(32 days)
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.
This document is a 510(k) premarket notification for a medical device called the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. It's a submission to the FDA to demonstrate that the modified device is "substantially equivalent" to an already marketed device, meaning it's equally safe and effective.
Here's the breakdown of the information requested, based on the provided text:
Acceptance Criteria and Study Details:
The provided document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving these criteria were met using those metrics. Instead, the document focuses on demonstrating "substantial equivalence" to a predicate device through performance testing (bench testing) and similarity in intended use, materials, and technological characteristics.
Therefore, a table of acceptance criteria and reported device performance, and most of the detailed questions about studies, cannot be directly answered from the provided text as they relate to clinical effectiveness studies with human subjects or AI algorithm performance.
However, based on the available information, we can infer the acceptance criteria for a 510(k) submission of this type:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Description (Inferred) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The modified device must be substantially equivalent to a legally marketed predicate device in intended use, materials, and technological characteristics. | The document explicitly states: "The modified device is substantially equivalent to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance." This claim is made based on the comparison to the predicate. |
| Performance (Bench) | The device's physical and functional properties must meet established design specifications and demonstrate performance consistent with its intended use and comparative to the predicate device. | "Performance testing (bench) further supports a substantial equivalence claim." While specific numerical results are not provided, the testing was deemed sufficient to support the claim. |
| Safety & Effectiveness | The device must be safe and effective for its intended use. | The collective evidence (substantial equivalence in characteristics and performance testing) "provides assurance that the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use." |
Important Note: The document focuses on demonstrating substantial equivalence, not on providing efficacy and safety data from clinical trials in the way an AI algorithm or a novel drug might. The "acceptance criteria" here are primarily satisfied by demonstrating that the device is fundamentally the same as a previously approved device.
The following questions relate to performance studies, often associated with AI/ML devices or clinical trials. Since this document is a 510(k) for a physical medical device (a balloon catheter) demonstrating substantial equivalence, these specific types of studies are not described or relevant in this context.
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set from patient data. The "ground truth" for the bench testing would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from data.
9. How the ground truth for the training set was established: Not applicable.
§ 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).