(30 days)
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
The Pantera LEO PTCA catheter is a sterile, single-use, intravascular balloon catheter for the dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation balloon is designed to inflate to a known diameter and length at a specific inflation pressure consistent with the compliance chart, which is included in the Instructions for Use (IFU), Compliance Data Card (CDC), and on the labels. The dilatation catheter has a soft tip that is tapered at the distal end of the catheter to facilitate advancement of the catheter. The balloon is folded to achieve a low crossing profile and is connected to the tip. A radiopaque marker is located at each end of the balloon cylindrical section to facilitate fluoroscopic visualization and positioning of the balloon catheter to and across the lesion. The proximal section of the catheter is a single lumen stainless steel hypotube with a single Luer port for the inflation / deflation of the balloon. The Pantera LEO has two coatings; a hydrophobic silicone coating on the outer surface of the hypotube (proximal outer shaft) and balloon, and a hydrophilic polymeric-based coating on the outer surface of the distal outer shaft. The dilatation catheter is compatible with guide wire and guiding catheter sizes according to the recommendations on the label.
Please note that the provided document is a 510(k) Summary for a medical device (Pantera LEO PTCA Catheter) seeking clearance as substantially equivalent to a predicate device. This type of regulatory submission primarily focuses on demonstrating equivalence through non-clinical (bench and biocompatibility) testing, rather than extensive clinical studies that would typically involve humans and advanced AI/algorithm performance.
Therefore, many of the questions related to AI performance, human reader studies, and large-scale clinical ground truth will not be applicable to this document. The focus here is on physical device performance and material safety.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from industry standards/guidance) | Reported Device Performance |
|---|---|---|
| Design Verification In-vitro Testing | The device must meet required performance specifications as per Class II Special Controls Guidance for PTCA Catheters (Sept 8, 2010). | Pantera LEO met all specified design and performance requirements. Performance specifically demonstrated equivalence or betterment compared to the predicate device. |
| Dimensional Verification | (Conformity to design specifications) | Met specifications. |
| Balloon Preparation, Deployment, and Retraction | (Smooth and intended function) | Met specifications. |
| Balloon Rated Burst Pressure | (Ability to withstand specified pressure without failure) | Met specifications. |
| Balloon Fatigue (Repeat Balloon Inflations) | (Durability over multiple inflations) | Met specifications. |
| Balloon Compliance (Diameter vs. Pressure) | (Balloon inflates to known diameter and length at specific pressure as per compliance chart) | Met specifications; compliance chart provided. |
| Tip Pull Test | (Adequate tip securement) | Met specifications. |
| Flexibility and Kink Test | (Resistance to kinking, adequate flexibility) | Met specifications. |
| Catheter Bond Strength | (Integrity of catheter components) | Met specifications. |
| Torque Strength | (Ability to transmit torque without failure) | Met specifications. |
| Radiopacity | (Visibility under fluoroscopy) | Met specifications. |
| Coating Integrity | (Coating remains intact and functional) | Met specifications. |
| Particulate Evaluation | (Minimal particulate shedding) | Met specifications. |
| Shelf Life Testing | Supports a 3-year shelf life. | Supported a 3-year shelf life. |
| Balloon Inflation and Deflation Time | (Within acceptable limits for clinical use) | Met specifications. |
| Additional Tests for In-Stent Restenosis/Stent Expansion | ||
| Balloon Rated Burst Pressure in Stent | (Ability to withstand specified pressure within a stent) | Met specifications. |
| Balloon Fatigue / Repeat Balloon Inflation in Stent | (Durability over multiple inflations within a stent) | Met specifications. |
| Biocompatibility Testing | No evidence of adverse biological effects as per ISO 10993-1 and 2016 FDA Guidance for ISO 10993. | No evidence of adverse biological effects; concluded biologically safe for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each in-vitro bench test. However, these are generally performed on a sufficient number of device units (e.g., typically 3-10 or more, depending on the test) to statistically demonstrate compliance with engineering specifications.
- Data Provenance: All data presented is from non-clinical (in-vitro bench) testing and biocompatibility testing conducted by BIOTRONIK, Inc. This is prospective internal testing, not data from human subjects or clinical trials. The country of origin of the data is implicitly where the testing was performed, which would be associated with the manufacturer (BIOTRONIK, Inc. – Lake Oswego, Oregon, USA, with potentially some testing at manufacturing sites in other countries, though not specified).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. For this type of device (PTCA catheter), "ground truth" in the context of AI or diagnostic imaging is not relevant. The "ground truth" for the non-clinical tests is established by objective physical measurements against engineering specifications and accepted industry standards (e.g., ISO, ASTM, FDA guidance documents). These tests do not rely on expert consensus or interpretation of clinical images.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image review. The non-clinical tests described are objective physical evaluations with pass/fail criteria based on measured performance against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- Not applicable. This document is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance were not conducted as they are irrelevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not applicable. This device is a physical medical instrument (PTCA catheter), not an algorithm or AI system. Standalone algorithm performance studies are not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical bench testing, the "ground truth" is defined by engineering specifications, industry standards, and regulatory guidance documents. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and FDA guidance, ensuring biological safety based on established scientific principles. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical tests.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through traditional engineering methods and validated through the referenced non-clinical tests.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
§ 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.