BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC

K113267 · CooperVision, Inc. · LPL · Dec 2, 2011 · Ophthalmic

Device Facts

• Record ID: K113267
• Device Name: BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

SPHERICAL Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity. TORIC Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters. The lens may be prescribed for Daily Wear in not-aphakic persons. The eyecare practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear the lens is to be discarded after each removal. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system. The Biomedics (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Biomedics 52 (ocufilcon B) is a Group IV, high-water, ionic, silicone hydrogel soft contact lens; hemispherical shell design; incorporates phthalocyanine blue handling tint and UV blocker. Intended for daily wear to correct myopia, hyperopia, and astigmatism. Prescribed by eyecare practitioners for single-use or frequent replacement; frequent replacement requires chemical disinfection. Device provides vision correction and UV radiation protection for the cornea/eye. No changes to material, manufacturing, or lens parameters compared to predicates; submission specifically addresses modifications to shelf-life/stability protocols.

Clinical Evidence

No clinical data required. Technical characteristics, formulation, manufacturing, and sterilization processes remain unchanged from currently marketed predicates. Bench testing only.

Technological Characteristics

Material: ocufilcon B (HEMA-based, Group IV, high water, ionic polymer). Design: Hemispherical shell, spherical and toric configurations. Features: Phthalocyanine blue handling tint, UV blocker. Energy source: N/A. Connectivity: N/A. Sterilization: Unchanged from predicate processes.

Indications for Use

Indicated for correction of visual acuity in non-aphakic, non-diseased eyes with myopia or hyperopia and refractive astigmatism (up to 2.00D for spherical, 10.00D for toric). Prescribed for daily wear, either single-use disposable or frequent replacement.

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

• Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocker Daily Wear Contact Lens (K003136)
• Biomedics 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lens for Daily Wear (K020389)

Submission Summary (Full Text)

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K113267

.

DEC - 2 2011

# 510(k) Summary

# 1. Applicant Name and Address

CooperVision, Inc. 6150 Stoneridge Mall Drive Suite 370 Pleasanton CA 94588

2. Contact

Gwen Sharp Regulatory Affairs [phone] [e-mail]

3. Date Prepared

November 3, 2011

4. Device Identification

| Trade Name: | Biomedics 52<br>Biomedics 52 1-Day |
|---------------------------|-------------------------------------------------------------|
| Common Name: | Soft Contact Lens |
| Classification<br>Name: | Soft (hydrophilic) Contact Lens –<br>Daily Wear; Disposable |
| Device<br>Classification: | Class II (21 CFR 886.5925) |
| FDA Material<br>Class: | FDA Group IV, High Water, Ionic<br>Polymer |
| Product Code: | MVN, LPL |

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# 5. Device Description

The Biomedics 52 (ocufilcon B) soft contact lens is a Group IV, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, ocufilcon B. is composed of polymerized material of HEMA and cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lenses are manufactured in spherical and toric configurations. The Biomedics 52 (ocufilcon B) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510(k)s.

# 6. Intended Use

# SPHERICAL

Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.

### TORIC

Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters.

The lens may be prescribed for Daily Wear in not-aphakic persons. The eyecare practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear the lens is to be discarded after each removal. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

The Biomedics (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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# 7. Predicate Device(s)

- Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocker Daily Wear Contact Lens . (K003136) January 16, 2001
- Biomedics 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lens for . Daily Wear (K020389) June 4, 2002

# 8. Characteristics of Substantial Equivalence

The soft contact lenses have the following similarities to the predicate lens that previously received 510(k) clearance:

- . have the same indicated use,
- incorporate the same design, .
- incorporate the same materials, .
- have the same shelf life, and .
- . are packaged and sterilized using the same materials and processes.

The modifications to the stability/shelf life protocol include an alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.

In summary, the ocufilcon B soft contact lenses described in this submission are substantially equivalent to the predicate device.

### 9. Physiochemical Studies

Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses.

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K 11 i 320

#### 10. Toxicology Studies

Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol. Change will not affect lenses ability to remain non-toxic and biocompatible with the ocular environment.

#### 11. Conclusions of Non-Clinical Tests Performed:

#### l Physiochemical:

The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses.

#### 트 Toxicology:

Results from in-vivo and in-vitro studies originally conducted remain valid and verify that the lenses remain non-toxic and are biocompatible with the ocular environment.

#### 12. Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and therefore are equivalent to ocufilcon B soft contact lenses currently marketed by Cooper Vision, therefore no clinical data is required.

#### 13. Conclusions

Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the ocufilcon B soft contact lens described in this document are substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

CooperVision, Inc. c/o Ms. Gwen Sharp Global Regulatory Affairs 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588

DEC - 2 2011

Re: K113267

Trade/Device Name: Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocker Daily

Wear Contact Lens

Biomedics 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lenses

Regulatory Class: Class II

Product Code: LPL and MVN

Dated: November 3, 2011

Received: November 4, 2011

Dear Ms. Sharp:

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 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Gwen Sharp

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Alexander

Image /page/5/Picture/7 description: The image shows the name and title of Malvina B. Eydelman, M.D. She is the Director of the Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices. The text also mentions the Office of Device Evaluation and the Center for Devices and Radiological Health.

Enclosure

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#### Indications for Use

510(k) Number (if known): K113267

Device Name: Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocker Daily Wear Contact Lens

> Biomedics 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lens for Daily Wear

#### Indications for Use:

#### SPHERICAL

Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.

#### TORIC

Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters.

The lens may be prescribed for Daily Wear in not-aphakic persons. The cyecare practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear the lens is to be discarded after each removal. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

The Biomedics (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rusanand

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K113267