COMPACT INTUITIV Multiple-Use Pack

K151783 · Abbott Medical Optics, Inc. · HQC · Sep 2, 2015 · Ophthalmic

Device Facts

• Record ID: K151783
• Device Name: COMPACT INTUITIV Multiple-Use Pack
• Applicant: Abbott Medical Optics, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Sep 2, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

Device Story

Reusable phacoemulsification fluidics pack; accessory for COMPACT INTUITIV System. Provides fluid path for irrigation and aspiration during cataract surgery. Consists of housing manifold, irrigation/aspiration tubing, inlet connector, and drain pump connection. Used in surgical setting by ophthalmologists. Supports peristaltic aspiration via tubing interface and molded cartridge to generate fluid outflow from eye. Reusable up to 20 times (initial use plus 19 reprocessing cycles). Facilitates lens removal; improves surgical efficiency through reusable design. Healthcare providers use system controls to manage fluidics; output is controlled aspiration/irrigation flow.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included parametric measurements and irrigation/aspiration testing. Biocompatibility, sterilization, and reprocessing/re-sterilization evaluations performed per ISO 10993, ISO 11135, ISO 14937, and ANSI/AAMI standards.

Technological Characteristics

Reusable phacoemulsification fluidics pack. Components: housing manifold, irrigation/aspiration tubing, inlet connector, drain pump connection. Peristaltic aspiration mechanism. Materials validated for 20-cycle reuse. Sterilization: Ethylene Oxide (initial) and steam/moist heat (reprocessing). Standards: ISO 14971, ISO 10993 series, ISO 11135, ISO 11979-5, ANSI/AAMI ST79, ISO 14937, ANSI/AAMI ST72, ANSI/AAMI ST81, ISO 11737-2, ISO 17665-1.

Indications for Use

Indicated for use with the COMPACT INTUITIV System by ophthalmologists experienced in phacoemulsification for the emulsification and removal of cataractous lenses during anterior segment ophthalmic surgery.

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

• Single-Use Fluidics Pack, Model OPO80 (K133115)
• Sovereign Reusable Tubing Pack, Model OPO55 (K981116)

Reference Devices

• COMPACT INTUITIV Phacoemulsification System (K133115)
• Sovereign Cataract Extraction Phacoemulsification System (K981116)
• Sovereign Compact Phacoemulsification System (K111446)
• Sovereign Compact Disposable Tubing Set, Model OPO61 (K981116)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 2, 2015

Abbott Medical Optics, Inc. Priya Viswanathan, RAC Sr. Specialist, Regulatory Affairs 1700 East Saint Andrew Place Santa Ana, CA 92705

Re: K151783

Trade/Device Name: COMPACT INTUITIV Multiple-Use Pack, Model OP085 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: June 29, 2015 Received: July 1, 2015

Dear Ms. Viswanathan:

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.

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Kesia Y. Alexander -A

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)

Device Name

COMPACT INTUITIV Multiple-Use Pack, Model OPO85

Indications for Use (Describe)

The OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(K) SUMMARY 6

### 6.1 APPLICANT INFORMATION

Abbott Medical Optics Inc. (AMO) is submitting an Abbreviated 510(k) premarket notification for the Multiple-Use Pack, Model OPO85, which is an accessory to the COMPACT INTUITIV Phacoemulsification System cleared under the premarket notification. K133115. 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:

6

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

Priya Viswanathan, RAC Sr. Specialist, Regulatory Affairs 1700 East St. Andrew Place Santa Ana, CA 92705 Tel: [phone] Fax: [phone] Email: Priya. [e-mail]

Priya

Date of 510(k) Summary Preparation:

June 29, 2015.

