The CARDIOSAVE IABP (Hybrid Model) 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.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump (Hybrid Model). The modification involves adding a new Top Protection Cover.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
New Risks Introduced	The modification does not introduce any new risks.
New Questions of Safety and Effectiveness	The modification does not raise any new questions of safety and effectiveness.
Performance Impact of Modification	The modification does not impact the performance characteristics of the predicate device.
Meeting Acceptance Criteria	The results of the tests conducted demonstrate that the proposed device met its respective acceptance criteria.
Intended Use Equivalence	The Top Protection Cover is similar to the predicate device in the intended use.
Fundamental Scientific Technology Equivalence	The Top Protection Cover is similar to the predicate device in the fundamental scientific technology of the device.
Performance Equivalence with Predicate	The design verification testing established that the CARDIOSAVE IABP (Hybrid Model) with the new Top Protection Cover performs the same as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data or a specific number of units used for testing the Top Protection Cover. The testing appears to be focused on engineering verification of the physical modification itself, rather than clinical performance on a sample of patients.

Sample Size: Not explicitly stated as a number of devices or clinical cases. The testing would likely involve a representative number of units to prove the effectiveness of the cover.
Data Provenance: The document does not mention data provenance in terms of country of origin or retrospective/prospective studies. This is expected given the nature of the modification (a physical cover) and the type of testing performed (engineering verification).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the study described is an engineering verification for a physical modification, not a clinical study requiring expert assessment for ground truth determination.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. Adjudication methods are typically used in clinical trials or studies where human interpretation or decision-making is being evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The modification is a physical cover, not a software algorithm or a device requiring human interpretation for its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is an Intra-Aortic Balloon Pump, which is a physical device with electromechanical functions, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the engineering design requirements and safety standards for a medical device and its components. The device needs to prove that the new Top Protection Cover effectively prevents liquid spills from entering the unit and causing malfunction or damage, and that it does not negatively impact the existing performance of the IABP.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring model training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set. The "ground truth" in the development process would be established by the design specifications, risk assessment, and regulatory requirements for the device and its modification.

Summary of the Study:

The study performed was focused on design verification testing for a new Top Protection Cover on an existing CARDIOSAVE IABP (Hybrid Model). The primary goal of the cover is to protect against liquid spills.

The manufacturer, Datascope Corp., completed the following activities:

Risk Assessment: To ensure the modification does not introduce new risks.
Verification Testing: To confirm the cover meets its intended protective function and does not alter the IABP's performance.

The conclusion is that the modification does not impact the performance characteristics of the predicate device, does not introduce any new risks, and does not raise any new questions of safety and effectiveness. The design verification testing established that the device with the new cover performs the same as the predicate device. No clinical testing was deemed necessary due to the nature of the modification.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Nameand Address:	Datascope Corp.1300 MacArthur Blvd.Mahwah, NJ 07430
Contact Personfor thissubmission:	Hemang KotechaRegulatory Affairs Specialist IIDatascope Corp1300 MacArthur Blvd.Mahwah, NJ 07430Phone: (973) 709-7376Fax: (973) 629-1482hemang.kotecha@getinge.com
Date Prepared:	April 27, 2018
DeviceInformation:	Trade Name: CARDIOSAVE IABP (Hybrid Model)Common/Generic Name: Intra-Aortic Balloon PumpClassification Name: Intra-Aortic Balloon and control systemRegulation Number: 21 CFR 870.3535Regulatory Class: Class IIProduct Code: DSP
Predicate DeviceInformation:	CARDIOSAVE Intra-Aortic Balloon Pump (K112372)
DeviceDescription:	The CARDIOSAVE IABP (Hybrid Model) is a cardiac assistdevice. It supports the heart's left ventricle by increasingcoronary perfusion and reducing left ventricular work. Coronaryperfusion is increased by augmenting blood pressure duringthe diastolic phase of the cardiac cycle. This increase in aorticpressure promotes more blood flow through the coronary
Datascope Corp.	Special 510(k) : Corrective Action Being AffectedCARDIOSAVE IABP Modification: Top Protection Cover
	arteries. Left ventricular work is reduced by decreasing aorticend-diastolic pressure and reducing resistance to ventricularejection, resulting in a decrease in blood pressure during thesystolic phase of the cardiac cycle.
	These beneficial effects are caused by the inflation anddeflation of an intra-aortic balloon (IAB) in the patient'sdescending aorta. The balloon's inflation and deflation must beproperly synchronized with the cardiac cycle. IAB inflation isinitiated at the onset of diastole at the dicrotic notch andremains inflated through diastole. The IAB is then deflated at,or just prior to, the onset of systole and the balloon remainsdeflated throughout systole. Hence, the therapy is also referredto as counterpulsation. This is the same intended use as otherIABPs.
Indications ForUse:	The CARDIOSAVE IABP (Hybrid Model) is indicated for acutecoronary syndrome, cardiac and non-cardiac surgery, orcomplications of heart failure.
Intended Use:	The CARDIOSAVE IABP (Hybrid Model) is anelectromechanical system used to inflate and deflate intra-aortic balloons. The IABP provides temporary support to the leftventricle via the principle of counterpulsation. The intra-aorticballoon is placed in the descending aorta, just distal to the leftsubclavian artery. Once the balloon is positioned, the pump isadjusted to trigger in synchrony with the ECG or arterialpressure waveform to ensure that inflation and deflation occurat the appropriate points during the cardiac cycle.
	The target population is adult. The balloon pump is intended foruse in the health care facility setting.
Comparison ofTechnologicalCharacteristicswith the PredicateDevice:	The proposed CARDIOSAVE IABP (Hybrid Model), which isthe subject of this submission, contains the sametechnologically characteristics as the predicate CARDIOSAVEIntra-Aortic Balloon Pump (K112372).
	The proposed modification is the addition a new Top ProtectionCover that shall be installed on top of the CARDIOSAVE cart.
	The Top Protection Cover provides protection against liquidspills, such as saline, that may occur on top of the unit. It is
Datascope Corp.	Special 510(k) : Corrective Action Being AffectedCARDIOSAVE IABP Modification: Top Protection Cover
	designed to remove any paths for the liquid that is spilled on topof the unit and prevent flow of the liquid into the interfacingpanels, connector receptacles and air vents. Such liquid spills arehazardous as they can create bridges of resistance between thecircuit components; causing the circuit not to function asintended; potentially damage the unit and possibly causing it toshut down during operation. This may impact the initiation orcontinuation of therapy.
PerformanceData:	Datascope Corp. development process required that thefollowing activities be completed during the development of thenew Top Protection Cover:• Risk Assessment• Verification testing
	The modification proposed within this submission forCARDIOSAVE IABP (Hybrid Model) does not impact theperformance characteristics of the predicate device.
	The results of the tests conducted demonstrate that theproposed device met its respective acceptance criteria.According to the risk assessment performed, the modificationdoes not introduce any new risks and does not raise any newquestions of safety and effectiveness.
Clinical Tests:	There was no clinical testing deemed necessary for theproposed device.
Conclusion:	Based upon the information submitted in this Special 510(k)submission, the proposed device is substantially equivalent tothe 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.

Regulation Number and Section

§ 870.3535 Intra-aortic balloon and control system.

(a)
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.(b)
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.