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510(k) Data Aggregation

    K Number
    K990509
    Device Name
    OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
    Manufacturer
    IMPLEMED, INC.
    Date Cleared
    1999-05-18

    (89 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Abbreviated
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K933400
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OLIGON™ FOLEY CATHETER is used to pass fluids to or from the urinary tract.

    Device Description

    The OLIGON™ FOLEY CATHETER is an all silicone, dual lumen Folcy catheter (manufactured for Implemed, Inc. by Kendall I Icalthcare Products Company) which has been coated with Implemed's proprietary OLIGON'IM matcrial. The OLIGON™ coating is a patented silver based coating which has been shown in laboratory testing to actively release silver ions when exposed to saline. Under these test conditions, the 16 Fr catheters (91 cnt surface area) released a total of 3,4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface arca) would release a total of 3.6 milligrams of silver over 28 days.

    The OLIGON™ FOLEY CATHETER is supplied in two sizes; 16 Fr. and 18 Fr. (outer diameler). OLIGON™ Folcy catheters are supplied storile for single use. Individual catheters are packaged in sterilizable Tyvek/mylar pouches.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of information rather than making assumptions:

    Acceptance Criteria and Device Performance

    This document describes a medical device (a Foley catheter) that is being put forward for substantial equivalence to a predicate device. The primary "performance" being evaluated is its equivalence to an existing device and its compliance with relevant standards.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance/Compliance
    Intended UseThe device is intended to pass fluids to or from the urinary tract.The OLIGON™ FOLEY CATHETER has the same intended use as the predicate device: to pass fluids to or from the urinary tract.
    Technological CharacteristicsSubstantial equivalence to the predicate device, especially regarding functional aspects for passing fluids to and from the urinary tract.The technological characteristics of the OLIGON™ FOLEY CATHETER are substantially equivalent to those of the predicate device. Functionally, they are identical with respect to intended use.
    Performance Standard (Foley Catheter)Conformance to ASTM Standard F 623-89, "Standard Performance Specification for Foley Catheter."Both the subject device and the predicate device conform to the requirements of the ASTM Standard F 623-89.
    BiocompatibilityEvaluation and successful meeting of biocompatibility requirements contained within applicable parts of ANSI/AAMI/ISO Standard 10993: Biological Evaluation of Medical Devices.The OLIGON™ FOLEY CATHETER has been evaluated according to the applicable Parts of the ANSI/AAMI/ISO Standard 10993 and has successfully met the biocompatibility requirements.
    SterilizationSupply as sterile via EtO sterilization processes conforming to ANSI/AAMI/ISO Standard 11135, "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization."Both the subject device and the predicate device are supplied sterile via EtO sterilization processes conforming to the ANSI/AAMI/ISO Standard 11135.
    Silver Ion Release (Specific to OLIGON™)Active release of silver ions when exposed to saline. (Specific quantitative criteria from the document: 16 Fr catheters release a total of 3.4 mg of silver over 28 days; 18 Fr catheters release 3.6 mg of silver over 28 days. Release rate ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction).Laboratory testing showed the OLIGON™ coating actively releases silver ions when exposed to saline: 16 Fr catheters released 3.4 mg over 28 days; 18 Fr catheters released 3.6 mg over 28 days. The coating has been shown to release silver ions at a rate of ≥ 5.0 x 10-5 mg/cm2 · hour on first extraction. The predicate device does not have such a coating.

    Study Details:

    Based on the provided text, this submission is for a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than an extensive clinical trial or AI performance study typically associated with device performance claims like sensitivity, specificity, etc. The "study" referenced is primarily a series of bench tests and laboratory evaluations confirming physical, chemical, and biological properties, and conformance to standards.

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

      • Test Set Sample Size: The document mentions "16 Fr catheters (91 cm2 surface area)" and "18 Fr catheters (96 cm2 surface area)" for silver ion release testing. It does not specify the number of individual catheters tested for this or any other criteria (e.g., biocompatibility, ASTM standard conformance).
      • Data Provenance: The data is from "laboratory testing" and refers to "Implemed's proprietary OLIGON™ material." This is likely internal company testing, not specified as retrospective or prospective, nor does it specify country of origin beyond the company's US address.

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

      • Not applicable. The "ground truth" here is compliance with established engineering and biocompatibility standards, and measurable physical/chemical properties (like silver release), not clinical diagnoses or interpretations by human experts.

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

      • Not applicable. This type of adjudication method is used for clinical studies involving human interpretation or diagnosis, which is not described here.

    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 is a medical device (catheter) submission, not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is mentioned or relevant in this context.

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

      • No. This is a medical device (catheter) submission, not an AI/software device.

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

      • For the silver release data: Laboratory measurements and quantitative chemical analysis.
      • For standard conformance: Engineering and design specifications and test results demonstrating compliance with recognized standards (ASTM, ISO/AAMI).
      • For biocompatibility: Laboratory assays and tests confirming the absence of adverse biological reactions as per ISO/AAMI 10993.

    7. The sample size for the training set:

      • Not applicable. This is not an AI/machine learning device submission, so there is no concept of a "training set."

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

      • Not applicable, as there is no training set.
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