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 8Fr. Introducer Set is comprised of an Introducer Sheath and Introducer Dilator for percutaneous insertion of the MEGA & SENSATION PLUS 8Fr. 50cc IABs. The flexible high density polyethylene (HDPE) dilator is inserted through and twist locked into the 8Fr. introducer sheath for insertion over a quide wire for percutaneous access to the femoral artery. The dilator is then removed from the sheath after which the 8Fr 50cc Intra-aortic Balloon (IAB) Catheter is inserted over a guide wire and through the 8Fr introducer sheath for placement within the thoracic anta for counterpulsation therapy. The introducer sheath is comprised of a hub housing that includes an integral hemostasis valve to prevent bleeding about the IAB catheter and a sheath tube comprised of a flat coiled stainless wire between a layer of PTFE and Pebax for reinforcement to provide kink resistance within the vasculature.

AI/ML Overview

The provided 510(k) summary for the MEGA AND SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter (K133074) describes a device modification, specifically to the introducer set. Therefore, the acceptance criteria and study information pertain to demonstrating the substantial equivalence of this modified introducer set to its predicate device, rather than proving the overall clinical effectiveness of an entirely new device from scratch.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a modified device, the "acceptance criteria" are not framed as specific performance metrics like sensitivity/specificity for a diagnostic AI. Instead, they are framed around demonstrating that the modified components (the introducer set) perform as safely and effectively as the predicate device and that the modifications do not raise new questions of safety or effectiveness.

Acceptance Criteria Category	Description	Reported Device Performance/Study Findings
Biocompatibility	The device components that come into contact with the body must be compatible with biological tissues and fluids, causing no adverse reactions.	Performed. The text states "Biocompatibility" was one of the completed activities. The conclusion states "The design verification and validation testing established that the enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices." Implies satisfactory results, confirming biocompatibility similar to the predicate.
Insertion Skinline to Artery	The introducer set must allow for safe and effective percutaneous access to the femoral artery. This likely involves assessing ease of insertion, minimizing trauma, and maintaining vessel integrity during the procedure.	Performed. The text states "Insertion Skinline to Artery" was one of the completed activities. The conclusion states "The design verification and validation testing established that the enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices." Implies satisfactory results within acceptable limits for safe insertion.
Introducer Set Verification	Verification of the physical and functional aspects of the modified introducer set (e.g., dimensions, force to insert, kink resistance, hemostasis valve function). This ensures it meets design specifications and functions as intended.	Performed. The text states "Introducer Set Verification" was one of the completed activities. The main modifications were "minor dimensional changes" to the Reinforced Sheath's tip diameter, tube inner diameter and outer diameter, and the Sheath Dilator's outer diameter. The conclusion states "The design verification and validation testing established that the enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices" and "These modifications will not impact the safety and effectiveness of the enhanced 8Fr. Introducer Set." This indicates that the dimensional changes were verified and found to not negatively impact performance. The description of the predicate device's features (flat coiled stainless wire between PTFE and Pebax for reinforcement to provide kink resistance) implies this performance characteristic was maintained or improved.
Package Performance	The packaging must maintain product sterility and integrity during shipping and storage until use.	Performed. The text states "Package Performance" was one of the completed activities. It also states the modified device uses "the same packaging" as the predicate. Implies satisfactory results, ensuring the packaging protects the device as required.
Product Stability	The device must maintain its functional characteristics and sterility over its shelf life.	Performed. The text states "Product Stability" was one of the completed activities. Implies satisfactory results, confirming the device remains stable over time.
Sterilization	The device must be able to be effectively sterilized to ensure patient safety.	Performed. The text states "Sterilization" was one of the completed activities. It also states the modified device is "sterilized using the same materials and processes" as the predicate. Implies satisfactory results, confirming effective sterilization.
No New Risks Identified	The modifications should not introduce new safety concerns or increase existing risks.	"After review of the Risk Management Plan, there were no new risks identified with this modification to the enhanced 8Fr. Introducer Set."
Substantial Equivalence to Predicate	The modified device must be as safe and effective as the predicate device(s) and raise no new questions of safety or effectiveness.	"Based upon the information submitted... the enhanced 8Fr. Introducer Set is substantially equivalent to the currently marketed 8Fr. Introducer Set... The enhanced 8Fr. Introducer Set is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices. These modifications will not impact the safety and effectiveness of the enhanced 8Fr. Introducer Set."

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any of the non-clinical tests (e.g., how many introducer sets were tested for kink resistance, biocompatibility, etc.).
- Data provenance: Not explicitly stated, but these are non-clinical (lab/bench) tests conducted by the manufacturer (Datascope Corp.) as part of their "development process." It's assumed to be internally generated data, not patient data from a specific country or retrospective/prospective 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 in the context of this 510(k). The "ground truth" for non-clinical tests is established by passing predefined engineering specifications and compliance with voluntary standards, as evaluated by the manufacturer's development and quality control teams, and then reviewed by the FDA. There is no mention of external "experts" establishing ground truth for these tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically refers to resolving disagreements among human readers/experts in diagnostic imaging studies. The studies performed were non-clinical bench and lab tests.
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 study was not done. The device is an Intra-Aortic Balloon Catheter Introducer Set, not an AI diagnostic tool where human readers' performance with/without AI assistance would be relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical device (introducer set), not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by engineering specifications, performance standards, and regulatory requirements (e.g., biocompatibility standards, mechanical test specifications) that the device must meet to function safely and effectively as an introducer set. There is no "expert consensus" or "pathology" in the typical clinical sense for these verification tests.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The "development process" involved design and testing of physical components.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.

