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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the CARDIOSAVE Intra-Aortic Balloon Pump (IABP). However, the application is specifically for a modification to the existing device: a new CARDIOSAVE Li-Ion battery transport and storage case.

Therefore, the acceptance criteria and study described are not for the entire IABP device, but rather for the safety and performance of this new battery case.

Here's an analysis based on the provided text, addressing your requested information points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Requirement)	Reported Device Performance (Compliance)
IEC 62133 Edition 2.0 2012-12: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.	The new CARDIOSAVE Li-Ion battery transport and storage case to be used for the CARDIOSAVE Li-Ion batteries for protective purposes when not installed in the IABP complies with IEC 62133 Edition 2.0 2012-12. The results of the tests conducted demonstrate this compliance.
(Implicit) Device functions as well as the predicate device (regarding the battery case).	The design verification and validation testing established that the CARDIOSAVE IABP with the new CARDIOSAVE Li-Ion battery transport and storage case performs as well as the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a numerical sample size (e.g., number of battery cases tested). It generally refers to "tests conducted."
Data Provenance: The data was generated through "Performance testing" as part of Datascope Corp.'s development process. The country of origin is not explicitly stated. The nature of the testing (bench testing, design validation) makes it inherently prospective in relation to the design of the new case.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this submission. The "ground truth" for the battery case's performance is objective compliance with an international safety standard (IEC 62133) rather than subjective expert interpretation. The performance is assessed via engineering tests, not clinical or diagnostic evaluations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where there might be disagreement in interpretation (e.g., medical image reading). For objective engineering compliance testing, the results are typically pass/fail based on predefined criteria, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or decision support tools that involve human interpretation. This submission is for a medical device accessory (battery case) and its compliance with safety standards.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical accessory (battery case), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the battery case's performance is objective compliance with regulatory and international safety standards, specifically IEC 62133 Edition 2.0 2012-12. This is not based on expert consensus, pathology, or outcomes data, but rather on engineering test results demonstrating adherence to the specifications of the standard.

8. The sample size for the training set

Not applicable. This submission is not for an AI model or a device that uses machine learning. Therefore, there is no "training set" in this context. The study performed involves testing physical hardware.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or implied by the nature of the device modification.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is centered horizontally. The background is white.

Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Public Health Service

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

January 31, 2017

Datascope Corp. Helder Sousa Manager, Regulatory Affairs 1300 MacArthur Blvd. Mahwah, New Jersey 07430

Re: K163542

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: December 15, 2016 Received: December 16, 2016

Dear Helder 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

M.A. Hillemann

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications For Use

510(k) Number (if known): K163542

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)

{3}------------------------------------------------

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.1300 MacArthur Blvd.Mahwah, NJ 07430
Contact person and telephone number:	Helder A. SousaManager, Regulatory Affairs
Phone:Fax:Email:Date prepared:	(973) 709-7465(973) 629-1325helder.sousa@getinge.comDecember 15, 2016

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
Regulatory Class:	Class II
Product Code:	DSP

PREDICATE DEVICE INFORMATION:

CARDIOSAVE Intra-Aortic Balloon Pump (K151254).

DEVICE DESCRIPTION:

{4}------------------------------------------------

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 identical to the predicate CARDIOSAVE Intra-Aortic Balloon Pump (K151254) with the exception of the new CARDIOSAVE Li-Ion battery transport and storage case to be used for the CARDIOSAVE batteries for protective purposes.

PERFORMANCE DATA:

The new CARDIOSAVE Li-Ion battery transport and storage case to be used for the CARDIOSAVE Li-lon batteries for protective purposes when not installed in the IABP complies with IEC 62133 Edition 2.0 2012-12: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.

Datascope Corp. development process required that the following activities be completed during the development of the new CARDIOSAVE Li-lon battery transport and storage case:

Requirements specification review ●
Performance testing
. Design validation

The results of the tests conducted demonstrate that the new CARDIOSAVE Li-Ion battery transport and storage case to be used for the CARDIOSAVE Li-lon batteries when not installed in the IABP complies with IEC 62133 Edition 2.0 2012-12.

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 IABP. The CARDIOSAVE IABP with the new CARDIOSAVE Li-lon battery transport and storage case 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 IABP with the new CARDIOSAVE Li-lon battery transport and storage case performs as well 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.