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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the IMPELLA Controller with Flow Control. This submission primarily focuses on the device's substantial equivalence to a predicate device and its compliance with various electrical, safety, and software standards. It doesn't present an acceptance criteria table with reported device performance in the typical format of clinical or diagnostic studies. Instead, the "acceptance criteria" are implied by the standards and testing performed to demonstrate that the new Flow Control Mode is safe and effective and that the device as a whole is substantially equivalent to its predicate.

Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:

Acceptance Criteria and Study Summary for IMPELLA Controller with Flow Control

The IMPELLA Controller with Flow Control is a medical device (a non-roller type cardiopulmonary blood pump) that received 510(k) clearance based on its substantial equivalence to a predicate device, the IMPELLA Controller (K093801). The primary change in the new device is a software modification to include a "Flow Control Mode." The studies performed were largely in vitro bench tests and compliance assessments against recognized standards to demonstrate that this new mode did not introduce new safety or effectiveness concerns and that the device's overall performance remained consistent with its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary based on substantial equivalence, specific numerical performance metrics for acceptance criteria and device performance, as might be found in a diagnostic accuracy study, are not explicitly provided. Instead, the acceptance criteria are met by demonstrating compliance with established standards and proper functioning of the new feature.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied by document)	Reported Device Performance (as per document)
Electromagnetic Compatibility (EMC)	Conformance with IEC 60601-1-2, including IEC 61000-3-X and IEC 61000-4-X, and EN 55011.	Testing found "in conformance" with specified standards.
Electrical Safety	Conformance with IEC 60601-1 - Part 1.	Testing found "in conformance" with specified standard.
Packaging and Shipping	Conformance with ISTA 2A and EN 868.	Testing found "in conformance" with specified standards.
Altitude and Vibration	Testing per RTCA/DO-160C during operation.	Testing performed "per" specified standard.
Software Design & Testing	Compliance with "Guidance for Industry and FDA Staff - Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices" (2005).	Software design & testing "complied with" the FDA guidance document.
System Durability (In Vitro)	New Flow Control Mode does not compromise system durability, similar to predicate.	System Durability Testing was completed. (Specific results not detailed, but implied to be acceptable as no new safety/effectiveness issues were raised).
System Characterization (In Vitro)	Performance characteristics of the new Flow Control Mode meet specifications.	System Characterization Test was completed. (Implied acceptable performance).
System Flow Characterization (In Vitro)	Flow Control Algorithm behaves as designed, and the two control modes (Flow Control and Speed Control) are equivalent for use with IMPELLA pump catheters.	System Flow Characterization Test was completed and showed "the Flow Control Algorithm behaves as designed, and that the 2 control modes are equivalent for use with the IMPELLA pump catheters."
Overall Safety & Effectiveness	The IMPELLA Controller with Flow Control does not raise new issues with safety or effectiveness compared to the predicate device.	"The results of the bench testing demonstrated that the IMPELLA Controller with Flow Control did not raise new issues with safety or effectiveness."

2. Sample Size for Test Set and Data Provenance

The "studies" described are primarily in vitro (bench) tests and compliance assessments for a medical device's control unit, not clinical trials involving human subjects or diagnostic image analysis. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data are not directly applicable here. The "test set" would refer to the physical device prototypes and test setups used in the various engineering and performance evaluations.

Sample Size: Not specified in terms of units or duration beyond mentioning "System Durability Testing," "System Characterization Test," and "System Flow Characterization Test." These would involve testing an unspecified number of device units or components under defined conditions.
Data Provenance: The tests are in vitro (bench testing) and compliance assessments performed by the manufacturer, ABIOMED, Inc., presumably at their facilities. There's no mention of country of origin for clinical data as no clinical data is presented for this specific 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This 510(k) summary does not involve determining "ground truth" through expert review in the sense of clinical diagnosis or image interpretation. The "ground truth" for the engineering and performance tests would be defined by the technical specifications, international standards, and the expected behavior of the device as designed. The expertise involved would be that of the engineers and quality assurance personnel conducting the tests and verifying compliance. No specific number or qualification of "experts" is provided in the document for establishing such ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or diagnostic interpretation that would require an adjudication method like 2+1 or 3+1. The results of the engineering tests would be documented, analyzed against predefined acceptance criteria (specifications and standards), and validated by engineers and quality control personnel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a hardware/software control unit for a blood pump, not an imaging device or diagnostic algorithm that would typically involve human readers interpreting cases with and without AI assistance. The "AI" in this context is the software's "Flow Control Algorithm," which controls the mechanical pump.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a form of standalone performance study was done for the algorithm, albeit in an in vitro context. The document states:

"Performance characteristics of the IMPELLA Controller with Flow Control were tested in vitro to verify that the new Flow Control Mode met its specifications."
"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."

This demonstrates that the "Flow Control Algorithm" operating within the device was tested independently (without human intervention during the test itself, although humans initiated and monitored the tests) to ensure it performed as designed and met its specifications in vitro.

7. Type of Ground Truth Used

The "ground truth" for the in vitro performance studies and compliance testing was based on:

Engineering Specifications: The pre-defined design requirements and specifications for the device's functionality, especially the new Flow Control Mode.
International Standards: Adherence to established and recognized standards for medical devices (e.g., IEC 60601-1-2 for EMC, IEC 60601-1 Part 1 for electrical safety, RTCA/DO-160C for altitude/vibration).
Predicate Device Performance: The established, safe, and effective performance of the existing IMPELLA Controller (K093801), against which the new device's overall safety and effectiveness were compared to establish substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This submission does not describe a machine learning algorithm that requires a "training set" of data in the typical sense. The software modification is explicitly stated as implementing a "Flow Control Mode" and its algorithm's behavior was verified through in vitro testing. There's no indication that machine learning was used where a training set distinct from a test set would be defined.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of the information provided.

Summary

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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

K110845

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:

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.

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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.

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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

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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

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6.0 INDICATIONS FOR USE

510(k) Number (if known):

K110845

Device Name: IMPELLA Controller with Flow Control

Indications for Use:

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

Regulation Number and Section

§ 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.