CARDIOSAVE Hybrid Intra-Aortic Balloon Pump

K151254 · Datascope Corp. · DSP · Jul 2, 2015 · Cardiovascular

Device Facts

• Record ID: K151254
• Device Name: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Jul 2, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

Device Story

CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is a cardiac assist device supporting the left ventricle. It uses an intra-aortic balloon (IAB) placed in the descending aorta; the device inflates and deflates the balloon synchronized with the cardiac cycle (counterpulsation). Inflation during diastole increases coronary perfusion; deflation during systole reduces left ventricular work and resistance to ejection. The system is used in clinical settings to assist patients with acute coronary syndrome, surgical complications, or heart failure. The device includes an AC/DC power supply to drive the console. Healthcare providers monitor the synchronized therapy to improve patient hemodynamics.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Cardiac assist device using counterpulsation via intra-aortic balloon. Features an AC/DC Bulk Senior Power Supply. Complies with IEC 60601-1 (electrical safety, rough handling, humidity) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients with acute coronary syndrome, those undergoing cardiac or non-cardiac surgery, or patients experiencing complications of heart failure.

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

• CARDIOSAVE Intra-Aortic Balloon Pump (K112372)

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 features a stylized image of an eagle with three profiles of human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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

July 2, 2015

Datascope Corp. Helder A. Sousa Manager, Regulatory Affairs 1300 MacArthur Blvd. Mahwah, NJ 07430

Re: K151254/S001

Trade/Device Name: CARDIOSAVE Intra-Aortic Balloon Pump Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class II Product Code: DSP Dated: June 2, 2015 Received: June 3, 2015

Dear Mr. Sousa:

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.

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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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/ResourcesforYou/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 yours.

M.A. Hillebrenner

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): K151254

Device Name: CARDIOSAVE Intra-Aortic Balloon Pump

- The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute Indications For Use: coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.
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)

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## SECTION 15

# 510(K) SUMMARY

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# CARDIOSAVE INTRA-AORTIC BALLOON PUMP

510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

## GENERAL INFORMATION

| Submitter's name and address: | Datascope Corp.<br>1300 MacArthur Blvd.<br>Mahwah, NJ 07430 |
|--------------------------------------------|----------------------------------------------------------------------------|
| Contact person and telephone number: | Helder A. Sousa<br>Manager, Regulatory Affairs |
| Phone:<br>Fax:<br>Email:<br>Date prepared: | [phone]<br>[phone]<br>[e-mail]<br>May 8, 2015 |

### DEVICE INFORMATION:

| Trade Name: | CARDIOSAVE Intra-Aortic Balloon Pump |
|----------------------|-----------------------------------------|
| Common/Generic Name: | Intra-Aortic Balloon Pump (IABP) |
| Classification Name: | Intra-Aortic Balloon and control system |
| Regulation Number: | 21 CFR 870.3535 |
| Product Code: | DSP |

### PREDICATE DEVICE INFORMATION:

The modified CARDIOSAVE Intra-Aortic Balloon Pump is substantially equivalent in function and intended use to the predicate CARDIOSAVE Intra-Aortic Balloon Pump (K112372).

#### DEVICE DESCRIPTION:

The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) 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. 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 an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB 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 counterpulsation. This is the same intended use as other IABPs.

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#### INDICATIONS FOR USE:

The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATES:

The modified CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is substantially equivalent to the predicate CARDIOSAVE Intra-Aortic Balloon Pump (K112372). The changes essentially consist of an alternative AC/DC Bulk Senior Power Supply with an increased load driving capacity ensuring the correct output voltage to the CARDIOSAVE Hybrid IABP console.

#### NON-CLINICAL TESTS:

The alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE Hybrid IABP complies with IEC60601-1-2 EMC Collateral Standard, IEC60601-1 for rough handling and movement across a threshold and Electrical Safety Tests of IEC60601-1 including humidity soak.

Datascope Corp. development process required that the following activities be completed during the development of the alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE IABP:

- Requirements specification review ●
- . Performance testing
- . Design validation

The results of the tests conducted demonstrate that the functionality and performance characteristics of the alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE IABP is comparable to the currently marketed predicate.

#### 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 modified device is substantially equivalent to the currently marketed CARDIOSAVE Hybrid IABP. The CARDIOSAVE Hybrid IABP with the alternative AC/DC Bulk Senior Power Supply is similar to the predicate device in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the CARDIOSAVE Hybrid IABP with the alternative AC/DC Bulk Senior Power Supply performs as well as the predicate device.