(252 days)
The NavajoTM PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliofemoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Navajo™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal adaptor, coaxial lumen shaft, and a distal dilatation balloon. The Navajo PTA Balloon Dilatation Catheter is compatible with guide wires with a maximum diameter of 0.035" and with 5F to 7F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating on the shaft and is available in useable catheter lengths of 80, 100, 120 and 130cm.
The provided document describes the Navajo™ PTA Balloon Dilatation Catheter and its substantial equivalence to a predicate device, the AgilTrac .035 Peripheral Dilatation Catheter (K022738). The document summarizes performance testing but does not provide specific acceptance criteria or detailed study results with exact performance metrics in a way that directly translates to the requested table format for "reported device performance."
Therefore, the response below will reconstruct the information where possible and explicitly state what is not available based on the provided text.
Acceptance Criteria and Device Performance
The document states, "All tests confirmed the products met the pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each performance test are not explicitly provided, nor are the exact numerical "reported device performance" values. Instead, a list of performance tests is given. For some characteristics (e.g., Rated Burst Pressure), the comparison to the predicate device implies acceptable performance.
Note: The table below summarizes the types of performance characteristics tested. Actual numerical acceptance criteria and reported performance values are not detailed in this document.
| Performance Characteristic | Acceptance Criteria (Implied/General) | Reported Device Performance (Implied/General) |
|---|---|---|
| Catheter Dimensions, Balloon & Tip Profile | Met predefined specifications for dimensions and profile. | Met predefined specifications. |
| Catheter Prep, In/deflation Time | Met predefined specifications for preparation and inflation/deflation. | Met predefined specifications. |
| Catheter Fatigue Integrity | Withstood anticipated fatigue cycles without failure. | Demonstrated integrity over fatigue cycles. |
| Balloon Compliance | Met predefined compliance specifications. | Met predefined specifications. |
| Balloon Rated Rupture Pressure (RBP) | Equal to or higher than predicate device's RBP. | Same or higher RBP than predicate, indicating better safety margin. |
| Catheter Shaft Pressure Integrity | Withstood specified internal pressures without leakage/failure. | Demonstrated integrity under specified pressures. |
| Catheter Interface Compatibility, GW Lumen Collapse Pressure | Compatible with specified guidewires (0.035"), resistant to lumen collapse. | Compatible with 0.035" guidewires, resistant to lumen collapse. |
| Catheter Luer - Shaft Tensile Strength | Met predefined tensile strength requirements. | Met predefined requirements. |
| Catheter Shaft - Balloon Bond Tensile Strength | Met predefined tensile strength requirements. | Met predefined requirements. |
| Catheter Soft Tip Tensile Strength | Met predefined tensile strength requirements. | Met predefined requirements. |
| Catheter Shaft Coating Integrity | Demonstrated integrity of the hydrophilic coating. | Maintained coating integrity. |
| Catheter Flexibility, Kink and Torque Strength | Met predefined requirements for flexibility, kink resistance, and torqueability. | Exhibited acceptable flexibility, kink resistance, and torque strength. |
Detailed Study Information (Based on provided text):
The document describes pre-clinical (bench) testing rather than a clinical study involving patients or human readers. Therefore, several requested categories are not applicable.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document refers to "Navajo™ PTA Balloon Dilatation Catheters" in plural, implying multiple units were tested.
- Data Provenance: Not specified, but generally refers to in-house laboratory testing (bench testing) as implied by the nature of the "Performance Testing" listed. It is retrospective in the sense that the tests were completed and then reported.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was not a study requiring expert readers to establish ground truth for clinical outcomes or image interpretations. The "ground truth" was established by engineering specifications and objective measurements against defined standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication process is mentioned or implied for these types of engineering performance tests.
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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 was not an AI-assisted diagnostic or interpretative device, nor was it a human factors study. It was a physical medical device performance study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not involve an algorithm performed in a standalone manner.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests was based on engineering specifications, regulatory standards (ISO), and objective physical measurements. For example, a "Rated Burst Pressure" test would compare the actual burst pressure of the balloon against a predetermined, specified safe operating pressure.
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI or machine learning model that undergoes "training."
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an algorithm was involved.
§ 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).