(29 days)
Not Found
No
The summary describes an electromechanical system that synchronizes balloon inflation/deflation with ECG or arterial pressure waveforms. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics associated with learning algorithms, or image processing.
Yes.
The device description clearly states it is a "cardiac assist device" that "supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work," which are direct therapeutic actions.
No
The device is described as a "cardiac assist device" that "provides temporary support to the left ventricle" by physically assisting blood flow ("inflating and deflating intra-aortic balloons"). Its purpose is therapeutic (to reduce left ventricular work and increase coronary perfusion), not to diagnose a condition.
No
The device is described as an "electromechanical system" and a "cardiac assist device" that involves the physical inflation and deflation of an intra-aortic balloon, clearly indicating hardware components beyond just software.
Based on the provided information, the CARDIOSAVE™ Intra Aortic Balloon Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CARDIOSAVE™ Function: The description clearly states that the CARDIOSAVE™ is an electromechanical system that inflates and deflates an intra-aortic balloon placed inside the patient's body. It directly interacts with the patient's circulatory system to provide temporary cardiac support.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is based on mechanical action within the body synchronized with physiological signals (ECG or arterial pressure).
Therefore, the CARDIOSAVE™ Intra Aortic Balloon Pump falls under the category of a therapeutic or life-support device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARDIOSAVE™ Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
Product codes
DSP
Device Description
The CARDIOSAVE™ Intra-Aortic Balloon Pump (1ABP) 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.
The CARDIOSAVE™ Intra-Aortic Balloon Pump (IABP) is substantially equivalent to the Datascope Corp CS300 IABP. The changes in the CARDIOSAVE™ IABP design essentially consist of both dimensional and weight reduction of the device, a change from a sealed lead acid battery to a "hot swappable" Lithium Ion battery, minor user interface improvements, material modification to two internal components of the IABP, an improved lead fault detection, elimination of the manual fill capability due to the dissolution of the pediatric IAB Catheter market (rendered obsolete through other technology), and modification to the Autofill process from a volume based process to a pressure based process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending aorta, just distal to the left subclavian artery
Indicated Patient Age Range
adult
Intended User / Care Setting
health care facility setting
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)
Non-clinical tests were conducted including: Requirements specification review, Hardware and software testing, Code design and code reviews, Environmental testing, Safety testing, Performance testing, Hardware and software validation. No clinical evaluation of the modified device was conducted or required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Confidential
112372
CARDIOSAVE™ Intra-Aortic Balloon Pump 510(k) Summary Prepared in accordance with 21 CFR Part 807.92
SEP 1 5 2011
GENERAL INFORMATION
Submitter's name and address:
Cardiac Assist, MAQUET Cardiovascular LLC 1300 MacArthur Blvd. Mahwah, NJ 07430
Contact person and telephone number:
Helder A. Sousa Regulatory Affairs Program Manager
Phone: Fax: Email: Date prepared:
(201) 995-8710 . (201) 995-8960 heider.sousa@maquetcv.com August 16, 2011
DEVICE INFORMATION:
| Trade Name: | CARDIOSAVE™ Intra-Aortic Balloon Pump |
|---|---|
| Common/Generic Name: | Intra-aortic balloon and control system |
| Classification Name: | Intra-aortic balloon and control system |
| Regulation Number: | 21 CFR 870.3535 |
| Product Code: | DSP |
· PREDICATE DEVCE INFORMATION:
The CARDIOSAVE™ Intra-Aortic Balloon Pump is substantially equivalent in function and intended use to the CS300 Intra-Aortic Balloon Pump (K063525).
DEVICE DESCRIPTION AND INTENDED USE:
The CARDIOSAVE™ Intra-Aortic Balloon Pump (1ABP) 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.
1
TECHNOLOGICAL CHARACTERISTICS:
The CARDIOSAVE™ Intra-Aortic Balloon Pump (IABP) is substantially equivalent to the Datascope Corp CS300 IABP. The changes in the CARDIOSAVE™ IABP design essentially consist of both dimensional and weight reduction of the device, a change from a sealed lead acid battery to a "hot swappable" Lithium Ion battery, minor user interface improvements, material modification to two internal components of the IABP, an improved lead fault detection, elimination of the manual fill capability due to the dissolution of the pediatric IAB Catheter market (rendered obsolete through other technology), and modification to the Autofill process from a volume based process to a pressure based process.
NON-CLINICAL TESTS:
The CARDIOSAVE™ Intra-Aortic Balloon Pump 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 CARDIOSAVE™ Intra-Aortic Balloon Pump:
- Requirements specification review .
- Hardware and software testing .
- Code design and code reviews .
- . Environmental testing
- Safety testing .
- Performance testing �
- Hardware and software validation .
CLINICAL TESTS:
No clinical evaluation of the modified device was conducted or required.
CONCLUSION:
Based upon the information submitted in this Special 510(k) premarket notification, MAQUET's CARDIOSAVE™ Intra-Aortic Balloon Pump is substantially equivalent to the currently marketed CS300 Intra-Aortic Balloon Pump (K063525). The CARDIOSAVE™ Intra-Aortic Balloon Pump is similar to the predicate device in the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. Department of Health & Human Services USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WQ66-G609 Silver Spring, MD 20993-0002
MAQUET Cardiovascular, LLC. c/o Mr. Helder A. Sousa Regulatory Affairs Program Manager 1300 MacAthur Blvd. Mahwah, NJ 07430
SEP 15 2011
Re: K112372
Trade/Device Name: CARDIOSAVE ™ Intra-Aortic Balloon Pump Regulatory Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: III (three) Product Code: DSP Dated: August 16, 2011 Received: August 17. 2011
Dear Mr. 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.
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
3
Page 2 - Mr. Helder A. Sousa
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/ReportalProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
Enclosure
4
Indications for Use
510(k) Number (if known): K112372
Device Name: CARDIOSAVE™ Intra-Aortic Balloon Pump
Indications For Use:
The CARDIOSAVE™ Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target population is adult. The balloon pump is intended for use in the health care facility setting.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR Over-The-Counter Use (21 CFR 801 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 | K112372 |
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