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510(k) Data Aggregation

    K Number
    K123196
    Device Name
    PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
    Manufacturer
    COVIDIEN
    Date Cleared
    2013-01-31

    (112 days)

    Product Code
    MSD,NYU
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K111372,K112477
    Predicate For
    K140884
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Palindrome™ Precision Symmetric Tip Dual Lumen Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement.

    The Palindrome™ Precision RT Reverse-Tunneled Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.

    The Palindrome™ Precision H Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

    The Palindrome™ Precision SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

    The Palindrome™ Precision HSI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

    Device Description

    The Palindrome™ Precision Symmetric Tip Dual Lumen Catheter has a radiopaque shaft with two large D-shaped inner lumens designed in opposing configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter hub which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

    The Palindrome™ Precision RT Reverse-Tunneled Catheter will be supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vein first before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde fashion. The fully assembled Palindrome™ Precision RT Reverse-Tunneled Catheter has a 15.0 Fr. radiopaque shaft with two large D-shaped inner lumens designed in an opposing configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

    The Palindrome™ Precision H Chronic Catheter with Heparin coating has a radiopaque polyurethane shaft with two D-shaped inner lumens designed in opposing configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface from the tip of the catheter to the cuff on the external surface and throughout the entire length on the internal surface (tip to luer adapters). The heparin coating serves to reduce platelet adhesion.

    The Palindrome™ Precision SI Chronic Catheter with Silver Impregnated sleeve has a radiopaque polyurethane shaft with two D-shaped inner lumens designed in opposing configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

    The Palindrome™ Precision HSI Chronic Catheter with Heparin coating and Silver Impregnated sleeve has a radiopaque polyurethane shaft with two large D-shaped inner lumens designed in opposing configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface from the tip of the catheter to the cuff on the external surface and throughout the entire length on the internal surface (tip to luer adapters). The heparin coating serves to reduce platelet adhesion. The catheter also contains a silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

    AI/ML Overview

    The provided text describes several dialysis catheters (Palindrome™ Precision Symmetric Tip Dual Lumen Catheter, Palindrome™ Precision RT Reverse-Tunneled Catheter, Palindrome™ Precision H Chronic Catheter, Palindrome™ Precision SI Chronic Catheter, Palindrome™ Precision HSI Chronic Catheter) and their performance data. However, the information presented is from a 510(k) summary for medical device clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than proving device efficacy through clinical trials. As such, many of the typical acceptance criteria and study details requested for an AI/ML or diagnostic device are not applicable or not provided in this document.

    Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in the format of specific thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) that an AI/ML or diagnostic device would typically have. Instead, it refers to "relevant acceptance criteria" in the context of engineering and material performance tests.

    Acceptance Criteria CategoryReported Device Performance (or testing conducted)
    Material/Mechanical PerformanceThe "Risk Analysis activities identified the need to conduct additional testing to confirm that the modified chronic catheters continued to meet the relevant acceptance criteria." Testing included: Dynamic flowStatic flowCatheter insertion forceThrombogenicityRecirculationMarker band integrityLong term soakMechanical hemolysisLeachabilityTensileHeparin activityHeparin concentrationHeparin durability Results Report: "The results of the performance testing show that the modified devices continue to meet the relevant product specifications."
    Coating Performance (Heparin)For Palindrome™ Precision H and HSI Chronic Catheters: "The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing."
    Coating Performance (Silver)For Palindrome™ Precision SI and HSI Chronic Catheters: "The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing."
    Substantial Equivalence"Based on non-clinical testing results, Covidien has demonstrated that the modified catheters are substantially equivalent to their respective existing catheters." (This is the primary "acceptance criterion" for 510(k) clearance).

    Detailed Study Information (where applicable or derivable from the text):

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

      • The document mentions "bench and animal testing" for the coating performance and various "performance testing" for material and mechanical characteristics. However, specific sample sizes (number of units tested, number of animals) for these tests are not provided.
      • Data Provenance: Not explicitly stated, but "bench and animal testing" implies laboratory and pre-clinical data, likely from an internal testing facility or contract research organization. There is no mention of human clinical data or geographical origin of data. The testing is retrospective in the sense that it's performed on manufactured devices to support a premarket notification.

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

      • This question is not applicable as the document describes physical medical devices (catheters) and their engineering/material performance, not a diagnostic or AI/ML device that requires expert-established ground truth. The "ground truth" here would be the physical measurement results of the various performance tests.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • This is not applicable for the type of device and testing described. Adjudication methods are typically for human interpretation of data in diagnostic studies.

    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:

      • This is not applicable. This document describes an implanted medical device, not a diagnostic imaging or AI-assisted interpretation tool. No human readers or AI assistance are involved in the performance evaluation described.

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

      • This is not applicable as the device is a physical medical catheter, not an algorithm.

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

      • The "ground truth" for the device's performance is derived from objective physical and chemical measurement results from the various performance tests (e.g., flow rates, tensile strength, heparin concentration, platelet adhesion, microbial colonization inhibition). For the coating performance, it refers to "bench and animal testing" outcomes as proof of performance.

    7. The sample size for the training set:

      • This is not applicable. The Palindrome™ Precision catheters are physical devices, not an AI/ML algorithm that requires a training set.

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

      • This is not applicable as there is no training set for a physical medical catheter.
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