(90 days)
The PTA-Duo PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
The PTA-Duo PTA Balloon Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The PTA-Duo PTA Balloon Catheter is a 0.035" guide-wire compatible, non-compliant, high pressure balloon catheter with a proprietary valve system which allows distal injection of contrast media without the need to remove the guidewire. By providing an angioplasty balloon with distal contrast injection capability. the user is able to treat obstructive lesions within the arteriovenous dialysis fistulae without having to lose guidewire position to visualize the result.
This document describes the design verification and validation of the PTA-Duo PTA Balloon Catheter through various tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text details various tests performed and concludes that the device "met all predetermined acceptance criteria" and "all test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the PTA-Duo PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." However, specific quantitative acceptance criteria or detailed numerical results for each test are not explicitly provided in the given text.
Below is a table summarizing the types of tests mentioned. Without specific acceptance values from the document, we can only state that the device met those unstated criteria.
| Category | Test Performed | Reported Performance |
|---|---|---|
| Biocompatibility | ISO MEM Elution Assay | Met established specifications; materials are non-toxic and non-sensitizing. |
| ASTM Hemolysis Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Complement Activation C3a and SC5b-9 Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Partial Thromboplastin Time | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Four Hour Thromboresistance Evaluation | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Materials Mediated Rabbit Pyrogen | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Guinea Pig Maximization Sensitization | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Acute Systemic Injection Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Intracutaneous Reactivity Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Pyrogen (LAL) Chromogenic | Met established specifications; materials are non-toxic and non-sensitizing. | |
| In-Vitro Performance | Balloon Crossing Profile | Met established specifications necessary for consistent performance. |
| Catheter Shaft Diameter | Met established specifications necessary for consistent performance. | |
| Guidewire Lumen Diameter | Met established specifications necessary for consistent performance. | |
| Catheter Shaft Markings | Met established specifications necessary for consistent performance. | |
| Balloon Working Length | Met established specifications necessary for consistent performance. | |
| Balloon Rated Burst Pressure | Met established specifications necessary for consistent performance. | |
| Balloon Compliance/Outer Diameter | Met established specifications necessary for consistent performance. | |
| Balloon Inflation/Deflation Time | Met established specifications necessary for consistent performance. | |
| Balloon Fatigue | Met established specifications necessary for consistent performance. | |
| Catheter Body Burst Strength | Met established specifications necessary for consistent performance. | |
| Catheter Bond and Tip Pull Strength | Met established specifications necessary for consistent performance. | |
| Catheter Torque Strength | Met established specifications necessary for consistent performance. | |
| Contrast Media Flow Rate | Met established specifications necessary for consistent performance. | |
| Simulated Use/Flexibility/Kink | Met established specifications necessary for consistent performance. | |
| Radiopacity | Met established specifications necessary for consistent performance. | |
| In-Vivo Performance | Angioplasty procedure on synthetic AV grafts (ovine) | Vessel and organ response comparable between test and control device treatments. Met established specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Biocompatibility: Not specified for each test, but standard models like guinea pigs and rabbits are mentioned.
- In-Vitro Performance: Not specified, but generally involves multiple samples of the manufactured device.
- In-Vivo Testing: "ovine specimens" (sheep) with synthetic arteriovenous access grafts. The exact number of specimens is not provided, but it states "test and control comparator groups," implying more than one animal.
- Data Provenance: The studies were internal company studies ("Hotspur Technologies, Inc.") and conducted in accordance with "21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'." The country of origin is not explicitly stated, but the company address is in Mountain View, CA, USA, and the submission is to the US FDA. This indicates US-based studies. The studies are prospective in nature for device verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The tests performed are primarily bench (in-vitro) and animal (in-vivo) studies focused on the physical and biological performance of the device itself, rather than diagnostic interpretation requiring human experts to establish ground truth. Physical measurements, chemical analyses, and histological examinations establish the "ground truth" for device performance.
4. Adjudication Method for the Test Set:
Not applicable for this type of device performance testing. Ground truth is established by objective measurements and scientific analysis, not by expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation of outputs (e.g., medical images) and AI assistance. This document describes the validation of a physical medical device (balloon catheter) where performance is measured objectively.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Biocompatibility: Ground truth was established by laboratory assays measuring cellular response, immune response, and material interactions with biological systems according to ISO and ASTM standards.
- In-Vitro Performance: Ground truth was established by direct physical measurements (e.g., diameter, length, pressure, time) and engineering tests (e.g., fatigue, burst strength, torque).
- In-Vivo Testing: Ground truth was established by surgical observation, post-survival observation, and histological examination of vessel and organ response in ovine specimens, comparing the test device to controls.
8. The Sample Size for the Training Set:
Not applicable. This document pertains to the verification and validation of a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).