(26 days)
The MedAmicus FlowGuard Peelable Introducer in indicated for indications i or ooc. This modifines pacing leads or catheters in the venous system.
The McdAmicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard 100 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 "tear-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 FlowGuard11M 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™ Peclable Introducers.
This document describes a 510(k) premarket notification for the MedAmicus FlowGuard™ Peelable Introducer (K040150). This submission is for a material revision to the sheath handle of an already approved device (K030905). Due to the nature of this submission being for a minor change to an existing device, the studies conducted are primarily focused on verifying that the material change does not negatively impact the device's performance or safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions "Design Verification of the device has been completed to verify the changes to the device." This implies various internal tests were conducted against pre-defined acceptance criteria. However, the specific quantitative acceptance criteria and the detailed results of these tests are not provided in the given text.
The text states: "Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity." This indicates an acceptance criterion related to handle integrity over time, but the specific metrics are not given.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistent handle integrity over shelf life | "Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity." |
| No adverse impact from new material on device functionality | "Design Verification of the device has been completed to verify the changes to the device." |
| (Specific performance metrics derived from a Risk Analysis per EN1441:1998) | (Details not provided in the text) |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the sample sizes used for the design verification or shelf-life testing. The data provenance is internal to MedAmicus, and the nature of the studies (design verification, shelf-life testing) suggests a prospective approach to test the modified device. There is no mention of country of origin for the data beyond the manufacturer's location in Minneapolis, MN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are engineering design verification and shelf-life tests, not clinical or diagnostic studies requiring expert-established ground truth. Device performance in these contexts is typically evaluated against engineering specifications and material properties, not subjective expert assessment.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices to assess the impact of AI on human reader performance, which is not relevant for a catheter introducer with a material change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the design verification and shelf-life testing would be engineering specifications, material properties, and established performance benchmarks for the predicate device. These are objectively measurable criteria, not expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm requiring training data. The studies performed are for a physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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).