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 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.

AI/ML Overview

The Alcon Laboratories, Inc. CENTURION® Vision System, an ophthalmic surgical device, received 510(k) clearance based on substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The provided document focuses primarily on non-clinical testing and regulatory compliance rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI/ML product would be assessed.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this submission. The "acceptance criteria" here refers to compliance with safety standards and demonstration of equivalence to existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Compliance with Standards/Equivalence to Predicates)	Reported Device Performance (Demonstrated Compliance/Equivalence)
Sterilization (Ethylene Oxide) ISO 11135-1: 2007	Validated per standard
Sterilization (Radiation) ISO 11137-1: 2006, ISO 11137-2: 2007	Validated per standard
Ophthalmic Implants - Mechanical Properties BS EN ISO 11979-3: 2006	Not explicitly detailed, but implied by overall compliance.
Risk Management EN ISO 14971: 2007	Compliance demonstrated
Medical Electrical Equipment - Safety (General, Collateral, Particular, Usability, High Frequency Surgical, Lens Removal/Vitrectomy) IEC 60601 series, IEC 80601-2-58: 2008	Compliance demonstrated
Biocompatibility (Evaluation & Testing, In Vitro Cytotoxicity, Ethylene Oxide Sterilization Residuals, Irritation/Hypersensitivity, Systemic Toxicity, Sample Prep) ISO 10993 series	Evaluations performed to specified standards
Quality System Compliance 21 CFR 820	Compliance stated
Substantial Equivalence to Predicate Devices (e.g., Alcon INFINITI® Vision System)	Demonstrated through non-clinical testing and comparison of technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not describe a "test set" in the context of clinical data for an AI/ML device. The testing involved non-clinical evaluations of the device's components and system against engineering and safety standards. Therefore, concepts like country of origin for data or retrospective/prospective are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth as typically defined for AI/ML validation (e.g., diagnostic labels) is not part of this device's regulatory review, which focuses on hardware safety and performance.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication in the context of clinical interpretation or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a hardware surgical device, not an AI/ML diagnostic or assistive tool where human reader performance would be assessed with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a surgical system that is operated by a human surgeon. It does not have a "standalone algorithm" that performs clinical tasks independently.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering standards, material specifications, and performance requirements for medical devices, particularly ophthalmic surgical systems. This includes:

Standards Compliance: Adherence to ISO and IEC standards for sterilization, biocompatibility, electrical safety, risk management, and mechanical properties.
Functional Equivalence: Demonstration that the new device performs its intended functions (e.g., emulsification, aspiration, IOL injection) similarly and safely compared to previously cleared predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

{0}------------------------------------------------

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: (949) 753-6307 Fax: (949) 753-6237

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(Evergreen II)	K112425	11/21/2011
CONSTELLATION® VisionSystem	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 MicrosurgicalSystem (Stellaris)	K082473	01/05/2009
Alcon Vision System	K063583	05/09/2008
AMO Ophthalmic Surgical System(Whitestar Signature)	K060366	04/07/2006
Gemini Ophthalmic SurgicalSystem (ACCURUS®)	K911808	06/25/1991

{1}------------------------------------------------

5.2 Device Description

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 -Requirements for development, validation, and routine control ofa sterilization process for medical devices.
ISO 11137-1: 2006	Sterilization of health care products - Radation-Part1:Requirements for the development, validation and routinecontrol of a sterilization process for medical devices.
ISO 11137-2: 2007	Sterilization of health care products - radiation - Part2:Establishing the sterilization dose.

{2}------------------------------------------------

Standard #	Title
BS EN ISO11979-3: 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,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 80601-2-58:2008	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: Evaluationand Testing within a Risk management Process
ISO 10993-5: 2009	Biological Evaluation of medical devices -- Part 5: Tests for InVitro cytotoxicity
ISO 10993-7: 2010	Biological Evaluation of Medical Devices -- Part 7: EthyleneOxide Sterilization Residuals
ISO 10993-10: 2006	Biological Evaluation of Medical Devices -- Part 10: Tests forIrritation and Delayed-Type Hypersensitivity
ISO 10993-11: 2006	Biological Evaluation of Medical Devices -- Part 11: Tests forSystemic Toxicity
ISO 10993-12: 2009	Biological Evaluation of Medical Devices --Part 12: SamplePreparation 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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{6}------------------------------------------------

INDICATIONS FOR USE STATEMENT

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

Indications for Use:

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

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
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.(b)
Classification. Class II.