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    K Number
    K955011
    Device Name
    CANDELA HCS 2000 URETHERAL WARMER CATHETER
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-04-03

    (154 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K950633,K952595
    Why did this record match?
    Device Name :

    CANDELA HCS 2000 URETHERAL WARMER CATHETER

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

    The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.

    Device Description

    The principal components of the Candela Urethral Warmer are: (1) a saline bottle filled with a saline solution; (2) infrared lamps; (3) a temperature controller; (4) a roller pump; (5) delivery tubing and a balloon catheter with a radiopaque marker at its center; (6) pump tubing (7) return tubing; (8) a urethral/bladder sound (K950633); and (9) a console. The console houses the saline reservoir, the infrared lamps, and the roller pump and digital temperature readouts and buttons for operating the device appear on the front of the console.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Candela HCS 2000 Urethral Warmer Catheter System, based on the provided text:

    Summary of Acceptance Criteria and Device Performance:

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred)Reported Device PerformanceStudy Details (Where applicable)
    Temperature ControlAlarm sounds when saline temperature is outside acceptable range.Alarm sounds when temperature is outside the acceptable range (tested 20 times for over/under temperatures).Bench testing with open-ended tubing; temperature controller disabled from infrared lamps for manual control.
    Heating Effectiveness (Infrared Lamps)Tissue surrounding the balloon catheter remains unfrozen during cryosurgery.Tissue surrounding the urethral balloon catheter remained unfrozen in a dog kidney model and a beef liver slab model.Animal study (dog kidney) and ex-vivo study (beef liver slab).
    Low Volume AlarmAlarm activates when a significant amount of saline is lost.Alarm sounds when an average of 1,110 ml of saline (including 500 ml priming volume) is lost.Bench testing with open-ended tubing; 15-minute intervals between three samples.
    Pressure Resistance of Tubing/CatheterTubing and catheter can withstand normal working pressure without bursting.Delivery and return tubings and balloon catheter did not burst at a pressure more than three times the normal operating pressure. Destruction of the joint was observed (not a device-critical failure).Bench testing; pressure in the system recorded with and without blocked return tubing.
    Balloon Catheter ComplianceBalloon catheter inflates to a fixed size regardless of flow rate or back pressure.No significant difference in priming volume and balloon catheter diameter with pump settings of "3" or higher.Bench testing with a pressure gauge; pump speed increased from "one" to "five."
    BiocompatibilityMaterials are biocompatible for their intended use.Materials (silicon tubing, general components) proven biocompatible by similar uses in cleared products and biocompatibility data for silicon tubing.Referenced existing biocompatibility data and prior clearances.
    Overall Safety and EffectivenessNo new questions of safety or effectiveness raised compared to predicate device by technological differences.All technological differences (two digital readouts, infrared heating, low volume alarm, console configuration, unidirectional flow, material differences) were found not to raise new questions of safety or effectiveness through testing and comparison.Comprehensive comparison and specific tests detailed above.

    Detailed Study Information:

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

      • Temperature Control Study: Not explicitly stated as a "test set" in the traditional sense of patient data. The test involved repeated cycling (20 times for over-temperatures and 20 times for under-temperatures) of the alarm system in a bench setting.
      • Heating Effectiveness Study (Dog Kidney): 1 dog (retrospective or prospective not specified, but implied prospective for the study).
      • Heating Effectiveness Study (Beef Liver): 1 slab of beef liver (ex-vivo, thus no country of origin or retrospective/prospective).
      • Low Volume Alarm Study: Multiple tests across 15-minute intervals (number of samples not explicitly stated beyond "a set of tests"). Bench testing.
      • Pressure Resistance Study: Bench testing of tubing and catheter.
      • Balloon Catheter Compliance Study: Bench testing.
      • Biocompatibility: Referenced existing data, not a new study with a "test set" in this submission.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were primarily bench tests and animal/ex-vivo models where objective measurements (temperature, volume, pressure, physical observation of freezing) served as the "ground truth." No human expert consensus was required to interpret these physical parameters.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The "ground truth" was established by direct physical measurements and observations rather than expert review or interpretation.

    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: Not applicable. This is a medical device (urethral warmer), not an AI/imaging diagnostic device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device. The "performance" is its mechanical and thermal functionality.

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

      • Temperature Control: Direct measurement of saline temperature against pre-set acceptable range.
      • Heating Effectiveness: Direct observation of tissue freezing (or lack thereof) via thermocouples and stained tissue (Tripan Blue).
      • Low Volume Alarm: Direct measurement of saline loss volume.
      • Pressure Resistance: Direct measurement of pressure and physical observation of rupture/integrity.
      • Balloon Catheter Compliance: Direct measurement of priming volume and balloon diameter.
      • Biocompatibility: Existing biocompatibility data and prior regulatory clearances for similar materials.

    7. The sample size for the training set: Not applicable. This is a medical device, not a machine learning algorithm.

    8. How the ground truth for the training set was established: Not applicable.

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