(94 days)
The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.
The Pioneer Plus catheter is a dual lumen catheter that is inserted through a commercially available 6F introducer sheath and placed percutaneously into a peripheral vessel. The Pioneer Plus catheter tracks to its intended site in the vasculature over a standard, commercially available 0.014" (0.36 mm) tracking guidewire. The Pioneer Plus catheter utilizes an extendable, hollow Nitinol needle - minimum internal needle diameter: 0.016" (0.43 mm): it is compatible with floppy 0.014" (0.36 mm) over the wire (OTW) guidewires to facilitate the redirection and placement of the guidewire into peripheral vessels. The needle orientation placement is achieved through the use of an intravascular ultrasound (IVUS) transducer mounted at the distal end of the Pioneer Plus catheter. The Pioneer Plus catheter operator navigates the peripheral vasculature under fluoroscopic guidance and uses IVUS imaging to direct the needle to achieve optimal placement. The operator uses the Needle Deployment Ring incorporated into the handle of the Pioneer Plus catheter to extend the needle from the catheter. The needle can be extended up to 7mm in length, or to a pre-determined distance using the Stop Ring. A 0.014" (0.36 mm) OTW guidewire (needle guidewire) can then be advanced through the needle and used to facilitate the placement of subsequent catheters once the Pioneer Plus device is withdrawn.
The provided text describes an FDA 510(k) summary for a medical device called the "Pioneer Plus Catheter." The acceptance criteria and the study proving the device meets these criteria are outlined in the "PERFORMANCE DATA" section.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Visual Inspection | Met acceptance criteria |
| Outer Diameter (OD) Measurement | Met acceptance criteria |
| Braid Durability | Met acceptance criteria |
| Bend Radius (Kink) | Met acceptance criteria |
| Tensile Testing | Met acceptance criteria |
The document states that "All testing met the acceptance criterial with 95/95 confidence/reliability."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of catheters tested for Bend Radius). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the modified device."
- Data Provenance: Not specified. The tests are described as "Bench testing," indicating they were performed in a lab setting, likely by the manufacturer (Philips Volcano). There is no information regarding country of origin of data, and it is inherently a prospective study as it's testing a modified device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing appears to be focused on engineering performance criteria rather than human interpretation or clinical outcomes that would require expert ground truth.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided. The tests are objective engineering measurements (e.g., OD measurement, tensile strength) rather than subjective assessments requiring adjudication.
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:
This information is not provided and is not applicable to the type of device and testing described. The Pioneer Plus Catheter is a physical medical device (catheter with ultrasound imaging), not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided and is not applicable. The device is not an algorithm, but a physical catheter. While it incorporates an intravascular ultrasound (IVUS) transducer, the performance evaluation described focuses on the physical integrity and characteristics of the catheter itself, not the standalone performance of an ultrasound imaging algorithm.
7. The type of ground truth used:
The ground truth for the performance tests appears to be known standards or product specifications. The document states, "Bench testing was conducted against known standards or product specification."
8. The sample size for the training set:
This information is not provided. The document describes testing of a physical medical device against engineering specifications. There is no mention of a "training set" as would be relevant for machine learning or AI algorithms.
9. How the ground truth for the training set was established:
This information is not provided as there is no mention of a "training set."
§ 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).