(143 days)
The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters, hereafter referred to as the EMPIRA Catheter, are similar in design. The catheters differ in available configurations (diameter versus balloon working length). The EMPIRA Catheter is a sterile, single-use rapid exchange catheter with a nylon-blend balloon near the distal tip. The distal section of the catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of a guide wire (≤ 0.014 in. / 0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal section of the catheter is a single lumen stainless steel PTFE coated hypotube with a single luer port for the inflation of the balloon. The balloon is designed to provide an inflatable segment of specified diameter and length at recommended pressures. The balloon is folded to achieve a low crossing profile and is connected to a tapered, soft tip. The tapered tip facilitates advancement of the catheter to and through the stenosis. A hydrophilic coating is applied from the distal tip to the guide wire port and over the balloon for increased lubricity. All models have two radiopaque marker bands that aid in the placement of the catheter's balloon segment under fluoroscopy. A balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed in the lumen to maintain patency. The proximal end of the catheter is comprised of a hypotube connected to a plastic hub. The hub can be connected to a standard inflation device and is used to inflate/deflate the balloon. A needle with a luer port is included for flushing the distal lumen prior to the insertion of a guide wire.
The EMPIRA Catheter is compatible with standard 0.014" coronary guide wires and 5F guiding catheters. The catheter length is approximately 139 cm. The EMPIRA and EMPIRA NC Rx PTCA Catheters are offered in diameters of 1.5- 4.0 mm and 2.0-4.0, respectively. The working lengths of the treatment balloon are offered in lengths from 6.0 to 30mm. The EMPIRA and EMPIRA NC Rx PTCA Balloon Dilatation Catheter product family consists of multiple sizes.
The provided text describes non-clinical testing performed on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters to demonstrate their substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-driven device.
The document lists various tests conducted, primarily focusing on biocompatibility, physical device characteristics, and packaging/sterilization. For most of these, the "Results" column simply states "PASS," indicating that the device met the criteria for each specific test. However, the specific acceptance criteria themselves are not explicitly detailed in a standalone table within the provided text. Instead, the document notes that testing was performed "in accordance with applicable requirements of FDA Guidance Document - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" and ISO standards.
Therefore, a table of acceptance criteria and reported device performance as typically expected for diagnostic devices is not directly extractable in the requested format. Instead, the document presents a summary of non-clinical tests and their pass/fail outcomes against established standards for PTCA catheters.
Given this context, here's an attempt to address your request based on the available information, noting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria for each test are not listed in the document, and only a "PASS" result is provided, a direct fulfillment of this table with detailed criteria is not possible. The table below lists the tests performed and their reported results against the implicit acceptance criteria of the referenced FDA Guidance and ISO standards.
| Acceptance Criteria (Implicit from reference standards) | Reported Device Performance (Result) |
|---|---|
| Biocompatibility (In accordance with ISO 10993): | |
| Cytotoxicity | PASS |
| Hemolysis | PASS |
| Platelet and Leukocyte Counts | PASS |
| Partial Thromboplastin Time (PTT) | PASS |
| Complement Activation | PASS |
| Thromboresistance | PASS |
| Bacterial Mutagenicity Test | PASS |
| Intracutaneous Reactivity | PASS |
| Materials Mediated Pyrogen | PASS |
| Sensitization | PASS |
| Acute Systemic Toxicity | PASS |
| USP Physico-chemical | PASS |
| Physical and Mechanical Characteristics (In accordance with FDA Guidance Document - Class II Special Controls Guidance Document for Certain PTCA Catheters): | |
| Dimensional Verification | PASS |
| Balloon Preparation, Deployment and Retraction | PASS |
| Balloon Rated Burst Pressure | PASS |
| Balloon Fatigue | PASS |
| Balloon Compliance (diameter vs. Pressure) | PASS |
| Balloon Inflation and Deflation Time | PASS |
| Catheter Bond Strength(s) | PASS |
| Tip Pull | PASS |
| Flexibility and Kink | PASS |
| Torque Strength | PASS |
| Radiopacity | PASS |
| Coating Integrity | PASS |
| Particulate Evaluation | PASS |
| Catheter Body Burst Pressure | PASS |
| Catheter Body Burst Pressure (In-Stent) (*for EMPIRA NC only) | PASS |
| Balloon Rated Burst Pressure (In-Stent) (*for EMPIRA NC only) | PASS |
| Balloon Fatigue (repeat balloon inflations; In-stent) (*for EMPIRA NC only) | PASS |
| Packaging and Sterilization: | |
| Packaging Integrity Testing (In accordance with ISO 11607-1 and ISO 11607-2) | PASS |
| Sterilization (In accordance with ISO 11135-1 and ISO 10993-7) | PASS |
| Shelf Life (In accordance with FDA Guidance Document - Class II Special Controls Guidance Document for Certain PTCA Catheters) | PASS |
| Animal Study: | |
| Comparative testing to currently legally marketed devices (in compliance with 21 CFR 58 - GLP) | PASS |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the sample sizes used for each non-clinical test (e.g., number of catheters tested for burst pressure, fatigue, etc.).
- Data Provenance: The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. These are non-clinical (laboratory/animal) studies, not human clinical trials.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to the provided document. The studies described are non-clinical, involving laboratory testing and an animal study, not human expert interpretation to establish ground truth for a diagnostic device.
4. Adjudication Method
This information is not applicable. The studies are non-clinical laboratory and animal tests, not studies requiring expert adjudication for a diagnostic output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a medical device (PTCA catheter), not an AI-driven diagnostic tool involving human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
No standalone algorithm performance was done, as this is a medical device (PTCA catheter), not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" implicitly refers to the known physical, chemical, and biological properties of the materials and device and their performance under predetermined test conditions as defined by the referenced ISO standards and FDA guidance documents. For the animal study, the ground truth would be the observed physiological responses and device performance in the animal model.
8. Sample Size for the Training Set
This is not applicable. The document describes non-clinical testing for a PTCA catheter, not an AI model that would require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as no AI model training was involved.
§ 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.