COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK

K133115 · Abbott Medical Optics, Inc. · HQC · Feb 27, 2014 · Ophthalmic

Device Facts

• Record ID: K133115
• Device Name: COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
• Applicant: Abbott Medical Optics, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Feb 27, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Modular ophthalmic microsurgical system for anterior segment cataract surgery; used by experienced ophthalmologists in surgical settings. System comprises console, wireless remote, four-button foot pedal, and sterile single-use fluidics pack. Operates via ultrasonic phacoemulsification, diathermy, irrigation, aspiration, and vitrectomy. Surgeon controls parameters via foot pedal and remote; console powers handpiece to emulsify lens; fluidics pack manages irrigation/aspiration flow. Output provides surgical lens removal; enables precise cataract extraction. Benefits include improved surgical efficiency and safety through updated hardware/electrical standards compared to predicate.

Clinical Evidence

No clinical studies were conducted. Safety and effectiveness were established through non-clinical bench testing, including electromechanical safety (IEC 60601 series), biocompatibility (ISO 10993 series), and sterilization validation. All performance functions (phaco, diathermy, irrigation, vitrectomy) met acceptance criteria.

Technological Characteristics

Modular phacoemulsification system. Components: console, wireless remote, foot pedal, single-use fluidics pack. Energy: ultrasonic, diathermy. Materials: patient-contact materials (needles, sleeves, tips) identical to predicate. Standards: ANSI/AAMI/ES 60601-1, EN/IEC 60601-1-2, IEC 60601-2-2, IEC 62366, ISO 14971, ISO 10993, ISO 11135. Sterilization: Ethylene Oxide for fluidics pack. Connectivity: wireless remote control.

Indications for Use

Indicated for patients undergoing cataract surgery requiring ultrasound disruption and extraction of the cataractous lens.

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

• SOVEREIGN Compact Phacoemulsification System (K111446)
• Wired Remote Control (K111446)
• SOVEREIGN COMPACT Open-Toe Foot Pedal (K111446)
• SOVEREIGN Compact Disposable Tubing Set, Model OPO61 (K981116)

Submission Summary (Full Text)

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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: [phone] Mobile: [phone] Fax: [phone] Email: [e-mail]

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)<br>Number | Date of<br>FDA<br>Clearance | Predicate Device/Accessory Name | 510(k) Holder |
|------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| COMPACT INTUITIV System Console | | | |
| K111446 | 12/29/2011 | SOVEREIGN Compact Phacoemulsification<br>System<br>Primary Predicate Device | Abbott<br>Medical Optics<br>Inc. |
| COMPACT INTUITIV Wireless Remote Control | | | |
| K111446 | 12/29/2011 | Wired Remote Control<br>An accessory to The SOVEREIGN<br>Compact Phacoemulsification System | Abbott<br>Medical Optics<br>Inc. |
| COMPACT INTUITIV Four-Button Foot Pedal | | | |
| K111446 | 12/29/2011 | SOVEREIGN COMPACT Open-Toe<br>Foot Pedal<br>An accessory to The SOVEREIGN<br>Compact Phacoemulsification System | Abbott<br>Medical Optics<br>Inc. |
| COMPACT INTUITIV Single-Use Pack, OPO80 | | | |
| K981116 | 5/19/1998 | SOVEREIGN Compact Disposable Tubing<br>Set, Model OPO61<br>An accessory to The SOVEREIGN<br>Compact Phacoemulsification System | Abbott<br>Medical Optics<br>Inc. |

#### DEVICE DESCRIPTION 6.3

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

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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: General<br>requirements for basic safety and essential<br>performance |
| EN/IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests |
| IEC 60601-2-2:2009 | Medical electrical equipment - Part 2-2: Particular<br>requirements for the basic safety and essential<br>performance of high frequency surgical equipment<br>and high frequency surgical accessories |
| IEC 62366: 2007 | Medical devices - Application of usability engineering<br>to medical devices |
| ISO 14971: 2007 | Medical devices - Application of risk management to<br>medical 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 [phone] or [phone] 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'