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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.

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.

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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

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.

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