(30 days)
Not Found
No
The document describes a software modification for a microprocessor-based pump motor driver, implementing a "Flow Control Mode" and an "Flow Control Algorithm". There is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on in vitro testing of the new control mode and algorithm, not on training or validating an AI/ML model.
Yes.
The device provides circulatory support, which is a therapeutic intervention.
No
The device is an extracorporeal bypass control unit used to provide circulatory support, which is a therapeutic function, not a diagnostic one. While it displays pressure measurements, this is described as "useful in determining intravascular pressure" rather than the primary means of diagnosis, and the overall intended use is life support.
No
The device is described as a "microprocessor-based pump motor driver incorporating an infusion system," which clearly indicates it includes hardware components beyond just software. The software modification is an additional operating mode implemented on existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "extracorporeal bypass control unit intended to be used to provide circulatory support". It also mentions displaying "pressure measurement readings, which are useful in determining intravascular pressure." These are all related to supporting and monitoring the patient's circulatory system in vivo (within the living body).
- Device Description: The description reinforces its function as a "microprocessor-based pump motor drivers incorporating an infusion system," again pointing to direct interaction with the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used to analyze these types of samples.
Therefore, the IMPELLA Controller with Flow Control is a medical device used for direct patient support and monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments.
The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.
Product codes (comma separated list FDA assigned to the subject device)
KFM, DWA
Device Description
The IMPELLA Controller with Flow Control is identical to the IMPELLA Controller in its physical characteristics. The only difference is that an additional operating mode. Flow Control Mode, has been implemented via a software modification. Both the IMPELLA Controller and the IMPELLA Controller with Flow Control are identical microprocessor-based pump motor drivers incorporating an infusion system. They both are intended to be used by trained healthcare professionals in hospital and medical transport environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals in hospital and medical transport environments.
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)
- Electromagnetic compatibility testing was in conformance with IEC 60601-1-2, including all pertinent IEC 61000-3-X and IEC 61000-4 --X standards for EMC/EMI along with EN 55011.
- Electrical safety testing was in conformance with IEC 60601-1- Part 1.
- Packaging and shipping testing was in conformance with ISTA 2A and EN 868.
- Altitude and vibration testing during operation was tested per RTCA/DO-160C.
Software design & testing for the IMPELLA Controller with Flow Control complied with: - FDA 2005 document titled "Guidance for Industry and FDA Staff- Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices".
Performance characteristics of the IMPELLA Controller with Flow Control were tested in vitro to verify that the new Flow Control Mode met its specifications. The main in vitro systems tests completed were: - System Durability Testing.
- System Characterization Test.
- System Flow Characterization Test.
Additional specialized performance testing was completed to verify that the 2 control modes are substantially equivalent. This testing showed that the Flow Control Algorithm behaves as designed, and that the 2 control modes are equivalent for use with the IMPELLA pump catheters.
The results of the bench testing demonstrated that the IMPELLA Controller with Flow Control did not raise new issues with safety or 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.
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
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(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 FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
IMPELLA Controller with Flow Control 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Requiations. Part 807.92.
A. Application Information:
Date Prepared:
April 27, 2011
Submitter's Name & Address:
ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923
Contact Person:
Dr. Robert Stewart Manager, FDA Programs Ph: 978-646-1567 Fax: 978-777-5692 E-mail: rstewart@abiomed.com
B. Device Information:
Trade or Proprietary Name: Common or Usual Name: Classification Name: Performance Standard:
IMPELLA Controller with Flow Control Non-roller type Cardiopulmonary Blood Pump Class III, KFM, 21 CFR - 870.4360 Performance standards do not currently exist for these devices. (i.e. none established under section 514 of the F D & C Act.)
C. Predicate Device:
The Impella Controller (K093801).
