The CENTURION® Vision system (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical 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 function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. 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

Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece.

The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

AI/ML Overview

This document describes the Centurion Vision System (Active Sentry™), a phacofragmentation system for cataract surgery. The submission to the FDA is for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating safety and performance comparison to the predicate, rather than establishing de novo clinical performance metrics against a defined acceptance criteria for a novel device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device's established safety and performance. The performance data presented primarily focuses on non-clinical testing.

Acceptance Criteria (Implicit - Demonstrating Equivalence to Predicate)	Reported Device Performance (Centurion Vision System (Active Sentry™))
Biocompatibility: Device materials are non-toxic and compatible with the human body.	PASS in all conducted biocompatibility tests for the Active Sentry® Handpiece, including: - Cytotoxicity (ISO Elution Method 1X MEM, ISO MTT Method) - Sensitization (ISO Maximization Sensitization Study) - Acute Systemic Toxicity (ISO Acute Systemic Toxicity Study) - Ocular Irritation (ISO Intraocular Injection Method) - Material Characterization (Leachables)
Electromagnetic Compatibility (EMC): Device operates without causing or being susceptible to electromagnetic interference.	PASS in all conducted electromagnetic compatibility and electrical safety tests, including: - EN 60601-1 (General requirements for basic safety and essential performance) - EN 60601-1-2 (Electromagnetic compatibility) - EN 60601-2-2 (Safety of high frequency surgical equipment) - EN 60601-1-8 (Alarm systems) - EN 80601-2-58 (Lens removal and vitrectomy devices) - IEC 60601-1-6 (Usability) - IEC 62366 (Usability engineering)
Electrical Safety: Device meets electrical safety standards.	PASS in all conducted electrical safety tests (as part of EN 60601-1, EN 60601-2-2, etc.).
Functional Equivalence: Device performs its intended functions similarly to the predicate.	Demonstrated through comparison of technological characteristics (same intended use, operating principle, basic phaco handpiece, consumables, technology, design, materials, shelf life, packaging, and sterilization). No specific quantitative functional performance metrics are provided in this summary, implying functional equivalence was accepted based on design and non-clinical testing.

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

Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to non-clinical laboratory testing, not human clinical trials with a defined patient sample size. The biocompatibility tests used cell lines (L-929 Mouse), guinea pigs, and rabbits. Electrical and EMC tests were performed on the device itself.
Data Provenance: The data provenance is from laboratory testing performed by Alcon Research, Ltd. or its contracted labs. The country of origin of the data is not explicitly stated but is implicitly where Alcon conducted its R&D and testing. The data is prospective in the sense that these tests were conducted specifically for this submission, but they are not clinical prospective studies.

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

This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus or clinical outcomes is relevant for diagnostic or AI-driven systems. For device safety and performance testing like biocompatibility, EMC, and electrical safety, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, EN, IEC) and the expertise of certified laboratory personnel. No clinical experts were involved in establishing the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts, typically in clinical studies or image interpretation tasks. The tests described here are laboratory-based and follow standardized protocols, yielding objective pass/fail results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical system, not a diagnostic imaging device or an AI-driven system requiring human-in-the-loop performance evaluation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware and software medical device for surgical procedures, not a standalone algorithm.

7. The Type of Ground Truth Used

For biocompatibility: The "ground truth" is established by the accepted physiological responses and safety profiles defined in the ISO standards for biological evaluation of medical devices.
For electrical safety and EMC: The "ground truth" is established by the specifications and limits defined in the international electrical safety and EMC standards (e.g., IEC 60601 series).
For functional aspects: The "ground truth" for functional equivalence is the performance and operating characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The development and verification process involves engineering design, prototyping, and testing, not algorithmic training on large datasets.

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

Not applicable, as there is no "training set" for an AI algorithm.

Summary

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

April 14, 2017

Alcon Research, Ltd. Mr. Paul Swift, RAC Director, Global Regulatory Affairs Project 6201 South Freeway Dr. Fort Worth, TX 76134-2099

Re: K161794

Trade/Device Name: Centurion Vision System (Active Sentry") Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: March 6, 2017 Received: March 8, 2017

Dear Mr. Swift:

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 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

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forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Bradley S. Cunningham -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) K161794

Device Name

CENTURION VISION SYSTEM (Active Sentry™)

Indications for Use (Describe)

The CENTURION® Vision system (Active SentryTM) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5 510(k) Summary

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

Submitter of the 510(k)

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	Paul Swift, RACDirector, Global Regulatory Affairs
Phone:	817.615.2952
Fax:	817.551.4630
Email:	Paul.Swift@alcon.com
Date Prepared:	December 16, 2016

Devices Subject to this 510(k)

Trade Names:	CENTURION® Vision System (Active Sentry®
Regulation Number:	21 CFR 886.4670
Regulation Name:	Phacofragmentation System
Regulatory Class:	Class II
Product Code:	HQC

A. Predicate Device

CENTURION Vision System K121555 December 21, 2012

B. Device Description

The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate

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the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

C. Indications for Use

The CENTURION® Vision system (Active Sentry®) 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 SN6OWF, SNWAD1, 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.

