(68 days)
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.
The Fortress Introducer Sheath System is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.
The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath (5F and 6F sizes) has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.
The System consists of the following components:
- A One Introducer Sheath with hemostasis valve
- A Two dilators: 5F and 6F 100cm version
- A One dilator: 5F and 6F 45cm version
This document is a 510(k) Premarket Notification from the FDA regarding the Fortress Introducer Sheath System. It details the device's indications for use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly stated as "Passed," indicating that the device met the pre-defined requirements for each test. The actual numerical or descriptive criteria for "passing" are not explicitly listed in this summary, but the "Test Result" column confirms that all tests were successfully completed according to their respective acceptance criteria.
| Test Name | Test Method | Reported Device Performance (Acceptance Criteria) |
|---|---|---|
| Balloon Pull Back Test (Robustness Test) | Visual Inspection | |
| Dimensional Inspection | ||
| Insertion Force Test | ||
| Pull Back Force Test | ||
| Destructive Pull Test | Passed | |
| Accelerated Aging | Visual Inspection | |
| Coating Integrity | ||
| Sheath Liquid Leakage - (Pressure Test) | ||
| Sheath System Insertion Force | ||
| Sheath Pull Out Test | ||
| Sheath Kink Resistance | ||
| Sheath Creep To Break | ||
| Sheath Force At Break | ||
| Dilator Force At Break | Passed | |
| Valve Leak Test | Pressure Test | Passed |
| Particulates Evaluation Test | Membrane Filtration | Passed |
| Biological Risk Assessment | Qualitative Evaluation | Passed |
| Cytotoxicity | Quantitative Evaluation | Passed |
| Pig Skin Test | Insertion Force Test | Passed |
| Visibility under X-ray | X-Ray Test | Passed |
| Packaging Integrity Validation | Visual Inspection | |
| Dye Penetration Test | ||
| Peel Test | ||
| Balloon Pull Back Test | ||
| Kink Test | ||
| Creep Test | ||
| Pull Test | Passed | |
| Sterilization Validation | LAL - Pyrogenicity Testing | |
| Bioburden | ||
| Bioburden Recovery Factor Determination | ||
| EO/ECH Residuals | Passed | |
| LAL Validation | Gel Clot Method | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the tests. The tests performed are primarily performance and safety tests on the device itself (e.g., mechanical testing, material compatibility, sterilization), not clinical studies with human subjects. Therefore, typical data provenance details like "country of origin" or "retrospective/prospective" are not applicable in the way they would be for a clinical trial. The testing appears to be laboratory-based verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The tests performed are laboratory-based engineering and biological compatibility tests, not evaluations requiring expert consensus on clinical imagery or patient data. The "ground truth" for these tests would be established by the industry standards and methodologies followed (e.g., ISO standards, ASTM standards, FDA guidance documents) by qualified laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements and evaluations against pre-defined engineering and safety specifications, not subjective assessments requiring adjudication among multiple observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing. The device is an introducer sheath system, which is a physical medical device, not an AI software or imaging diagnostic tool that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Fortress Introducer Sheath System is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established engineering principles, material science, biological compatibility standards, and regulatory guidance documents. For instance:
- Mechanical tests: "Ground truth" is defined by the device's design specifications and performance limits (e.g., strength, kink resistance, insertion force) derived from engineering analysis and comparison to predicate devices, verified through physical measurements.
- Biological tests (Cytotoxicity, LAL, Sterilization): "Ground truth" is defined by accepted biological safety standards and validated testing protocols to ensure the device is non-toxic, non-pyrogenic, and sterile.
- Visibility under X-ray: "Ground truth" is the device's observable radiopacity under X-ray imaging.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 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).