SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES

K122628 · Datascope Corp., Cardiac Assist Division · DSP · Sep 6, 2012 · Cardiovascular

Device Facts

• Record ID: K122628
• Device Name: SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
• Applicant: Datascope Corp., Cardiac Assist Division
• Product Code: DSP · Cardiovascular
• Decision Date: Sep 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use: Refractory Unstable Angina. Impending Infarction. Acute Myocardial Infarction. Refractory Ventricular Failure. Complications of Acute MI (ie. Acute MR or VSD or papillary muscle rupture) Cardiogenic Shock. Support for diagnostic, percutaneous revascularization and interventional procedures. Ischemia related intractable ventricular arrhythmias. Septic Shock. Intraoperative pulsatile flow generation. Weaning from cardiopulmonary bypass. Cardiac support for non-cardiac surgery. Prophylactic support in preparation for cardiac surgery. Post-surgical myocardial dysfunction/low cardiac output syndrome. Myocardial Contusion. Mechanical bridge to other assist devices. Cardiac support following correction of anatomical defects

Device Story

SENSATION PLUS 7.5Fr 40cc IAB Catheter is a cardiac assist device for placement in the descending aorta. It utilizes fiber-optic pressure sensor technology to monitor aortic pressure. The device functions via inflation and deflation of a balloon synchronized with the cardiac cycle; inflation during diastole increases coronary perfusion; deflation during systole reduces left ventricular work (counterpulsation). The system includes the catheter, insertion kit, and stabilization devices. It is used by clinicians in hospital settings to support patients with cardiac dysfunction or during surgical/interventional procedures. The output (pressure data) allows for precise synchronization of the balloon pump with the patient's heart rhythm, providing hemodynamic support and reducing myocardial oxygen demand.

Clinical Evidence

No clinical evaluation was performed. Substantial equivalence is supported by bench testing, including requirements specification review, performance testing, biocompatibility, sterility, shelf life, package testing, and design validations. In-vitro test results demonstrate functionality and performance comparable to currently marketed IAB catheters.

Technological Characteristics

7.5Fr 40cc IAB catheter featuring fiber-optic pressure sensor technology. Includes insertion kit and STATLOCK stabilization devices. Connectivity is via fiber-optic interface for pressure monitoring. Sterilization and material specifications are maintained per established standards for IAB catheters.

Indications for Use

Indicated for patients requiring cardiac assist due to refractory unstable angina, impending or acute myocardial infarction, cardiogenic shock, refractory ventricular failure, post-surgical myocardial dysfunction, or complications of acute MI (e.g., MR, VSD, papillary muscle rupture). Also indicated for support during interventional procedures, weaning from cardiopulmonary bypass, non-cardiac surgery, or as a bridge to other assist devices.

Regulatory Classification

Identification

An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.

Special Controls

*Classification.* (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device; (ii) Software verification, validation, and hazard analysis must be performed; (iii) The device must be demonstrated to be biocompatible; (iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; (v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and (vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation. (c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• MEGA® 7.5Fr 30cc & 40cc Intra-Aortic Balloon (IAB) Catheter and Accessories (K120868)
• SENSATION PLUS™ 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheter and Accessories (K112327)

Submission Summary (Full Text)

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## Datascope Corp. Premarket Notification Special 510(k) SENSATION™ PLUS 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories

## SENSATION™ PLUS 7.5Fr. 40cc Intra-Aortic Balloon Catheter

510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

SEP 6 2012

#### GENERAL INFORMATION

Submitter's name and address:

Datascope Corp. 15 Law Drive Fairfield, NJ 07004 Contact person and telephone number: Carla S. Cerqueira Regulatory Affairs Specialist II [phone] [phone] [e-mail] August 27, 2012

DEVICE INFORMATION:

Trade Name:

Date prepared:

Phone: Fax: ·

Email:

Common/Generic Name: Classification Name: Regulation Number: Product Code:

SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories Intra-Aortic Balloon Catheter (IAB) Intra-Aortic Balloon Catheters (IABs) 21 CFR 870.3535 DSP