Summary

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K133074

MEGA AND SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter 510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

GENERAL INFORMATION

Submitter's name and address:

Datascope Corp. 15 Law Drive Fairfield, NJ 07004

Contact person and telephone number:

Linda Slutzky Regulatory Affairs Specialist I

Phone: Fax: Email: Date prepared: (973) 709-7973 (973) 807-9210 linda.slutzky@maquet.com November 8. 2013

DEVICE INFORMATION:

Trade Name:	MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic BalloonCatheters and Accessories
Common/Generic Name:	Intra-Aortic Balloon (IAB) Catheter
Classification Name:	System, Balloon, Intra-Aortic & Control
Regulation Number:	21 CFR 870.3535
Product Code:	DSP

PREDICATE DEVICE INFORMATION:

The enhanced 8Fr. Introducer Set is substantially equivalent to the 8Fr. Introducer Set packaged in the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories predicate devices.

DEVICE DESCRIPTION AND INTENDED USE:

The 8Fr. Introducer Set is comprised of an Introducer Sheath and Introducer Dilator for percutaneous insertion of the MEGA & SENSATION PLUS 8Fr. 50cc IABs.

The flexible high density polyethylene (HDPE) dilator is inserted through and twist locked into the 8Fr. introducer sheath for insertion over a quide wire for percutaneous access to the femoral artery.

The dilator is then removed from the sheath after which the 8Fr 50cc Intra-aortic Balloon (IAB) Catheter is inserted over a guide wire and through the 8Fr introducer sheath for placement within the thoracic anta for counterpulsation therapy. The introducer sheath is comprised of a hub housing that includes an integral hemostasis valve to prevent bleeding about the IAB catheter and a sheath tube comprised of a flat coiled stainless wire between a layer of PTFE and Pebax for reinforcement to provide kink resistance within the vasculature.

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The intra-aortic balloon 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. The resulting increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is thus 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 cvcle. These beneficial effects are caused by the inflation and deflation of the intra-aortic balloon (IAB) Catheter in the patient's descending aorta.

The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of 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. The IAB Catheter then remains deflated throughout systole. Hence the therapy is also referred to as counterpulsation.

TECHNOLOGICAL CHARACTERISTICS:

o the same intended use,
o the same operating principles,
incorporates the same raw materials, o
incorporates the same basic design, 0
sterilized using the same materials and processes, o
the same packaging. o

The differences between the enhanced 8Fr. Introducer Set and the predicate Introducer Set for use with the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories are dimensional changes only. The minor dimensional changes are an increase to the Reinforced Sheath's tip diameter, tube inner diameter and outer diameter and to the Sheath Dilator's outer diameter.

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NON-CLINICAL TESTS:

The enhanced 8Fr. Introducer Set complies with the voluntary standards identified in Section 3 of this submission. Datascope Corp. development process required that the following activities be completed during the development of the enhanced 8Fr. Introducer Set:

. Biocompatibility
Insertion Skinline to Artery .
Introducer Set Verification �
Package Performance ●
. Product Stability
Sterilization

After review of the Risk Management Plan, there were no new risks identified with this modification to the enhanced 8Fr. Introducer Set. We determined that these tests demonstrate that this device modification is as safe and effective as the predicate devices.

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 enhanced 8Fr. Introducer Set is substantially equivalent to the currently marketed 8Fr. Introducer Set packaged with the MEGA (K091449) and SENSATION PLUS (K112327) 8Fr. 50cc Intra-Aortic Balloon (IAB) Catheters and Accessories. The enhanced 8Fr. Introducer Set is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the enhanced 8Fr. Introducer Set is safe and effective and performs as well as the predicate devices. These modifications will not impact the safety and effectiveness of the enhanced 8Fr. Introducer Set.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.

Public Health Service

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

December 12, 2013

Datascope Corp. Linda Slutzky Regulatory Affairs Specialist 15 Law Drive Fairfield, NJ 07004

Re: K133074

Trade/Device Name: MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories Regulation Number: 21CRF 870.3535 Regulation Name: Intra-Aortic Balloon Catheters (IAB) Regulatory Class: Class III Product Code: DSP Dated: November 8, 2013 Received: November 12, 2013

Dear Ms. Slutzky:

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. Ilisting 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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Show and State with 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

MA Hilleman

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): _K133074

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

Indications For Use:

and sales and a particular a comment of the contributed to the contributed to the contributed to the contributed to the tope of the contributed to the tope of the contributed

The MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters 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 (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);

MA. Hilliam

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.