(30 days)
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.
| 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.
§ 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.