(323 days)
Not Found
No
The summary describes an electromechanical system for inflating and deflating an intra-aortic balloon based on ECG or arterial pressure waveforms. There is no mention of AI, ML, or any learning algorithms. The operation modes are described as "auto" and "manual," which are typical for medical devices and do not inherently imply AI/ML.
Yes
The device is described as a "cardiac assist device" used to provide "temporary support to the left ventricle" and is indicated for conditions such as "Unstable refractory angina," "Cardiogenic shock," and "Post-surgical myocardial dysfunction," all of which are disease states or medical conditions.
No
Explanation: The device is described as a "cardiac assist device" that provides "temporary support to the left ventricle via the principle of counterpulsation." Its primary function is to inflate and deflate intra-aortic balloons to support the heart, which is a therapeutic function, not a diagnostic one. The indications for use are conditions requiring cardiac support and stabilization, not the identification or diagnosis of those conditions.
No
The device description explicitly states it is an "electromechanical system" and an "electro-mechanical system used to inflate and deflate" intra-aortic balloon catheters, indicating it includes hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used to provide temporary support to the left ventricle via counterpulsation by inflating and deflating an intra-aortic balloon placed in the descending aorta. This is a therapeutic intervention performed directly on the patient's circulatory system.
- Device Description: It is described as a "cardiac assist device" and an "electro-mechanical system used to inflate and deflate... intra-aortic balloon catheters." This aligns with a therapeutic device, not a diagnostic one.
- Anatomical Site: The device interacts with the descending aorta, which is within the patient's body. IVD devices typically analyze samples taken from the body (blood, urine, tissue, etc.).
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device's function is to provide mechanical support to the heart, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.
Indications for Use:
Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:
- Unstable refractory angina .
- Impending infarction ●
- Post Infarction Angina or Threatening Extension of Myocardial Infarction .
- Refractory ventricular failure .
- Mechanical complications because of myocardial infarction ●
- Cardiogenic shock .
- Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
- Ischemic related intractable ventricular arrhythmias .
- Septic shock .
- Interoperative pulsatile flow generation
- Weaning from cardiopulmonary bypass .
- Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
- Prophylactic support in preparation for cardiac surgery .
- . Post-surgical myocardial dysfunction
- Cardiac Contusion .
- Mechanical bridge to other assist devices ●
- Cardiac support following correction of anatomical defects ●
- Support for failed angioplasty and valvuloplasty
Product codes (comma separated list FDA assigned to the subject device)
74DSP
Device Description
The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.
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
adults
Intended User / Care Setting
health care facilities
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)
Three different types of pre-clinical testing were completed for the iPulse IABP Console: laboratory, software verification and electrical standards testing. The laboratory tests demonstrated equivalence to the 2 predicate IABP consoles, and included performance and reliability testing in accordance with the FDA's recommendations, as provided in: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Regulations", Preliminary Draft, 12/9/93. The software verification and electrical standards (EMI, EMC and Electrical Safety) testing demonstrated compliance with the applicable standards required for device clearance.
The pre-clinical test results demonstrate that the iPulse IABP Console is safe and effective, and performs equivalently to the 2 predicate IABP consoles.
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
Section 5.0- 510(k) Summary (Prepared in accordance with 21 CFR Part 807.92)
| a. Submitted | |
|---|---|
| Applicant Name: | ABIOMED, Inc. |
| 22 Cherry Hill Drive, Danvers, MA 01923 | |
| Contact Person: | Robert T.V. Kung, Ph.D. |
| Date Summary Prepared: | December 7, 2007 |
| b. Device information | |
| Trade Name: | iPulse Intra-Aortic Balloon Pump Console |
| Common Name: | Intra-Aortic Balloon Pump |
| Classification Name: | Intra-Aortic Balloon and Control System |
| (Class III under CFR870.3535) | |
| Product Code: | 74DSP |
c. Legally Marketed Predicate Devices
Datascope CS100 Intra-Aortic Balloon Pump (K031636)
Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256)
d. Device Description:
The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.
e. Intended Use:
The iPulse IABP Console can be used to provide temporary support to the left ventricle via the principle of counter-pulsation. An intra-aortic balloon (IAB) catheter is placed in the descending aorta, just distal to the left subclavian artery. Once the IAB is positioned, the iPulse IABP Console is adjusted to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The iPulse IABP Console is intended for use in health care facilities to improve cardiovascular functioning during the following situations:
- Unstable refractory angina .
- Impending infarction t
- Post Infarction Angina or Threatening Extension of Myocardial Infarction .
- Refractory ventricular failure .
