(182 days)
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
BIOTRONIK's Pantera Pro 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. Pantera Pro has balloon diameters ranging from ∅ 1.25 mm – 4.0 mm and balloon lengths ranging from ∅ 6 mm – 30 mm. All product sizes of Pantera Pro have a usable catheter length of 140 cm. The Pantera Pro has a soft tapered tip 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. The Pantera Pro has two coatings; a hydrophobic coating on the outer surface of the hypotube and a hydrophilic polymeric based coating on the outer surface of the distal outer shaft. In addition, a hydrophobic coating is applied on the balloons of sizes ∅ 2.5 – 4.0 mm whereas a hydrophilic coating is applied on the balloons of sizes ∅ 1.25 – 2.0 mm. The coating is activated by immersing the catheter in sterile saline prior to use. The Pantera Pro is compatible with guide wires of 0.014" (0.36 mm) diameter and guiding catheters with an inner diameter of ≥0.056" (1.42 mm; 5F). For all Pantera Pro product sizes, the nominal pressure (NP) required to achieve the nominal diameter is 7 atm and the rated burst pressure (RBP) is 14 atm.
The provided text describes a medical device, the Pantera Pro Coronary Dilatation Catheter, and its acceptance for market. However, it does not detail a study involving AI or human readers, so I will answer based on the information available regarding the device's performance through non-clinical testing.
The acceptance criteria for the Pantera Pro Coronary Dilatation Catheter are based on various in-vitro bench tests and biocompatibility testing, ensuring it meets performance specifications and is biologically safe for its intended use. The study proving the device meets these criteria is a non-clinical design verification in-vitro testing and biocompatibility assessment.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied/Derived from context) | Reported Device Performance (Summary from text) |
|---|---|---|---|
| Design Verification | Dimensional Verification (including visual inspection) | Meets design specifications | Completed with satisfactory results. |
| Balloon Preparation, Deployment and Retraction | Functionality within specification | Completed with satisfactory results. | |
| Balloon Rated Burst Pressure | ≥ 14 atm | Nominal pressure (NP) is 7 atm, Rated Burst Pressure (RBP) is 14 atm, consistent across sizes. Testing confirmed performance. | |
| Balloon Fatigue | Withstands repeated inflation cycles | Completed with satisfactory results. | |
| Balloon Compliance | Meets specified diameter at pressure | Completed with satisfactory results. | |
| Balloon Inflation and Deflation Time | Within clinically acceptable times | Completed with satisfactory results. | |
| Catheter Bond Strength | Sufficient to maintain integrity | Completed with satisfactory results. | |
| Tip Pull Test | Sufficient to prevent detachment | Completed with satisfactory results. | |
| Flexibility and Kink Test | Maintains patency and navigability | Completed with satisfactory results. | |
| Torque Strength | Sufficient for precise navigation | Completed with satisfactory results. | |
| Radiopacity | Sufficient for visualization during procedure | Completed with satisfactory results. | |
| Coating Integrity | Coatings remain intact and functional | Completed with satisfactory results. | |
| Particulate Evaluation | Meets cleanliness requirements | Completed with satisfactory results. | |
| Shelf Life testing | Supports claimed shelf life | Provided to support a 3-year shelf life. | |
| For Stent Expansion - Balloon Rated Burst Pressure in Stent | ≥ 14 atm (same as stand-alone but within stent) | Completed with satisfactory results. | |
| For Stent Expansion - Balloon Fatigue / Repeat Balloon Inflation in Stent | Withstands repeated inflation cycles within stent | Completed with satisfactory results. | |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement activation, In Vivo Thrombogenicity, Hemocompatibility - Chandler Test, Bacterial Reverse Mutation Assay - AMES test, Mouse Lymphoma Assay, Mammalian Micronucleus Test | Meets ISO 10993-1:2009 standards and | |
| FDA recommendations for limited exposure | All tests completed and the device "met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing." Biologically safe for intended use. | ||
| Sterilization | Sterility Assurance Level (SAL) | 1 x 10-6 | Sterilized with EO gas to achieve a SAL of 1 x 10-6. |
| Endotoxin Limit |
§ 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.