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510(k) Data Aggregation
(68 days)
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.
| Parameter/Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Met pre-determined engineering specifications for each test. | Met all pre-determined acceptance criteria. |
| Dimensional Verification | Within specified manufacturing tolerances. | Passed. |
| Balloon Prep, Pushability, Trackability, Deployment, Withdrawal, Reinsertion | Performed as intended without failure. | Passed. |
| Balloon Rated Burst Pressure (RBP) | Maintained integrity at/above specified pressure. | Passed. |
| Balloon Fatigue | Withstood repeated inflations without failure. | Passed. |
| Balloon Compliance | Maintained specified compliance at nominal and RBP. | Passed. |
| Balloon Inflation/Deflation Time | Within specified time limits. | Passed. |
| Catheter Bond Strength | Maintained integrity at specified force/stress. | Passed. |
| Flexibility and Kink Test | Demonstrated adequate flexibility and resistance to kinking. | Passed. |
| Torque Strength | Maintained integrity and responsiveness to torque. | Passed. |
| Radiopacity | Visible under fluoroscopy as specified. | Passed. |
| Coating Integrity | Coating remained intact and functional. | Passed. |
| Particulate Evaluation | Within acceptable limits for particulate burden. | Passed. |
| Guidewire Compatibility | Compatible with specified guidewires. | Passed. |
| Introducer Sheath Compatibility | Compatible with specified introducer sheaths. | Passed. |
| Biocompatibility | Meets ISO 10993-1:2009 standards for limited contact with blood. | Passed all tests leveraging Pirouette 018 data. |
| MTT Cytotoxicity | Non-cytotoxic. | Passed (leveraged from Pirouette 018). |
| ISO Maximization Sensitization | Non-sensitizing. | Passed (leveraged from Pirouette 018). |
| ISO Intracutaneous | Non-irritating. | Passed (leveraged from Pirouette 018). |
| ISO Systemic Toxicity | Non-systemically toxic. | Passed (leveraged from Pirouette 018). |
| ASTM Hemolysis | Acceptable hemolytic index. | Passed (leveraged from Pirouette 018). |
| Complement Activation Assay (C3a, SC5b-9) | Acceptable levels of complement activation. | Passed (leveraged from Pirouette 018). |
| ASTM Partial Thromboplastin Time | Acceptable impact on coagulation. | Passed (leveraged from Pirouette 018). |
| In Vivo Thromboresistance | Demonstrates acceptable thrombogenicity. | Passed (leveraged from Pirouette 018). |
| Pyrogenicity | Non-pyrogenic. | Passed (leveraged from Pirouette 018). |
| Sterilization, Shelf Life, Packaging | Meets relevant standards for sterility, shelf life, and packaging integrity. | All criteria determined to be met. |
| EO Sterilization Validation | Sterility maintained effectively. | Passed. |
| EO/ECH Residues | Residues within acceptable limits. | Passed. |
| Shelf Life Testing | Sterility and functionality maintained over shelf life. | Passed (leveraged from Pirouette 018). |
| Packaging Validation | Integrity maintained in specified conditions; protects sterility. | Passed (leveraged from Pirouette 018). |
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.
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(311 days)
The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 6, 8, 10, 12 millimeters and a balloon length of 4 centimeters. The balloon includes four polymer elements, which provide focal force upon inflation. These elements will aid in opening lesions. The catheters are 5.2 French, dependent upon device specification, and will be available in lengths of 50, 80, or 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.
The provided document describes the mechanical and performance testing of the Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter to demonstrate its substantial equivalence to a predicate device. This is a medical device, and the evaluation is based on engineering and material science tests, not artificial intelligence. Therefore, many of the requested fields related to AI/expert ground truth/etc. are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Balloon Compliance Testing | Labeled diameter at nominal pressure under simulated body temperature. | Each balloon met its labeled diameter at the nominal pressure. The acceptance criterion was met. |
| Balloon Profile Testing | Diameters less than maximum outside diameter for intended sheath size. | Diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The acceptance criterion was met. |
| Fatigue Testing | From leakage and damage on inflation after 10 cycles of inflation/deflation (ISO 10555-4). | Balloons were free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. Conformed to ISO 10555-4. The acceptance criterion was met. |
| Balloon Burst Testing | Burst at or above minimum rated burst pressure, with all failure modes being linear tears. | Balloons burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The acceptance criteria were met. |
| Balloon Inflation/Deflation Testing | Inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. | Balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The acceptance criteria were met. |
| Sheath Compatibility Testing | Capable of being inserted and retracted from an appropriately sized sheath without excessive resistance. | Catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The acceptance criterion was met. |
| Tensile Strength Testing | Peak load values in accordance with applicable values of ISO 10555-1. | Under proper clinical use of the device, the peak load values were in accordance with the applicable values of ISO 10555-1. The acceptance criteria were met. |
| Soft Tip Integrity Testing | Soft tip did not separate, kink, accordion, deform, or show other anomalies after clinically relevant model passage. | Soft tip did not separate from the catheter, kink, accordion, deform, or show any other anomalies after passage through a clinically relevant model. The acceptance criterion was met. |
| Balloon Working Length Testing | Matched labeled length within expected tolerance. | Balloon working length for the catheters was matched the labeled length within the expected tolerance. The acceptance criterion was met. |
| Simulated Use Testing | Adequate or better performance for preparation, introduction, pushability, trackability, inflatability, deflatability, and interaction with supporting devices. | Devices were adequate or better in terms of preparation, introduction, pushability, trackability, inflatability, deflatability, and interaction with supporting devices. |
| Torque Strength | Withstood at least two rotations before failure. | Balloon catheters withstood at least two rotations before failure. The acceptance criterion was met. |
| Dimensional Verification Testing | Catheter inner diameter, catheter length, and catheter profile are all within acceptable tolerances. | Catheter inner diameter, catheter length, and catheter profile were all within acceptable tolerances. The acceptance criteria were met. |
| Element Effectiveness Testing | Applied at least 20% greater stress in a simulated model than a standard PTA balloon (the predicate PTA5) at a given pressure. | Balloons applied at least 20% greater stress in a simulated model than a standard PTA balloon (the predicate PTA5) at a given pressure. The acceptance criterion was met. |
| Animal Testing | Adequate or better performance for preparation, introduction, pushability, trackability, flexibility, radiopacity, inflatability, deflatability, interaction with supporting devices, and inspection after use. No significant differences in arterial impact relative to the predicate device. | Devices were adequate or better in terms of preparation, introduction, pushability, trackability, flexibility, radiopacity, inflatability, deflatability, interaction with supporting devices, and inspection after use. No significant differences in arterial impact relative to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each test beyond indicating "each balloon" or "balloons" and "catheters". The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. These are engineering performance tests, typically performed in a controlled laboratory environment.
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 a medical device based on physical and mechanical properties, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as described above.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the engineering tests, the "ground truth" is defined by the physical specifications, industry standards (e.g., ISO 10555-1, ISO 10555-4), and internal design requirements of the device. For animal testing, it involves direct observation of performance and arterial impact.
8. The sample size for the training set
Not applicable. This device does not use an AI training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI training set.
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