(16 days)
The MedAmicus FlowGuard™ Peelable Introducer indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The MedAnicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard™ Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "teat-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard™ Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard 100 Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peelable Introducers.
This document describes the MedAmicus FlowGuard™ Peelable Introducer, a medical device used for the percutaneous insertion of pacing leads or catheters into the venous system. The submission is a 510(k) premarket notification for a modified packaging configuration of an already approved device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety & Effectiveness not affected by new packaging configurations | A packaging validation will be completed to ensure this. This validation is summarized in Section X of the submission and is based on a Risk Analysis per EN1441:1998. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical performance evaluation for the device itself. The primary study mentioned is a "packaging validation."
- Sample Size: Not explicitly stated for the packaging validation.
- Data Provenance: The study is described as an internal packaging validation based on a risk analysis. No country of origin for data is mentioned, nor is it specified if it's retrospective or prospective, though a validation is typically prospective for new configurations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study described is a packaging validation and risk analysis, not a clinical study involving experts establishing ground truth for device performance in patients.
4. Adjudication Method for the Test Set
Not applicable, as there is no clinical test set requiring adjudication mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. The document focuses on a packaging change and its validation, not a multi-reader evaluation of clinical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical introducer, not an algorithm or AI system.
7. Type of Ground Truth Used
For the packaging validation, the "ground truth" would be the established safety and effectiveness parameters of the original device, against which the new packaging's impact is assessed through risk analysis and testing (e.g., sterility, package integrity, material compatibility).
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
Summary of the Study Discussed:
The primary "study" mentioned is a packaging validation. The purpose of this validation is to ensure that changing the device's packaging configurations (individually pouched and bulk non-sterile, in addition to the original convenience kit) does not negatively affect the safety and effectiveness of the MedAmicus FlowGuard™ Peelable Introducer.
- Methodology: The validation will be completed based on a Risk Analysis, following internal procedures compliant with European Standard EN1441:1998 Medical Devices - Risk Analysis. This risk analysis involved comparing the risks associated with the new packaging configurations against the currently approved convenience kit packaging.
- Outcome: The document states that the packaging validation will be completed and summarized in Section X of the submission, confirming that "no effect on the safety and effectiveness of the device" is expected.
The FDA's letter (K030905) indicates that the device was found to be substantially equivalent to legally marketed predicate devices. This determination was based on the information provided, including the intention to complete the packaging validation as described.
§ 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).