(35 days)
The GliderfleX™ 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 GliderfleX™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.
The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains 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 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.
The GliderfleX™ PTA Balloon Catheters are supplied sterile and intended for single use only.
The provided text describes a medical device, the GliderfleX™ PTA Balloon Catheter, seeking 510(k) clearance from the FDA. The document outlines its intended use, device description, and performance data from bench testing to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it lists the types of in vitro bench tests performed and then concludes with a general statement about the results. The "reported device performance" is a high-level summary that the device "reliably achieved the desired effect and is safe for its intended use" and that "no new questions of safety or effectiveness were identified."
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Balloon Rated Burst Pressure | Met expectations |
| Balloon Inflation and Deflation | Met expectations |
| Balloon Fatigue | Met expectations |
| Catheter Body Strength (Bond Strength) | Met expectations |
| Torsional Strength | Met expectations |
| Catheter Diameter, Balloon Profile and Tip Configuration | Met expectations |
| Balloon Compliance | Met expectations |
| Trackability, Pushability | Met expectations |
| Kink Resistance | Met expectations |
| Device Interface Compatibility | Met expectations |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the bench tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically not applicable to purely in vitro bench testing of a device.
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. The study described is an in vitro bench test of the device's physical and mechanical properties. There is no "ground truth" derived from expert interpretation of clinical data in this context. The "ground truth" is established by the specifications and engineering requirements of the device itself.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are relevant in studies involving human interpretation or clinical outcomes, which are not detailed in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes in vitro bench testing of the physical properties of the device, not a study involving human readers or clinical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the GliderfleX™ PTA Balloon Catheter. This is a physical medical device (catheter), not a software algorithm or AI system. Therefore, "standalone algorithm" performance is not relevant.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and industry standards for balloon catheters. The bench tests evaluated the device's ability to meet predefined physical and mechanical properties, not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set
This information is not applicable. There is no concept of a "training set" for a physical medical device undergoing in vitro bench testing. Training sets are typically used in machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" mentioned or implied by the described studies.
§ 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).