(30 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 Select Catheter 053 (predicate device), which is 3.5F and has multiple tip configurations, and a Neuron Select Catheter 070 (modified device) which is 5F and has multiple tip configurations. The Neuron Intracranial Access System also has a Neuron Delivery Catheter size 053, which tapers from 6F to 5F, and a Neuron Delivery Catheter 070, which is 6F. 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™ Select Catheter, and its substantial equivalence to a predicate device, rather than providing data from a study directly comparing the device against acceptance criteria in the style you've requested for AI/software-based devices.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided by this type of regulatory submission for a physical medical device.
However, I can extract information related to the general "acceptance criteria" and "study" mentioned for this device:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, acceptance criteria are generally established through testing against design specifications, manufacturing standards, and regulatory requirements rather than performance metrics like sensitivity/specificity.
| Acceptance Criterion (Generalized from "Testing" section) | Reported Device Performance (Generalized) |
|---|---|
| Adherence to device specifications (e.g., dimensions, material properties, functionality of components) | "The devices tested acceptably met the specifications." |
| Biocompatibility | "demonstrated to be both biocompatible" |
| Suitability for intended use | "suitable for this use." |
| Substantial equivalence to predicate device (Neuron Intracranial Access System (K070970)) in terms of: |
- Intended use
- Method of operation
- Methods of construction
- Materials used | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This document refers to "Bench testing, in vitro testing, and in vivo testing" which would involve testing a certain number of devices or components, but the exact sample sizes are not detailed in this summary.
- Data Provenance: Not specified, but generally, such testing is conducted within controlled laboratory environments (bench, in vitro) and/or animal models (in vivo) as part of the device development and validation process.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For physical devices, "ground truth" often refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on diagnostic images. Experts involved would typically be engineers, material scientists, and medical professionals contributing to design validation, but not in the context of establishing "ground truth" for a test set as you would for an AI algorithm.
4. Adjudication method
- Not Applicable. Adjudication methods are typically relevant for human interpretation of data, especially in the context of AI performance evaluation where there might be disagreements among human experts. This is not mentioned or relevant for the testing of this physical catheter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers. This document describes a physical catheter, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Engineering specifications, material testing results, and functional performance benchmarks. For example, tests would confirm catheter dimensions, tensile strength, pushability, trackability, torque response, lubricity, burst pressure, and biocompatibility against predefined acceptable ranges.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. Training sets are relevant for AI/machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As above, this is a physical medical 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).