### 6.2 SUBJECT DEVICE

Trade/Proprietary Name: Multiple-Use Pack - OPO85 Phacoemulsification Pack, Fluidics Pack Common Name: Classification Name: Phacofragmentation System per 21 CFR 886.4670 Product Code: HQC Requlatory Class: 11

### 6.3 SUBSTANTIAL EQUIVALENCE SUMMARY

The Multiple-Use Pack, Model OPO85, is a new optional phacoemulsification fluidics pack designed to facilitate anterior segment ophthalmic surgical procedures. The device is an optional accessory for use with the COMPACT INTUITIV Phacoemulsification System (K133115), which is designed for use in the surgical setting for ophthalmologists with experience as phacoemulsification surgeons in the emulsification and removal of a cataractous lens from the eye.

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The OP085 Pack is claimed to be substantially equivalent to the following predicates:

- A Primary predicate: Single-Use Fluidics Pack, Model OPO80 cleared on February 27, 2014 (K133115), designed for use with the COMPACT INTUITIV Phacoemulsification System (K133115).
- Sovereign Reusable Tubing Pack, Model OPO55 A Secondary predicate: cleared on May 19, 1998, designed for use with the Sovereign Cataract Extraction Phacoemulsification System (K981116).

COMPACT INTUITIV System and its components were shown to be substantially equivalent to the Sovereign Compact Phacoemulsification System (K111446) and the Sovereign Compact Disposable Tubing Set, Model OPO61 (K981116) in the Premarket Notification, K133115.

The two predicate fluidics packs are both designed for use in phacoemulsification procedures to provide all the tubing required for irrigation and share similarities in design, technology and functionality. The predicate devices to which substantial equivalence of the Multiple-Use Pack, Model OP085 is claimed are listed below.

| 510(k) Number | Date of FDA<br>Clearance | Predicate<br>Device/Accessory<br>Name | 510(k) Holder |
|---------------|--------------------------|-------------------------------------------------------|-------------------------------|
| K133115 | February 27, 2014 | Primary Predicate<br>Single-Use Pack,<br>OPO80 | Abbott Medical<br>Optics Inc. |
| K981116 | May 19, 1998 | Secondary Predicate<br>Reusable Tubing Pack,<br>OPO55 | Abbott Medical<br>Optics Inc. |

# Predicate Devices to which Substantial Equivalence is claimed for the Multiple-Use Pack, Model OP085

# 6.4 DEVICE DESCRIPTION

The Multiple-Use Pack, Model OPO85 is a reusable phacoemulsification pack that is an optional accessory for use with the COMPACT INTUITIV Phacoemulsification System (K133115), which is used to facilitate the emulsification and removal of a cataractous lens. The primary predicate device, the Single-Use Fluidics Pack, Model OPO80, is cleared for use with the COMPACT INTUITIV System and the secondary predicate device, the Sovereign Reusable Pack, Model OPO55, is cleared for use with the Sovereign Phacoemulsification System. Both the predicates share the same technology, intended use, and performance specifications as the subject device. The Multiple-Use Pack, Model OPO85, consists of a housing manifold, irrigation and aspiration tubing, irrigation inlet tubing connector, and a drain pump tubing connection. Like the secondary predicate device, Model OPO55, the OPO85 Pack is designed for reuse up to 19 times, for a total of 20 uses.

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#### TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6.5

Similar to the predicate devices, the Multiple-Use Pack, Model OPO85 supports peristaltic aspiration by means of a tubing interface in combination with a molded cartridge designed to generate fluid outflow from a patient's eye through an aspiration tubing line. The main technological characteristics in which the Multiple-Use Pack, Model OP085, is involved include irrigation and aspiration. All performance functions of the OP085 Pack are identical to those of the primary predicate device, OP080 (K133115). The performance functions for the reusability is identical to the secondary predicate device, OPO55 (K981116).

The basic scientific concepts, energy source, design, intended use and FDA-recognized consensus standards used for performance testing of the Multiple-Use Pack, Model OP085, are identical to those of the primary predicate, Single-Use Fluidics Pack, Model OP080 (K133115). The intended use of the Multiple-Use Pack, Model OP085 is anterior seqment ophthalmic surgery, which is the same intended use as both predicate devices.

