(86 days)
The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.
The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial, dual lumen design with a inflatable balloon on the distal end and compatible with 0.035" guidewires. Two radiopaque markers indicate the dilating portion of the balloon and aid in balloon placement. The device is available with balloon diameters of 7.0 - 10.0 mm, balloon lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.
The provided text describes the 510(k) summary for the Admiral™.035 Dilatation Catheter, a Peripheral Transluminal Angioplasty (PTA) Catheter. The document outlines performance testing conducted to demonstrate its safety and effectiveness, and for comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material Composition | To be constructed of similar materials to the predicate device. | Constructed of similar materials to the predicate device and other currently marketed PTA Catheters. |
| Dimensions (Diameter & Length) | To be available in similar diameters and lengths to the predicate device. | Available in similar diameters and lengths as the predicate device. |
| Design | To have a similar design to the predicate device. | Has a similar design as the predicate device (Over-the-Wire, Coaxial, dual lumen design with an inflatable balloon on the distal end and compatible with 0.035" guidewires; two radiopaque markers). |
| Indications for Use | To have the same indications for use as the predicate device. | Has the same indications as the predicate device. |
| Biocompatibility | Must pass all biocompatibility testing. | The Admiral™.035 Dilatation Catheter has passed all Biocompatibility testing. |
| Balloon Minimum Burst Strength | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Balloon Minimum Burst Strength, to demonstrate Safety and Effectiveness. |
| Compliance | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Compliance, to demonstrate Safety and Effectiveness. |
| Fatigue | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Fatigue, to demonstrate Safety and Effectiveness. |
| Inflation/Deflation performance | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Inflation/Deflation performance, to demonstrate Safety and Effectiveness. |
| Bond Strengths | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Bond Strengths, to demonstrate Safety and Effectiveness. |
| Coating Integrity | (Not explicitly stated, but assumed to meet industry standards for safety and efficacy). | Performance testing was conducted, including Coating Integrity, to demonstrate Safety and Effectiveness. |
| Overall Safety and Effectiveness | To demonstrate safety and effectiveness. | Bench and Biocompatibility testing has demonstrated the safety and effectiveness of the device. |
| Substantial Equivalence | To achieve substantial equivalence to the predicate device. | The Admiral™.035 Dilatation Catheter is substantially equivalent to the predicate device and other currently marketed PTA Catheters. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for specific performance tests (e.g., how many catheters were tested for burst strength, fatigue, etc.). It only states that "Performance testing was conducted." The data provenance is also not detailed regarding geographical origin or whether the tests were retrospective or prospective, though bench testing implies a controlled, prospective lab environment. However, the study is a bench study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on human or animal subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. This is a medical device, and the evaluation is based on engineering and materials performance, not on interpretation of medical images or patient data by human experts for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as there are no human interpretations or judgments to adjudicate in the described bench testing.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a physical medical device (catheter), not an AI diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI technology. It is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is established through:
- Engineering specifications and standards: The device's physical properties are measured against established engineering requirements and industry norms for catheters.
- Predicate device characteristics: The predicate device serves as a benchmark for comparison in terms of materials, design, dimensions, and intended use.
- Biocompatibility standards: International and national standards for biological safety of medical devices are used as the ground truth for biocompatibility testing.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI or machine learning device requiring a training set.
§ 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).