(178 days)
VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.
The VasCon NeuroPath™ Guiding Catheter is a single lumen catheter, incorporating a PEBAX® body reinforced with a stainless steel wire braid. The intermediate segment is also PEBAX® with a stainless steel coil to reduce kinking and to promote improved torque response. The tip is composed of radiopaque 35D PEBAX® to reduce potential vessel injury. They are available in 5Fr and 6Fr, 90 and 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate devices.
The provided text describes a 510(k) submission for a medical device, the VasCon NeuroPath™ Guiding Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proof of independent safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of a standalone performance evaluation with a test set, expert ground truth, or MRMC comparative effectiveness study.
Here's why, and what information is available:
- No Acceptance Criteria or Reported Device Performance (as requested): The document states that "Mechanical laboratory testing has been performed on the VasCon NeuroPath™ Guiding Catheter to assure compliance to the specifications." However, it does not specify what those "specifications" are, nor does it report the results of these tests against any defined acceptance criteria (e.g., minimum tensile strength, maximum kinking angle, etc.). The conclusion simply states the device is "safe and effective for its intended use" based on these tests and biocompatibility, as compared to predicate devices.
- No Sample Size for Test Set or Data Provenance: As there is no standalone performance study described, this information is not present.
- No Number of Experts or Qualifications for Ground Truth: No expert-derived ground truth is mentioned.
- No Adjudication Method: Not applicable as there's no expert review or ground truth establishment described.
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study would involve human readers and their performance with and without AI assistance. The submission is for a physical medical device, not an AI or software device, so such a study would not be relevant or expected.
- No Standalone Performance Study (as requested): The submission relies on demonstrating substantial equivalence to predicate devices based on "non-clinical tests" (mechanical and biocompatibility testing) and "technological characteristics are equivalent to the predicate devices." A standalone performance study with a test set and defined performance metrics is not described.
- No Type of Ground Truth Used: Not applicable, as there's no clinical or expert-defined "ground truth" established for device performance. The "truth" here is compliance with engineering specifications and biocompatibility, which are confirmed through laboratory tests.
- No Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are relevant to AI/machine learning models. This submission is for a physical medical device (guiding catheter), not a software or AI device, so there is no training set mentioned or implied.
Summary based on the provided text:
| Information Requested | Description from Text |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided in the document. The document states "Mechanical laboratory testing has been performed on the VasCon NeuroPath™ Guiding Catheter to assure compliance to the specifications," but the specific specifications (acceptance criteria) and the quantitative results (reported performance) are not detailed. It only concludes that the device is "safe and effective for its intended use" based on these tests and equivalence to predicate devices. |
| 2. Sample size used for the test set and data provenance | Not applicable/Not provided. This information is typically relevant for clinical studies or AI algorithm performance evaluations. The submission describes non-clinical mechanical and biocompatibility testing without specifying sample sizes for these tests, nor does it involve a "test set" in the context of clinical data. |
| 3. Number of experts used to establish the ground truth for the test set and qualifications of those experts | Not applicable/Not provided. No expert-established ground truth is mentioned. The assessment of the device is based on mechanical performance and biocompatibility testing against engineering specifications, and comparison to predicate devices, not on interpretation by clinical experts. |
| 4. Adjudication method for the test set | Not applicable/Not provided. This would be relevant if multiple experts were establishing a ground truth for clinical cases, which is not described. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of AI assistance | No. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The VasCon NeuroPath™ Guiding Catheter is a physical medical device, not an AI/software product, so an MRMC comparative effectiveness study is not relevant or described. |
| 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | No (in the context of an algorithm). The document describes "non-clinical tests" (mechanical and biocompatibility) performed on the physical device itself. This is not a "standalone" performance evaluation of an algorithm. The core of the 510(k) is demonstrating substantial equivalence to predicate devices based on these tests and technological characteristics. |
| 7. The type of ground truth used | Engineering specifications and biocompatibility standards / Predicate device characteristics. For this medical device, the "ground truth" for demonstrating safety and effectiveness is compliance with internal engineering specifications (though not detailed) through mechanical testing and adherence to biocompatibility standards, and importantly, demonstrating that its "technological characteristics are equivalent to the predicate devices." No clinical outcomes data or pathology reports are mentioned as "ground truth" for the device's basic function. |
| 8. The sample size for the training set | Not applicable/Not provided. This is relevant for AI/machine learning models. This submission is for a physical medical device and does not involve a "training set." |
| 9. How the ground truth for the training set was established | Not applicable/Not provided. As there is no training set discussed, the method for establishing its "ground truth" is not applicable. The basis for proving the device is safe and effective lies in comparing its mechanical properties and biocompatibility to accepted standards and predicate devices. |
§ 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).