MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES

K133074 · Datascope Corp. · DSP · Dec 12, 2013 · Cardiovascular

Device Facts

• Record ID: K133074
• Device Name: MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Dec 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters 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

Intra-aortic balloon (IAB) catheter system provides cardiac assist by increasing coronary perfusion and reducing left ventricular work via counterpulsation. Device consists of 8Fr. introducer sheath and dilator for percutaneous femoral artery access; IAB catheter placed in descending aorta. Inflation/deflation synchronized with cardiac cycle: inflation at dicrotic notch (diastole) to augment aortic pressure; deflation prior to systole to reduce afterload. Used in clinical settings by trained medical professionals. Modification involves enhanced 8Fr. introducer set with minor dimensional changes to sheath and dilator to facilitate catheter insertion. Benefits include improved hemodynamic support for patients with compromised cardiac function.

Clinical Evidence

No clinical evaluation was performed. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility, insertion force, package performance, product stability, and sterilization validation.

Technological Characteristics

8Fr. introducer set includes HDPE dilator and reinforced sheath (stainless steel coil between PTFE and Pebax layers). Features integral hemostasis valve. Dimensional modifications include increased tip diameter, tube inner/outer diameters, and dilator outer diameter. Sterilized using established processes. No software or electronic components.

Indications for Use

Indicated for patients requiring cardiac assist due to refractory unstable angina, impending or acute myocardial infarction, cardiogenic shock, refractory ventricular failure, complications of acute MI, ischemia-related intractable ventricular arrhythmias, septic shock, or post-surgical myocardial dysfunction. Also indicated for support during diagnostic/interventional procedures, intraoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support for cardiac surgery, myocardial contusion, mechanical bridge to other assist devices, and support following correction of anatomical defects.

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 (K091449)
• SENSATION PLUS (K112327)

Submission Summary (Full Text)

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K133074

# MEGA AND SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter 510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

#### GENERAL INFORMATION

Submitter's name and address:

Datascope Corp. 15 Law Drive Fairfield, NJ 07004

Contact person and telephone number:

Linda Slutzky Regulatory Affairs Specialist I

Phone: Fax: Email: Date prepared: [phone] [phone] [e-mail] November 8. 2013

#### DEVICE INFORMATION:

| Trade Name: | MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon<br>Catheters and Accessories |
|----------------------|-------------------------------------------------------------------------------------|
| Common/Generic Name: | Intra-Aortic Balloon (IAB) Catheter |
| Classification Name: | System, Balloon, Intra-Aortic & Control |
| Regulation Number: | 21 CFR 870.3535 |
| Product Code: | DSP |

#### PREDICATE DEVICE INFORMATION:

The enhanced 8Fr. Introducer Set is substantially equivalent to the 8Fr. Introducer Set packaged in the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories predicate devices.

#### DEVICE DESCRIPTION AND INTENDED USE:

The 8Fr. Introducer Set is comprised of an Introducer Sheath and Introducer Dilator for percutaneous insertion of the MEGA & SENSATION PLUS 8Fr. 50cc IABs.

The flexible high density polyethylene (HDPE) dilator is inserted through and twist locked into the 8Fr. introducer sheath for insertion over a quide wire for percutaneous access to the femoral artery.

The dilator is then removed from the sheath after which the 8Fr 50cc Intra-aortic Balloon (IAB) Catheter is inserted over a guide wire and through the 8Fr introducer sheath for placement within the thoracic anta for counterpulsation therapy. The introducer sheath is comprised of a hub housing that includes an integral hemostasis valve to prevent bleeding about the IAB catheter and a sheath tube comprised of a flat coiled stainless wire between a layer of PTFE and Pebax for reinforcement to provide kink resistance within the vasculature.

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The intra-aortic balloon 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 of the cardiac cycle. The resulting increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is thus 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 cvcle. These beneficial effects are caused by the inflation and deflation of the intra-aortic balloon (IAB) Catheter in the patient's descending aorta.

The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of 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. The IAB Catheter then remains deflated throughout systole. Hence the therapy is also referred to as counterpulsation.

# TECHNOLOGICAL CHARACTERISTICS:

The enhanced 8Fr. Introducer Set is substantially equivalent to the 8Fr. Introducer Set packaged in the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories predicate devices. The enhanced 8Fr. Introducer Set and the predicate devices have the following similarities:

- o the same intended use,
- o the same operating principles,
- incorporates the same raw materials, o
- incorporates the same basic design, 0
- sterilized using the same materials and processes, o
- the same packaging. o

The differences between the enhanced 8Fr. Introducer Set and the predicate Introducer Set for use with the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories are dimensional changes only. The minor dimensional changes are an increase to the Reinforced Sheath's tip diameter, tube inner diameter and outer diameter and to the Sheath Dilator's outer diameter.

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# NON-CLINICAL TESTS:

The enhanced 8Fr. Introducer Set complies with the voluntary standards identified in Section 3 of this submission. Datascope Corp. development process required that the following activities be completed during the development of the enhanced 8Fr. Introducer Set:

- . Biocompatibility
- Insertion Skinline to Artery .
- Introducer Set Verification �
- Package Performance ●
- . Product Stability
- Sterilization

After review of the Risk Management Plan, there were no new risks identified with this modification to the enhanced 8Fr. Introducer Set. We determined that these tests demonstrate that this device modification is as safe and effective as the predicate devices.

### CLINICAL TESTS:

There was no clinical evaluation of the modified device.

#### Conclusion:

Based upon the information submitted in this Special 510(k) premarket notification, the enhanced 8Fr. Introducer Set is substantially equivalent to the currently marketed 8Fr. Introducer Set packaged with the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories. The enhanced 8Fr. Introducer Set 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 enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices. These modifications will not impact the safety and effectiveness of the enhanced 8Fr. Introducer Set.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.

#### Public Health Service

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

December 12, 2013

Datascope Corp. Linda Slutzky Regulatory Affairs Specialist 15 Law Drive Fairfield, NJ 07004

Re: K133074

> Trade/Device Name: MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories Regulation Number: 21CRF 870.3535 Regulation Name: Intra-Aortic Balloon Catheters (IAB) Regulatory Class: Class III Product Code: DSP Dated: November 8, 2013 Received: November 12, 2013

Dear Ms. Slutzky:

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. Ilisting 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.

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

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Show and State with 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

MA Hilleman

for 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): _K133074

#### Device Name: MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories

#### Indications For Use:

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The MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters 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);

MA. Hilliam