(133 days)
The Neuron™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Neuron Intracranial Access System has a Neuron Delivery Catheter (outer catheter), which is available with a diameter of 6F proximal and 5F distal, and a Neuron Select Catheter (inner catheter), which measures 3.5F and has multiple tip configurations. The Neuron Delivery Cather may be used with a guidewire or with the Neuron Select Catheters. Materials used in the Neuron Intracranial Access System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.
This 510(k) summary describes a medical device, the Neuron™ Intracranial Access System, which is a catheter. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal clinical study.
Therefore, many of the requested categories for AI/clinical study performance data are not applicable to this document, as it pertains to a traditional medical device (catheter) and not an AI/ML-driven diagnostic or therapeutic system.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How did it perform) |
|---|---|
| Intended Use Equivalence: The Neuron Intracranial Access System's intended use is substantially equivalent to legally marketed predicate devices. | "The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The indication statement of the Neuron Intracranial Access System is substantially equivalent to the legally marketed predicate devices." |
| Method of Operation Equivalence: The method of operation of the Neuron Intracranial Access System is identical or substantially equivalent to predicate devices. | "The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices." |
| Methods of Construction Equivalence: The methods of construction of the Neuron Intracranial Access System are identical or substantially equivalent to predicate devices. | "The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices." |
| Materials Used Equivalence: The materials used in the Neuron Intracranial Access System are identical or substantially equivalent to predicate devices and are biocompatible and suitable for use. | "Materials used in the Neuron Intracranial Access System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use." |
| "The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices." | |
| Bench, In Vitro, and In Vivo Testing: Adherence to specifications through testing. | "Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the bench, in vitro, or in vivo testing.
- The document does not specify data provenance (e.g., country of origin, retrospective/prospective). This type of detail is generally not included in a 510(k) summary for a catheter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This information is not relevant to a 510(k) submission for a non-AI medical device like a catheter. Ground truth as typically understood in AI/ML is not a concept applied in this context. The "ground truth" here is the physical performance against specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments, often in clinical trials or expert review panels for AI/ML outputs. This isn't relevant for a catheter's bench, in vitro, and in vivo performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device (catheter), not an AI/ML system, so MRMC studies or human reader improvement with AI are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" would be objective physical and material properties, mechanical performance specifications, and biological responses (e.g., biocompatibility) as measured in bench, in vitro, and in vivo tests. It is not an expert consensus on an image or pathology.
8. The sample size for the training set
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).