(176 days)
The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.
The Dr. Amplatz Micro Plug includes the Micro Plug Device which is a self-expanding braided Nitinol vascular occlusion implant that is supplied with components used for implantation.
The Micro Plug Device has been designed with a material, size, configuration and shape that allows introduction through a catheter for the occlusion of blood vessels in the peripheral vasculature. The Micro Plug Devices are provided in four different diameters (3 mm - 6 mm) to treat different sized blood vessels in the peripheral vasculature. The Micro Plug Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Micro Plug Device is packaged collapsed within a Loader and attached to a 180 cm Delivery Wire that is provided within a hoop dispenser.
The delivery system includes a 125 cm Delivery Catheter that is provided within a hoop dispenser for delivery and implantation of the Device; the Delivery Catheter contains a standard luer hub adapter at the proximal end and a single radiopaque marker band at the distal end. The Delivery Catheter is hydrophilic coated. Tuohy Borst Valves are provided for flushing; a Torque Device is provided for releasing the Device.
The Dr. Amplatz Micro Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature by physicians trained in vascular embolization.
The Dr. Amplatz Micro Plug is a vascular embolization device. The provided text outlines the performance data used to establish its substantial equivalence to a predicate device. However, the document does not contain a table of acceptance criteria and reported device performance values, nor does it describe a study involving human readers or a standalone AI algorithm. It focuses on non-clinical testing for equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document. The document lists various performance evaluations conducted (Simulated Use, Tensile Strength, Radial Force, etc.) and states that "Test results demonstrated that all acceptance criteria were met," but it does not specify the numerical acceptance criteria for each test or the actual performance values obtained.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any individual test. The document refers to "evaluations" and "tests" but doesn't quantify the number of devices or samples used for each test (e.g., how many plugs were tested for tensile strength).
- Data Provenance: The studies were non-clinical (bench testing, material testing, and animal study).
- Country of Origin: Not specified.
- Retrospective or Prospective: Not applicable as these are laboratory and animal studies, not human data collection in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The "ground truth" for these tests would be established by the testing methodology and instruments, with interpretation by qualified engineers/scientists, rather than a panel of clinical experts determining "ground truth" on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. This concept typically relates to human-reviewed data where disagreements need resolution. For bench and animal testing, results are typically objective and follow pre-defined protocols and acceptance limits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no MRMC study, human reader comparison, or AI assistance evaluation was performed or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This device is a physical medical implant, not a software algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is derived from:
- Established Test Standards/Protocols: Performance against industry standards (e.g., for tensile strength, fatigue, corrosion, MRI compatibility).
- Predicate Device Characteristics: Comparison against the known characteristics and performance of the predicate device (Amplatzer Vascular Plug).
- Biocompatibility Standards: Performance against ISO standards for biological evaluation of medical devices.
- Histopathological Analysis (for animal study): Tissue response and acute/chronic performance observed in the animal model.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).