(19 days)
The Glider™ PTCA Balloon Dilatation 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 braid reinforced 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 currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.
The provided text describes a 510(k) submission for the Glider™ PTCA Balloon Catheter, focusing on its substantial equivalence to predicate devices and the performance testing conducted. It does not describe a study involving AI, human readers, or the establishment of ground truth by experts in the context of an AI device.
Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as they relate to an AI device.
The document details the following for the Glider™ PTCA Balloon Catheter:
1. Acceptance Criteria and Device Performance:
The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported numerical results for each test. Instead, it states that "No new questions of safety or effectiveness were identified during device testing." This implies that the device met the implied acceptance criteria for each test to demonstrate substantial equivalence to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional Verification (within specified tolerances) | Tested; no new safety/effectiveness issues identified |
| Balloon Preparation, Deployment & Retraction (functional) | Tested; no new safety/effectiveness issues identified |
| Flexibility & Kink (adequate) | Tested; no new safety/effectiveness issues identified |
| Balloon Rated Burst Pressure (RBP) (meets specifications) | Tested; no new safety/effectiveness issues identified |
| Balloon Fatigue (withstands stress over time) | Tested; no new safety/effectiveness issues identified |
| Balloon Compliance (expands to known diameters/lengths) | Tested; no new safety/effectiveness issues identified |
| Balloon Inflation and Deflation (functional) | Tested; no new safety/effectiveness issues identified |
| Catheter Bond Strength (adequate) | Tested; no new safety/effectiveness issues identified |
| Tip Pull Test (adequate strength) | Tested; no new safety/effectiveness issues identified |
| Torque Strength (adequate) | Tested; no new safety/effectiveness issues identified |
| Radiopacity (visible under fluoroscopy) | Tested; no new safety/effectiveness issues identified |
| Catheter Coating Integrity (intact) | Tested; no new safety/effectiveness issues identified |
| Particulate Evaluation (within limits) | Tested; no new safety/effectiveness issues identified |
| Biocompatibility Testing (Passes all listed tests) | Tested; no new safety/effectiveness issues identified |
Biocompatibility Tests listed:
- Hemolysis Assay Direct Contact
- Hemolysis Assay Extract Method
- Platelet & Leucocyte Counts
- Partial Thromboplastin Time
- Thromboresistance
- Complement Activation C3a and SC5b-9 Assay
- MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
- Intracutaneous Reactivity Test
- Guinea Pig Maximization Sensitization Test
- Materials Mediated Rabbit Pyrogen Test
- Acute Systemic Injection Test
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample size for each performance test. It only states that "all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544." The testing appears to be primarily bench testing conducted on physical devices, not clinical data. The data provenance is not explicitly stated as country of origin, but the submission is from TriReme Medical, Inc. based in California, USA, implying the testing was likely conducted in the USA or under US regulations for medical devices. The nature of these tests classifies them as prospective bench tests on manufactured devices, not retrospective analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a premarket notification for a medical device (PTCA Balloon Catheter), not an AI device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the design specifications and established engineering/biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a submission for a physical medical device, not an AI device where human adjudication of results is relevant. The "adjudication" for these tests lies in comparing test results against predefined engineering and regulatory standards.
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 document describes a physical medical device (PTCA Balloon Catheter), not an AI-assisted diagnostic or interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the performance testing mentioned, the "ground truth" is based on established engineering standards, device specifications (e.g., balloon diameters at specific pressures, bond strengths), and biocompatibility guidelines outlined in FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010). There is no "expert consensus" on clinical cases, pathology, or outcomes data used to establish ground truth for these bench tests.
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.
§ 870.5100 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.