(102 days)
The RevCore Thrombectomy Catheter is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.
The RevCore Thrombectomy Catheter is a single-use, sterile medical device designed for use in the peripheral vasculature. The RevCore Thrombectomy Catheter comprises reinforced polymeric and metal coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Thrombectomy Catheter distal tip and coring element are radiopaque. The RevCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, catheter shafts, and a handle, providing wall-to-wall contact, allowing the engagement and retrieval of clot from blood vessels and from implanted venous stents. The catheter shafts introduce the nitinol coring element percutaneously. The handle allows the physician to retract and turn the nitinol coring element to engage clot, as well as control the diameter of the nitinol coring element with a knob.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: RevCore™ Thrombectomy Catheter
The document states that the RevCore Thrombectomy Catheter underwent various performance, biocompatibility, and sterilization tests to demonstrate substantial equivalence to its predicate and reference devices. However, it does not explicitly provide a table of acceptance criteria with corresponding performance results for each test. Instead, it lists the types of tests performed and generally states that "acceptance criteria were met."
Therefore, I will create a table summarizing the types of tests performed and the general statement about their success.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criteria Category (Implied) | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Packaging Tests & Inspections | - Pouch Seal Inspection |
- Pouch Dye Penetration
- Pouch Bubble Leak
- Aseptic Presentation | All non-clinical test results demonstrated that acceptance criteria were met. |
| Dimensions & Key Characteristics | - Visual and Dimensional Inspections (RevCore Catheter, RevCore Coring Element, RevCore Delivery Catheter) - Guidewire Compatibility | All non-clinical test results demonstrated that acceptance criteria were met. |
| Performance & Functional Evaluation| - Deairing/Flushing Testing - Knob Torque Testing
- Deployment and Retraction Force through the Delivery Catheter
- Coring Element Retraction into Delivery Catheter Inspection
- Distal Catheter Kink Radius Testing
- Coring Element Durability Inspection (Post-Simulated Use)
- Insertion through Sheath
- Retraction Force through Sheath
- Sheath Inspection (Post-Simulated Use)
- Leakage Testing, Sheath (Post-Simulated Use)
- Vacuum Testing, Sheath (Post-Simulated Use)
- Leakage Testing, RevCore Catheter (Post-Simulated Use)
- Delivery Catheter Durability Inspection (Post-Simulated Use)
- Simulated Use Tracking and Tensile Testing (Post-Simulated Use)
- Simulated Use Tracking and Torque Testing (Post-Simulated Use)
- Corrosion Testing
- Particulate Matter Determination
- Luer Testing
- Safety Testing in Stent Model | All non-clinical test results demonstrated that acceptance criteria were met. |
| Characterization Tests | - Radial Force Characterization - Efficacy Testing (Clot & Stent Model)
- SEM of Stents/RevCore Coring Elements Post-Treatment | All non-clinical test results demonstrated that acceptance criteria were met. |
| Leveraged Tests | - Pouch Seal Strength - Simulated Use Tracking and Rotation Testing
- Delivery Catheter Radiopacity | All non-clinical test results demonstrated that acceptance criteria were met. |
| Pre-Clinical Study | - GLP Animal Study (to evaluate safety and performance) | The GLP animal testing met the predetermined acceptance criteria. |
| Biocompatibility | - Cytotoxicity - Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogenicity (Material Mediated)
- Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity, Platelet and Leukocyte, Partial Thromboplastin Time (PTT)) | All non-clinical test results demonstrated that acceptance criteria were met. |
| Sterilization | - Sterilization using EtO to achieve a sterility assurance level (SAL) of 10^-6 in accordance with ISO 11135:2014 and AAMI TIR 28:2016. | Successfully achieved SAL of 10^-6 without deviations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each of the listed tests (e.g., number of catheters tested for durability, number of animals in the GLP study).
- Sample Sized Used for the Test Set: Not specified in detail for individual tests. A "GLP Animal Study" was performed, implying animal subjects were used, but the number is not provided.
- Data Provenance: The studies are described as "non-clinical performance testing" and a "Pre-Clinical Study (GLP Animal Study)," indicating experimental lab/animal data rather than human patient data, and thus no country of origin is specified in that context. The context is a regulatory submission to the FDA in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The testing described is performance, preclinical animal, and biocompatibility testing for a medical device, which typically relies on established laboratory protocols, measurement standards, and animal models rather than expert consensus on ground truth in the context of imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human review of data (e.g., medical images) to establish ground truth or resolve discrepancies. The provided document describes device performance and preclinical animal testing.
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. Such studies are typically conducted for diagnostic devices or AI algorithms that involve human interpretation, to assess the impact of the device on reader performance. This document pertains to a thrombectomy catheter, which is an interventional device, not a diagnostic one involving human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device described is an interventional medical device (thrombectomy catheter), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
For the performance and functional tests, the "ground truth" would be established engineering specifications, material properties, and predetermined acceptance thresholds for various physical and mechanical properties. For the GLP Animal Study, the "ground truth" would be the observed safety and performance outcomes against predefined endpoints in the animal model. For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and the specific metrics of those tests (e.g., cytotoxicity levels, hemocompatibility parameters).
8. The Sample Size for the Training Set
This question is not applicable as the device described is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device described is a physical medical device, not an AI or machine learning model.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).