(63 days)
The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The Enpath ViaSeal Valved Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The ViaSeal Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. The ViaSeal Valved Peelable Introducer has a "peel-away" feature common to the predicate device. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.
The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch.
Introducer sizes of the sheath and dilator range from 7 French to 10.5 French. The materials and construction are the same for all French sizes. Enpath ViaSeal Valved Peelable Introducer kits will be packaged and ETO sterilized for one time use and sealed in a Tyvek/LDPE pouch.
The provided text is a 510(k) summary for the Enpath Medical ViaSeal Valved Peelable Introducer. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the manner typically seen for novel therapeutic devices or diagnostic AI systems.
Therefore, many of the specific questions about acceptance criteria, detailed study design, and AI model performance metrics cannot be directly answered from this document.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of specific acceptance criteria with quantifiable metrics such as sensitivity, specificity, accuracy, or a detailed breakdown of device performance against these. Instead, it makes a general statement about performance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | Performs per specification requirements and is equivalent to the predicate device. |
| Safety | Does not create additional risk to the patient or user. |
| Hemostasis | Performs hemostasis to venous pressures. |
| Dimensional | Tested for dimensional specifications. |
| Regulatory | Substantially equivalent to predicate devices (FlowGuard Valved Peelable Introducer, K040150, and Thomas Medical Products Inc. SafeSheath MSP Introducer Kit, K003731). |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not mentioned. The study was primarily non-clinical "performance testing."
- Data provenance: Not applicable/Not mentioned for clinical data. The performance testing would have been conducted internally by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a study requiring expert-established ground truth for diagnostic or interpretative tasks. It was performance testing of a medical device.
4. Adjudication method for the test set
Not applicable. This was not a study requiring adjudication of expert interpretations.
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. This is a non-AI medical device (a catheter introducer). No MRMC study was conducted, and no AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic performance. For a medical device like this, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., ability to peel, maintain hemostasis, dimensions). These would be established through engineering and quality control standards.
8. The sample size for the training set
Not applicable. This is a non-AI medical device; no training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" refers to a series of non-clinical performance tests conducted by Enpath Medical Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.
- Study Title: "Summary of Studies" (as per the 510(k) document)
- Study Type: Non-clinical (in vitro/bench testing)
- Objective: To verify that the device functions in a safe and effective manner and performs per specification requirements, equivalent to predicate devices, without creating additional risk.
- Tests Performed:
- Device specifications verification
- Dimensional testing
- Functional testing
- Hemostasis testing to venous pressures
- Results: "Test 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."
- Key Finding for Approval: The device was deemed "substantially equivalent" to the Enpath Medical FlowGuard Valved Peelable Introducer (K040150) and the Thomas Medical Products Inc. SafeSheath MSP Introducer Kit (K003731) based on these non-clinical tests.
- Clinical Evaluations: Explicitly stated: "No clinical evaluations for this submission have been conducted."
§ 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).