(104 days)
Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.
The Peripheral Guide Catheter is a family of single use, catheters that are intended to facilitate introduction of interventional/diagnostic devices.
The NexGen Peripheral Guide Catheter features a proximal hub for attaching to ancillary devices such as Rotating Hemostasis Valves and Syringes and a distal, atraumatic tip that is radiopaque.
The catheter has a single lumen that can be used to facilitate introduction of interventional /diagnostic devices and injection of physician specified fluids.
The Guide Catheter comes in two profiles, 4F and 8F and multiple lengths. The 4F profile has a 65cm and 150cm working length and the 8F profile has a 20cm and 90cm working length.
Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.
The provided text describes a 510(k) summary for the NexGen Peripheral Guide Catheter. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility assessments. The document does not include information about acceptance criteria and a study proving a device meets those criteria in the context of clinical performance, specifically for an AI/ML powered device.
Therefore, many of the requested sections about AI/ML specific study design (e.g., sample size for test set, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set size and ground truth establishment) cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists several performance tests conducted to verify the device met design specifications and its intended use. However, it does not explicitly state specific acceptance criteria (e.g., "tensile strength must be > X N") nor the quantitative results ("reported device performance") for each test. It only states that the tests were "successfully completed."
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Sufficient Tensile Strength | Successfully completed Tensile Test |
| Adequate Catheter Torque | Successfully completed Catheter Torque Test |
| Withstand Burst Pressure | Successfully completed Catheter Burst Pressure Test |
| No Leakage | Successfully completed Catheter Leak Test |
| Resistance to Kinking | Successfully completed Catheter Kink Diameter Test |
| Good Pushability & Trackability | Successfully completed Catheter Pushability Trackability Test |
| Sufficient Flow Rate | Successfully completed Catheter Flow Rate Test |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing of a physical medical device, not a study involving a "test set" of data or patient cases for an AI/ML algorithm.
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 is not an AI/ML study. Ground truth in this context would relate to engineering specifications and measurements, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study.
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 not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be the established engineering and materials science standards and specifications against which the device's performance was measured. For example, a predefined burst pressure limit or a specific tensile strength requirement.
8. The sample size for the training set
Not applicable. This is not an AI/ML study.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML study.
§ 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).