(112 days)
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:
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | - Dimensional verification |
- 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.
§ 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).