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510(k) Data Aggregation

    K Number
    K211802
    Device Name
    GoBack Crossing Catheter
    Manufacturer
    Upstream Peripheral Technologies, Ltd
    Date Cleared
    2022-03-01

    (264 days)

    Product Code
    PDU
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K001577,K150836,K151880,K182937
    Why did this record match?
    Reference Devices :

    K001577, K150836, K151880

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

    The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

    Device Description

    The Upstream GoBack Crossing Catheter is a sterile, single-use, single lumen crossing catheter. The Upstream GoBack Crossing Catheter is intended for use with 0.014" coated or noncoated guidewires. The effective length of the GoBack Crossing Catheter is 80 cm or 120 cm with an outer diameter of either 0.96 mm (2.9 Fr) or 1.4 mm. (4.0 Fr). The GoBack Crossing Catheter is made from three lavers; a reinforced polyimide shaft with stainless steel distal tip (in the 2.9 Fr device) or stainless steel and Nylon 12 distal tip (in the 4.0 Fr device), nitinol hypotube, and PTFE polymer sleeve over the nitinol hypotube inside the shaft. The nitinol hypotube has a pre-shaped curved lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube / needle can move at limited displacement inside the shaft by moving a sliding knob in the catheter handle. The nitinol tube (with the PTFE sleeve) and the polyimide shaft may rotate together using a rotation knob on the catheter handle.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called the "Upstream GoBack Crossing Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.

    Therefore, the information required to answer the prompt (acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic algorithms) is not present in the provided text.

    The text details the following regarding performance testing and a clinical study, but these are geared towards demonstrating equivalence, not proving a device meets a pre-defined acceptance criterion for an AI/diagnostic system:

    Performance Testing Summary (Non-Clinical):

    • Biocompatibility Testing: Performed per ISO 10993-1:2018 and FDA guidance, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), hemocompatibility (hemolysis, complement activation and thromboresistance), LAL, and Material Mediated pyrogenicity.
    • Device Dimensional and Functional Testing:
      • Performed on sterile 2.9 Fr and 4 Fr models: Particulates, Torque (at break and transfer), Force at break, Delivery, Radio-opacity, Surface, Needle tip protrusion, Catheter dimensions.
      • Performed on a sterile 2.9 Fr model: Air leakage, Liquid leakage, Force at break, Radio-opaque, RO marker movement, Bend to kink, Needle penetration, Transfer torsional forces.
    • Other Performance Testing:
      • Demonstrated no coating abrasion or peeling when polymer-coated guidewires were passed through the catheter.
      • Established a 2-year shelf life.

    Clinical Testing Summary:

    • Study Design: Retrospective data.
    • Sample Size: 151 patients.
    • Data Provenance: Not specified (e.g., country of origin).
    • Purpose: Demonstrated that the GoBack Crossing Catheter performed equivalently to the predicate in subintimal re-entry procedures. It also validated that the device can be used for both intraluminal lesion crossing and subintimal re-entry.
    • Reported Performance:
      • Intraluminal crossing (62 subjects): Technical success rate of 88.7%.
      • Subintimal re-entry crossing (89 subjects): Technical success rate of 88.8%.
      • Major Adverse Event (MAE) rate across all procedures: 0%.
    • Ground Truth: Implied clinical outcomes/procedural success, but not explicitly defined with expert consensus, pathology, or adjudication.
    • Experts/Adjudication: Not mentioned.
    • MRMC Study: Not applicable/not performed for this type of device submission.
    • Standalone Performance: Not applicable/not performed.
    • Training Set: Not applicable, as this is a medical device, not an algorithm requiring a training set.

    In summary, the provided document does not contain the information required to populate the fields of the request, as it pertains to a traditional medical device (catheter) rather than an AI/diagnostic algorithm.

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