The Sovereign Compact Phacoemulsification 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.

Device Description

The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that 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."

The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.

AI/ML Overview

This document describes the regulatory submission for the "Sovereign Compact Phacoemulsification System," which is an upgrade to an existing medical device. As such, the submission focuses on proving substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this regulatory submission for the "Sovereign Compact Phacoemulsification System." This is typical for submissions focused on substantial equivalence to existing, already cleared devices, especially when the changes are primarily software or minor hardware enhancements.

Instead of defining new "acceptance criteria," the submission argues that the device meets the safety and effectiveness profile of its predicate devices through non-clinical testing. The "reported device performance" is implicitly that it performs "equivalently" to the predicate devices in the described modes of surgery.

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Safety and Effectiveness	Equivalent to predicate devices (Sovereign Compact K003638, AMO Ophthalmic Surgical System K060366, Sovereign Phaco Handpiece K981116)	"The subject device was found to perform equivalently to the predicate device during the following modes of anterior segment ophthalmic surgery: phacoemulsification, irrigation, diathermy and vitrectomy."
Compliance with Safety Standards	Compliance with applicable safety standards	"The System and Handpiece 690880 have undergone testing and are in compliance with applicable safety standards."
Functional Equivalence	Functional requirements and specifications met	"Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release."

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

The document does not specify a "test set" in the context of clinical trials or AI/algorithm validation for performance metrics. The evaluation relies on non-clinical testing. Therefore, information regarding sample size and data provenance in this context is not applicable. The "test" here refers to engineering and functional verification and validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the submission did not involve clinical studies requiring expert ground truth establishment for a test set of data. The "ground truth" for the device's functionality and safety is based on engineering specifications, regulatory standards, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication for performance measurement.

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

No MRMC study was done. This device is a surgical system, not an AI or imaging diagnostic tool where MRMC studies are typically performed. The comparison is against predicate devices in terms of function and safety, not an evaluation of human reader improvement with AI assistance.

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

Not applicable. This is a medical device, a phacoemulsification system, which by its nature is used with a human surgeon (human-in-the-loop). There is no "algorithm only" performance study in the context of diagnostic or AI systems for this type of device.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering specifications and regulatory standards: The device was tested to ensure it met its defined functional and safety requirements, which are derived from engineering principles and relevant standards.
Performance of predicate devices: The primary ground truth for demonstrating substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices (Mojave Cataract Extraction System (K003638), AMO Ophthalmic Surgical System (K060366), and Sovereign Phaco Handpiece (K981116)). The new device is asserted to perform "equivalently" in the same surgical modes.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical system, not an AI or machine learning algorithm that requires a "training set" of data in the conventional sense. The "development" or "training" involves engineering design, prototyping, and testing.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The "ground truth" for the device's development and validation came from established engineering principles, design specifications, and the performance characteristics of previously cleared predicate devices.

Summary

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

DEC 2 1 2011

SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446

4. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.

Applicant:

Abbott Medical Optics Inc. 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162, USA

Contact Person:

Rosanne M. Yetemian, PhD, MSRS Regulatory Affairs Specialist 1700 E. St. Andrew Place Santa Ana, CA 92705 Tel: (714) 247-8282 Fax: (714) 247-8487 Email: rosanne.yetemian@amo.abbott.com

R.H

Date of 510(k) Summary Preparation:

November 28, 2011

Device that is the subject of this notification:

Trade/Proprietary Name:	The Sovereign Compact Phacoemulsification System
Classification Name:	Phacofragmentation System
Regulation Number:	21 CFR 886.4670
Regulation Name:	Phacofragmentation system
Regulatory Class:	Class II
Product Code:	HQC

The devices to which substantial equivalence is claimed:

Table 4-1: Predicate Devices to Which Substantial Equivalence is Claimed
Predicate Device Name	Predicate Trade Name	510(k) Holder	510(k) Number	Clearance Date
Sovereign Compact Phacoemulsification System Predicate Devices
Mojave CataractExtraction System	Sovereign Compact	AMO	K003638	02/13/2001
AMO OphthalmicSurgical System	WhiteStar Signature	AMO	K060366	04/07/2006
AMO Ultrasonic Handpiece 690880 Predicate Device
Sovereign PhacoHandpiece	Sovereign Handpiece	AMO	K981116	05/19/1998

ABBOTT MEDICAL OPTICS INC.

510(k) SUMMARY

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

SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446

4.1 DEVICE DESCRIPTION SUMMARY

The materials, basic scientific concepts, physical properties and intended use of The System are identical to those of The Mojave Cataract Extraction System (branded as Sovereign Compact) (K003638) predicate device. The AMO Ophthalmic Surgical System was also listed as a predicate because it shares the same available software modes as The System. Both predicate devices are manufactured by Abbott Medical Optics Inc. (AMO).

The System will be marketed as either a complete unit or an optional software upgrade kit for current Sovereign Compact Systems in the field.

In addition, the enhancements made to The System include an optional feature-activated capability for the use of the AMO Ultrasonic Handpiece 690880 (Handpiece 690880), which is substantially equivalent to the Sovereign Phaco Handpiece cleared under the Sovereign Cataract Extraction System 510(k) (K981116). Handpiece 690880 is intended for use during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.

4.2 INDICATIONS FOR USE

The Sovereign Compact Phacoemulsification 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.

4.3 TECHNOLOGICAL CHARACTERISTICS

For anterior segment (cataract) surgical procedures, the system provides the following main diathermy, phacoemulsification, irrigation and aspiration, and vitrectorny. The modes: technological characteristics of the device are substantially equivalent to those cleared under the 510(k)s of the Mojave Cataract Extraction System (K003638) and the AMO Ophthalmic Surgical System (K060366). The technological characteristics of the AMO Ultrasonic Handpiece are substantially equivalent to those of the Sovereign Phaco Handpiece cleared under 510(k) of the Sovereign Cataract Extraction System (K981116).

