CENTURION VISION SYSTEM

K121555 · Alcon Laboratories, Inc. · HQC · Dec 21, 2012 · Ophthalmic

Device Facts

• Record ID: K121555
• Device Name: CENTURION VISION SYSTEM
• Applicant: Alcon Laboratories, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CENTURION® Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectorny, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Device Story

Phacofragmentation system for cataract surgery; performs emulsification, irrigation, aspiration, anterior vitrectomy, bipolar coagulation, and IOL injection. System utilizes handpieces for lens removal and AutoSert IOL Injector for delivery of ACRYSOF lenses. Operated by ophthalmic surgeons in clinical/surgical settings. Provides automated control of fluidics and energy delivery for lens fragmentation. Output allows surgeon to remove cataractous material and implant IOLs, facilitating visual restoration. System design emphasizes safety and performance consistency compared to predicate phacoemulsification platforms.

Clinical Evidence

Bench testing only. Compliance with ISO 11135-1, ISO 11137-1/2, ISO 10993 series, IEC 60601-1, IEC 60601-1-1, EN 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-2, and IEC 80601-2-58 demonstrated functional equivalence and safety.

Technological Characteristics

Phacofragmentation system; includes AutoSert IOL Injector handpiece. Complies with IEC 60601-1, IEC 60601-2-2, and IEC 80601-2-58. Biocompatibility per ISO 10993. Sterilization via EtO or Gamma radiation per ISO 11135-1 and ISO 11137-1/2. Programmable electrical medical system per IEC 60601-1-4.

Indications for Use

Indicated for patients undergoing cataract surgery requiring emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material, and lens epithelial cells; anterior vitrectomy; bipolar coagulation; and intraocular lens (IOL) implantation. Compatible with specific ACRYSOF IOL models.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• Alcon INFINITI® Vision System (Evergreen II) (K112425)
• CONSTELLATION® Vision System (K101285)
• Alcon Enhanced UltraVit® Probe (K093305)
• Alcon UltraChopper® Tip (K091777)
• INFINITI® w/OZil® IP (K082845)
• Bausch & Lomb Microsurgical System (Stellaris) (K082473)
• Alcon Vision System (K063583)
• AMO Ophthalmic Surgical System (Whitestar Signature) (K060366)
• Gemini Ophthalmic Surgical System (ACCURUS®) (K911808)

Submission Summary (Full Text)

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Alcon Laboratories, Inc.
Traditional 510(k) Premarket Notification
CENTURION® Vision System

Dec 21, 2012

# DEC 2 1 2012

#### PREMARKET NOTIFICATION 510(k) SUMMARY 5.

The 510(k) Summary is provided here and is also included in Attachment B.

The submitter of the 510(k) is:

Charles Ogbonna BSc, PhD, MBA. Assistant Director, Regulatory Affairs Alcon Research, Ltd. 18500 Alton Parkway Irvine, CA 92618 Phone: [phone] Fax: [phone]

Device Subject to this 510(k):

Trade Name: Common Name: Classification Name: CENTURION® Vision System Phacofragmentation System Phacofragmentation System (per 21 CFR 886.4670)

#### 5.1 Predicate Devices:

The legally marketed devices to which we are claiming equivalence to are:

| Predicate Device | 510 (k) number | Predicate Cleared Date |
|---------------------------------------------------------|----------------|------------------------|
| Alcon INFINITI® Vision System<br>(Evergreen II) | K112425 | 11/21/2011 |
| CONSTELLATION® Vision<br>System | K101285 | 11/12/2010 |
| Alcon Enhanced UltraVit® Probe | K093305 | 04/02/2010 |
| Alcon UltraChopper® Tip | K091777 | 10/20/2009 |
| INFINITI® w/OZil® IP | K082845 | 02/12/2009 |
| Bausch & Lomb Microsurgical<br>System (Stellaris) | K082473 | 01/05/2009 |
| Alcon Vision System | K063583 | 05/09/2008 |
| AMO Ophthalmic Surgical System<br>(Whitestar Signature) | K060366 | 04/07/2006 |
| Gemini Ophthalmic Surgical<br>System (ACCURUS®) | K911808 | 06/25/1991 |

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#### 5.2 Device Description

The CENTURION® Vision System is a phacofragmentation system similar to the Alcon INFINITI® Vision System (Evergreen II - K112425). It is designed for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection.

