SUS (STENFILCON A) CONTACT LENS

K131378 · CooperVision, Inc. · LPL · Aug 30, 2013 · Ophthalmic

Device Facts

• Record ID: K131378
• Device Name: SUS (STENFILCON A) CONTACT LENS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

SUS (stenfilcon A) ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia in aphakic and non-aphakic persons with nondiseased eye in powers from -20.00 D to +20.00 D. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not interfere with visual acuity. SUS (stenfilcon A) TORIC Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. SUS (stenfilcon A) MULTIFOCAL Soft Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not interfere with visual acuity. SUS (stenfilcon A) MULTIFOCAL TORIC Soft Contact Lenses are indicated for the optical correction of distance and near vision in presbyopia phakic persons with non-diseased eyes who may have 10.00 D of stigmatism or less.

Device Story

SUS (stenfilcon A) is a daily wear, single-use soft contact lens. Available in aspherical, toric, multifocal, and multifocal toric designs. Manufactured from silicone hydrogel (46% stenfilcon A, 54% water) without surface treatment. Features include blue visibility tint (Reactive Blue #246) and UV blocker. Supplied sterile in buffered saline. Intended for vision correction in patients with non-diseased eyes. Prescribed by eye care professionals. Benefits include vision correction and handling visibility.

Clinical Evidence

Three-month clinical study, 90 subjects (60 test, 30 control). Primary endpoints: biomicroscopy, adverse event rates, and visual acuity. Results showed test lens substantially equivalent to control in safety and efficacy.

Technological Characteristics

Silicone hydrogel material (stenfilcon A); 54% water content; molded manufacturing; moist heat sterilization; blister packaging; Reactive Blue #246 tint; Norbloc UV blocker; high oxygen permeability.

Indications for Use

Indicated for correction of ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Power range -20.00D to +20.00D; astigmatic correction up to -10.00D.

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

• CooperVision AVAIRA (enfilcon A) (K071736)
• CooperVision CLEARSIGHT 1 DAY (ocufilcon B) (K020389)

Submission Summary (Full Text)

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# K131378

AUG 3 0 2013

## 510(k) Summary

Date:

Submitter Information

Contact .

Device Identification

Predicate Device(s)

May 10, 2013

CooperVision, Inc. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 USA [phone]

Annette Nelson Dept. of Regulatory Affairs [e-mail] [phone]

Common Name: Soft Contact Lens

Trade Name: SUS (stenfilcon A) Soft Contact Lens Class. Name: Soft (hydrophilic) Contact Lens -Daily Wear; Disposable Class II [21 CFR 886.5925 (b) (1)] Classification:

Product Code: LPL. MVN

#### Material

CooperVision AVAIRA (enfilcon A) K071736 (Silicone Hydrogel)

Indication, Wear Schedule CooperVision CLEARSIGHT 1 DAY (ocufilcon B) K020389 (Daily wear, single use)

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#### Description of Device

- The SUS (stenfilcon A) Contact Lens Visibility Tinted with UV Blocker is available as . an aspherical lens, toric lens, multifocal lens, and multifocal toric lens.
- The lenses are made of a silicone hydrogel material which is not surface treated and is . characterized by high oxygen permeability (Dk).
- The SUS (stenfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the . lens more visible for handling.
- . A Norbloc UV Blocker is used to reduce the amount of ultraviolet light transmitted into the eye.
- The SUS (stenfilcon A) lens is supplied sterile, packaged in a buffered saline solution. .
- The composition of the lens is 46% stenfilcon A and 54% water by weight when hydrated . and stored in buffered saline solution.

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### Indications for Use

| Lens Design | Indication |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Asphereical | SUS (stenfilcon A) ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. |
| Toric | SUS (stenfilcon A) TORIC Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. |
| Multifocal | SUS (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. |
| Multifocal Toric | SUS (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less |

・

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#### Technological Characteristics:

The technological characteristics of the SUS (stenfilcon A) Contact Lenses are compared to the characteristics of the predicate device, CooperVision AVAIRA (enfilcon A) Contact Lens, in the following tables.

| Material Comparison | | |
|----------------------|-------------------------------------|------------------------------------|
| | Predicate Device | Subject Device |
| Product Name | CooperVision<br>AVAIRA (enfilcon A) | CooperVision<br>SUS (stenfilcon A) |
| Material USAN Name | Enfilcon A | Stenfilcon A |
| 510(k) Number | K071736 | TBD – Current Submission |
| FDA Category (Group) | Silicone Hydrogel | Silicone Hydrogel |
| Manufacturing Method | Molded | Molded |
| Sterilization | Moist Heat | Moist Heat |
| Packaging | Blister | Blister |
| Visibility Tint | Phthalocyanine Blue | Reactive Blue #246 |

| Parameter Comparison | | | | |
|---------------------------|---------------------|---------|--------------------------|---------|
| | Predicate Device | | Subject Device | |
| | CooperVision | | CooperVision | |
| | Avaira (enfilcon A) | | SUS (stenfilcon A) | |
| | K071736 | | TBD - Current Submission | |
| | Measured | Labeled | Measured | Labeled |
| Water Content, % | 45% | 46% | 54.3% | 54% |
| Refractive Index @ 20°C | 1.402 | 1.40 | 1.4011 | 1.40 |
| *Oxygen Permeability (Dk) | 99.6 | 100 | 79.2 | 80 |
| Base Curve, mm | 8.45 | 8.5 | 8.33 | 8.4 |
| Diameter, mm | 14.26 | 14.2 | 14.12 | 14.2 |

