(28 days)
The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, dual lumen coaxial shaft, and a distal dilatation balloon. The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.018" and with 4F and 5F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90 and 130cm.
This document describes the 510(k) summary for the Medtronic Invatec PACIFIC XTREME™ PTA Balloon Dilatation Catheter (K103464). The acceptance criteria and the study to prove the device meets these criteria are based on non-clinical performance (bench testing) and biocompatibility testing, demonstrating substantial equivalence to predicate devices, as no clinical investigation was performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA guidance/ISO standards) | Reported Device Performance (Summary of Bench Testing) |
|---|---|
| Minimum Balloon Burst Strength (RBP) | Performed and passed |
| Balloon Compliance (diameter vs pressure) | Performed and passed |
| Balloon Inflation and Deflation time | Performed and passed |
| Balloon Fatigue (repeat balloon inflations) | Performed and passed |
| Flexibility and Kink Test | Performed and passed |
| Torque Strength | Performed and passed |
| Balloon Preparation | Performed and passed |
| Guidewire Compatibility | Performed and passed |
| Coating Durability | Performed and passed |
| Coating Lubricity | Performed and passed |
| Catheter Diameter-balloon profile usable length | Performed and passed |
| Tensile Strength | Performed and passed |
| Catheter Body Burst Pressure | Performed and passed |
| Introducer Sheath Compatibility | Performed and passed |
| Biocompatibility Criteria (ISO 10993-1, G95-1, Class II Special Controls Guidance PTCA Catheters) | |
| Cytotoxicity | Performed and passed |
| Maximization Sensitization | Performed and passed |
| Intracutaneous Study | Performed and passed |
| Systemic Toxicity | Performed and passed |
| Material Mediated Pyrogen | Performed and passed |
| Hemolysis | Performed and passed |
| In Vivo Thromboresistance | Performed and passed |
| Lee White Coagulation Test | Performed and passed |
| Complement Activation | Performed and passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific bench or biocompatibility test. The document refers to "testing" being conducted and "finished PACIFIC XTREME™ PTA Balloon Catheters" being tested. Specific numbers of units tested are not provided.
- Data Provenance: The studies were conducted in vitro (bench testing) and in vivo (biocompatibility, e.g., animal studies for some tests like Thromboresistance and Intracutaneous). The country of origin is not specified but implicitly within the Medtronic Inc. testing framework. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies are focused on physical and biological properties of the device (bench and biocompatibility testing) rather than interpretation by human experts. The "ground truth" for these tests is defined by established international standards (ISO, FDA guidance) and internal Medtronic Invatec Risk Analysis criteria.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements and assessments against predefined physical or biological endpoints, not subjective interpretation 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:
- Not applicable. This device is a medical catheter, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Bench Testing: Ground truth is established by engineering specifications, validated test methods, and compliance with relevant ISO standards (e.g., for burst pressure, flexibility, etc.) and FDA guidance documents.
- Biocompatibility Testing: Ground truth is established by the pass/fail criteria outlined in ISO 10993-1, FDA Blue Book Memorandum #G95-1, and the FDA guidance for Class II PTCA Catheters. The studies were conducted in accordance with the GLP regulations (21 CFR 58).
8. The sample size for the training set:
- Not applicable. This is a traditional medical device, not a machine learning or AI algorithm that requires a training set. The "training" for the device's design and manufacturing process would involve internal development and quality control, but this is not typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and manufacturing is derived from industry standards, engineering principles, and clinical requirements for safety and efficacy in its intended use.
§ 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).