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D. Comparison to Technological Characteristics with the Predicate Device

Characteristic	CENTURION® Vision System	CENTURION® Vision System(Active Sentry®)
510 (k) #	K121555	K161794
Intended Use	Anterior Segment OphthalmicSurgery	Anterior Segment OphthalmicSurgery
Hardware (Modular) Design	Yes	Yes
Microprocessor based	Yes	Yes
Programmable for multiplesurgeons	Yes	Yes
User Interface	Footswitch, Touch Screen andRemote control	Footswitch, Touch Screen andRemote control
Self-Diagnostics	Yes	Yes
Real-Time Display	Yes	Yes
Software platform	Windows based	Windows based
U/S Pulse Mode	Yes	Yes
Heads-Up Display	Yes (optional only)	Yes (optional only)
Anterior Vitrectomy	Yes	Yes
Posterior Vitrectomy	No	No
Occlusion Mode
Longitudinal	Yes	Yes
Torsional	Yes	Yes
Operating U/S Frequency
Longitudinal	44kHz nominal	44kHz nominal
Torsional	32kHz nominal	32kHz nominal
Support for ALCON®UltraChopper® Tip	Yes (K091777)	Yes (K091777)
Power Watch Mode	Yes	Yes
IOL Injection Mode	Yes	Yes
Coagulation/Cautery/Diathermy	Yes	Yes
Irrigation
Gravity	Yes	Yes
Pressurized	Yes	Yes
Maximum Irrigation PressureThreshold (in mmHg)	Less than 207	Less than 207
Aspiration Pump Type	Peristaltic	Peristaltic
Vacuum Range (in mmHg)	0-650(+)	0-650(+)
Console Screen	Active Matrix color LCD	Active Matrix color LCD
Multi-function Foot Pedal
Wired	Yes	Yes
Wireless	Yes	Yes
Characteristic	CENTURION®Vision System	CENTURION® Vision System(Active Sentry®)
Remote Control	Yes(if selected)	Yes(if selected)
Automatic IV Pole	Yes	Yes
Voice Confirmation	Yes	Yes
Prime Mode	Yes	Yes
Machine Height Width andDepth	63" x 23" x 30" max	63" x 23" x 30" max
Machine Weight	235 lbs max	235 lbs max
Electrical Power Specifications	100-240 V AC, 50/60 Hz	100-240 V AC, 50/60 Hz
Operating Temperature Range	10 - 35°C	10 - 35°C
Maximum Humidity(RH = Relative Humidity)	95% RH noncondensing	95% RH noncondensing
Disposable Pack - ProvidedSterile	Yes	Yes
Disposable Pack - Method ofsterilization	EtO and Gamma	EtO and Gamma

Table 1 Substantial equivalence comparison

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E. Performance Data

Performance of the CENTURION® Vision System (Active Sentry®) has been demonstrated through various performance validations, biocompatibility testing and electromagnetic compatibility and electrical safety testing.

Table 2: Summary of biocompatibility studies for the Active Sentry® Handpiece

Biocompatibility Testing forActive Sentry Handpiece	Cell Line/Species	Test Media Extract	TestResult
CytotoxicityISO Elution Method 1X MEM	L-929 Mouse	MEM Extract	PASS
CytotoxicityISO MTT Method	L-929 Mouse	MEM Extract	PASS
SensitizationISO Maximization SensitizationStudy	Guinea Pig	Saline & Sesame Oil Extracts	PASS
Acute Systemic ToxicityISO Acute Systemic Toxicity Study	Mouse	Saline & Sesame Oil Extracts	PASS
Ocular IrritationISO (Intraocular Injection) Method	Rabbit	Balanced Salt Solution (BSS® IrrigatingSolution)	PASS
Material Characterization(Leachables)ISO Method	Not Applicable	Isopropanol and Purified Water	PASS

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Table 3: CENTURION® Vision System (Active Sentry®) electromagnetic compatibility and electrical safety

DocumentNumber	Revision	Document Name	Result
EN 60601-1	2013	Medical Electrical Equipment, Part 1 – General requirements for basic safetyand essential performance. (Including A1:2013)(Equivalent to IEC 60601-1: 2005+ A1: 2012)	PASS
EN 60601-1-2	2007	Medical electrical equipment Part 1: General requirements for basic safetyand essential performance - 2. Collateral Standard: Electromagneticcompatibility-Requirements and test.(Equivalent to IEC 60601-1-2: 2007)	PASS
EN 60601-2-2	2009	Medical electrical equipment – Part 2: General requirements for basic safetyand essential performance - Particular requirements for the Safety of highfrequency surgical equipment.(Equivalent to IEC 60601-2-2: 2009)	PASS
EN 60601-1-8	2007	Medical Electrical Equipment, Part 1: General requirements for basic safetyand essential performance - 6. Collateral standard for alarm systems(Equivalent to IEC 60601-1-8: 2006)	PASS
EN 80601-2-58	2009	Medical Electrical Equipment, Part 2-58: Particular requirements for the basicsafety and essential performance of lens removal devices and vitrectomydevices for ophthalmic surgery (Equivalent to IEC 80601-2-58:2008)	PASS
IEC 60601-1-6	2010	Medical Electrical Equipment Part 1-6: General requirements for safety -collateral standard: usability (Including A1:2013)	PASS
IEC 62366	2007	Medical Devices - Application of usability engineering to medical devices(Including A1:2014)	PASS

F. Conclusions

The modified CENTURION® Vision System (Active Sentry®) is substantially equivalent to the originally submitted CENTURION® Vision System in that both devices:

. have the same indicated use.
. use the same operating principle,
. incorporate the same basic phaco handpiece, same consumables and accessories cleared in the original submission as a system
. use the same technology including components used.
o are of the same design, incorporate the same materials, have the same shelf life, and are packaged and sterilized using the same materials and processes;

In summary, the changes made to the CENTURION® Vision System (Active Sentry®) described in this submission are substantially equivalent to the predicate device: CENTURION® Vision System.

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.