(45 days)
The Glider™ PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The Glider™ 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" 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 within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip.
The Glider™ PTA Balloon Catheters are supplied sterile and intended for single use.
Here's an analysis of the provided text regarding the TriReme Medical Glider™ PTA Balloon Catheter:
The provided document is a 510(k) Summary and related FDA correspondence for a medical device. It does not contain information about acceptance criteria, device performance metrics, or a study that specifically "proves the device meets acceptance criteria" in the way one would describe an AI/software-as-a-medical-device (SaMD) study.
This document describes a physical medical device (a balloon catheter) and its clearance through the FDA's 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel clinical effectiveness through large-scale trials with predefined acceptance criteria.
Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission. I will address the points that can be inferred or explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable in the context of an AI/SaMD device. For physical devices like this catheter, "acceptance criteria" are typically related to engineering specifications (e.g., burst pressure, fatigue resistance, dimensional accuracy) and "performance" refers to how the device meets these specifications during bench testing. This document states "Bench testing was performed... 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." However, specific quantifiable acceptance criteria and their corresponding reported values are not disclosed in this summary. The FDA's 510(k) summary typically doesn't detail these engineering specifics.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for a clinical test set in the context of AI/SaMD. The "test set" here would refer to the physical devices subjected to bench testing. The sample size for these engineering tests is not provided in the summary. Data provenance is not relevant in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable for a physical device. "Ground truth" as it relates to expert consensus for image annotation or clinical diagnosis is not relevant for the bench testing of a physical catheter.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for AI/SaMD, to establish ground truth from expert opinions. This is not relevant for bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a type of clinical trial often used for diagnostic devices (including AI/SaMD) to compare the performance of human readers with and without AI assistance. This document describes a physical interventional device, and no such study is mentioned or implied.
6. If a Standalone (Algorithm Only) Performance Study was done
- No. This question is exclusively applicable to AI/SaMD.
7. The Type of Ground Truth Used
- Not applicable for a clinical ground truth. For the bench testing of this physical device, the "ground truth" would be established by objective, measurable physical properties and engineering standards (e.g., pressure sensors for burst pressure, calipers for dimensions, flow meters for fluid dynamics). It's based on physical measurements against pre-defined engineering specifications, not expert consensus or pathology in a clinical sense.
8. The Sample Size for the Training Set
- Not applicable. This question exclusively applies to AI/SaMD.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This question exclusively applies to AI/SaMD.
Summary of what can be extracted from the document:
- Device Name: Glider™ PTA Balloon Catheter
- Intended Use: Balloon dilatation of lesions in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries), not for coronary or cerebral vasculature.
- Regulatory Pathway: 510(k) Premarket Notification.
- Basis for Clearance: Substantial equivalence to predicate devices (NanoCross PTA Dilatation Catheter (K090849) and Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)).
- Evidence of Performance: "Bench testing was performed... 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."
- Conclusion: "Performance testing and biocompatibility testing demonstrated that the Glider™ PTA Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing."
Key Takeaway: This document is about the regulatory clearance process for a physical medical device. The types of "acceptance criteria" and "studies" you're asking about are more typical for AI/Software as a Medical Device (SaMD) or clinical trial reports, which differ significantly from a 510(k) summary for a physical product.
§ 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).