(149 days)
The Admiral Xtreme PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Admiral Xtreme is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter. The device is provided sterile (EtO).
The catheter has a dual-lumen shaft that is branched at the proximal end. One lumen forms the entrance to the central lumen for the guidewire, and the other lumen is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter and balloon are designed to reach targeted inflation diameters, depending on the balloon size and defined pressure.
The Admiral Xtreme is compatible with guidewires with a maximum diameter of 0.035" (0.89 mm) and with 5F, 6F or 7F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 80, 130 or 150cm.
Balloon sizes range from 3.0mm to 12.0mm in diameter, with balloon lengths from 20mm to 300mm. The balloons reach nominal diameter at 6atm or 8atm (Nominal Pressure) and have Rated Burst Pressure (RBP) of 14atm, 12atm and 11atm depending on the balloon diameter and balloon length.
The provided text describes the 510(k) summary for the Medtronic Admiral Xtreme PTA balloon dilatation catheter. It details the device, its intended use, and comparative testing to establish substantial equivalence to a predicate device. However, it does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested, especially concerning AI/algorithm performance.
Instead, the document outlines bench testing, biocompatibility testing, and a comparison to a predicate device for safety and effectiveness. This is typical for a traditional medical device (catheter) submission, not an AI/algorithm-based device.
Therefore, many of the requested fields cannot be filled from the provided text as they are specific to the evaluation of AI/ML or diagnostic image analysis devices.
Here's an attempt to extract and interpret the information based on the provided text, while also noting what is not present:
Acceptance Criteria and Device Performance for Medtronic Admiral Xtreme PTA Balloon Dilatation Catheter (K173515)
This submission describes a traditional medical device (PTA balloon catheter), not an AI-powered or algorithm-only device for which acceptance criteria and studies would typically focus on diagnostic performance metrics like sensitivity, specificity, AUC, or reader studies with AI assistance. The "acceptance criteria" referred to in this document are engineering and performance specifications for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Dimensional Verification | "All the pre-determined acceptance criteria were met and the testing passed." |
| Balloon Prep, Deployment, Retraction | "All the pre-determined acceptance criteria were met and the testing passed." |
| Balloon Rated Burst Pressure (RBP) | "All the pre-determined acceptance criteria were met and the testing passed." |
| Balloon Fatigue (repeated inflations) | "All the pre-determined acceptance criteria were met and the testing passed." |
| Balloon Compliance (Diameter vs. Pressure) | "All the pre-determined acceptance criteria were met and the testing passed." |
| Balloon Inflation/Deflation Time | "All the pre-determined acceptance criteria were met and the testing passed." |
| Catheter Bond Strength | "All the pre-determined acceptance criteria were met and the testing passed." |
| Tip Pull | "All the pre-determined acceptance criteria were met and the testing passed." |
| Flexibility and Kink | "All the pre-determined acceptance criteria were met and the testing passed." |
| Torque Strength | "All the pre-determined acceptance criteria were met and the testing passed." |
| Coating Integrity | "All the pre-determined acceptance criteria were met and the testing passed." |
| Hub Test | "All the pre-determined acceptance criteria were met and the testing passed." |
| Laser Marking Visual Inspection | "All the pre-determined acceptance criteria were met and the testing passed." |
| Catheter Burst Pressure | "All the pre-determined acceptance criteria were met and the testing passed." |
| Catheter Fatigue | "All the pre-determined acceptance criteria were met and the testing passed." |
| Particulate Evaluation | "All the pre-determined acceptance criteria were met and the testing passed." |
| Radiopacity | Leveraged from the predicate device (implies met predicate's criteria). |
| Biocompatibility Testing | |
| Cytotoxicity Study (ISO MEM Elution) | "All the pre-determined acceptance criteria were met and the testing passed." |
| ASTM Hemolysis Study | "All the pre-determined acceptance criteria were met and the testing passed." |
| Infrared Spectroscopy Study | "All the pre-determined acceptance criteria were met and the testing passed." |
| Other Biocompatibility (leveraged from predicate/reference) | Implied to have met relevant criteria given leveraging for substantial equivalence. |
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study described is a series of non-clinical bench tests and biocompatibility evaluations designed to demonstrate that the modified Admiral Xtreme PTA balloon catheter is substantially equivalent to a previously cleared predicate device. The testing plan was developed based on risk assessment of device modifications and recommendations from FDA guidance and ISO standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. For bench testing, sample sizes typically refer to the number of individual devices or components tested for each specific test. This detailed breakdown is not provided in the summary.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of diagnostic data. The tests are bench tests performed in a lab setting, not on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a physical catheter, not a diagnostic imaging or AI device requiring expert-established ground truth from medical images or data. Ground truth for performance tests would be established by measurement instruments against engineering specifications.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication of diagnostic data is involved as this is not a diagnostic device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (comparing human readers with or without AI assistance) is specific to AI/ML diagnostic tools. This device is a physical catheter.
6. Standalone (Algorithm Only) Performance Study:
- No. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the performance characteristics of this physical device are engineering specifications, material science standards, and established regulatory benchmarks for medical devices of its type. For biocompatibility, it's the biological response measured against ISO standards for safety.
8. Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply.
§ 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).