1
- Mechanical complications because of myocardial infarction
- . Cardiogenic shock
- Support and stabilization of high risk patients undergoing diagnostic and . non-surgical procedures
- . Ischemic related intractable ventricular arrhythmias
- Septic shock ◆
- Interoperative pulsatile flow generation .
- . Weaning from cardiopulmonary bypass
- Cardiac support for high risk surgical patients and coronary angiography . and angioplasty patients
- . Prophylactic support in preparation for cardiac surgery
- Post-surgical myocardial dysfunction .
- ◆ Cardiac Contusion
- . Mechanical bridge to other assist devices
- Cardiac support following correction of anatomical defects .
- . Support for failed angioplasty and valvuloplasty
f. Technological Characteristics and Comparison to Predicate Device(s):
The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters. The iPulse console and the predicate consoles have equivalent performance for counter-pulsation therapy
Table 1 provides a comparison of the iPulse IABP Console with the with predicate IABP consoles. This table illustrates the equivalency of the iPulse IABP Console with its predicates.
| Property | iPulse Console | CS100 Console-
K031636 | AutoCAT2 Console-
K002256 |
|-----------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Intended Duration of Use | Temporary use:
Approx. ≤ 30 days | Temporary use:
Approx. ≤ 30 days | Temporary use:
Approx. ≤ 30 days |
| IAB Catheter Tested | 8F, 40 cc | 8F, 40 cc | 8F, 40 cc |
| IABP Drive System | Electro-pneumatic
with replaceable
helium cylinder | Electro-pneumatic with
replaceable helium
cylinder | Electro-pneumatic
with replaceable
helium cylinder |
| User Interface/Display Type | Laptop | Laptop | Laptop |
| Maximum Beat Rate | 200 BPM | 185 BPM | 200 BPM |
| Trigger Signals Accepted | ECG, Aortic pressure | ECG, Aortic pressure | ECG, Aortic pressure |
| Console Size (on Cart) | 30"Hx23"Wx11"D | 26.6"Hx20.5"Wx10.8"D | 37.8"Hx14"Wx20"D |
| Console Weight | 126 lbs | 126 lbs | 86 lbs |
| Voltage Requirement | 120/240 Vac | 120/240 Vac | 120/240 Vac |
| Battery Type | Sealed Lead Acid | Sealed Lead Acid | Sealed Lead Acid |
| Battery Runtime (minimum) | 2.5 hours | 2.25 hours | 2.0 hours |
Table 1- Comparison Table for iPulse IABP Console
2
g. Pre-clinical Test Results:
Three different types of pre-clinical testing were completed for the iPulse IABP Console: laboratory, software verification and electrical standards testing. The laboratory tests demonstrated equivalence to the 2 predicate IABP consoles, and included performance and reliability testing in accordance with the FDA's recommendations, as provided in: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Regulations", Preliminary Draft, 12/9/93. The software verification and electrical standards (EMI, EMC and Electrical Safety) testing demonstrated compliance with the applicable standards required for device clearance.
The pre-clinical test results demonstrate that the iPulse IABP Console is safe and effective, and performs equivalently to the 2 predicate IABP consoles.
h. Conclusion:
Based on the information presented in this 510(k) pre-market notification, the iPulse IABP Console is considered substantially equivalent to the currently marketed predicate devices.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abiomed. Inc. c/o Dr. Robert T.V. Kung Senior Vice President Chief Scientific Officer 22 Cherry Hill Drive Danvers, MA 01923
K070225 Re:
iPulse IABP Console Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: Class III Product Code: DSP Dated: December 7, 2007 Received: December 10, 2007
Dear Dr. Kung:
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 such 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.
4
Page 2- Dr. Robert T.V. Kung
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Cl.S.M.
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 070225
510(k) Number (if known):
Device Name: iPulse Intra-aortic Balloon Pump Console
Intended Use:
The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.
Indications for Use:
Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:
- Unstable refractory angina .
- Impending infarction ●
- Post Infarction Angina or Threatening Extension of Myocardial Infarction .
- Refractory ventricular failure .
- Mechanical complications because of myocardial infarction ●
- Cardiogenic shock .
- Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
- Ischemic related intractable ventricular arrhythmias .
- Septic shock .
- Interoperative pulsatile flow generation
- Weaning from cardiopulmonary bypass .
- Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
- Prophylactic support in preparation for cardiac surgery .
- . Post-surgical myocardial dysfunction
- Cardiac Contusion .
- Mechanical bridge to other assist devices ●
- Cardiac support following correction of anatomical defects ●
- Support for failed angioplasty and valvuloplasty
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ko70225
(Division Sign-Off
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number
Page 1 of 1
.