#### PREDICATE DEVICE INFORMATION:

K120868 MEGA® 7.5Fr 30cc & 40cc Intra-Aortic Balloon (IAB) Catheter and Accessories

K112327 SENSATION PLUS™ 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheter and Accessories

#### DEVICE DESCRIPTION AND INTENDED USE:

The SENSATION PLUS™ 7.5 Fr. 40cc IAB Catheter is an enhanced MEGA® 7.5Fr IAB Catheter (K120868) device which includes a catheter, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change - the stylet wire (a packaging component) was removed. The SENSATION PLUS™ 7.5Fr. 40cc Insertion kit contains the same components as currently used with the MEGA® 7.5Fr 40cc IAB Catheter (K120868), with the sole exception that the SENSATION PLUS™ 7.5Fr. 40cc Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION PLUS™ 8Fr. 50cc Insertion Kit (K112327).

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase

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#### Datascope Corp. Premarket Notification Special 510(k) SENSATION™ PLUS 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories

of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the Intra-Aortic Balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to. the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpuisation. This is the same intended use as other IAB Catheters.

#### TECHNOLOGICAL CHARACTERISTICS:

The SENSATION PLUS™ 7.5Fr. 40cc IAB Catheter has the same fiber-optic pressure sensor technology as the predicate SENSATION PLUS™ 8Fr. 50cc IAB Catheter, and the same membrane volume and catheter french size as the MEGA® 7.5Fr. 40cc IAB Catheter.

#### NON-CLINICAL TESTS:

The SENSATION PLUS 7.5Fr 40cc IAB Catheter complies with the voluntary standards identified in Section 3 of this submission. Datascope Corp.'s development process required that the following activities be completed during the development of the SENSATION PLUS™ 7.5Fr 40cc IAB Catheter:

- . Requirements specification review
- Performance testing .
- Biocompatibility testing .
- . Sterility testing
- Shelf life testing .
- . Package testing
- . Design validations

The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed IAB Catheters.

#### CLINICAL TESTS:

There was no clinical evaluation of the modified device.

#### CONCLUSION:

Based upon the information submitted in this Special 510(k) premarket notification, MAQUET's SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is substantially equivalent to the currently marketed MEGA® 7.5Fr 40cc IAB Catheter (K120868) and SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327). The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the SENSATION PLUS™ 7.5Fr. 40cc IAB Catheter is safe, effective and performs as well as the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

#### Public Health Service

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

> 6 2012 SEP

Datascope Corp. c/o Ms. Carla S. Cerqueira Regulatory Affairs Specialist II 15 Law Drive Fairfield, NJ 07004

Re: K122628

SENSATION PLUSTM 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories Regulation Number: 21 CFR 870.3535 Regulation Name: System, Balloon, Intra-Aortic and Control Regulatory Class: Class III Product Code: DSP Dated: August 27, 2012 Received: August 28, 2012

Dear Ms. Cerqueira:

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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# Page 2 - Ms. Carla S. Cerqueira

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

g Hillen

Cr Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications For Use

# 510(k) Number (if known): _ KIZZ 628

Device Name: SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories

Indications For Use:

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use:

- Refractory Unstable Angina.
- Impending Infarction. .
- Acute Myocardial Infarction. .
- Refractory Ventricular Failure. .
- Complications of Acute MI (ie. Acute MR or VSD or papillary . muscle rupture)
- · Cardiogenic Shock.
- Support for diagnostic, percutaneous revascularization and . interventional procedures.
- Ischemia related intractable ventricular arrhythmias. .
- . Septic Shock.
- Intraoperative pulsatile flow generation. .
- Weaning from cardiopulmonary bypass. .
- Cardiac support for non-cardiac surgery. .
- Prophylactic support in preparation for cardiac surgery. .
- . Post-surgical myocardial dysfunction/low cardiac output syndrome.
- Myocardial Contusion. .
- Mechanical bridge to other assist devices.
- Cardiac support following correction of anatomical defects

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) M 7 - 8 on Slan-Off) sion of Cardiovasculare Devices