SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)

K133472 · Souflon Pharmaceuticals, Ltd. · LPL · Mar 4, 2014 · Ophthalmic

Device Facts

• Record ID: K133472
• Device Name: SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
• Applicant: Souflon Pharmaceuticals, Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters. The SAUFLON CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less. The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less. Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact lens with UV blocker and Handling Tint help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Hemispherical flexible soft contact lens; somofilcon A (silicone hydrogel) material; contains UV-absorbing monomer and CI Reactive Blue Dye 4 handling tint. Covers cornea and adjacent sclera; daily disposable; single use. Corrects refractive ametropia (myopia, hyperopia, presbyopia, astigmatism). Provides UV radiation protection. Prescribed by eye care professionals; patient self-applied. Manufactured via cast molding. Hydrated state: 56% water content. Lens dimensions: 13.0-18.0mm diameter, 0.03-0.70mm center thickness, 7.5-9.50mm base curve. Powers: -30.00 to +30.00 DS.

Clinical Evidence

Clinical study compared subject device to Air Optix Aqua. Evaluated safety and efficacy; results confirmed safety, acceptability, and substantial equivalence to predicate devices.

Technological Characteristics

Material: somofilcon A (hydrophilic co-polymer of silicone and hydrophilic monomers cross-linked with tetraethyleneglycol dimethacrylate). UV blocker: benzophenone. Tint: CI Reactive Blue Dye 4. Water content: 56%. Oxygen permeability (Dk): 60 x 10-11 (cm²/sec)(ml O2/ml x mmHg) at 35°C. Refractive index: 1.4008. Packaging: buffered saline with methyl ether cellulose in hermetically sealed polypropylene blisters.

Indications for Use

Indicated for daily wear single use correction of myopia, hyperopia, presbyopia, and astigmatism (up to 10.00D) in phakic or 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

• Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker (K130331)
• Acuvue Trueye (Narafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens (K073485)
• Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Tinted Contact Lens (K033919/K073459)

Reference Devices

• Air Optix Aqua (used in clinical study)

Submission Summary (Full Text)

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#### SAUFLON CLARITI I DAY TINTED CONTACT LEÑS 510(k)

**MAR 04 2014**
K133472

## 510(K) SUMMARY AS REQUIRED BY SECTION 807.92(c)

#### 1.- SUBMITTER INFORMATION:

Sauflon Pharmaceuticals Ltd. Company Name:

49-53 York Street Address: Twickenham Middlesex TWI 3LP

020 8322 4200 Phone:

Fax: [phone]

Contact Person: Dr Christopher Smejkal

DATE SUMMARY PREPARED: 15th October 2013

#### DEVICE NAME:

| Trade Name: | Sauflon Clariti 1 Day (somofilcon A) Soft<br>(hydrophilic) Daily Disposable Contact Lens with UV<br>Blocker and Handling Tint |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft Contact Lens |
| Classification: | CLASS 11 (21 CFR 886.5925) CODE -LPL, MVN<br>SOFT (HYDROPHILIC) CONTACT LENS |
| Duration of Contact: | A daily replacement lens for surface contact of the eye<br>and intended for daily removal and less than 24 hours<br>contact duration. |

### 2.- SUBSTANTIAL ÉQUIVALENCE:

The sponsor considers the Sauflon Clariti 1 Day (somofilcon. A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint to be substantially cquivalent to the Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker, cleared pursuant to K 130331. Acuvue Trueye (Narafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Timed Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459.

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## SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k)

#### 3 .- DESCRIPTION of the DEVICE:

The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is available as a single vision, toric, multifocal and multifocal toric lens. The lens muterial (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofileon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. A handling tint is added to the composition of the lens to make the lens visible for handling.

The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm

The Sauflon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent schera, with the following dimensions:

| Chord Diameter: | 13.0mm to 18.0mm |
|-------------------------|-------------------------|
| Centre Thickness: | 0.03mm to 0.70mm |
| Base Curve: | 7.5mm to 9.50mm |
| Powers: | -30.00 DS to +30.00 DS |
| Toric Cylinder options: | -0.75 to -9.75 |
| Toric Axis options: | 10° to 180° (5° steps). |

Multifocal Add: .

> Add power up to +4.00 labelled with indicative add strength to be read in conjunction with the fitting guide.

The physical/optical properties of the lenses are:

| • Refractive Index: | 1.4008 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------|
| • %Transmittance @ 590nm: | 98.30 |
| • %Transmittance @ 280-315nm: | 0.71 |
| • %Transmittance @ 316-380nm: | 20.62 |
| • Surface Character: | Hydrophilic |
| • Water Content: | 56% |
| • Oxygen Permeability (DK): | 60 x 10-11 (cm²/sec) (ml O2/ml x mmHg)<br>at 35°C (Fatt Method for determination<br>of oxygen permeability). |
| • Specific Gravity: | 1.17 |

#### 4 .- INDICATIONS FOR USE

Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for:

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#### SAUFLON CLARITI 1 DAY TINTED CONTACT LENS 510(k)

The SAUFLON CLARITI 1 DAY (somotilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia-and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopers or less and may exhibit astigmatism up to 1.50 Diopters or less.

The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less.

