LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190878
    Device Name
    Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
    Manufacturer
    Salter Labs, Inc.
    Date Cleared
    2020-01-10

    (281 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K100546
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K100546

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

    The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.

    Device Description

    The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane) and The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. They are made primarily of polyvinylchloride with either a polyurethane (PU) or PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the Salter Labs Trach-Vac Endotracheal Tube. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/ML device.

    Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

    However, I can extract information related to the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence for a non-AI/ML medical device.

    1. Table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics and thresholds. Instead, it demonstrates performance by showing compliance with recognized standards and similarity to a predicate device. The "reported device performance" is essentially the device meeting these standards and exhibiting similar characteristics to the predicate.

    Acceptance Criterion (Implicit)Reported Device Performance
    Biocompatibility: Meet ISO 10993-1 for prolonged mucosal contact.Passed ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation / Intracutaneous Reactivity and Skin Sensitization), and ISO 10993-18 (Chemical Characterization with Toxicological Risk Assessment). Material contacts classified as "Externally Communicating / Tissue and Surface Contact / Mucosal" with "Prolonged Duration of Use (> 24 hr, < 30 days)."
    Physical and Mechanical Properties: Comply with relevant ISO standards.Bench testing performed and passed for: - ISO 5361-1 (ET Tubes)- ISO 803369-7 (Luer fitting)- ISO 5356-1 (Conical Connectors = 15/22 mm)
    Aging Performance:Age testing performed (results not detailed, but implied as satisfactory for release).
    Overall Equivalence to Predicate Device (K110269): Intended Use, Patient Population, Environment of Use, Technology and Principle of Operation.- Intended Use: Similar for airway management, mechanical ventilation, anesthesia, and subglottic secretion removal.- Patient Population: Both for adult patients requiring airway management and potential subglottic suctioning.- Environment of Use: Both for clinical settings (hospital, ICU, ER, OR, field).- Technology and Principle Operation: Both are cuffed tubes with a suctioning lumen; utilize same mechanisms for cuff inflation and subglottic evacuation; sterile and single-use; same sizes (6.0-9.0 mm ID), Magill curve, 2 Murphy eyes, 15mm conical connector, and 6% Male Luer connector suction port. - Shelf life: 5 years.
    Feature: Flexible Tip Design: Performance similar to reference device K100546.The proposed device includes a flexible tip, similar to the Parker Flex Tip cleared under reference device K100546.

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

    This information is not applicable as this document is not for an AI/ML device and does not involve test sets of patient data. The "test set" here refers to the physical devices undergoing bench and biocompatibility testing. The exact number of devices tested for each bench test is not specified in this summary but is typically part of the detailed test reports. The provenance of the data is from the manufacturer's own internal testing.

    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)

    This information is not applicable. This document does not describe a study involving expert-established ground truths for patient data. Ground truth in this context would be established by laboratory testing methods and compliance with engineering standards by qualified technical personnel.

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

    This information is not applicable. No adjudication method for expert review of data is mentioned, as it's not relevant for this type of device submission.

    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

    This information is not applicable. An MRMC study is relevant for AI/ML devices involving human interpretation of outputs. This device is an endotracheal tube and does not involve "readers" or "AI assistance."

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

    This information is not applicable. This device has no algorithm component.

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

    This information is not applicable in the context of medical imaging or clinical data. "Ground truth" for this device is established by:

    • Adherence to international standards (e.g., ISO for biocompatibility, ET tubes, Luer fittings, conical connectors).
    • Physical and mechanical property measurements.
    • Chemical characterization.
    • Visual inspection and functional testing.

    8. The sample size for the training set

    This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

    This information is not applicable. There is no "training set" or corresponding ground truth establishment process for this device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1