#### 6.6 INDICATIONS FOR USE

The Indications for Use statement of the Multiple-Use Pack, Model OPO85 is the following:

The OP085 is used with the COMPACT INTUITIV System. The OP085 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

#### 6.7 SUMMARY OF PERFORMANCE DATA

The Multiple-Use Pack, Model OPO85 has undergone design verification and validation testing, which include parametric measurements testing and irrigation and aspiration testing. The test results demonstrate that the subject device, the Multiple-Use Pack, Model OPO85, performs as safely and as effectively as the predicate device, the Single-Use Pack, Model OPO80. During performance testing, all anterior segment ophthalmic surgery modes that require the OPO85 functionality, including irrigation/aspiration, were conducted; all tests passed and all acceptance criteria were met.

Components of the Multiple-Use Pack, Model OPO85, 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 OPO85 Pack has a similar safety, effectiveness and performance profile as the predicate device. Biocompatibility, sterilization, and reprocessing/re-sterilization evaluations of the materials that comprise the patient-contacting fluid path were performed to the following standards:

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| Standard Number | Standard Title |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 14971:2007 | Medical devices – Application of risk management to<br>medical devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1:<br>Evaluation and testing within a risk management<br>process |
| AAMI/ANSI/ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5:<br>Tests for in vitro cytotoxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices – Part 7:<br>Ethylene oxide sterilization residuals |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10:<br>Tests for irritation and skin sensitization |
| ISO 10993-12:2012 | Biological evaluation of medical devices – Part 12:<br>Sample preparation and reference materials |
| ISO 11135:2014 | Sterilization of health care products – Ethylene Oxide<br>– Requirements for development, validation and<br>routine control of a sterilization process for medical<br>devices |
| ISO 11979-5:2006 | Ophthalmic implants - intraocular lenses – Part 5:<br>Biocompatibility |
| ANSI/AAMI ST79-2010 | Comprehensive guide to steam sterilization and<br>sterility assurance for health care facilities. |
| ISO 14937:2009 | Sterilization of health care products - general<br>requirements for characterization of a sterilizing agent<br>and the development, validation and routine control of<br>a sterilization process for medical devices. |
| ANSI/AAMI ST72:2002 | Bacterial endotoxins – Tests methodologies, routine<br>monitoring and alternatives to batch testing |
| ANSI/AAMI ST81:2004/2010 | Sterilization of medical devices– Information to be<br>provided by the manufacturer for the processing of<br>resterilizable medical devices |
| ANSI/AAMI/ISO 11737-2:2009 | Sterilization Of Medical Devices - Microbiological<br>Methods - Part 2: Tests Of Sterility Performed In The<br>Definition, Validation And Maintenance Of A<br>Sterilization Process. |
| ANSI/AAMI/ISO 17665-1:2006 | Sterilization Of Health Care Products -- Moist Heat --<br>Part 1: Requirements For The Development,<br>Validation, And Routine Control Of A Sterilization<br>Process For Medical Devices |

All additional accessories required to use the OPO85 in the surgical setting, which include the Administration Set (P/N OM2505191) and Drain Bag (P/N OPO56), are the same as those used with the secondary predicate device, the Reusable Tubing Pack, Model OPO55, and have been cleared in previous 510(k) filings and are not within the scope of this premarket notification.

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# 6.8 SUMMARY OF CLINICAL TESTS

No clinical studies were deemed necessary to determine the safety and effectiveness of the Multiple-Use Pack - OPO85.

# 6.9 CONCLUSIONS

The technological characteristics that determine the functionality and performance of the Multiple-Use Pack, Model OP085, are believed to be substantially equivalent to those for the cleared Single-Use Pack, Model OPO80 primary predicate device (K133115) and Reusable Tubing Pack, Model OPO55 secondary predicate device (K981116). The Multiple-Use Pack, Model OPO85, 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.