(141 days)
The NC Gallant PTCA Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.
The NC Gallant is a sterile, single-use, intravascular medical device. The NC Gallant is a double lumen catheter comprising an expandable non-compliant (NC) coronary balloon on a rapid exchange (RX) catheter.
Here's a breakdown of the acceptance criteria and the study information for the Medinol Ltd. NC Gallant PTCA Catheter, based on the provided FDA 510(k) summary:
This device is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is typically subject to bench testing and biocompatibility testing to establish substantial equivalence. It's important to note that for this type of device, the "acceptance criteria" are generally met by demonstrating that the device performs comparably to legally marketed predicate devices across a series of established engineering and biocompatibility tests. There isn't typically a "performance metric" in the same way an AI/ML device would have for diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Completed |
| Sensitization | Completed | |
| Intracutaneous Toxicity | Completed | |
| Material Mediated Pyrogenicity | Completed | |
| In Vitro Hemolysis | Completed | |
| Partial Thromboplastin Time | Completed | |
| In Vivo Thromboresistance | Completed | |
| Bacterial Reverse Mutation | Completed | |
| Mouse Lymphoma Assay | Completed | |
| Mouse Peripheral Blood Micronucleus Study | Completed | |
| C3a Complement Activation Assay | Completed | |
| SC5b-9 Complement Activation Assay | Completed | |
| In-Vitro Performance | Visual and Handling Performance | Completed |
| Dimensional Verification | Completed | |
| Crossing Profile | Completed | |
| Simulated Use | Completed | |
| Kissing Balloon Technique (KBT) | Completed | |
| Balloon Rated Burst Pressure | Completed | |
| Balloon Fatigue (Repeat Balloon Inflations) | Completed | |
| Balloon Diameter vs. Balloon Pressure (Compliance), Balloon Diameter at NIP, Balloon Diameter at RBP, Markers Positioning, Balloon Working Length | Completed | |
| Catheter Bond Strength | Completed | |
| Tip Pull Test | Completed | |
| Flexibility and Kink Resistance | Completed | |
| Torque Strength | Completed | |
| Catheter Radiopacity | Completed | |
| Particulate Evaluation | Completed | |
| Coating Integrity | Completed | |
| Balloon Rated Burst Pressure (in Stent) | Completed | |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | Completed | |
| Catheter corrosion resistance | Completed | |
| Packaging Integrity | Completed | |
| Environmental & Shipping & Accelerated Shelf-Life | Completed | |
| In-Vivo Performance | GLP Acute Performance Study of Novel NC PTCA Balloons in Porcine Model | Completed |
Overall Conclusion: The document states, "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, the NC Gallant may be considered substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance
The document describes bench testing, biocompatibility testing, and a GLP acute performance study in a porcine model. These types of studies use manufactured devices and animal models, not human patient data in the way an AI/ML diagnostic device would. Therefore, the concept of "sample size for the test set" concerning human patient data or "data provenance" (country of origin, retrospective/prospective) is not directly applicable here.
- Bench Testing: Involves testing multiple units of the manufactured device to various physical and mechanical specifications. The specific number of units tested for each in-vitro test is not detailed in this summary but would be part of the full submission.
- Biocompatibility Testing: Involves testing materials and components according to established standards. The sample sizes for these tests are dictated by the specific ISO standards (e.g., ISO 10993 series) applied.
- Porcine Model Study: This is an animal study. The specific number of animals used is not provided in this summary but would be part of the GLP (Good Laboratory Practice) study report. The document states it's a "Porcine Model."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of medical device submission. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or assessment made by human experts or pathology. For a PTCA catheter, performance is evaluated against engineering specifications, biocompatibility standards, and observable outcomes in animal models or clinical trials (though a clinical trial is not described as the primary method for substantial equivalence here beyond the porcine model). The "ground truth" is typically defined by regulatory standards and established scientific methods for testing medical device properties.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert opinions are resolved to establish a single ground truth, which is relevant for AI/ML diagnostic performance studies. For physical devices like catheters, performance is evaluated by measurable outcomes from tests, not subjective interpretations.
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
This question is not applicable. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI. The NC Gallant PTCA Catheter is a physical interventional device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This refers to the performance of an AI algorithm independently. The NC Gallant PTCA Catheter is a physical device.
7. The type of ground truth used
For this device, the "ground truth" is established through:
- Engineering specifications and standards: Performance metrics like burst pressure, flexibility, and dimensions are compared against predetermined valid ranges and the performance of predicate devices.
- Biocompatibility standards (e.g., ISO 10993 series): These define acceptable levels of biological response to materials.
- Observations from the GLP acute performance study in a porcine model: This would involve evaluating the device's function, safety, and any tissue reactions in a living system according to predefined criteria for successful deployment and physiological response.
8. The sample size for the training set
This question is not applicable. This refers to AI/ML development. The NC Gallant PTCA Catheter is a physical medical device; it does not involve a training set as an AI algorithm would.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
§ 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.