(81 days)
The NeuronTM 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 size 053 (predicate device), which is available with an inner diameter of 0.053in, and a Neuron Delivery Catheter 070 (modified device), which is available with an inner diameter of 0.070in. The Neuron Intracranial Access System also has a Neuron Select Catheter (used with predicate device), which measures 3.5F and has multiple tip configurations.
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™ Delivery Catheter, which is a Percutaneous Catheter. The document is primarily focused on demonstrating "substantial equivalence" of the new device (070 size) to a previously cleared predicate device (053 size), rather than presenting a performance study with detailed acceptance criteria and results as typically seen for novel devices or AI/software products.
Therefore, many of the requested categories related to AI/software performance studies, ground truth establishment, expert review, and MRMC studies are not applicable to this document. The information provided heavily emphasizes physical device testing and regulatory comparison.
Here's an attempt to extract relevant information and note where the requested categories are not applicable based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from the document) |
|---|---|
| Substantial Equivalence to Predicate Device | The Neuron Delivery Catheter size 070 is substantially equivalent to the predicate device (Neuron Intracranial Access System (K070970)) regarding: |
- Intended Use
- Method of Operation
- Methods of Construction
- Materials Used |
| Material Biocompatibility | Materials used are manufactured from medical grade materials that have historically been demonstrated to be both biocompatible and suitable for this use. They are similar or identical to the predicate devices. |
| Bench Testing | Performed on device materials, components, subassemblies, and final assemblies. Met the specifications. |
| In Vitro Testing | Performed on device materials, components, subassemblies, and final assemblies. Met the specifications. |
| In Vivo Testing | Performed on device materials, components, subassemblies, and final assemblies. Met the specifications. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies." However, it does not specify the sample sizes for these tests (e.g., number of catheters tested, number of in vivo subjects/animals).
- Data Provenance: Not specified. Given it's pre-market testing for a US FDA submission, it's likely conducted in the US or collaborating labs, but this is not explicitly stated.
- Retrospective or Prospective: These would typically be prospective tests designed to evaluate the new device.
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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 is a physical medical device (catheter), not an AI/software product requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance would be engineering specifications and successful completion of physical and biological tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert consensus on interpretation, which is not relevant for this type of device submission. The success criteria for physical testing would be adjudicated by qualified engineers and technical staff following established protocols.
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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 not an AI/software device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical and biological testing, the "ground truth" would be objective engineering specifications, material standards, and established biocompatibility benchmarks. For instance, a test might verify that the catheter's inner diameter is precisely 0.070 inches, or that it withstands a certain pressure without leaking. Biocompatibility would be assessed against ISO standards, chemical analysis, and potentially animal or in vitro cell culture studies.
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The sample size for the training set:
- Not Applicable. This is not an AI/software device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. This is not an AI/software 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).