Search Results

The IMPEDE Embolization Plug is a permanent implant, blood contacting pushable embolization device comprised of a self-expanding porous, degradable polyurethane-based foam plug, a distal pre-shaped helical platinum-iridium alloy anchor coil, an etched passivated superelastic nitinol core wire, and a proximal platinum-iridium alloy marker band. The device is pre-loaded in the IMPEDE Introducer Sheath which is made of a PEEK tube and a polycarbonate luer hub. The assembled unit is supplied e-beam sterile for single use. The device is delivered with the plug in the crimped state to the target vessel using a guidewire through a standard angiographic catheter. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to embolize the target vessel. The anchor coil stabilizes the device within the vessel to allow precise control of placement and to minimize risk of device migration and unintended thromboembolism while the plug expands to embolize and conform to the vessel lumen.

AI/ML Overview

The provided text is a 510(k) summary for the IMPEDE Embolization Plug. It describes the device, its intended use, and comparison to predicate devices, along with performance data submitted to the FDA. However, it does not contain specific acceptance criteria with numerical thresholds or detailed results from a study proving these criteria were met. Instead, it lists the types of performance data that were provided in support of substantial equivalence.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.

Here's the information that can be extracted or deduced from the provided text, along with notations for information that is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993-1. (Specific criteria and quantitative results not detailed in the provided text, but testing for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Hemocompatibility, Intramuscular Implantation, Materials Mediated Pyrogenicity, Systemic Toxicity, Subchronic Toxicity, and Chronic Toxicity was conducted for the implant. Introduction Sheath testing included Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Materials Mediated Pyrogenicity, and Systemic Toxicity.)
Mechanical, Visual, and Material Characterization	Bench testing conducted included: Simulated use testing (Accessory Compatibility, Delivery Performance (Working Time, Deliverability, Migration), Implantation Performance (Plug Expansion, Migration, Bond Integrity)), Extractables and Leachables Toxicological Analysis, Degradation Products Toxicological Analysis, In-Vitro Degradation Rate Analysis, Radiopacity, Radial Force, Particulate Testing, MRI Compatibility, Packaging/Sterilization, Material Characterization, Corrosion Testing, Dimensional Inspection, Visual Inspection. (Specific criteria and quantitative results not detailed in the provided text).
In-Vivo Performance	Evaluated in animal studies. (Specific criteria and quantitative results not detailed in the provided text).
Degradation Rate (Foam)	Slow degradation with >90% remaining at 30 days in swine. Near complete degradation at majority of implant sites by 180 days (rat) and 26 weeks (rabbit). (Specific acceptance thresholds for degradation are not provided.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for each test beyond the number of animals in some studies.
Data Provenance:
- Animal Studies:
  - 30, 60, and 90-day porcine large animal study
  - 90 day standard subcutaneous rat study
  - 90 and 180-day custom (foam only) subcutaneous rat study
  - 4, 13, and 26-week intramuscular implant rabbit study
- Bench Testing & Biocompatibility: Performed according to ISO 10993-1. No specific country of origin or whether data was retrospective/prospective is mentioned, but typically these tests are prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for a device of this type. The studies described are primarily non-clinical (bench and animal studies) and do not involve human diagnostic interpretation where expert ground truth would be established in this manner.

4. Adjudication Method (for the test set)

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. This type of study is more common for diagnostic devices where human reader performance is being evaluated with and without AI assistance. This document describes a vascular embolization device, not typically a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not a software algorithm or AI.

7. Type of Ground Truth Used

Non-clinical endpoints: The studies appear to use direct measurements and observations from bench tests and animal models as their "ground truth" or primary endpoints.
- For biocompatibility: Histology, toxicology analyses, serology, etc.
- For mechanical testing: Physical property measurements, visual inspection, simulated use outcomes (e.g., successful deployment, migration, expansion).
- For degradation: Histology and remaining foam analysis.

8. Sample Size for the Training Set

Not applicable. This document describes the testing of a physical medical device. It does not refer to an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1