(90 days)
The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.
The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.
The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process.
The provided document describes a 510(k) submission for the NeuroEdge™ Infusion Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for a novel device.
Therefore, the document does not contain specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating that the new device is "substantially equivalent" to existing devices.
Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fully answered by this document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or clinical endpoints. The primary "acceptance" for a 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, design, materials, and construction. | "Performance testing was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its intended use." (K011646, p.1, Section 6) |
Explanation: The document states that performance testing was done, but does not provide specific numerical acceptance criteria (e.g., minimum flow rate, maximum burst pressure, specific clinical success rates) or the quantitative results from those tests. The "reported device performance" is a general statement that the tests support safety and performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "performance testing" but does not detail the number of units tested or the number of cases/patients involved in any clinical or simulated use tests.
- Data Provenance: Not specified. Given the nature of a 510(k) for a device like this, the performance testing would typically involve bench testing (in-vitro) and potentially some animal studies, rather than human patient data, unless specifically required based on the predicate device or unique risks. The document does not indicate if any human data was used, retrospectively or prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/not mentioned. "Ground truth" in the context of expert review for medical imaging or diagnostic devices is not relevant here. The performance testing would be engineering or laboratory-based, assessing physical properties and functional aspects of the catheter against design specifications, not expert interpretation of clinical data.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not mentioned. Adjudication methods (like 2+1, 3+1 consensus) are used when multiple human readers interpret ambiguous clinical data to establish a ground truth. This is not the type of study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
-
MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. These studies are typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The NeuroEdge™ Infusion Catheter is a delivery device (catheter) for diagnostic, embolic, and therapeutic agents.
-
Effect Size of Human Readers with vs. without AI Assistance: Not applicable. This device does not incorporate AI for diagnostic assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Not applicable. This device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance study was performed.
7. Type of Ground Truth Used:
- Type of Ground Truth: For the "performance testing," the "ground truth" would be the engineering specifications and validated test methods. For example, if testing catheter flexibility, the ground truth would be a defined acceptable range of flexibility. If testing flow rate, the ground truth would be a specified flow rate under certain conditions. The document does not provide details on these specific ground truths or specifications.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.
In summary: The provided document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" of the NeuroEdge™ Infusion Catheter to legally marketed predicate devices. It mentions "performance testing" was conducted to verify design specifications and support safety and performance, but it does not provide the specific details (acceptance criteria, methodologies, sample sizes, or results) of these tests that would be required to answer most of your questions in the context of a detailed study report for a novel medical device or AI system.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).