D. Device Description:
The IMPELLA Controller with Flow Control is identical to the IMPELLA Controller in its physical characteristics. The only difference is that an additional operating mode. Flow Control Mode, has been implemented via a software modification. Both the IMPELLA Controller and the IMPELLA Controller with Flow Control are identical microprocessor-based pump motor drivers incorporating an infusion system. They both are intended to be used by trained healthcare professionals in hospital and medical transport environments.
E. Intended Use:
The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter. or fixed-wing aircraft) environments.
The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.
F. Technological Characteristics:
The IMPELLA Controller with Flow Control employs identical functional scientific technology as its predicate device cleared under K093801.
1
G. Comparison to Predicate Device:
The IMPELLA Controller with Flow Control has the same intended use as its predicate system, the IMPELLA Controller. The primary function of the IMPELLA Controller with Flow Control is identical to that of the predicate system, which is supplying motor power and infusate to control and monitor an IMPELLA Percutaneous Support Catheter. Both the IMPELLA Controller with Flow Control and its predicate system are software driven. microprocessor-based consoles. It has a hardware configuration identical to the IMPELLA Controller.
The only difference between the IMPELLA Controller with Flow Control and the predicate IMPELLA Controller is a modification in the internal software to allow a Flow Control Mode of operation, which permits the User to set the circulatory support level (i.e. outflow from the nonroller pump) of the IMPELLA Percutaneous Support Catheters. The IMPELLA Controller, on the other hand, uses a Speed (called "Performance level") Control Mode (P1 to P9) to control the RPM of the miniature centrifuqal pump motors in the IMPELLA Percutaneous Catheters. The Speed Control Mode is still available in the IMPELLA Controller with Flow Control. The equivalency of the indications for use, the design features and the functional characteristics of the IMPELLA Controller with Flow Control raise no new safety or effectiveness issues.
H. Summary of Performance Data:
As with the predicate IMPELLA Controller (cleared under K093801):
International standards were met for the IMPELLA Controller with Flow Control:
- Electromagnetic compatibility testing was in conformance with IEC 60601-1-2, including ● all pertinent IEC 61000-3-X and IEC 61000-4 --X standards for EMC/EMI along with EN 55011.
- . Electrical safety testing was in conformance with IEC 60601-1- Part 1.
- Packaging and shipping testing was in conformance with ISTA 2A and EN 868. .
- Altitude and vibration testing during operation was tested per RTCA/DO-160C.
Software design & testing for the IMPELLA Controller with Flow Control complied with:
-
FDA 2005 document titled "Guidance for Industry and FDA Staff- Guidance for the � Content of Pre-market Submissions for Software Contained in Medical Devices".
Performance characteristics of the IMPELLA Controller with Flow Control were tested in vitro to verify that the new Flow Control Mode met its specifications. The main in vitro systems tests completed were: -
System Durability Testing. .
-
. System Characterization Test.
-
System Flow Characterization Test.
Additional specialized performance testing was completed to verify that the 2 control modes are substantially equivalent. This testing showed that the Flow Control Algorithm behaves as designed, and that the 2 control modes are equivalent for use with the IMPELLA pump catheters.
The results of the bench testing demonstrated that the IMPELLA Controller with Flow Control did not raise new issues with safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a single snake winding around a staff, topped with a stylized bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
ABIOMED, Inc. c/o Dr. Robert Stewart 22 Cherry Hill Drive Danvers, MA 01923
APR 2 7 2011
Re: K110845
Trade/Device Name: IMPELLA Controller with Flow Control Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary bypass blood pump Regulatory Class: III Product Code: KFM, DWA Dated: March 25, 2011 Received: March 28, 2011
Dear Dr. Stewart:
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. 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
3
Page 2 - Dr. Robert Stewart
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,
$\beta$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6.0 INDICATIONS FOR USE
510(k) Number (if known):
Device Name: IMPELLA Controller with Flow Control
Indications for Use:
The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments.
The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.
Prescription Use × (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)
fo (Division Sign-Off)
iovascular Devices
510(k) Number K110845