Search Results

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.

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.

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.

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.

Ask a specific question about this device

The IMPELLA Controller 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 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 also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller is a microprocessor-based pump motor driver and purge system. It is designed to operate on AC current (110-240 VAC, 47-63 Hz) or on an internal, rechargeable battery. The IMPELLA Controller generates the signals required to power the drive motor of one of ABIOMED's IMPELLA Percutaneous Support Catheters (the IMPELLA RECOVER LP 2.5 (cleared under K063723), the IMPELLA 5.0 LP and the IMPELLA 5.0 LD (cleared under K083111). The IMPELLA Controller also serves to deliver an infusate of the catheter's drive motor, and to provide useful information regarding the catheter's performance. It is intended to be used by trained healthcare professionals in hospital and medical transport environments. It is lightweight, portable and has an accompanying cart for ease of transport within the hospital.

The provided text describes the IMPELLA Controller's acceptance criteria and the study that proves it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the IMPELLA Controller were its conformity to established international and internal performance standards, and its equivalence to the predicate device.

2. Sample size used for the test set and the data provenance:

The text does not specify a sample size for a "test set" in the context of patient data or clinical trials. The performance testing was conducted in vitro, meaning in a controlled laboratory environment, not on human subjects. Therefore, there is no direct patient data or provenance mentioned. The testing focused on the device's technical specifications and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document section related to performance data. As the tests were in vitro, the "ground truth" would be established by technical specifications and reference standards, rather than expert consensus on patient data.

4. Adjudication method for the test set:

An adjudication method for a "test set" in the context of reviewing clinical cases or images is not applicable here, as the study was in vitro and focused on engineering and functional performance, not clinical scenarios requiring expert interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC comparative effectiveness study was not performed. The IMPELLA Controller is a medical device for circulatory support and not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The performance testing described was primarily "standalone" in the sense that it evaluated the device's technical capabilities and compliance with standards without a human operator's variable input being a primary focus of the performance assessment (though it is intended for use by trained healthcare professionals). The tests focused on the device's inherent design and functionality, such as system durability, flow characterization, and sensor response.

7. The type of ground truth used:

The ground truth used for the in vitro testing was established based on:

• Established engineering design specifications (e.g., specific flow rates, pressure readings, durability benchmarks that the device was designed to meet).
• International and national standards for medical device safety, electromagnetic compatibility, electrical safety, biocompatibility, sterility, software design, packaging, and transport (e.g., IEC 60601 series, ISO 10993 series, FDA guidance documents).
• Performance characteristics of the predicate device, which served as a benchmark for equivalence in internal performance testing.

8. The sample size for the training set:

The concept of a "training set" is typically associated with machine learning or AI algorithm development. Since the IMPELLA Controller is a hardware-based medical device with microprocessor control, and the provided text does not mention any machine learning components, there is no training set in that context.

9. How the ground truth for the training set was established:

As there is no mention of a training set for machine learning in the provided document, the mechanism for establishing its ground truth is not applicable. The "ground truth" for the device's development and verification would stem from engineering principles, medical requirements for circulatory support, and regulatory standards.

Ask a specific question about this device