(72 days)
The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.
The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-thewire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, coaxial dual lumen shaft, and a distal dilatation balloon. Hydrophilic coating covers the distal 240 mm of the catheter and radiopaque markers indicate the proximal and distal dilating surface of the balloon and facilitate placement across the stenosis. The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is compatible with 4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.
The provided text describes a 510(k) premarket notification for a medical device, the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance data often found in AI/Reader studies.
Therefore, many of the requested categories (2, 3, 4, 5, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided primarily pertains to the general performance data and conclusion.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench test acceptance criteria for the device | Demonstrated that the device could meet the bench test acceptance criteria, and was comparable to the predicate devices. |
| Biocompatibility testing in accordance with ISO 10993-Part 1 | Biocompatibility testing was previously performed in accordance with ISO 10993-Part 1 (for related devices, as this is a new model/length). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on bench testing and comparison to predicate devices, not a clinical study on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No expert ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No test set adjudication is mentioned.
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
Not applicable. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The device (catheter) performance was evaluated via bench testing.
7. The type of ground truth used
For bench testing, the "ground truth" would be established engineering specifications, performance standards, and the performance characteristics of the predicate devices. The study compares the new device's physical and mechanical properties against these established benchmarks.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and fundamental technology are stated to be "same or similar" to previously cleared devices.
9. How the ground truth for the training set was established
Not applicable. There is no "ground truth for a training set" as it's not an AI/machine learning 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).