(31 days)
Not Found
No
The summary describes a mechanical cardiac assist device that synchronizes balloon inflation/deflation with the cardiac cycle based on physiological signals. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes.
The device's description explicitly states it is a "cardiac assist device" that "supports the heart" to improve coronary perfusion and reduce ventricular work in patients suffering from acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, which are all therapeutic interventions.
No
The device is described as a cardiac assist device that supports the left ventricle by increasing coronary perfusion and reducing work, which are therapeutic functions, not diagnostic ones.
No
The device description clearly details a physical device (intra-aortic balloon pump) that interacts directly with the patient's circulatory system, involving mechanical inflation and deflation of a balloon. This is not a software-only device.
Based on the provided information, the CARDIOSAVE IABP (Hybrid Model) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- CARDIOSAVE IABP Function: The description clearly states that the CARDIOSAVE IABP is a cardiac assist device that directly interacts with the patient's circulatory system by inflating and deflating a balloon within the aorta. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use describes treating conditions like acute coronary syndrome and heart failure, which are clinical interventions, not laboratory-based diagnostics.
Therefore, the CARDIOSAVE IABP falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac surgery, or complications of heart failure.
Product codes (comma separated list FDA assigned to the subject device)
DSP
Device Description
The CARDIOSAVE IABP (Hybrid Model) 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.
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
The balloon pump is intended for use in the 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)
Datascope Corp. development process required that the following activities be completed during the development of the new Top Protection Cover:
• Risk Assessment
• Verification testing
The modification proposed within this submission for CARDIOSAVE IABP (Hybrid Model) does not impact the performance characteristics of the predicate device.
The results of the tests conducted demonstrate that the proposed device met its respective acceptance criteria. According to the risk assessment performed, the modification does not introduce any new risks and does not raise any new questions of safety and effectiveness.
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.
CARDIOSAVE Intra-Aortic Balloon Pump (K112372)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 31, 2018
Datascope Corp. Hemang Kotecha Regulatory Affairs Specialist II 1300 MacArthur Blvd. Mahwah, New Jersey 07430
Re: K181122
Trade/Device Name: CARDIOSAVE Intra-Aortic Balloon Pump (Hybrid Model) Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: April 27, 2018 Received: April 30, 2018
Dear Hemang Kotecha:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
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) K181122
Device Name CARDIOSAVE IABP (Hybrid Model)
Indications for Use (Describe)
The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac surgery, or complications of heart failure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
CARDIOSAVE INTRA-AORTIC BALLOON PUMP (HYBRID MODEL)
[Prepared in accordance with 21 CFR Part 807.92]
| Submitter's Name
and Address: | Datascope Corp.
1300 MacArthur Blvd.
Mahwah, NJ 07430 |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person
for this
submission: | Hemang Kotecha
Regulatory Affairs Specialist II
Datascope Corp
1300 MacArthur Blvd.
Mahwah, NJ 07430
Phone: (973) 709-7376
Fax: (973) 629-1482
hemang.kotecha@getinge.com |
| Date Prepared: | April 27, 2018 |
| Device
Information: | Trade Name: CARDIOSAVE IABP (Hybrid Model)
Common/Generic Name: Intra-Aortic Balloon Pump
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 (K112372) |
| Device
Description: | The CARDIOSAVE IABP (Hybrid Model) 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 |
| Datascope Corp. | Special 510(k) : Corrective Action Being Affected
CARDIOSAVE IABP Modification: Top Protection Cover |
| | 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. |
| Indications For
Use: | The CARDIOSAVE IABP (Hybrid Model) is indicated for acute
coronary syndrome, cardiac and non-cardiac surgery, or
complications of heart failure. |
| Intended Use: | The CARDIOSAVE IABP (Hybrid Model) is an
electromechanical system used to inflate and deflate intra-
aortic balloons. The IABP 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. |
| Comparison of
Technological
Characteristics
with the Predicate
Device: | The proposed CARDIOSAVE IABP (Hybrid Model), which is
the subject of this submission, contains the same
technologically characteristics as the predicate CARDIOSAVE
Intra-Aortic Balloon Pump (K112372). |
| | The proposed modification is the addition a new Top Protection
Cover that shall be installed on top of the CARDIOSAVE cart. |
| | The Top Protection Cover provides protection against liquid
spills, such as saline, that may occur on top of the unit. It is |
| Datascope Corp. | Special 510(k) : Corrective Action Being Affected
CARDIOSAVE IABP Modification: Top Protection Cover |
| | designed to remove any paths for the liquid that is spilled on top
of the unit and prevent flow of the liquid into the interfacing
panels, connector receptacles and air vents. Such liquid spills are
hazardous as they can create bridges of resistance between the
circuit components; causing the circuit not to function as
intended; potentially damage the unit and possibly causing it to
shut down during operation. This may impact the initiation or
continuation of therapy. |
| Performance
Data: | Datascope Corp. development process required that the
following activities be completed during the development of the
new Top Protection Cover:
• Risk Assessment
• Verification testing |
| | The modification proposed within this submission for
CARDIOSAVE IABP (Hybrid Model) does not impact the
performance characteristics of the predicate device. |
| | The results of the tests conducted demonstrate that the
proposed device met its respective acceptance criteria.
According to the risk assessment performed, the modification
does not introduce any new risks and does not raise any new
questions of safety and effectiveness. |
| Clinical Tests: | There was no clinical testing deemed necessary for the
proposed device. |
| Conclusion: | Based upon the information submitted in this Special 510(k)
submission, the proposed device is substantially equivalent to
the currently marketed CARDIOSAVE IABP (Hybrid Model). |
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5
Protection Cover is similar to the predicate device in the intended use and the fundamental scientific technology of the device. The design verification testing established that the CARDIOSAVE IĂBP (Hybrid Model) with the new Top Protection Cover performs same as the predicate device.