% |
| DK @35°C (Edge Corrected) | $22.0 \times 10^{-11}$ | $15.50 \times 10^{-11}$ |
| Powers | -20.00 to +20.00 D | -20.00 to +20.00 D |
| Colour | Aquamarine Visibility | Clear and Aqua Visibility |
| Refractive Index | 1.4020 | 1.4052 |
| Tensile Strength | 1.47 | 0.66 |
| Modulus | 0.52 | 0.48 |
| Elongation at Break | 280 | 179 |
| Toughness | 1.39 | 0.38 |
| Manufacturing Method | Cast Moulding | Cast Moulding |

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Image /page/2/Picture/0 description: The image shows the logo for Sauflon Pharmaceuticals Limited. The logo consists of a stylized image of two overlapping water droplets on the left. To the right of the image is the text "SAUFLON PHARMACEUTICALS LIMITED" stacked on top of each other. The text is in a simple sans-serif font.

### PRECLINICAL TESTING

The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) show the lenses to be non-toxic and non-irritating. Furthermore, the results of residual monomer and colour leachability testing demonstrate that the respective extracts did not contain significant levels of leachable colour or residual monomers.

The physical optical, and chemical properties of the Sauflon 55 UV (methafilcon A) Soft Hydrophilic Visibility Tinted Contact Lens for Daily Wear are equivalent to those of the FREOUENCY 55 (methafilcon A) Hydrophilic Contact lenses for Daily Wear (clear and tinted). This lens is in group 4, lonic, high water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994.

The lens will be sterilised and packaged in the same manner as previously cleared in K973063. This lens will also be sterility released by parametric release, as cleared in K971164.

#### INDICATIONS FOR USE

The Sauflon 55 UV (methafilcon) Soft (Hydrophilic) Visibility Tinted Contact Lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

#### PARAMETERS AVAILABLE:

#### Sauflon 55 UV Contact Lens

Powers: +8.00 to-10.00 D Centre Thickness: 0.07mm 14.2mm Diameter: Base Curve: 8.6, 8.9mm (minus lenses) and 8.8mm (plus lenses)

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Image /page/3/Picture/0 description: The image shows the logo for Sauflon Pharmaceuticals Limited. The logo consists of a stylized eye on the left and the company name on the right. The eye is made up of two curved shapes, one inside the other, with a dark circle in the center. The company name is written in a simple, sans-serif font.

# Transmittance Curves

The figure below shows transmittance curves comparing the Sauflow fight and UV blocker, (Methafilcon A with UV Blocker) contact lens with visibility tint and UV blooker, (Methafilcon A with UV Blocker) Oxhact fers War Wallam and

Image /page/3/Figure/3 description: The image shows a graph of the percent transmission versus wavelength in nanometers. The x-axis represents the wavelength, ranging from 200 to 800 nm. The y-axis represents the percent transmission, ranging from 0 to 100. There are three different lines on the graph, each representing a different material or condition, showing how the transmission varies with wavelength.

#### Key:

Sauflon 55UV (Methafilcon A with UV blocker) soft contact lens with a visibility tint and UV blocker. Currents for a -6.750 lens with a contre thickness 0.060 mm, which represents the transmittence characteristics of the thickness '0.000' this UV-absorbing lens to be marketed.

24 Year old human comea *1 . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .

25 year old crystalline lens *2 ー・ー・ー・ー・ー・ー・・

#### N.B

- Lerman, S., Radiant Energy and the eye, MacMillan, New York, 1980, p.58, 1 fig2-21
- Waxler, M. Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, S. 2 Boca Raton, Florida, 1986, p. 10, fig. 5.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three heads or faces, which are represented by curved lines. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 6 2001

Dr. Ligia Delacruz Sauflon Pharmaceuticals Ltd. 49-53 York Street Twickenham, Middlesex United Kingdom

Re: K013649

Trade/Device Name: SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: SOFT (HYDROPHILIC) CONTACT LENS Regulatory Class: II Product Code: LPL Dated: October 31, 2001

Received: November 5, 2001

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. Iisting 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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph 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

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Image /page/6/Picture/0 description: The image shows the logo for Sauflon Pharmaceuticel Limited. The logo consists of a stylized eye on the left and the company name on the right. The eye is a black circle with a white crescent shape inside, and the company name is written in a simple, sans-serif font.

# INDICATIONS FOR USE STATEMENT

#### K013649 510(k) Number (if known):

Device Name:

Indications For Use:

Sauflon 55 UV (methafilcon A) soft (hydrophilic) visibility tinted contact lens for Daily Wear

The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

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

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

OR

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

Daniel W.C. Brown, Ph.D.
(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devices

**510(k) Number** K013649