(28 days)
Not Found
No
The document describes a mechanical cardiac assist device (intra-aortic balloon catheter) that uses fiber optic technology for pressure monitoring and synchronizes inflation/deflation with the cardiac cycle. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "cardiac assist device" that supports the heart's left ventricle and provides "therapy" through counterpulsation, which directly treats various cardiac conditions listed in the "Intended Use / Indications for Use" section.
No
The device is described as a "cardiac assist device" that supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Its primary function is therapeutic (counterpulsation), not diagnostic, even though it is indicated for "Support for diagnostic, percutaneous revascularization and interventional procedures." The device itself does not diagnose conditions.
No
The device description clearly details a physical catheter with accessories, an insertion kit, and stabilization devices, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is a cardiac assist device. It is placed inside the patient's descending aorta to physically support the heart's function by influencing blood flow and pressure.
- Intended Use: The intended uses listed are all related to treating or supporting patients with various cardiac conditions by directly interacting with their circulatory system. None of the indications involve analyzing samples taken from the body.
Therefore, this device falls under the category of a therapeutic or supportive medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
DSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's descending aorta just below the subclavian artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
There was no clinical evaluation of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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
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
4
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,
/2
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