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 Description

The SENSATION® PLUS 8 Fr. 50cc IAB Catheter (SENSATION Plus) is an enhanced SENSATION 7Fr IAB Catheter which includes a catheter with accessories, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber optic technology of the SENSATION 7Fr IAB Catheter with the increased membrane volume and French size of the Mega" 50cc 8Fr. IAB Catheter (K091449). The SENSATION® Plus Insertion kit contains the same components as currently used with the Mega 50cc 8Fr IAB Catheter with the sole exception that the SENSATION® Plus Insertion Kit does not contain two lengths (4-ft) of pressure tubing, due to the fact that pressure monitoring is accomplished via the fiber optic cable. In addition, the SENSATION® Plus Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION® Insertion Kit.

The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter 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 the intra-aortic balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the 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 and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IAB Catheters.

AI/ML Overview

The provided document refers to a Special 510(k) premarket notification for the SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter. This device is presented as substantially equivalent to existing predicate devices based on non-clinical tests. No clinical studies are mentioned for this device, and therefore, there is no information on acceptance criteria based on clinical performance, nor any studies proving the device meets such criteria.

The document explicitly states: "There was no clinical evaluation of the modified device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them from the provided text, as this medical device's approval appears to be based on substantial equivalence demonstrated through non-clinical testing.

However, I can extract information about the non-clinical tests conducted, which are used to demonstrate substantial equivalence.

Non-Clinical Test Information (from the document):

A table of acceptance criteria and the reported device performance:
The document does not provide a table with specific acceptance criteria or quantitative performance results for the device. It generally states that the "results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed IAB Catheters."
Sample size used for the test set and the data provenance: Not applicable, as detailed information about in-vitro test sets or data provenance is not provided. The tests are "in-vitro," meaning they are not conducted on living organisms and thus have no country of origin or retrospective/prospective nature in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies and expert consensus, is not relevant for in-vitro non-clinical tests.
Adjudication method: Not applicable for non-clinical in-vitro tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states: "There was no clinical evaluation of the modified device."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical intra-aortic balloon catheter, not an AI algorithm.
The type of ground truth used: Not applicable in the context of clinical or AI performance. For non-clinical tests, "ground truth" would relate to engineering specifications and physical measurements, which are not detailed here.
The sample size for the training set: Not applicable. There is no mention of a training set for an AI algorithm or a clinical study.
How the ground truth for the training set was established: Not applicable.

Summary

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K112327 pg 1 of 3

Cardiac Assist, MAQUET Cardiovascular LLC

Confidential Premarket Notification Special 510(k) SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories

SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter

510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

SEP - 9 2011

GENERAL INFORMATION

Submitter's name and address: LLC

Cardiac Assist, MAQUET Cardiovascular

15 Law Drive Fairfield, NJ 07004

Contact person and telephone number:

Helder A. Sousa Requlatory Affairs Program Manager

Phone: Fax: Email: Date prepared: (201) 995-8710 (201) 995-8960 helder.sousa@maquetcv.com August 10, 2011

DEVICE INFORMATION:

Trade Name:	SENSATION ™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories
Common/Generic Name:	Intra-Aortic Balloon Catheter (IAB)
Classification Name:	Intra-Aortic Balloon Catheters (IABs)
Regulation Number:	21 CFR 870.3535
Product Code:	DSP

PREDICATE DEVICE INFORMATION:

The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is substantially equivalent in function and intended use to the SENSATION® 7Fr. IAB Catheter (K063525) and MEGA™ 8Fr. IAB Catheter (K091449).

DEVICE DESCRIPTION AND INTENDED USE:

The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and

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

Confidential

Cardiac Assist, MAQUET Cardiovascular LLC Premarket Notification Special 510(k) SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories

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 the intra-aortic balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the 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 and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IAB Catheters.

TECHNOLOGICAL CHARACTERISTICS:

The SENSATION™ PLUS 8Fr. 50cc IAB Catheter has the same fiber-optic pressure sensor technology as the predicate SENSATION 7Fr. IAB Catheter, and the same membrane volume and French size as the MEGA 8Fr. 50cc IAB Catheter.

NON-CLINICAL TESTS:

The SENSATION PLUS IAB Catheter complies with the voluntary standards identified in Section 3 of this submission. Cardiac Assist, MAQUET Cardiovascular LLC's development process required that the following activities be completed during the development of the SENSATION PLUS IAB Catheter:

Requirements specification review �
Performance testing .
. Biocompatibility testing
Sterility testing �
. Shelf life testing
Design validation ●

The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed IAB Catheters.

CLINICAL TESTS:

There was no clinical evaluation of the modified device.

Conclusion:

Based upon the information submitted in this Special 510(k) premarket notification, MAQUET's SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is substantially equivalent to the currently marketed SENSATION® 7Fr. IAB Catheter (K063525) and MEGA™ 8Fr. IAB Catheter (K091449). The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is similar to the predicate devices in the intended use and the

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

K112327 pg 3 of 3

Confidential

Cardiac Assist, MAQUET Cardiovascular LLC Premarket Notification Special 510(k) SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories

fundamental scientific technology of the device. The design verification and validation testing established that the SENSATION Plus IAB Catheter is safe and effective and performs as well as the predicate devices.

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human figures, represented by curved lines, stacked on top of each other.

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

Datascope Cardiac Assist c/o Ms. Helder A. Sousa Regulatory Affairs Program Manager 1300 MacArthur Blvd Mahwah, NJ 07430

SEP - 9 2011

Re: K112327

SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: Class III Product Code: DSP Dated: August 10, 2011 Received: August 12, 2011

Dear Ms. 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 Amendminists, or lo devices that have been reclassified in accordance with the provisions of the Fedral 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, inting 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 midning.

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

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Page 2 - Ms. Helder A. Sousa

Enclosure

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 is 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Ki12327

Indications For Use

510(k) Number (if known): K112327

Device Name: SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories

Indications For Use:

MAQUET's SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter 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

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K112327

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.