(74 days)
The PTFE 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 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.
The Greatbatch Medical PTFE Peelable Introducer underwent performance testing to establish substantial equivalence to a predicate device (K093023).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical or percentage terms in the provided document. Instead, the document indicates that the device must "Pass" a series of functional and dimensional tests to verify that it "continues to function in a safe and effective manner" and "performs per specification requirements." The reported device performance for all tested parameters was "Pass."
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sheath Compatibility with Dilator | Conforms to specifications | Pass |
| Initial Handle Break Force, Sheath | Conforms to specifications | Pass |
| Peel Force | Conforms to specifications | Pass |
| Peelability | Conforms to specifications | Pass |
| Sheath/Tube Handle Integrity | Conforms to specifications | Pass |
| Dilator Hub/Tube Tensile Force | Conforms to specifications | Pass |
| Handle ID (min) | Conforms to specifications | Pass |
| Dilator Hub ID | Conforms to specifications | Pass |
| Tip ID | Conforms to specifications | Pass |
| Flat on Tip | Conforms to specifications | Pass |
| Tip Angle | Conforms to specifications | Pass |
| Length | Conforms to specifications | Pass |
2. Sample Size and Data Provenance
The document does not specify the exact sample size used for each test. It mentions that "Testing for this device was performed," but provides no details on the number of units tested. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This is a medical device (introducer) and the study involved performance testing against engineering specifications, not clinical assessment or interpretation. Therefore, no experts were used to establish ground truth in the context of clinical accuracy or interpretation.
4. Adjudication Method
Not applicable. As noted above, this study involved performance testing against engineering specifications, not expert review of clinical cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is not an AI-assisted diagnostic tool, but rather a physical medical introducer. The study focused on its functional and dimensional characteristics.
6. Standalone Performance (Algorithm Only)
No, standalone performance was not assessed in the context of an algorithm. This device is a physical medical device. The tests performed are described as "functional and dimensional testing" to ensure the device performs "per specification requirements."
7. Type of Ground Truth Used
The ground truth used was engineering specifications and established performance requirements for medical introducers, based on the predicate device. The tests were designed to verify that the device meets these pre-defined standards for functionality and dimensions.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device and does not involve a training set as would be used for an AI/ML algorithm. The performance testing was to demonstrate substantial equivalence to a predicate device, not to train a model.
9. How Ground Truth for the Training Set was Established
Not applicable, as there was no training set. The "ground truth" equivalent for the testing was the established performance standards and specifications derived from the predicate device and general medical device requirements, which were used to evaluate the manufactured PTFE Peelable Introducer.
§ 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).