The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

Device Description

The COMPACT INTUITIV System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The system has the same surgical functionality and software features found in the primary predicate device, the SOVEREIGN Compact Phacoemulsification System (K111446) cleared on December 29, 2011. Like the predicate, the COMPACT INTUITIV is a mid-tier peristaltic system with a user-friendly interface that has updated technology and hardware to meet current electrical and material safety standards. The COMPACT INTUITIV consists of the System Console, the Wireless Remote Control, the Four-Button Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "COMPACT INTUITIV System," a phacoemulsification system used for cataract surgery. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested details, such as a table of acceptance criteria for a novel algorithm, sample sizes for test sets, expert-established ground truths, and multi-reader multi-case studies, are not applicable or not provided in this document. The device in question is a physical surgical system, not an AI or imaging diagnostic tool that would typically involve such performance metrics.

However, I can extract information related to the device's validation and the methods used to demonstrate its safety and effectiveness, which serves as its "acceptance criteria" in the context of a 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria for the COMPACT INTUITIV System are fundamentally tied to its substantial equivalence to predicate devices (SOVEREIGN Compact Phacoemulsification System and SOVEREIGN Compact Disposable Tubing Set) regarding safety, effectiveness, and performance. The "performance" here refers to its functional operation in all anterior segment ophthalmic surgery modes.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criterion (from standards/testing)	Reported Device Performance
Electromechanical Safety	Compliance with ANSI/AAMI/ES 60601-1:2005 (General requirements for basic safety and essential performance)	Compliant; all tests passed.
	Compliance with EN/IEC 60601-1-2:2007 (Electromagnetic compatibility)	Compliant; all tests passed.
	Compliance with IEC 60601-2-2:2009 (Safety and essential performance of high frequency surgical equipment)	Compliant; all tests passed.
Usability Engineering	Compliance with IEC 62366:2007 (Application of usability engineering to medical devices)	Compliant.
Risk Management	Compliance with ISO 14971:2007 (Application of risk management to medical devices)	Compliant.
Functional Performance	Perform safely and effectively in all anterior segment ophthalmic surgery modes (phacoemulsification, diathermy, irrigation, vitrectomy) as well as predicate device.	All tests passed; all acceptance criteria were met. Device performs as safely and effectively as predicate devices.
Biocompatibility (Fluidics Pack)	Compliance with ISO 10993-1, -5, -7, -10, -12 for materials in patient fluid path.	All acceptance criteria were met. Device has similar safety, effectiveness, and performance profile as predicate.
Sterilization (Fluidics Pack)	Compliance with EN/ISO 11135-1:2007 (Ethylene Oxide sterilization) for Single-Use Pack.	All acceptance criteria were met. Device has similar safety, effectiveness, and performance profile as predicate.
Intended Use	Same intended use as predicate devices (anterior segment ophthalmic surgery).	Identical intended use.
Technological Characteristics	Same software modes, basic scientific concepts, energy source, compact design as predicate devices.	Identical to predicate device.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states that "Testing of all anterior segment ophthalmic surgery modes, including phacoemulsification, diathermy, irrigation, and vitrectomy, was conducted." This implies an engineering/bench testing approach rather than a patient-based test set with a specific sample size.
- Data Provenance: The document does not specify a country of origin for any "data" in the sense of clinical or image data. The testing was non-clinical, involving engineering verification and validation. The manufacturer is Abbott Medical Optics Inc., located in Santa Ana, CA, USA.
- Retrospective or Prospective: Not applicable as no clinical or human-subject data was used. The testing was non-clinical (bench testing) and prospective in nature for validating the new device design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a physical surgical device undergoing non-clinical technical and safety testing, "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The "ground truth" for these tests would be the established performance characteristics and safety standards outlined in the regulatory guidances and predicate device specifications.
Adjudication method for the test set:
- Not applicable. Since there's no diagnostic task or human variable interpretation, there's no need for an adjudication method like 2+1 or 3+1. Test results are objective (e.g., meeting a power output specification, passing a bio-compatibility test).
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:
- No MRMC study was done. This type of study is relevant for diagnostic systems (e.g., AI in radiology), not for a surgical device like the COMPACT INTUITIV System. The device does not involve "human readers" or "AI assistance" in that context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical device, not an algorithm, so the concept of "standalone algorithm performance" is not relevant. The device itself operates, but always with a human surgeon-in-the-loop.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" was based on:
  - Compliance with recognized industry standards: (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, ISO 14971 for risk management).
  - Performance specifications of the predicate devices: The COMPACT INTUITIV System was tested to perform "as safely and as effectively as" the predicate devices.
  - Internal AMO requirements and specifications: The device was developed and tested against these.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model. This is a hardware device being validated against engineering and safety specifications.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm.