*Dk units: (cm/sec)x(ml O2)/(ml x mm Hg)

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#### Technological Characteristics:

The technological characteristics of the SUS (stenfilcon A) Contact Lenses are compared to the characteristics of the predicate device, CooperVision CLEARSIGHT 1 DAY (ocufilcon B) Contact Lens, in the following tables.

| Material Comparison | | |
|----------------------|---------------------------------------------------|------------------------------------|
| | Predicate Device | Subject Device |
| Product Name | CooperVision<br>CLEARSIGHT I DAY<br>(ocufilcon B) | CooperVision<br>SUS (stenfilcon A) |
| Material USAN Name | Ocufilcon B | Stenfilcon A |
| 510(k) Number | K020389 | TBD - Current Submission |
| FDA Category (Group) | Group IV | Silicone Hydrogel |
| Manufacturing Method | Molded | Molded |
| Sterilization | Moist Heat | Moist Heat |
| Packaging | Blister | Blister |
| Visibility Tint | Vat Blue 6 | Reactive Blue #246 |

| Parameter Comparison | | | | |
|---------------------------|----------------------------------------------------------------------------------|---------|----------------------------------------------------------------------------------|---------|
| | Predicate Device<br>CooperVision<br>CLEARSIGHT 1 DAY<br>(ocufilcon B)<br>K020389 | | Subject Device<br>CooperVision<br>SUS (stenfilcon A)<br>TBD – Current Submission | |
| | Measured | Labeled | Measured | Labeled |
| Water Content, % | 51.04 | 52% | 54.3% | 54% |
| Refractive Index @ 20°C | 1.415 | 1.41 | 1.4011 | 1.40 |
| *Oxygen Permeability (Dk) | 16.17 | 16.8 | 79.2 | 80 |
| Base Curve, mm | 8.85 | 8.7 | 8.33 | 8.4 |
| Diameter, mm | 14.12 | 14.2 | 14.12 | 14.2 |

*Dk units: (cm/sec)x(ml O2)/(ml x mm Hg)

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#### Non-clinical Testing

A series of in-vitro and in-vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.

The results of the non-clinical testing/evaluation demonstrate that:

- The lens material and/or extracts are non-toxic, non-irritating and non-sensitizing under . the experimental conditions; and
- The lens physical and material properties are consistent with currently marketed lenses. . The following tests were performed to show substantial equivalence:
- o Extractables Residuals by Soxhlet extraction
- Modulus, Elongation and Tensile Strength Testing o
- Oxygen Permeability and Transmissibility o
- Water Content o
- Light Transmittance o
- Refractive Index o
- Contact Angle ୍
- Lens Parameters o
- Shelf Life o

#### Clinical Testing

A three-month clinical study was completed to evaluate the safety and efficacy of the SUS (stenfilcon A) Contact Lens for daily wear, single use only.

The study evaluated ninety (90) male and female subjects who were randomized and dispensed lenses in a 2:1 ratio with 60 subjects dispensed into the Test lenses and 30 subjects dispensed into the Control lenses. The primary outcome measures were biomicroscopy and adverse event rates along with lens visual acuity comparisons between the Control control control contact lenses. Secondary outcome measures included average lens wearing times and subjective lens comfort assessed by frequency or symptoms.

The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy.

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#### Conclusion Drawn from Studies

Validity of Scientific Data:

A contract laboratory under Good Laboratory Practice Regulations conducted toxicology studies. Microbiology, chemistry, shelf-life stability, and leachability studies were conducted by CooperVision laboratories and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence:

Information presented in this Premarket Notification establishes that the SUS (stenfilcon A) Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and the requested indication.

Risk and Benefits:

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear single use basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.

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

August 30, 2013

CooperVision, Inc. % Ms. Annette Nelson Senior Regulatory Affairs Specialist 6150 Stoneridge Mall Road. Suite 370 Pleasanton, CA 94588

Re: K131378

Trade/Device Name: SUS (stenfilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL, MVN Dated: July 15, 2013 Received: July 16, 2013

Dear Ms. Nelson:

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. 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 cither 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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You must comply with all the Act's requirements, including, but not fimited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/MedicalDeyices/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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## Indications for Use

#### .510(k) Number (if known): K131378

Device Name: SUS (stenfilcon A) Soft (hydrophilic) Contact Lenses for Single Use Daily Wear

Indications for Use:

#### Aspherical

SUS (stenfilcon A) ASPHERE Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia in aphakic and non-aphakic persons with nondiseased eye in powers from -20.00 D to +20.00 D. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not interfere with visual acuity.

#### Toric

SUS (stenfilcon A) TORIC Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

#### Multifocal

SUS (stenfilcon A) MULTIFOCAL Soft Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not interfere with visual acuity.

#### Multifocal toric

SUS (stenfilcon A) MULTIFOCAL TORIC Soft Contact Lenses are indicated for the optical correction of distance and near vision in presbyopia phakic persons with non-diseased eyes who may have 10.00 D of stigmatism or less.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) _X_ | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C)_ |
|-----------------------------------------------------|--------|-------------------------------------------------|
|-----------------------------------------------------|--------|-------------------------------------------------|

Concurrence of CDRH, Office of Device Evaluation (ODE)

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