(58 days)
The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 014 RX PTA Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.014" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 014 RX PTA Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device, the Surmodics™ Sublime™ Radial Access 014 RX PTA Dilatation Catheter. This document asserts substantial equivalence to a predicate device, meaning it's claimed to be as safe and effective as a legally marketed device, and therefore does not typically involve the extensive clinical trials and efficacy studies seen with novel devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formalized table of acceptance criteria with quantified performance targets and corresponding results. Instead, it states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." for the biocompatibility tests and that performance bench testing results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device."
Here's a summary of the types of tests performed and the implicit "acceptance criteria" met:
| Acceptance Criteria Category | Reported Device Performance | Implicit Acceptance Criteria |
|---|---|---|
| Performance Bench Testing | ||
| Rated burst pressure (RBP) | Met criteria | RBP is sufficient for intended use and comparable to predicate. |
| Inflation & deflation time | Met criteria | Inflation/deflation times are within acceptable ranges for clinical use. |
| Balloon diameters at nominal pressure | Met criteria | Balloon diameters at nominal pressure are within specifications. |
| Simulated use pushability & trackability | Met criteria | Device can be successfully maneuvered and positioned in simulated vessels. |
| Coating lubricity | Met criteria | Coating reduces friction sufficiently. |
| Coating durability | Met criteria | Coating integrity is maintained during use. |
| Coating length | Met criteria | Coating covers the specified length of the device. |
| Ancillary tool compatibility (guidewire) | Met criteria | Device is compatible with specified guidewires. |
| Tip profile | Met criteria | Tip profile is within dimensions for safe navigation. |
| Multiple inflation/fatigue & leak test | Met criteria | Balloon can withstand multiple inflations and does not leak. |
| Tensile strength | Met criteria | Catheter components have sufficient tensile strength. |
| Flexibility & kink | Met criteria | Device is flexible enough for navigation and resists kinking. |
| Particulate | Met criteria | Particulate matter is within acceptable limits. |
| Torque strength | Met criteria | Device can be torqued without structural failure. |
| Biocompatibility Testing | ||
| MEM Elution Cytotoxicity | Met documented acceptance criteria | No cytotoxic effects observed. |
| Kligman Maximization Sensitization | Met documented acceptance criteria | No significant sensitization response observed. |
| Irritation by Intracutaneous Injection | Met documented acceptance criteria | No significant irritation observed. |
| Acute Systemic Toxicity by Systemic Injection | Met documented acceptance criteria | No acute systemic toxic effects observed. |
| Rabbit Pyrogen Test (Material Mediated) | Met documented acceptance criteria | No pyrogenic response observed. |
| Hemolysis ASTM Method | Met documented acceptance criteria | No significant hemolysis observed. |
| SC5b Complement Activation Assay | Met documented acceptance criteria | No significant complement activation observed. |
| Thrombogenicity Testing | Met documented acceptance criteria | No significant thrombogenic potential observed. |
| Sterilization Testing | ||
| Sterilization Product Testing | Demonstrated suitability | Sterilization cycle effectively sterilizes the device. |
| Product Bioburden | Demonstrated suitability | Bioburden level is acceptable for sterilization. |
| LAL/Endotoxin Testing | Demonstrated suitability | Endotoxin levels are below acceptable limits. |
| Residual Degas Assessment | Demonstrated suitability | EO residuals are within acceptable limits after degassing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes for the performance bench tests, biocompatibility tests, or sterilization tests. It only lists the types of tests performed.
Regarding data provenance:
- The tests were conducted by the manufacturer, Creagh Medical, Ltd., dba Surmodics, Inc.
- The sterilization site is Synergy Health Ireland.
- The device is intended for the U.S. market, regulated by the FDA.
- The data would be considered retrospective in the sense that these are studies conducted on manufactured devices as part of the development and regulatory submission process, not ongoing clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The type of device (dilatation catheter) and the studies performed (bench, biocompatibility, sterilization) do not inherently require "ground truth" to be established by experts in the same way an AI diagnostic device would. For these types of tests, ground truth is typically established by physical measurement against engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert panel reviews for diagnostic devices to resolve discrepancies in interpretations of medical images or patient data. The current document describes bench, biocompatibility, and sterilization testing, which rely on standardized laboratory procedures and measurements.
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 device is a physical medical instrument (a dilatation catheter), not an AI algorithm assisting human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was done:
No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any artificial intelligence algorithms.
7. The Type of Ground Truth Used:
For the performance bench testing, the "ground truth" would be the engineering specifications, industry standards (e.g., ISO), and design requirements for a PTA balloon catheter.
For biocompatibility, the ground truth is established by internationally recognized standards and guidelines (ISO 10993-1), with testing against biological responses (e.g., cytotoxicity, irritation, hemolysis).
For sterilization, the ground truth is established by sterilization standards (ISO 11135) and validated procedures to ensure sterility assurance levels.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. "Training set" refers to data used to train machine learning models. This device is a physical catheter, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as above (not an AI device).
§ 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).