(49 days)
The SUBMARINE™ PLUS 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 SUBMARINE PLUS Balloon Dilatation Catheter is a catheter with 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 0.018 inch (0.45 mm). 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. 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 (balloon excluded). The SUBMARINE PLUS Balloon Dilatation Catheter is available in different balloon sizes (balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.018" and the usable catheter length is 130 or 90 cm.
The SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter demonstrated its safety and effectiveness through in vitro testing.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Balloon Compliance | Testing conducted. Results are indicative of safety and effectiveness. |
| Balloon Burst Pressure | Testing conducted. Results are indicative of safety and effectiveness. |
| Balloon Fatigue | Testing conducted. Results are indicative of safety and effectiveness. |
| Shaft Burst Pressure | Testing conducted. Results are indicative of safety and effectiveness. |
| Bond Strength | Testing conducted. Results are indicative of safety and effectiveness. |
| Catheter Dimensions | Testing conducted. Results are indicative of safety and effectiveness. |
| Guidewire Compatibility | Testing conducted. Results are indicative of safety and effectiveness. |
| Introducer Compatibility | Testing conducted. Results are indicative of safety and effectiveness. |
| Biocompatibility | |
| Biocompatibility Assessment | All materials used are biocompatible based on biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes in vitro testing. Therefore, there is no "test set" in the context of human patient data. The sample sizes for each specific in vitro test (e.g., number of catheters tested for burst pressure) are not explicitly stated in this summary. The data provenance is from laboratory testing performed by Invatec Innovative Technologies, based in Roncadelle (BS) Italy. This testing is prospective in nature, as it was conducted specifically to demonstrate the device's characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. As the study involved in vitro testing, there was no human test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for each test was determined by established engineering and material science standards and measurements.
4. Adjudication Method:
Not applicable. There was no clinical data or expert review requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done for this device. This is an in vitro performance study for a medical device (catheter), not an AI algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical medical instrument (catheter), not a software algorithm.
7. Type of Ground Truth Used:
The ground truth used for this study was based on engineering specifications, material science standards, and direct physical measurements obtained during the in vitro testing. For example, balloon burst pressure would be compared against a defined maximum pressure, and dimensions against designed specifications.
8. Sample Size for the Training Set:
Not applicable. As this is an in vitro performance study of a physical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the reasons stated above.
§ 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).