Search Results

Pirouette 035 PTA Catheter is intended for balloon of the iliac, femoral, popliteal, infra-popliteal and renal arteries.

The Pirouette 035 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 quidewire lumen allowing the catheter to track over a quidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .035 inch (0.89 mm) wire guides. The Pirouette 035 PTA Catheter Family includes multiple balloon sizes ranging from 3 to 12 mm in diameter and 20 to 200mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the quidewire hub of the manifold. The effective lengths of the catheter are 75cm and 130cm.

The provided text is a 510(k) summary for the Pirouette 035 Percutaneous Transluminal Angioplasty (PTA) Catheter. It describes the device, its intended use, and compares it to a predicate device (Pirouette 018). The core of the performance data section relies on non-clinical bench testing and leveraging data from the predicate device for biocompatibility, sterilization, shelf life, and packaging. No clinical studies were performed for the purpose of obtaining safety and effectiveness data for the Pirouette 035.

Therefore, I cannot provide information on acceptance criteria and study details related to AI or human expert performance, as the device is a physical medical catheter, not an AI-powered diagnostic or assistive tool. The concept of "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for the physical device.

However, I can extract the relevant information from the document regarding the non-clinical testing and general acceptance criteria for this type of medical device.

Here's a breakdown based on the provided document, addressing the closest equivalent concepts:

Acceptance Criteria and Device Performance (Non-Clinical)

The document describes various non-clinical tests performed on the Pirouette 035 catheter. The acceptance criteria for these tests are generally stated as the device "met the pre-determined acceptance criteria," implying that the device demonstrated performance within specified engineering tolerances for each test. The document does not provide specific numerical thresholds or target values for these criteria, but rather lists the types of tests conducted.

1. A table of acceptance criteria and the reported device performance:

Since specific numerical acceptance criteria are not provided in the document, the table will reflect the types of tests performed and the general statement of performance.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify the sample sizes for any of the non-clinical tests (e.g., how many catheters were burst tested). It only lists the types of tests.
• Data Provenance: The bench testing (non-clinical tests) was performed by ArraVasc Limited (the manufacturer). The company is based in Ireland (2 Ballybrit Business Park, Galway, Ireland). The data is prospective in the sense that the tests were conducted specifically for the submission of the Pirouette 035.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of device and study. "Ground truth" established by human experts, especially for image interpretation or diagnosis, is a concept relevant to AI/ML or diagnostic devices. For a physical catheter, the "ground truth" and performance evaluation are based on objective engineering measurements and laboratory tests against predefined physical and chemical specifications, not subjective expert assessment. The experts involved would be engineers and lab technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This question is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth from multiple human readers in AI/imaging studies. For bench testing of a physical device, results are objective measurements against specifications, not subjective reads 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:

• No. This type of study (MRMC, AI assistance) is not applicable as the device is a physical catheter, not an AI or diagnostic tool. The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This question is not applicable as the device is a physical catheter, not an algorithm. Bench testing evaluates the physical device's performance standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for the non-clinical tests is the objective engineering specifications and industry standards (e.g., ISO 10555-1, ISO 10555-4, ISO 10993-1). The device's performance is measured directly against these benchmarks.

8. The sample size for the training set:

• This question is not applicable. "Training set" refers to data used to train an AI model. For a physical device, there is no AI training set.

9. How the ground truth for the training set was established:

• This question is not applicable for the same reason as #8.

Ask a specific question about this device

Pirouette 018 is intended for balloon dilation of the iliac, femoral, poplitean and renal arteries.

Percutaneous Transluminal Angioplasty Catheter (PTA Catheter).

This document describes a 510(k) premarket notification for a medical device called the "Pirouette 018," which is a Percutaneous Transluminal Angioplasty (PTA) Catheter. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "The results showed that the Pirouette 018 met the pre-determined acceptance criteria." However, it does not provide a specific table detailing the acceptance criteria for each test or the quantitative reported device performance against those criteria. It lists the tests performed, implying satisfactory results.

Here's a table based on the provided text, outlining the tests and the general outcome, but without specific numerical acceptance criteria or performance values:

• Balloon preparation, pushability, trackability, deployment, withdrawal, and balloon reinsertion
• Balloon rated burst pressure (RBP)
• Balloon fatigue (repeated balloon inflations)
• Balloon Compliance at nominal and rated burst inflation pressure
• Balloon Inflation/Deflation Time
• Catheter Bond Strength (Tip to balloon, balloon to proximal shaft, shaft to manifold)
• Flexibility and Kink test
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate evaluation
• Guide wire compatibility
• Introducer sheath compatibility | "The results showed that the Pirouette 018 met the pre-determined acceptance criteria." (Specific numerical results and acceptance criteria are not provided) |
  | Biocompatibility Tests | - MTT Cytotoxicity Study
• ISO Maximization Sensitization Study
• ISO Intracutaneous Study
• ISO Systemic Toxicity Study
• ASTM Hemolysis
• C3a Complement Activation Assay
• SC5b-9 Complement Activation Assay
• ASTM Partial Thromboplastin Time
• In Vivo Thromboresistance Study Jugular Vein
• Pyrogenicity | "The test results show that the Pirouette 018 is biocompatible." (Specific numerical results and acceptance criteria are not provided) |
  | Sterilization, Shelf Life, and Packaging Validation | - EtO sterilization validation
• EtO/ECH residue determination
• Shelf life testing
• Packaging validation | "Test results show that the Pirouette 018 is sterile and is maintained by the packaging during the entire shelf life of the device. From the results it was also concluded that the device meets the criteria for Residual Testing, i.e. EtO/ECH residues." (Specific numerical results and acceptance criteria are not provided) |

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data."

Therefore, there is no "test set" in the context of human clinical data or patient outcomes. The testing described is entirely non-clinical (bench testing) and biocompatibility. The sample sizes for these bench tests are not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable, as no clinical data was used for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As no clinical studies were performed, there was no "test set" requiring expert ground truth establishment for patient data. The non-clinical tests rely on established engineering and materials science principles, and the biocompatibility tests on standardized laboratory protocols.

4. Adjudication Method for the Test Set

Not applicable. No clinical data and no "test set" from human participants means no adjudication method was needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data." Therefore, no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests, the "ground truth" is defined by the pre-determined acceptance criteria and the recommendations outlined in applicable FDA guidance documents, ISO 10555-1, and 10555-4. For biocompatibility, it's defined by ISO 10993-1:2009 standards. These standards and internal specifications serve as the "ground truth" against which the device performance was measured. No patient-specific ground truth (like pathology or outcomes data) was used for this submission.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device