(28 days)
The ADMIRAL XTREME™ PTA Balloon Dilatation 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 ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.
This is a 510(k) summary for a medical device, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. It's important to understand that this document describes a submission for regulatory clearance, not a scientific study proving clinical effectiveness or diagnostic accuracy in the way an AI algorithm study would.
Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this type of device submission. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering performance testing.
Here's an breakdown of the available information based on your request, with clarifications on why certain categories are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas of acceptance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Catheter and Balloon Dimensional Testing | Device met the acceptance criteria. (Specific dimensions and tolerances are not provided in this summary but would have been part of the full submission). |
| Minimum Balloon Burst Strength (RBP) | Device met the acceptance criteria. (Specific RBP values are not provided). |
| Balloon Compliance | Device met the acceptance criteria. |
| Balloon Inflation and Deflation Time | Device met the acceptance criteria. |
| Balloon Fatigue | Device met the acceptance criteria. |
| Tensile Strength | Device met the acceptance criteria. |
| Flexibility and Kink Test | Device met the acceptance criteria. |
| Torque Strength | Device met the acceptance criteria. |
| Balloon Preparation | Device met the acceptance criteria. |
| Catheter Body Burst Pressure | Device met the acceptance criteria. |
| Guidewire Compatibility | Device met the acceptance criteria. (Compatible with guidewires with a maximum diameter of 0.035"). |
| Introducer Sheath Compatibility | Device met the acceptance criteria. (Compatible with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon). |
| Radiopacity | Device met the acceptance criteria. |
| Coating Lubricity | Device met the acceptance criteria. |
| Coating Durability | Device met the acceptance criteria. |
| Biocompatibility | Requirements were previously met with the predicate device according to ISO 10993 and FDA Blue Book Memorandum #G95-1. (No new materials were used). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: This document does not specify the exact sample sizes used for each of the verification tests. These would typically be determined by engineering and statistical principles relevant to device testing (e.g., number of units tested for burst strength, fatigue, etc.).
- Data Provenance: The testing appears to be internal verification testing performed by the manufacturer (Invatec S.p.A.). The country of origin of the data would therefore be Italy (where Invatec S.p.A. is located). This is prospective testing, as it was conducted specifically for this submission to verify the performance of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, as typically applied to AI or diagnostic image analysis, is not relevant here. The "ground truth" for these engineering tests are established physical standards, measurements, and specifications.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, this is physical device testing, not a clinical study requiring expert adjudication of outcomes or diagnostic findings. The results are based on objective measurements against predefined engineering specifications.
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 submission is for a physical medical device (PTA balloon catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effectiveness metrics are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable. As above, this is not an AI algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Standards: The "ground truth" for this device's performance is based on established engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. For example, balloon burst strength is measured against a specified pressure value, and dimensions are checked against design blueprints.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, this is not an AI algorithm.
§ 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).