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510(k) Data Aggregation

    K Number
    K041890
    Device Name
    CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
    Manufacturer
    CRYOCOR, INC.
    Date Cleared
    2004-09-22

    (72 days)

    Product Code
    OCL
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

    The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.

    Device Description

    The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the CryoCor Model 1255 Surgical Probe, based on the provided text:

    Acceptance Criteria and Device Performance

    CriterionReported Device Performance
    Met design and performance requirements"Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements."
    Biocompatibility with blood-contacting materials (ISO 10993-1)"Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible."
    Sterilization validation (E-beam radiation)"The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle."

    Study Details

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

      • Sample Size: The document only mentions "Bench testing" and does not specify a numerical sample size for the test set.
      • Data Provenance: Not explicitly stated, but "Bench testing" implies laboratory-controlled conditions, not human clinical trial data. The device is intended for use in cardiac surgery, but no clinical data is presented for this submission.

    2. 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. The testing described is bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for bench testing would be predefined engineering specifications.

    3. Adjudication method for the test set:

      • This information is not provided as the disclosed testing is bench testing, not a clinical study requiring adjudication of expert interpretations.

    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, an MRMC comparative effectiveness study was not done. This device is a surgical probe, not an AI-powered diagnostic tool that would typically involve human readers or AI assistance in interpretation.

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

      • No, this is not applicable. The device is a physical surgical probe, not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • For the bench testing, the "ground truth" would be the engineering design specifications and performance requirements for the device. For biocompatibility, it would be the standards set by ISO 10993-1. For sterilization, it would be the validated E-beam radiation cycle parameters.

    7. The sample size for the training set:

      • This information is not applicable/not provided as the device is a physical surgical probe, not a machine learning algorithm that requires a training set.

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

      • This information is not applicable as the device is a physical surgical probe, not a machine learning algorithm.
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