The System, which is the subject device, is an upgrade to the existing predicate device, the Mojave Cataract Extraction System (branded as Sovereign Compact and cleared on February 13, 2001 under K003638). Since the clearance of this device, The System has been upgraded

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

to include software modes that are also available with the second predicate, the AMO Ophthalmic Surgical System (K060366).

The differences between The System and its two predicate devices include:

AMO Ultrasonic Handpiece 690880 compatibility 0
Support for the latest version of the Surgical Media Center (SMC) o
The ability to view vacuum units in kilopascals (kPa) o
Support for an IV pole extension o

A comparison summary of The System and the two predicate devices is provided in Table 4-2. All unique features available with The System with respect to both predicates are underlined for clarity.

Features andCharacteristics	Proposed DeviceThe Sovereign CompactPhacoemulsificationSystem	Predicate DeviceMojave CataractExtraction System(K003638)	Predicate DeviceAMO Ophthalmic-Surgical System(K060366)
Intended Use	Anterior SegmentOphthalmic Surgery	Anterior SegmentOphthalmic Surgery	Anterior and Posterior(optional) SegmentOphthalmic Surgery
TechnologicalCharacteristics
User Interface	Key panel, remotecontrol, footpedal	Key panel, remotecontrol, footpedal	Touch screen, remotecontrol, footpedal
Hardware:-Console	Compact system consolewith display screen andkey entry	Compact system consolewith display screen andkey entry	Upper-Tier systemconsole with displayscreen and key entry
-Footpedal	Wired(closed or open-toe)	Wired(closed toe)	Wired or wireless(open-toe)
-Remote control unit	Wired	Wired	Wireless
-Console stand	Cart with mayo tray andarticulating arm	Cart with mayo tray andarticulating arm	Cart with mayo tray andarticulating arm
-IV Pole	Yes(with optional extension)	Yes	Yes
Software:-OS for Safety CriticalFunctions	Same	Same	Same
Available Modes:	Same	No	Same
Specifications:-Aspiration Pump Type	Peristaltic	Peristaltic	Peristaltic and Venturi
- Handpiece 690880compatibility	Yes	No	No
-SMC Support	Yes	No	No
-Multilingual support	Yes	No	Yes
-Vacuum/pressure	mmHg, kPa	mmHg	mmHg

Table 4-2 Comparison Overview of The System to the Predicate Devices

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

SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446

Features andCharacteristicsAccessories	Proposed DeviceThe Sovereign CompactPhacoemulsificationSystem	Predicate DeviceMojave CataractExtraction System(K003638)	Predicate DeviceAMO OphthalmicSurgical System(K060366)
Disposable Accessories	• Tips and Sleeves• Fluidics Packs• Administration Set• Sterilization Tray• Phaco Handpieces	• Tips and Sleeves• Fluidics Packs• Administration Set• Sterilization Tray• Phaco Handpieces	• Tips and Sleeves• Fluidics Packs• Administration Set• Sterilization Tray• Phaco Handpieces
Reusable Accessories	• Fluidics Pack• Irrigation/AspirationHandpiece• Diathermy Cord withBipolar Forceps• Vitrectomy Handpiece	• Fluidics Pack• Irrigation/AspirationHandpiece• Diathermy Cord withBipolar Forceps• Vitrectomy Handpiece	• N/A (Disposable Only)• Irrigation/AspirationHandpiece• Diathermy Cord withBipolar Forceps• Vitrectomy Handpiece

4.4 SUMMARY OF NON-CLINICAL. TESTS

The System and Handpiece 690880 have undergone testing and are in compliance with applicable safety standards. The subject device was found to perform equivalently to the predicate device during the following modes of anterior segement ophthalmic surgery: phacoemulsification, irrigation, diathermy and vitrectomy. Therefore, the subject device and the predicate devices have similar safety, effectiveness, and performance profiles.

4.5 SUMMARY OF CLINICAL TESTS

No clinical studies were deemed necessary to determine the safety and effectiveness or substantial equivalence of The System and Handpiece 690880 to their predicate devices.

4.5 CONCLUSIONS

The technological characteristics that determine the functionality and performance of The Sovereign Compact Phacoemulsification System and the AMO Ultrasonic Handpiece 690880 are substantially equivalent to those of the predicate devices listed. The Sovereign Compact Phacoemulsification System and the AMO Ultrasonic Handpiece will be manufactured in . compliance with FDA and ISO quality systems requirements. The data presented from the nonclinical tests demonstrate that the device is safe and effective, and performs as safely and effectively as the legally marketed predicate devices. Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

Abbott Medical Optics, Inc. c/o Rosanne Yetemian, PhD, MSRS Regulatory Affairs Specialist 1700 E. St. Andrew Place Santa Ana, CA 92705

DEC 2 1 2011

Re: K111446

Trade/Device Name: Sovereign Compact Phacoemulsification System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: December 19, 2011 Received: December 20, 2011

Dear Dr. Yetemian:

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.

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

Page 2 - Dr. Rosanne Yetemian

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 (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.

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological. 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): K111446

Device Name: The Sovereign Compact Phacoemulsification System

Indications For Use:

The Sovereign Compact Phacoemulsification 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

CLC

(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological as
The Cources of Devices Ear. Division of OF
Nose and Throat Devices

K118146

510(k) Number

Sovereign Compact Phacoemulsification System Abbott Medical Optics Inc.

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.