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510(k) Data Aggregation

    K Number
    K211273
    Device Name
    Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
    Manufacturer
    Ethicon Endo-Surgery, LLC
    Date Cleared
    2021-05-21

    (24 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K063192,K002906
    Why did this record match?
    Device Name :

    Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

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

    The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.

    The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.

    Device Description

    The HARMONIC® Blue Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with a compatible HARMONIC Generator. The Blue Hand Piece is permanently attached to a blue cord which connects to the front of the Generator.

    The Blue Hand Piece is a re-useable instrument with a limited service life. The Blue Hand Piece is programmed with a counter to limit the service life to 100 procedures. The generator will give a Hand Piece error after 100 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

    The HARMONIC® Gray Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blades. This Hand Piece is intended for use with a compatible Ethicon Generator.

    The Hand Piece is permanently attached to a cord which connects to the front of the Generator.

    The Hand Piece is a re-useable instrument with a limited service life. The Hand Piece is programmed with a counter to limit the service life to 95 procedures. The generator will give a Hand Piece error after 95 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

    The Hand Piece is packaged with a Blade Wrench and Test Tip. The Blade Wrench is used to secure instrument blades to the Hand Piece. The Hand Piece. Blade Wrench, and Test Tip are packaged non-sterile and must be sterilized per their insert instructions prior to use.

    AI/ML Overview

    This document describes a 510(k) premarket notification for two medical devices: the HARMONIC® Blue Hand Piece and the HARMONIC® Gray Hand Piece. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

    Acceptance Criteria and Device Performance:

    The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., specific force, temperature, or bleed control thresholds). Instead, the acceptance criteria are implicitly defined by demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices and that the changes do not raise new questions of safety or effectiveness.

    The reported device performance section focuses on the verification that the modifications do not negatively impact the existing performance or introduce new risks.

    Acceptance Criteria (Implicit)Reported Device Performance and Study Findings
    Maintain identical Indications for Use as predicate devices.Identical: The Indications for Use for both the HARMONIC® Blue Hand Piece and HARMONIC® Gray Hand Piece are stated to be identical to their respective predicate devices. They are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired, and can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
    Maintain identical Contraindications as predicate devices.Identical: Contraindications are stated to be identical to the predicate devices.
    Maintain non-sterile, single-patient use characteristics.Identical: Both new hand pieces are stated to be Non-Sterile, Single Patient Use, consistent with the predicate devices.
    Bio-Compatibility of Materials: All tissue-contacting materials comply with ISO 10993-1.Compliant: Bio-Compatibility evaluation was conducted, and all tissue-contacting materials are reported to comply with ISO 10993-1, consistent with the predicate devices.
    Maintain identical Packaging Method.Identical: The Packaging Method is stated to be identical to the predicate devices, with the addition of a new protective end cap for the Gray Hand Piece in packaging which does not alter the fundamental packaging method to ensure sterility or protection during transport.
    Maintain identical Device Operation.Identical: Device Operation is stated to be identical to the predicate devices, despite some internal technological differences such as the connector interface, software compatibility, EEPROM upgrade, and cable design harmonization and component modification. The fundamental operational principle of converting electrical energy to mechanical motion for the instrument blade remains unchanged.
    Device modifications (connector, software compatibility, EEPROM, cable design, cable components, protective end cap) do not introduce risks or degrade safety/effectiveness.Confirmed: Risk analyses for each device modification were provided and concluded that the risk profile of the new devices has not changed. Verification testing, Biocompatibility evaluation, and Electrical testing were conducted to confirm that the modifications do not raise new issues of safety or effectiveness.

    Study Information:

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

      • The document does not specify a distinct "test set" in the context of a clinical study or a separate performance evaluation on patient data.
      • The evaluation primarily involved verification testing, biocompatibility evaluation, and electrical testing on the modified devices. These tests would have been performed on a sample of the manufactured devices, but the specific number of units tested is not provided.
      • The data provenance is implied to be from laboratory and engineering testing of the devices themselves, rather than clinical patient data.

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

      • No information is provided about experts used to establish ground truth. This is not a clinical study involving interpretation of medical images or patient outcomes. The evaluation is focused on engineering and performance validation against internal specifications and regulatory standards.

    3. Adjudication method for the test set:

      • No adjudication method is described, as the studies conducted are not clinical studies requiring expert consensus on ground truth. The evaluation likely involved objective measurements and comparisons against established engineering specifications and regulatory standards.

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

      • No. This document describes a 510(k) submission for surgical hand pieces, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and was not conducted.

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

      • Not applicable. This device is a surgical instrument and does not involve an algorithm with standalone performance.

    6. The type of ground truth used:

      • The ground truth in this context is based on engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and the established safety and effectiveness profile of the predicate devices. The aim was to ensure that the modified devices adhered to these objective standards and did not deviate from the performance of the predicate.

    7. The sample size for the training set:

      • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" here refers to the design and manufacturing processes guided by established engineering principles and prior device knowledge.

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

      • Not applicable. As this is not an AI/ML device, there isn't a training set in that sense. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements, which are developed through years of research, testing, and clinical experience with similar medical devices.
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