#### 5.3 Indications for Use:

The CENTURION Vision system is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal.

The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

#### Brief Summary of Nonclinical test and Results: 5.4

Safety tests of the CENTURION® Vision System have demonstrated its compliance with applicable requirements of the following standards:

| Standard # | Title |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11135-1: 2007 | Sterilization of health care products - Ethylene oxide -<br>Requirements for development, validation, and routine control of<br>a sterilization process for medical devices. |
| ISO 11137-1: 2006 | Sterilization of health care products - Radation-Part1:<br>Requirements for the development, validation and routine<br>control of a sterilization process for medical devices. |
| ISO 11137-2: 2007 | Sterilization of health care products - radiation - Part2:<br>Establishing the sterilization dose. |

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| Standard # | Title |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BS EN ISO<br>11979-3: 2006 | Ophthalmic implants - Intraocular Lenses - Part 3: Mechanical properties and test methods |
| EN ISO 14971: 2007 | Medical Devices: Application of Risk Management to Medical Devices |
| IEC 60601-1: 2005,<br>A2: 1995 | Medical Electrical Equipment - Part 1: General requirements for safety |
| IEC 60601-1-1: 2000 | Medical electrical equipment. Part 1-1: General requirement for safety -- Collateral standard: Safety requirements for medical electrical systems |
| EN 60601-1-2: 2007 | Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-4: 1999 | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996/A1:1999) |
| IEC 60601-1-6: 2010 | Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. |
| IEC 60601-2-2: 2009 | Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment. |
| IEC 80601-2-58:<br>2008 | Medical electrical equipment -- Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |

Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:

| Standard # | Title |
|--------------------|----------------------------------------------------------------------------------------------------------------|
| ISO 10993-1: 2009 | Biological Evaluation of Medical Devices -- Part 1: Evaluation<br>and Testing within a Risk management Process |
| ISO 10993-5: 2009 | Biological Evaluation of medical devices -- Part 5: Tests for In<br>Vitro cytotoxicity |
| ISO 10993-7: 2010 | Biological Evaluation of Medical Devices -- Part 7: Ethylene<br>Oxide Sterilization Residuals |
| ISO 10993-10: 2006 | Biological Evaluation of Medical Devices -- Part 10: Tests for<br>Irritation and Delayed-Type Hypersensitivity |
| ISO 10993-11: 2006 | Biological Evaluation of Medical Devices -- Part 11: Tests for<br>Systemic Toxicity |
| ISO 10993-12: 2009 | Biological Evaluation of Medical Devices --Part 12: Sample<br>Preparation and Reference Materials |

Centurion® accessories that are provided sterile and intended for single use only are EtO or Gamma sterilized. The sterilization process has been validated per ISO 11135-1: 2007: Medical Devices – Validation and Routine Control of Ethylene

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Oxide Sterilization or per ISO 11137-1: 2006, Sterilization of health care products -Radiation - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization, and re-use of the handpieces are provided in the Directions for Use of the product.

Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. The Centurion® Vision System has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971: 2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

### Public Health Service

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

December 21, 2012

Alcon Research, Ltd. Attention: Charles Ogbonna BSc, PhD, MBA Assistant Director, Regulatory Affairs 18500 Alton Parkway Irvine, CA 92618

Re: K121555

Trade/Device Name: CENTURION® Vision System Regulation Number: 21 CFR 886.4670 ~ Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: October 12, 2012 Received: October 15, 2012

Dear Dr. Ogbonna:

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

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Page 2 - Dr. Ogbonna

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,

Victor Krauthamer -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 STATEMENT

510(k) Number (if known): ____K121555 Device Name: CENTURION® Vision System

Indications for Use:

The CENTURION® Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectorny, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Ophthalmic and Ear, Nose and Throat Devices KIZISIS 510(k) Number