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510(k) Data Aggregation

    K Number
    K983010
    Device Name
    SELF CATH SET/SAFETY CATH
    Manufacturer
    RUSCH INTL.
    Date Cleared
    1999-02-12

    (168 days)

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

    The Self Cath is a flexible tubular device to pass fluids to or from the urinary tract. The set is intended to allow for the catheterization of the individual.

    Device Description

    The catheter consists of a funnel, a clear tube and a soft, Tiemann tip. The tube has two (2) drainage eyes at the distal end that are opposite and offset. The funnel, at the proximal end, is sized to connect to the drainage baq provided in the kit. For the 'HomeSet', the catheter is packed in an inner plastic bag and a Paper-Film outer pouch. For the 'Travelset', the catheter is packed in the inner plastic bag and is in the sterile paper-film kit tray with the other contents. The kit comes in two configurations. One is a 'HomeSet' and the other is a 'Travelset'. Each set comes in men's and woman's configurations which differs by the length of the catheter. The 'HomeSet' consists of: (1) 1.5 l drainage catch bag with closure cap, (3) Dab cloths, (3) compression gauze, (1) Tweezers, (1) Table cloth (to set kit contents on), (1) disposal Bag, (1) cleaning wipe. The 'Travelset' consists of: (1) Safety Cath, (1) 1.5 l drainage catch bag with closure cap, (2) Dab cloths, (3) compression gauze, (1) Table cloth (to set kit contents on), (1) Chair Cloth (for under the genital area), (1) disposal Baq, (2) Rubber qloves, (1) cleaning wipe. Attached to the back of the kit is a bottle of water soluble antiseptic (approx 15 ml).

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification for a medical device called the "Self Cath Set" and "Safety Cath" (Urology Drainage Catheter). The FDA's letter (Page 2-3) confirms the device's substantial equivalence to legally marketed predicate devices, allowing it to proceed to market. However, a significant portion of the request cannot be fully answered as the document doesn't contain a detailed study report with specific acceptance criteria, performance metrics, sample sizes for training/test sets, or information on expert involvement and ground truth establishment for a medical device AI/ML model. This document is related to a traditional medical device (catheter kit), not an AI/ML diagnostic tool.

    Therefore, for the aspects that would typically be found in an AI/ML study, the answer will state that the information is "Not Available/Applicable" as this is not an AI/ML device submission.

    Here's the information based on the provided document:

    Acceptance Criteria and Device Performance

    Since this is a submission for a traditional medical device (catheter kit) and not an AI/ML diagnostic or predictive device, the "acceptance criteria" and "device performance" are primarily focused on substantial equivalence to a predicate device in terms of design, materials, and intended use, rather than quantifiable performance metrics like sensitivity, specificity, or AUC of an algorithm.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (Summary of Findings)
    Design Equivalence:The Self Cath is described as "equivalent in design, use and materials to the predicate products." It consists of a funnel, clear tube, soft Tiemann tip, and two drainage eyes. It is provided in 'HomeSet' and 'Travelset' configurations, differing by catheter length for men's and women's configurations. The components of each kit are listed (e.g., drainage bag, dab cloths, etc.).
    Material Equivalence:The Self Cath is described as "equivalent in design, use and materials to the predicate products." No specific material details are provided beyond this general statement.
    Intended Use Equivalence:The Self Cath is intended as "a flexible tubular device to pass fluids to or from the urinary tract" and to "allow for the catheterization of the individual," which is consistent with the stated intended use of the predicate device, the Rüsch Catheter for intermittent catheterization.
    Performance (Safety & Effectiveness):The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, implying that its safety and effectiveness are comparable. This assessment is based on the information provided in the 510(k) and comparison to the predicate device.
    Compliance with General Controls:The device is subject to general controls provisions of the Act, including annual registration, device listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration, which manufacturing processes must adhere to.
    Drug Component Assessment:The FDA noted that the kit contains Povidone Iodine or Benzalkonium Chloride (BZK), which are regulated as drugs. The substantial equivalence determination does not apply to the drug component, and the applicant is advised to contact the Center for Drug Evaluation and Research for marketing these drugs.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not Available/Applicable: This is not a study involving a test set of data for an AI/ML model. The submission is for a traditional medical device (catheter kit) and relies on demonstrating substantial equivalence to a predicate device, rather than a clinical study with a test set in the context of AI/ML.

    3. 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 Available/Applicable: This information is not relevant for a traditional medical device 510(k) submission. The FDA's review committee and staff perform the assessment of substantial equivalence.

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

    • Not Available/Applicable: This is not a study involving a test set for an AI/ML model.

    5. 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 Available/Applicable: This is not an AI/ML device, so no MRMC study comparing human readers with and without AI assistance would have been conducted or is relevant.

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

    • Not Available/Applicable: This is not an AI/ML algorithm or device.

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

    • Not Available/Applicable: For this traditional medical device submission, the "ground truth" for substantial equivalence is the existing regulatory status and performance of the legally marketed predicate device, as determined by the FDA. There isn't a "ground truth" in the AI/ML sense of labeled data.

    8. The sample size for the training set

    • Not Available/Applicable: This is not an AI/ML device, so there is no training set.

    9. How the ground truth for the training set was established

    • Not Available/Applicable: This is not an AI/ML device, so there is no training set or ground truth establishment in that context.
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