Summary

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FEB 2 7 2014

510(K) SUMMARY 6

6.1 APPLICANT INFORMATION

Abbott Medical Optics Inc. (AMO) is submitting an Abbreviated 510(k) premarket notification for the COMPACT INTUITIV System. 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 21 CFR 807.92.

Submitter Information:

Contact Person:

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

Rosanne Yetemian, PhD, MSRS, RAC Manager, Regulatory Affairs 1700 East St. Andrew Place Santa Ana, CA 92705 Tel: (714) 247-8282 Mobile: (714) 313-8856 Fax: (714) 247-8784 Email: rosanne.yetemian@amo.abbott.com

R. H.

Date of 510(k) Summary Preparation:

Subject Device:

Trade/Proprietary Name: Common Name:

Classification Name: Product Code: Regulatory Class:

COMPACT INTUITIV System Cataract Extraction System or Phacoemulsification System Phacofragmentation System per 21 CFR 886.4670 HQC 11

September 27, 2013

6.2 SUBSTANTIAL EQUIVALENCE SUMMARY

The COMPACT INTUITIV System is a new phacoemulsification system designed for use in the surgical setting for ophthalmologists with experience as phacoemulsification surgeons to emulsify and remove a cataractous lens from the eye. The COMPACT INTUITIV surgical system consists of a system console that powers and operates the device, a wireless remote control, a programmable four-button foot pedal, and a sterile single-use fluidics pack. The COMPACT INTUITIV System console and its components are substantially equivalent to the console and accessories of AMO's SOVEREIGN Compact Phacoemulsification System cleared on December 29, 2011 (K111446), and the fluidics pack is substantially equivalent to AMO's SOVEREIGN Compact Disposable Tubing Set cleared on May 19, 1998 (K981116).

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The devices to which substantial equivalence of the COMPACT INTUITIV System and its accessories are claimed are listed below.

Predicate Devices to which Substantial Equivalence is claimed for the COMPACT INTUITIV System and its Components/Accessories

510(k)Number	Date ofFDAClearance	Predicate Device/Accessory Name	510(k) Holder
COMPACT INTUITIV System Console
K111446	12/29/2011	SOVEREIGN Compact PhacoemulsificationSystemPrimary Predicate Device	AbbottMedical OpticsInc.
COMPACT INTUITIV Wireless Remote Control
K111446	12/29/2011	Wired Remote ControlAn accessory to The SOVEREIGNCompact Phacoemulsification System	AbbottMedical OpticsInc.
COMPACT INTUITIV Four-Button Foot Pedal
K111446	12/29/2011	SOVEREIGN COMPACT Open-ToeFoot PedalAn accessory to The SOVEREIGNCompact Phacoemulsification System	AbbottMedical OpticsInc.
COMPACT INTUITIV Single-Use Pack, OPO80
K981116	5/19/1998	SOVEREIGN Compact Disposable TubingSet, Model OPO61An accessory to The SOVEREIGNCompact Phacoemulsification System	AbbottMedical OpticsInc.

DEVICE DESCRIPTION 6.3

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TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6.4

The main technological characteristics of the COMPACT INTUITIV System include ultrasonic phacoemulsification (phaco), diathermy, irrigation and aspiration, and vitrectomy. All main performance functions of the COMPACT INTUITIV System and fluidics pack, Model OP080 are also available with the AMO SOVEREIGN Compact System predicate device (K111446) and the SOVEREIGN Compact Disposable Tubing Set, Model OPO61 (K981116).

