(105 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 has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. 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 (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.
The provided document is a 510(k) summary for the AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER, a medical device. This type of document is for a medical device that does not use AI/ML technology, and therefore, many of the requested categories are not applicable. The document describes the device, its intended use, and how its safety and effectiveness were demonstrated through in-vitro testing and comparison to predicate devices, rather than a study with acceptance criteria and device performance as typically understood for AI/ML devices.
Here's an attempt to answer the questions based on the provided text, noting where information is not applicable or unavailable:
1. Table of acceptance criteria and the reported device performance
Since this is a physical medical device (a catheter) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on a series of in-vitro physical tests designed to ensure the device meets engineering specifications and safety standards, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Balloon Compliance | Demonstrated, indicating balloon inflates as expected. |
| Balloon Burst Pressure | Demonstrated, ensuring balloon can withstand pressure. |
| Balloon Fatigue | Demonstrated, indicating durability under repeated use. |
| Shaft Burst Pressure | Demonstrated, ensuring shaft integrity under pressure. |
| Bond Strength | Demonstrated, ensuring structural integrity of components. |
| Catheter Dimensions | Demonstrated, meeting specified dimensions. |
| Guidewire Compatibility | Demonstrated, compatible with 0.014-inch guidewires. |
| Introducer Compatibility | Demonstrated, compatible with introducer sheaths. |
| Biocompatibility | All materials proved biocompatible based on test results. |
2. Sample sized used for the test set and the data provenance
For physical medical devices, "test set" typically refers to the number of individual devices or components subjected to specific physical bench tests. The document does not specify the exact sample sizes (e.g., number of catheters tested for burst pressure), nor does it describe data provenance in terms of country of origin or retrospective/prospective, as these concepts are not applicable to the in-vitro mechanical and material tests described.
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 physical device testing is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation or labeling decisions, typically involving multiple human readers to establish a consensus ground truth. This is not relevant for the in-vitro physical testing of a catheter.
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/ML diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for demonstrating safety and effectiveness was based on:
- Engineering Specifications: Performance metrics (e.g., burst pressure, dimensions) were compared against predefined engineering and design specifications.
- Material Standards: Biocompatibility testing followed established material science standards.
- Predicate Device Equivalence: Performance was deemed "substantially equivalent" to legally marketed predicate devices through comparison of physical characteristics and mechanical testing data.
8. The sample size for the training set
Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary regarding AI/ML relevance:
The provided document describes a traditional 510(k) submission for a physical medical device (PTA balloon catheter). It focuses on demonstrating substantial equivalence to predicate devices through physical characteristics (design, materials, dimensions) and in-vitro performance testing (e.g., burst pressure, biocompatibility). None of the information suggests the involvement of AI/ML technology, hence many of the questions regarding AI/ML study design and performance metrics are 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).