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

The Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, available in non-sideport and sideport configurations, is a small diameter tubular shaped device with integrated proximal handles. Both configurations of the OptiSeal Valved PTFE Peelable Introducer are designed to provide a relatively atraumatic method for insertion of catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. Both introducer configurations peel away after use allowing the user to remove the introducer without removing the inserted catheter or pacing lead. The sideport configuration of the OptiSeal Valved Peelable Introducer is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The OptiSeal Valved PTFE Peelable Introducer is packaged in sterile convenience kits containing a Valved PTFE Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The convenience kits are packaged five (5) per box.

The provided text describes a 510(k) summary for the Greatbatch Medical OptiSeal™ Valved PTFE Peelable Introducer. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI device.

Therefore, many of the requested sections related to AI device performance, sample sizes for test/training sets, expert ground truth adjudication, and MRMC studies are not applicable to this submission.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the verification specifications for the physical product. The document states that the device passed all these criteria, implying successful performance. Specific quantitative criteria and results are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a medical introducer, not an AI/software device that uses data for testing. The "test set" here refers to physical product units tested against design specifications. The sample sizes for these engineering tests are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert review, is typically relevant for interpretative devices (e.g., imaging AI). For this physical medical device, "ground truth" refers to engineering specifications met through laboratory testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are for resolving discrepancies in expert interpretations, which is not relevant for the engineering tests performed on this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. These studies are typically performed for devices (often AI-powered) that assist human readers in tasks like image interpretation. This device is a physical introducer for catheters and leads. The summary explicitly states: "Given the limited scope of the modifications incorporated to create the OptiSeal Valved PTFE Peelable Introducer and identical intended use, no animal or clinical data was deemed necessary."

6. 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.

7. The Type of Ground Truth Used

For this device, the "ground truth" would be established by the engineering specifications and design requirements for each of the test categories (dimensional, strength, functional, etc.). The device's performance was compared against these pre-defined, objective criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used for this physical medical device.

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

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.

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

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.

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