Sauflon Clariti 1 Day (somolilcon A) Soft (hydrophilic) Daily Disposable Contact lens. with UV blocker and Handling Tim help protect against transmission of harmful UV radiation to the cornea and into the eye.

#### 5 .- PREDICATE DEVICES

The sponsor considers the SAUFLON CLARITI IDAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint to be substantially equivalent to the SAUFLON CLARIT IDAY (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker cleared pursuant to K130331, Acuvue Trueye (Narafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafileon B) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459.

The following table summarises the primary features for this comparison, illustrating the similarities and differences.

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SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k)

| | | | Comparison of Physical / Optical Properties for the SAUFLON CLARITI 1 DAY (somofilcon A) Silicone Hydrogel Contact Lens with UV<br>Blocker and handling tint versus Acuvue Trueye (Narafilcon A) and SAUFLON CLARITI I DAY SILICONE HYDROGEL |
|--------------------------------|-----------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LENS MATERIAL | PREDICATE DEVICE - ACUVUE<br>TRUEYE (K073485) | PREDICATE DEVICE - SAUFLON CLARITI<br>1 DAY SILICONE HYDROGEL (K130331) | SUBJECT DEVICE- SAUFLON CLARITI 1 DAY<br>WITH HANDLING TINT |
| narafilcon A Silicone Hydrogel | | somofilcon A Silicone Hydrogel | somofilcon A Silicone Hydrogel |
| INDICATIONS FOR<br>USE | Daily wear single use | Daily wear single use | Daily wear single use |
| MANUFACTURING<br>PROCESS | Cast Moulding | Cast Moulding | Cast Moulding |
| WATER CONTENT | 47% | 56% | 56% |
| REFRACTIVE<br>INDEX | 1.41 | 1.40 | 1.40 |
| LIGHT<br>TRANSMITTANCE | 85% minimum | ≥96% | ≥96% |
| DK @35°C (EDGE<br>CORRECTED) | 100 (polarographic method) | 60 (Coulometric method) | 60 (polarographic method) |
| COLOUR | Blue Visibility Tint | No Visibility Tint | Blue Visibility Tint |

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SAUFLON CLARITT I DAY TINTED CONTACT LENS 510(K)

| TINT | UV BLOCKER | MODULUS (MPa) | TENSILE STRENGTH (MPa) | ELONGATION AT BREAK % | PACKAGING MATERIALS | PACKAGING SOLUTION | PACKAGING METHOD |
|------------------------|---------------|---------------|------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------|
| CI Reactive Blue Dye 4 | Benzotriazole | 0.66 | 0.72 | 170 | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | Buffered saline solution containing up to 0.01% methyl ether cellulose | Hermetically sealed blister pack |
| none | Benzophenone | 0.55 | 1.05 | 163 | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | Borate buffered saline solution containing 0.005% poloxamer | Hermetically sealed blister pack |
| D&C Green No. 6 | Benzophenone | 0.55 | 1.05 | 163 | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons | Borate buffered saline solution containing 0.005% poloxamer | Hermetically sealed blister pack |

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#### SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k).

#### 6 .- PHYSICOCHEMICAL STUDIES

The physical; optical and chemical properties of the lenses as assessed by various test methods show substantial equivalency with the predicate devices as illustrated in the preceding table. Studies were also conducted to verify that leachable substances were either low or below measurable levels to assuage any concerns for its intended use.

#### 7 .- TOXICOLOGY STUDIES

Sauffon Clariti (somofilcon A) Soft (hydrophilic) Contact Lenses with UV Blocker and Handling Tint was assessed using ISO 10993 standards for cytotoxicity, ocular irritation and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the lens.

#### 8 .- HUMAN CLINICAL STUDIES

A clinical study was conducted to evaluate the safety and efficacy of Sauflon Clariti (somofileon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint by comparison with Air Optix Aqua hydrophilie contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint to the predicate device for its intended use.

#### 9 .- CONCLUSIONS

Based on the above evaluations the Sauflon Clariti 1 day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is substantially equivalent to the predicate, marketed lenses. Based on these evaluations the Sauflon Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint has been shown to be safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

March 4, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Sauflon Pharmaceuticals Ltd % Dr. Christopher Smejkal Head of Regulatory and Technical Affairs 49-53 York Street, Twickenham Middlesex TW1 3LP United Kingdom

Re: K133472

Trade/Device Name: Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 22, 2014 Received: January 30, 2014

Dear Dr. Smejkal:

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 I ou may atorely mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Dr. Christopher Smejkal

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kesia Y. Alexander -S

for Malvina B. Eydelman, 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 CLARITI I DAY TINTED CONTACT LENS 510(k)

. ......

## INDICATIONS FOR USE

| 510(k) Number (if known): K133472 | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily<br>Disposable Contact Lens with UV blocker and Handling Tint. |
| Indication for use: | The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic)<br>Daily Disposable Contact Lens with handling tint is indicated<br>for: |

The SAUFLON CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-discased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI I DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.

The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less.

Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact lens with UV blocker and Handling Tint help protect against transmission of harmful UV radiation to the cornea and into the eye.

7 Prescription Use (Part 21 CFR 801 Subpari D)

Over-The-Counter Use (2) CFR 801 Subpart C)

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

AND/OR

Alexander Bevl 2014.02 :20 09:37:20 -05'00'