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510(k) Data Aggregation

    K Number
    K112892
    Device Name
    IMPELLA 2.5 PLUS CATHETER
    Manufacturer
    ABIOMED, INC.
    Date Cleared
    2012-09-06

    (342 days)

    Product Code
    PBL
    Regulation Number
    N/A
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K110845,K063723
    Why did this record match?
    Product Code :

    PBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

    The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

    Device Description

    The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008 (under K063723). The predicate device, the IMPELLA 2.5, and the Impella 2,5 Plus have identical designs and materials of construction. The only design modifications made to the IMPELLA 2.5 for the Impella 2.5 Plus are slight increases in the diameters of the inflow can ula impeller and pump housing (from 12 F to 14 F). As a result of this increase, the Impella 2.5 Plus has approximately 30% higher flow than the IMPELLA 2.5.

    AI/ML Overview

    This 510(k) summary describes a medical device, the Impella 2.5 Plus, which is an updated version of a previously cleared device, the Impella 2.5. The submission focuses on demonstrating substantial equivalence to the predicate device due to minor design modifications (increased diameters of the inflow cannula impeller and pump housing).

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly state formal acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied to be substantially equivalent performance to the predicate device, the IMPELLA 2.5, and compliance with general design and safety standards.

    Acceptance Criteria (Implied)Reported Device Performance
    Functional Equivalence
    - Operate as intended- DVV testing demonstrated that the Impella 2.5 Plus operated as intended.
    - Substantial equivalence to predicate IMPELLA 2.5- DVV testing demonstrated that the Impella 2.5 Plus was substantially equivalent to the IMPELLA 2.5.
    - Identical functional scientific technology- The Impella 2.5 Plus employs identical functional scientific technology as the IMPELLA 2.5.
    Power/Flow Performance
    - Maintain adequate flow (or improve upon predicate)- Mean Flow: Up to 3.3 L/Min (60 mmHg differential pressure) - This is an improvement over the predicate's 2.5 L/Min.
    - Appropriate pump speed- Pump Speed: 46,000 RPM
    Safety and Compatibility
    - No new risks from minor design differences- Testing was completed to mitigate any possible new risks from the minor design differences. The results of bench testing demonstrated that the design changes did not raise any issues related to safety or effectiveness compared to the IMPELLA 2.5.
    - Compatibility with IMPELLA Controller- Software Verification testing was completed to verify the Impella 2.5 Plus could be used with the IMPELLA Controller. Electrical Standards and Safety testing (IEEC 60601-1, Applied Part) was completed to verify compliance for use of the Impella 2.5 Plus with the IMPELLA Controller.
    - Compliance with electrical safety standards- Electrical Standards and Safety testing (IEEC 60601-1, Applied Part) was completed to verify compliance.
    - Design modifications do not affect intended use or fundamental science- Design modifications: do not affect the intended use of the device, AND do not alter the fundamental scientific technology of the device.
    Biocompatibility/Material Integrity- The predicate device and Impella 2.5 Plus have identical designs and materials of construction (e.g., Polyurethane for catheter, cannula, and pigtail). Implicitly, this implies that previous biocompatibility and material integrity assurances for the predicate apply, and no new testing beyond comparison was deemed necessary for these aspects due to identical materials.

    2. Sample Size Used for the Test Set and Data Provenance

    The submission indicates that the studies conducted were bench tests and verification & validation (V&V) testing. It does not specify a "test set" in the context of patient data or clinical samples.

    • Sample Size: Not applicable in the sense of patient-based test sets. The sample size would refer to the number of devices tested in bench experiments. This detail is not provided in the summary.
    • Data Provenance: Not applicable in the sense of country of origin or retrospective/prospective clinical data for this type of submission. The performance data is derived from in vitro (bench) testing.

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

    Not applicable. The ground truth for this device's performance is established through engineering and scientific measurements and comparisons against established specifications and the predicate device's performance. It does not involve expert image interpretation or clinical diagnosis.

    4. Adjudication Method for the Test Set

    Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required. This device relies on direct physical measurements and engineering verification.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

    Not applicable. This device is a mechanical circulatory support device, not an AI-powered diagnostic or assistive tool for human readers.

    6. If a Standalone (i.e., Algorithm-only without human-in-the-loop) Performance Study Was Done

    Not applicable. This device is a physical medical device, not an algorithm. Its "standalone" performance is its bench-test performance as described.

    7. The Type of Ground Truth Used

    The "ground truth" for this submission is established by:

    • Engineering specifications and design requirements: The device's ability to meet its intended design parameters.
    • Performance of the predicate device (IMPELLA 2.5): The Impella 2.5 Plus is compared against the known performance characteristics of its legally marketed predecessor.
    • International standards: Compliance with relevant standards like IEC 60601-1 for electrical safety.
    • Functional operation: Verification that the device "operated as intended."

    8. The Sample Size for the Training Set

    Not applicable. This is a medical device, not an AI model, so there is no training set.

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

    Not applicable, as there is no training set for this device.

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