(26 days)
The GliderXtreme™ PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The GliderXtreme™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheaths (or 6F guide catheters). Overall catheter length is approximately 135 cm.
The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is available in multiple sizes and contains one or two radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter design of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. A second lumen intended for guidewire use is contained within the catheter. The balloon catheters are available in Rapid Exchange or Over-The-Wire configuration.
The GliderXtreme™ PTA Balloon Catheters are supplied sterile and intended for single use only.
The provided 510(k) summary for the GliderXtreme™ PTA Balloon Catheter (K101062) describes the performance data as "Bench testing was performed to support a determination of substantial equivalence." This means the device's performance was evaluated through a series of in vitro tests, not clinical studies involving human or animal subjects. As such, many of the requested categories (e.g., sample size for test set, experts, adjudication, MRMC studies, ground truth for training/test set) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists the types of tests performed but does not explicitly state quantitative acceptance criteria or specific numerical results. It broadly states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." And "Performance testing demonstrated that the GliderXtreme™ PTA Balloon Catheter reliably achieved the desired effect and is safe for its intended use."
| Test Category | Reported Device Performance |
|---|---|
| Balloon Rated Burst Pressure | Performed, details not provided. |
| Balloon Inflation and Deflation | Performed, details not provided. |
| Balloon Fatigue | Performed, details not provided. |
| Catheter Body Strength (Bond Strength) | Performed, details not provided. |
| Torsional Strength | Performed, details not provided. |
| Catheter Diameter, Balloon Profile and Tip Configuration | Performed, details not provided. |
| Balloon Compliance | Performed, details not provided. |
| Trackability, Pushability | Performed, details not provided. |
| Kink Resistance | Performed, details not provided. |
| Device Interface Compatibility | Performed, details not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The studies were bench testing (in vitro/laboratory tests), not clinical studies with patient data.
- Data Provenance: Not applicable, as no human data was used. The tests were performed in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No expert ground truth was established as this was bench testing.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was used as this was bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not performed. This device is a physical medical device, not a diagnostic algorithm that would typically involve human readers interpreting images.
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
- Not applicable for a "ground truth" in the diagnostic sense. For each bench test, the "ground truth" or reference was likely defined by engineering specifications, validated test methods, and industry standards for medical device performance. For example, balloon burst pressure would be compared against a predefined burst pressure specification.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of bench testing for a physical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" or associated ground truth for this type of submission.
§ 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).