(57 days)
Pirouette High Pressure (HP) PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, renal arteries, Arterio-venous Fistula (AVF) and Arterio-venous Graft (AVG).
The Pirouette High Pressure (HP) Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating. The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualisation of the catheter/balloon under fluoroscopy. The catheter is compatible with 0.018-inch (0.46 mm) wire guides. The Pirouette High Pressure (HP) PTA Catheter Family includes multiple balloon sizes ranging from 4 to 6 mm in diameter and 20 to 80mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the balloon range from 45cm to 75cm.
The provided document describes the ArraVasc Pirouette High Pressure (HP) PTA Catheter (K172033) and its substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The document focuses on regulatory approval based on comparison to existing devices and non-clinical performance testing.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
However, I can extract information related to the acceptance criteria and performance as presented for this conventional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "performance specifications" and "pre-determined acceptance criteria" that the device met during bench testing. While specific numerical acceptance criteria values are not explicitly listed in a table format in the provided text, the document states that the device met these criteria. The table below synthesizes the performance parameters and the reported outcome.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional verification | Met pre-determined acceptance criteria. |
| Balloon preparation | Met pre-determined acceptance criteria. |
| Pushability | Met pre-determined acceptance criteria. |
| Trackability | Met pre-determined acceptance criteria. |
| Deployment | Met pre-determined acceptance criteria. |
| Withdrawal | Met pre-determined acceptance criteria. |
| Balloon reinsertion | Met pre-determined acceptance criteria. |
| Balloon Rated Burst Pressure (RBP) | Met pre-determined acceptance criteria. The comparable RBP is 22 atm (4.0-5.0mm diameter) and 20 atm (6.0mm diameter). |
| Balloon Fatigue (repeated inflations) | Met pre-determined acceptance criteria. |
| Balloon Compliance (at nominal and RBP) | Met pre-determined acceptance criteria. |
| Balloon Inflation/Deflation Time | Met pre-determined acceptance criteria. |
| Bond Strength (Tip-to-balloon, balloon-to-proximal shaft, shaft-to-manifold) | Met pre-determined acceptance criteria. |
| Flexibility and Kink Test | Met pre-determined acceptance criteria. |
| Torque Strength | Met pre-determined acceptance criteria. |
| Radiopacity | Met pre-determined acceptance criteria. |
| Coating Integrity | Met pre-determined acceptance criteria. |
| Particulate evaluation | Met pre-determined acceptance criteria. |
| Guidewire compatibility | Met pre-determined acceptance criteria. Compatible with 0.018-inch wire guides. |
| Introducer sheath compatibility | Met pre-determined acceptance criteria. Compatible with 4-5 Fr introducer sheath. |
| Biocompatibility | Determined to be biocompatible by leveraging data from the reference device (Pirouette 018). |
| Sterilization validation | Met pre-determined acceptance criteria regarding sterility maintenance and acceptable EtO/ECH residues. |
| Shelf life testing | Met pre-determined acceptance criteria. |
| Packaging validation | Met pre-determined acceptance criteria. |
2. Sample size used for the test set and the data provenance
This is a conventional medical device (PTA catheter), not an AI/ML device. Therefore, there is no "test set" in the context of AI/ML validation with patient data. The "testing" refers to bench testing of the physical device. The sample sizes for each specific bench test (e.g., how many balloons were tested for RBP) are not provided in this summary. Data provenance is not applicable in the AI/ML sense; physical specimens of the device were tested in a laboratory setting. All testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a physical medical device, not an AI/ML diagnostic tool, there is no "ground truth" derived from expert consensus on medical images or clinical data. Device performance was assessed against engineering specifications and industry standards.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication of medical findings.
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 a physical interventional device, not an AI/ML diagnostic or assistive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10555-1, ISO 10555-4), and pre-determined acceptance criteria derived from these standards and the device's design requirements. For biocompatibility, it was established through studies on a reference device following ISO 10993-1:2009.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of 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).