(273 days)
The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Glider PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 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 and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braidreinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and 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 PTCA Balloon Catheter is supplied sterile and intended for single use.
The provided text describes the 510(k) summary for the Glider™ PTCA Balloon Catheter. This device is a medical instrument and its evaluation focuses on physical performance and biocompatibility, not on AI/ML algorithm performance. Therefore, many of the requested categories related to AI/ML studies (such as sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this document.
Here's the information that can be extracted from the provided text, adapted for a medical device that doesn't involve AI/ML:
Acceptance Criteria and Device Performance
The device performance was evaluated against the "FDA Guidance Class II Special Controls for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)." This guidance document specifies the acceptance criteria for the various performance tests. The given document states that the device was subjected to these tests and no new questions of safety or effectiveness were identified, implying that the device met the established acceptance criteria.
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| Dimensional Verification | Met criteria as no new safety/effectiveness issues identified. |
| Balloon Preparation, Deployment & Retraction | Met criteria as no new safety/effectiveness issues identified. |
| Flexibility & Kink | Met criteria as no new safety/effectiveness issues identified. |
| Balloon Rated Burst Pressure (RBP) | Met criteria as no new safety/effectiveness issues identified. |
| Balloon Fatigue | Met criteria as no new safety/effectiveness issues identified. |
| Balloon Compliance | Met criteria as no new safety/effectiveness issues identified. |
| Balloon Inflation and Deflation | Met criteria as no new safety/effectiveness issues identified. |
| Catheter Bond Strength | Met criteria as no new safety/effectiveness issues identified. |
| Tip Pull Test | Met criteria as no new safety/effectiveness issues identified. |
| Torque Strength | Met criteria as no new safety/effectiveness issues identified. |
| Radiopacity | Met criteria as no new safety/effectiveness issues identified. |
| Catheter Coating Integrity | Met criteria as no new safety/effectiveness issues identified. |
| Particulate Evaluation | Met criteria as no new safety/effectiveness issues identified. |
| Biocompatibility Testing (11 specific tests listed) | Met criteria as no new safety/effectiveness issues identified. |
Study Details (Non-AI/ML focused):
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (e.g., number of catheters tested) for each physical performance and biocompatibility test. It only lists the types of tests performed.
- Data Provenance: The testing was presumably conducted by TriReme Medical, Inc. or a contracted lab, as part of their submission to the FDA. The country of origin for the data is not specified, but the submitter is based in Pleasanton, CA, U.S.A. The studies are by nature prospective, as the device was manufactured and then tested to demonstrate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to a physical medical device like a PTCA catheter. "Ground truth" in this context would refer to the objective, measurable outcomes of the physical tests (e.g., actual burst pressure, measured dimensions). These are determined by laboratory equipment and standardized procedures, not by expert consensus in an observational or diagnostic context.
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Adjudication method for the test set:
- Not applicable for physical performance and biocompatibility testing. Results are typically quantitative and objective measurements against predefined specifications.
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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 as this is a physical medical device, not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device, not an AI/ML algorithm.
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The type of ground truth used:
- For physical performance tests, the "ground truth" is established by the objective measurement of physical properties (e.g., direct measurement of dimensions, pressures, forces) against engineering specifications and regulatory guidance.
- For biocompatibility tests, the "ground truth" is established by laboratory assays and biological testing outcomes (e.g., observation of cell viability, measurement of hemolysis rates) against established biocompatibility standards and limits.
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The sample size for the training set:
- Not applicable as this is a physical medical device. The concept of a "training set" is relevant for AI/ML models. For a physical device, development typically involves iterative design, prototyping, and testing, but not a "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable as this is a physical medical device.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.