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K Number
K093023
Device Name
PTFE PEELABLE INTRODUCER
Manufacturer
Greatbatch Medical
Date Cleared
2009-10-29

(30 days)

Product Code
DYB
Regulation Number
870.1340
Type
Special
Panel
CV
Reference & Predicate Devices
K081394
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Device Description

The Greatbatch Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire. The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Greatbatch Medical PTFE Peelable Introducer, as derived from the provided text:

Acceptance Criteria and Device Performance

Acceptance CriteriaReported Device Performance
Device functions in a safe and effective mannerTest results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
Meets device specificationsTest results verify that the device performs per specification requirements.
Functional and dimensional testing of the PTFE Peelable IntroducerTest results verify that the device performs per specification requirements.
Equivalent to the predicate device (Greatbatch Medical PTFE Peelable Introducer K081394)Test results verify that the device is equivalent to the predicate device.
Will perform as intendedThe testing performed confirms that the PTFE Peelable Introducer will perform as intended.

Study Information

  1. Sample size used for the test set and the data provenance:

    • The document does not specify a separate "test set" in the context of clinical or image-based studies.
    • The "Performance Testing" section states, "The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner." This refers to non-clinical, in-vitro testing rather than human or animal studies.
    • Data Provenance: Not applicable as no human or image data was used. The testing described is non-clinical/in-vitro.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. The "ground truth" for this device's performance was established through engineering specifications and non-clinical functional testing rather than expert review of clinical cases.

  3. Adjudication method for the test set:

    • Not applicable. There was no clinical test set requiring adjudication.

  4. 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:

    • No. This is a medical device (introducer), not an AI-powered diagnostic or image analysis system. Therefore, an MRMC study related to AI assistance is not relevant.

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

    • Not applicable. This is a physical medical device, not an algorithm.

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

    • Engineering specifications and functional performance metrics. The ground truth for proving the device's efficacy and safety relies on meeting pre-defined physical and functional requirements established through non-clinical testing.

  7. The sample size for the training set:

    • Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

  8. How the ground truth for the training set was established:

    • Not applicable, as there is no training set.

§ 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).