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K Number
K100799
Device Name
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
Manufacturer
CONTRACT MEDICAL INTL. GMBH
Date Cleared
2011-02-25

(340 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
K073035,K091329
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures.

Device Description

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and Luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The Fortress Introducer Sheath System consists of the following components: - One: introducer sheath - Two: dilators

AI/ML Overview

The provided text is a 510(k) summary for the Fortress Introducer Sheath System. It focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a study proving its performance against such criteria in the way described in the request. The document describes the device, its intended use, and its technological characteristics but lacks information related to clinical performance studies, ground truth establishment, or expert evaluation for decision-making regarding device efficacy.

Therefore, for each requested point:

  1. A table of acceptance criteria and the reported device performance

    • Not provided. The document does not list specific performance acceptance criteria or report performance against them. It relies on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics.

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

    • Not provided. No information about a specific test set, its sample size, or data provenance is mentioned as this is not a clinical study report.

  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 applicable/Not provided. Since no specific test set requiring ground truth establishment is described, this information is not present.

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

    • Not applicable/Not provided. There is no mention of an adjudication process for a test set.

  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 applicable/Not provided. This device is an introducer sheath system, a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.

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

    • Not applicable/Not provided. As stated above, this is a physical medical device, not an algorithm.

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

    • Not applicable/Not provided. No clinical ground truth is established or discussed in this document. The "ground truth" for this 510(k) submission is the pre-existing safety and effectiveness profile of the predicate devices.

  8. The sample size for the training set

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

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

    • Not applicable/Not provided. As there is no training set, this information is not relevant or present.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).