The software modes, basic scientific concepts, energy source, compact design, intended use and FDA-recognized standards used for performance testing of The COMPACT INTUITIV System are identical to those of The SOVEREIGN Compact Phacoemulsification System (K111446). The intended use of the COMPACT INTUITIV System and its components is anterior segment ophthalmic surgery, which is the same intended use as the primary predicate device.

INDICATIONS FOR USE 6.5

The Indications for Use statement of the COMPACT INTUITIV System is the following:

The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Indications for Use statement of the Single-Use Fluidics Pack, Model OPO80 is the following:

The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only

6.6 SUMMARY OF NON-CLINICAL TESTS

The COMPACT INTUITIV System has undergone design verification and validation testing including electromechanical safety testing (IEC testing) and is in compliance with the applicable requirements of safety standards. The COMPACT INTUITIV System, its components and compatible accessories were tested and found to perform as safely and as effectively as the SOVEREIGN Compact Phacoemulsification System (K111446) primary predicate device and the SOVEREIGN Compact Disposable Tubing Set, Model OPO61 (K981116). Testing of all anterior segment ophthalmic surgery modes, including phacoemulsification, diathermy, irrigation, and vitrectomy, was conducted; all tests passed and all acceptance criteria were met. Therefore, the COMPACT INTUITIV System and the predicate devices have similar safety, effectiveness, and performance profiles.

The COMPACT INTUITIV System and its components were developed and tested for AMO requirements and specifications in accordance with the following FDA-recognized consensus standards:

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Standard Number	Standard Title
ANSI/AAMI/ES 60601-1:2005	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
EN/IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests
IEC 60601-2-2:2009	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipmentand high frequency surgical accessories
IEC 62366: 2007	Medical devices - Application of usability engineeringto medical devices
ISO 14971: 2007	Medical devices - Application of risk management tomedical devices

Components of the Single-Use Fluidics Pack, Model OP080, have indirect contact with the patient by providing a fluid path for sterile Balanced Salt Solution (BSS) to enter the eye during surgery. Verification and validation testing was completed and all acceptance criteria were met, demonstrating that the OPO80 Pack has a similar safety, effectiveness and performance profile as the predicate device. Biocompatibility and sterilization evaluations of the materials that make up the patient fluid path were performed to the following standards:

Standard Number	Standard Title
ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
AAMI/ANSI/ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10:2010	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
EN/ISO 11135-1:2007	Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11979-5:2006	Ophthalmic implants - intraocular lenses - Part 5: Biocompatibility

All materials coming into direct contact with the patient, which include handpiece needles, irrigation sleeves and tips, are the same as those used with the predicate device, have been cleared in previous 510(k) filings and are not within the scope of this premarket notification.

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SUMMARY OF CLINICAL TESTS 6.7

No clinical studies were deemed necessary to determine the safety and effectiveness of the COMPACT INTUITIV System and its accessories.

6.8 CONCLUSIONS

The technological characteristics that determine the functionality and performance of the COMPACT INTUITIV System are believed to be substantially equivalent to those cleared for the SOVEREIGN Compact Phacoemulsification System predicate device, (K111446) for anterior segment (cataract) surgery and the SOVEREIGN Compact Disposable Tubing Set, Model OPO61 (K981116). The COMPACT INTUITIV System will be manufactured in compliance with FDA and ISO quality system requirements. The data from the non-clinical tests demonstrate that the device is as safe and as effective and performs as safely and as effectively as the legally marketed predicate devices. Verification and validation testing demonstrate that the functional requirements and system specifications will be met prior to commercial release.

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Image /page/5/Picture/0 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 stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 27, 2014

Abbot Medical Optics, Inc. c/o Rosanne Yetemian, Ph.D., MSRS, RAC Manager, Regulatory Affairs 1700 E. St. Andrew Place Santa Ana, CA 92705

Re: K133115

Trade/Device Name: Compact intuitiv: System, wireless remote control. four-button foot pedal. single-use fluidics pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: January 17, 2014 Received: January 22, 2014

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 10 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.

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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/ucm I I 5809.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,

Deborah L. Falls -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): K133115

Device Name: COMPACT INTUITIV System

Indications for Use:

The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

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

Marsha L. Burke Nicholas -S 2014.02.24 19:36:27 -05'00'

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.