(152 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Passed |
| Strength | Passed |
| Functional | Passed |
| Packaging | Passed |
| Sterilization | Passed |
| Biocompatibility | Passed |
| Shelf life | Passed |
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.
§ 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).