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    K Number
    K963304
    Device Name
    STRYKER TEMPEST ORTHOPEDIC PUMP
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    1997-01-22

    (153 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K771200,K944593,K944583,K910858
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K771200, K944593

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

    The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints. The distension and saline circulation allow better viewing of the joint and tissues, as well as, irrigation of loose debris. The Tempest Orthopedic Pump replaces currently used manual infusion systems, utilizing either a build syringe or gravity flow. The Stryker Orthopedic Pump is to be used with Stryker Arthroscopes, and Pressure Sensing Cannula, found substantially equivalent under 510(k) number K771200, Arthroscopes, and K944593, Pressure Sensing Cannula, respectively.

    Device Description

    The Stryker Tempest Orthopedic Pump System, consisting of Pump Console which powers disposable Tube Set, and Pressure Sensing Cannula, 510(k) # K944583, during orthopedic surgery is equivalent in intended use, safety and offectiveness to existing Stryker Infusion Pump, 510(k) # K910858, used in similar applications, by Stryker Corporation. The disposable tube set utilized in Stryker Tempest Orthopedic Pump, will be provided sterile for single applications. The material of constructions, maximum pressure and flow rate are equivalent to currently marketed products. As proven in Orthopedic applications, these design offer the required precision for controlling the joints distension. The Tempest Orthopedic Pump technology utilized in equivalent to existing marketed products. Power modality, intended use, methods of sterliization and safety risks are substantially equivalent. The Stryker Tempest Orthopedic Purno is electrically powered and is designed to meet CSA Electromedical Standard Number C22.2 Number 125, and UL 544 Standards. A reusable hand control will be offered to allow surgeons to perform surgery in the sterile field.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Stryker Tempest Orthopedic Pump), which describes its equivalence to existing predicate devices. It does not contain the type of AI/ML performance study information typically requested for acceptance criteria. Therefore, I cannot provide the specific details you've asked for regarding acceptance criteria, study data, ground truth, or MRMC studies related to AI performance.

    However, I can extract information related to the device's functional and safety criteria mentioned in the document:

    Acceptance Criteria and Reported Device Performance (Based on functional and safety aspects of the device, not AI/ML performance):

    Acceptance Criteria (Functional/Safety)Reported Device Performance
    Electrical Safety Standards ComplianceMeets CSA Electromedical Standard Number C22.2 Number 125, and UL 544 Standards.
    Disposable Tube Set Sterilization ( 살 of 10^-6 )ETO sterilization processes validated per AAM standard ST 27. Gamma irradiation validation per AAM standard ST 32, method 1, section 5.2.3.1, for sterile packaged, single use disposable tube set. Minimum dose for a SAL of 10^-6 is 1.66 Mrad.
    Biocompatibility TestingIncludes USP Intracutaneous, USP Systemic Toxicity Test, Maximization, USP MEM Elution, and Hemolysis. (These validations are equivalent to existing marketed products.)
    Over-pressure Control (Normal Run/Stop Mode): Pump prevents pressure from exceeding 150 mmHg.If pressure exceeds 150 mmHg, the pump motor will stop, a red light emitting diode illuminates, and the outflow solenoid valve opens to relieve excess pressure.
    Over-pressure Alarm (Lavage Mode): Audible alarm for pressures above 150 mmHg for 3 seconds.Under Lavage mode, any pressure above 150 mmHg for 3 seconds will trigger an uninterrupted audible alarm.
    Pressure Change Detection: Pump motor stops if no pressure change detected within 4 seconds.If the pump does not detect a change in actual pressure within four seconds, the pump motor will stop, followed by an audible alarm. The only way to re-activate the pump is to depress the RUN/STOP switch.
    Overall Safety and Efficacy Equivalence to Predicate Device"The Stryker Tempest Orthopedic Pump System does not raise any new safety and efficacy concerns when compared to Infusion pump. Therefore, the Stryker Pump System is substantially equivalent to Stryker Infusion Pump System." (Predicate device: Stryker Infusion Pump, 510(k) # K910858)

    Regarding the other requested information (which are typically relevant for AI/ML device studies):

    • Sample sized used for the test set and the data provenance: Not applicable. This document describes a traditional medical device, not an AI/ML device. The "testing" referred to is against electrical safety standards, sterilization efficacy, and biocompatibility, not a clinical data test set.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically understood for AI/ML validation (e.g., disease presence) is not part of this submission.
    • Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    • 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: Not applicable. This is not an AI-assisted device.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. The "ground truth" for this device relates to established engineering standards (e.g., achieving a specific SAL, meeting electrical safety codes) and clinical equivalence to a predicate device.
    • The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/ML product.
    • How the ground truth for the training set was established: Not applicable.

    This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, technology, safety, and effectiveness, primarily through compliance with recognized standards and comparison of operational characteristics, rather than data-driven performance studies as seen with AI/ML devices.

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