CARDIOSAVE Intra-Aortic Balloon Pump

K181122 · Datascope Corp. · DSP · May 31, 2018 · Cardiovascular

Device Facts

• Record ID: K181122
• Device Name: CARDIOSAVE Intra-Aortic Balloon Pump
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: May 31, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CARDIOSAVE IABP (Hybrid Model) is an electromechanical system used to inflate and deflate intra-aortic balloons. The IABP provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target population is adult. The balloon pump is intended for use in the health care facility setting.

Device Story

Cardiac assist device; supports left ventricle via counterpulsation; increases coronary perfusion and reduces left ventricular work. Inputs: ECG or arterial pressure waveforms. Operation: synchronizes inflation/deflation of intra-aortic balloon (IAB) in descending aorta with cardiac cycle; IAB inflates during diastole and deflates during systole. Used in healthcare facilities by clinicians. Modification: addition of Top Protection Cover to prevent liquid ingress into internal circuit components, connector receptacles, and air vents; prevents electrical shorts or device shutdown during therapy. Benefits: maintains continuous cardiac support by protecting electronics from fluid spills.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electromechanical intra-aortic balloon pump. Modification includes a physical Top Protection Cover to prevent liquid ingress. System utilizes ECG or arterial pressure waveform triggering for counterpulsation. No changes to core sensing, energy source, or software algorithms.

Indications for Use

Indicated for adult patients with acute coronary syndrome, cardiac or non-cardiac surgery, or 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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May 31, 2018

Datascope Corp. Hemang Kotecha Regulatory Affairs Specialist II 1300 MacArthur Blvd. Mahwah, New Jersey 07430

Re: K181122

Trade/Device Name: CARDIOSAVE Intra-Aortic Balloon Pump (Hybrid Model) Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: April 27, 2018 Received: April 30, 2018

Dear Hemang Kotecha:

We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Nicole G. Ibrahim -S

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) K181122

Device Name CARDIOSAVE IABP (Hybrid Model)

Indications for Use (Describe)

The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac surgery, or complications of heart failure.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

## CARDIOSAVE INTRA-AORTIC BALLOON PUMP (HYBRID MODEL)

[Prepared in accordance with 21 CFR Part 807.92]

| Submitter's Name<br>and Address: | Datascope Corp.<br>1300 MacArthur Blvd.<br>Mahwah, NJ 07430 |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person<br>for this<br>submission: | Hemang Kotecha<br>Regulatory Affairs Specialist II<br>Datascope Corp<br>1300 MacArthur Blvd.<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | April 27, 2018 |
| Device<br>Information: | Trade Name: CARDIOSAVE IABP (Hybrid Model)<br>Common/Generic Name: Intra-Aortic Balloon Pump<br>Classification Name: Intra-Aortic Balloon and control system<br>Regulation Number: 21 CFR 870.3535<br>Regulatory Class: Class II<br>Product Code: DSP |
| Predicate Device<br>Information: | CARDIOSAVE Intra-Aortic Balloon Pump (K112372) |
| Device<br>Description: | The CARDIOSAVE IABP (Hybrid Model) is a cardiac assist<br>device. It supports the heart's left ventricle by increasing<br>coronary perfusion and reducing left ventricular work. Coronary<br>perfusion is increased by augmenting blood pressure during<br>the diastolic phase of the cardiac cycle. This increase in aortic<br>pressure promotes more blood flow through the coronary |
| Datascope Corp. | Special 510(k) : Corrective Action Being Affected<br>CARDIOSAVE IABP Modification: Top Protection Cover |
| | arteries. Left ventricular work is reduced by decreasing aortic<br>end-diastolic pressure and reducing resistance to ventricular<br>ejection, resulting in a decrease in blood pressure during the<br>systolic phase of the cardiac cycle. |
| | These beneficial effects are caused by the inflation and<br>deflation of an intra-aortic balloon (IAB) in the patient's<br>descending aorta. The balloon's inflation and deflation must be<br>properly synchronized with the cardiac cycle. IAB inflation is<br>initiated at the onset of diastole at the dicrotic notch and<br>remains inflated through diastole. The IAB is then deflated at,<br>or just prior to, the onset of systole and the balloon remains<br>deflated throughout systole. Hence, the therapy is also referred<br>to as counterpulsation. This is the same intended use as other<br>IABPs. |
| Indications For<br>Use: | The CARDIOSAVE IABP (Hybrid Model) is indicated for acute<br>coronary syndrome, cardiac and non-cardiac surgery, or<br>complications of heart failure. |
| Intended Use: | The CARDIOSAVE IABP (Hybrid Model) is an<br>electromechanical system used to inflate and deflate intra-<br>aortic balloons. The IABP provides temporary support to the left<br>ventricle via the principle of counterpulsation. The intra-aortic<br>balloon is placed in the descending aorta, just distal to the left<br>subclavian artery. Once the balloon is positioned, the pump is<br>adjusted to trigger in synchrony with the ECG or arterial<br>pressure waveform to ensure that inflation and deflation occur<br>at the appropriate points during the cardiac cycle. |
| | The target population is adult. The balloon pump is intended for<br>use in the health care facility setting. |
| Comparison of<br>Technological<br>Characteristics<br>with the Predicate<br>Device: | The proposed CARDIOSAVE IABP (Hybrid Model), which is<br>the subject of this submission, contains the same<br>technologically characteristics as the predicate CARDIOSAVE<br>Intra-Aortic Balloon Pump (K112372). |
| | The proposed modification is the addition a new Top Protection<br>Cover that shall be installed on top of the CARDIOSAVE cart. |
| | The Top Protection Cover provides protection against liquid<br>spills, such as saline, that may occur on top of the unit. It is |
| Datascope Corp. | Special 510(k) : Corrective Action Being Affected<br>CARDIOSAVE IABP Modification: Top Protection Cover |
| | designed to remove any paths for the liquid that is spilled on top<br>of the unit and prevent flow of the liquid into the interfacing<br>panels, connector receptacles and air vents. Such liquid spills are<br>hazardous as they can create bridges of resistance between the<br>circuit components; causing the circuit not to function as<br>intended; potentially damage the unit and possibly causing it to<br>shut down during operation. This may impact the initiation or<br>continuation of therapy. |
| Performance<br>Data: | Datascope Corp. development process required that the<br>following activities be completed during the development of the<br>new Top Protection Cover:<br>• Risk Assessment<br>• Verification testing |
| | The modification proposed within this submission for<br>CARDIOSAVE IABP (Hybrid Model) does not impact the<br>performance characteristics of the predicate device. |
| | The results of the tests conducted demonstrate that the<br>proposed device met its respective acceptance criteria.<br>According to the risk assessment performed, the modification<br>does not introduce any new risks and does not raise any new<br>questions of safety and effectiveness. |
| Clinical Tests: | There was no clinical testing deemed necessary for the<br>proposed device. |
| Conclusion: | Based upon the information submitted in this Special 510(k)<br>submission, the proposed device is substantially equivalent to<br>the currently marketed CARDIOSAVE IABP (Hybrid Model). |

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Protection Cover is similar to the predicate device in the intended use and the fundamental scientific technology of the device. The design verification testing established that the CARDIOSAVE IĂBP (Hybrid Model) with the new Top Protection Cover performs same as the predicate device.