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510(k) Data Aggregation

    K Number
    K210328
    Device Name
    SafeSept Blunt Needle
    Manufacturer
    Pressure Products Medical Device Manufacturing LLC
    Date Cleared
    2021-03-05

    (29 days)

    Product Code
    DRC
    Regulation Number
    870.1390
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K172934
    Why did this record match?
    Device Name :

    SafeSept Blunt Needle

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

    The SafeSept Blunt Needle is used in conjunction with a transseptal guidewire to puncture the interatinal septum during a transseptal catheterization procedure to gain left heart access. The SafeSept Blunt Needle is intended for single use only.

    Device Description

    The Transseptal Extended Cannula is a stainless-steel device that comes in three lengths, 71cm, 89cm and 98cm. The body of the Transseptal Extended Cannula is equivalent to the transseptal cannula length, 69.7cm for the 71cm extended cannula, 87.7cm for the 89cm extended cannula, and 96.7cm for the 98cm extended cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0195" at the distal end, terminating with a radiused tip. The components of the Transseptal Extended Cannula include the transseptal extended cannula, sterile packaging and labeling. There are six model numbers for the cannula: SBN071, SBN089, SBN098, SBN171, SBN189, and SBN198. The Transseptal Extended Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Extended Cannula is used in a healthcare facility/hospital.

    AI/ML Overview

    The provided text does not describe an AI/ML medical device and therefore does not contain information about acceptance criteria or studies that involved AI/ML performance.

    The document is a 510(k) premarket notification for a medical device called the "SafeSept Blunt Needle" (also referred to as "Transseptal Extended Cannula"). It outlines the device's indications for use, technological characteristics, comparison to a predicate device, and performance testing data.

    The performance testing listed includes:

    • Visual and dimensional inspection
    • Particulate testing (USP, Light Obscuration Method)
    • Mating Joint Pull test (Handle to Hub)
    • Mating Joint Pull test (Cannula to Extension)
    • Strength of Union Cannula Hub and Cannula
    • Guidewire Restriction Inspection
    • Radius Tip Inspection
    • Hub Female Luer Taper
    • Water Leak Testing
    • Air Leak Testing
    • Packaging Testing
    • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility including Hemolysis and Complement Activation)

    These tests are standard for physical medical devices to ensure their safety and effectiveness in their intended use, but they do not relate to the performance of an AI/ML algorithm.

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