(133 days)
The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature 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 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is an over the-wire (OTW) co-axial percutaneous transluminal angioplasty (PTA) catheter system designed for use with a 0.014" guidewire. The shaft of the PTA balloon catheter contains a distal balloon and a manifold on the proximal. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.014" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.
The document provided is a 510(k) summary for a medical device (014 Hydrophilic Coated PTA Balloon Dilatation Catheter) and does not contain information related to an AI/ML-driven device. Therefore, some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable.
The document describes the device's acceptance criteria in terms of various performance bench tests, biocompatibility, and sterilization, and confirms that the device meets these criteria through non-clinical testing.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Bench Testing) | Reported Device Performance (Implied as Met) |
|---|---|
| Rated Burst Pressure (RBP) | Met through testing |
| Balloon Diameter at Nominal Pressure | Met through testing |
| Multiple Inflation/Fatigue & Leak Test | Met through testing |
| Balloon Length & Marker Band Position | Met through testing |
| Inflation & Deflation Time | Met through testing |
| Ancillary Tool Compatibility (Guidewire) | Met through testing |
| Catheter Effective Length | Met through testing |
| Tensile Strength (strength of the catheter shafts, bonds and tip) | Met through testing |
| Device Compatibility (sheath, ancillary devices) | Met through testing |
| Tip Profile (Geometry of the catheter most distal tip) | Met through testing |
| Simulated Use | Met through testing |
| Flexibility & Kink | Met through testing |
| Coating Lubricity | Met through testing |
| Particulate | Met through testing |
| Radiopacity | Met through testing |
| Biocompatibility | |
| Neutral Red Cytotoxicity Testing | Biocompatible and suitable for intended use |
| Kligman Maximization Sensitization Test | Biocompatible and suitable for intended use |
| Irritation by Intracutaneous Injection | Biocompatible and suitable for intended use |
| Acute Systemic Toxicity by Systemic Injection | Biocompatible and suitable for intended use |
| Rabbit Pyrogen Test (Material Mediated) | Biocompatible and suitable for intended use |
| Hemolysis ASTM Method (Direct and Indirect) | Biocompatible and suitable for intended use |
| C3a Complement Activation Assay | Biocompatible and suitable for intended use |
| SC5b Complement Activation Assay | Biocompatible and suitable for intended use |
| In vivo Thrombogenicity Assay | Biocompatible and suitable for intended use |
| Sterilization | |
| Product Bioburden (Bioburden Validation) | Meets requirements of ISO 11135:2014, sterility maintained |
| LAL/Endotoxin Testing (LAL Validation) | Meets requirements of ISO 11135:2014, sterility maintained |
| Residual Degas Assessment | Meets requirements of ISO 11135:2014, sterility maintained |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "non-clinical testing" and "bench testing." It does not specify the exact sample sizes for each test performed. The tests are laboratory-based (bench, biocompatibility, sterilization), so "data provenance" in terms of clinical patient data or geographic origin is not applicable here. These are likely conducted in a controlled lab environment by the manufacturer (Creagh Medical, Ltd., dba Surmodics, Inc. in Ireland, with sterilization site in Ireland).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is not an AI/ML diagnostic or image analysis device that requires expert ground truth for interpretation. Ground truth for these types of engineering and biocompatibility tests typically comes from established scientific methods, standards (e.g., ISO), and regulatory guidelines, rather than expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no human interpretation or diagnostic ground truth to adjudicate for this type of device testing.
5. 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
Not applicable. This is not an AI-assisted device. The document explicitly states: "No clinical data is being submitted for the 014 Hydrophilic Coated PTA Balloon Dilatation Catheter."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests relies on pre-defined specifications, engineering tolerances, established scientific standards (e.g., ASTM for hemolysis), and regulatory standards (e.g., ISO for biocompatibility and sterilization). For instance, for bench tests like "Rated Burst Pressure," the ground truth is the specified burst pressure it must withstand. For "Biocompatibility," the ground truth is that the device must pass the criteria outlined in ISO 10993-1. For "Sterilization," the ground truth is compliance with ISO 11135:2014.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a training set.
§ 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).