(101 days)
Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis.
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
The Mullins-X catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped on the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
The provided text describes the Mullins-X PTV Catheter, a medical device. Here's an analysis of its acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Mullins-X Results |
|---|---|---|
| Visual Inspection | The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device. | All catheters were visually inspected without any anomalies. |
| Balloon Preparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | All catheters tested were without functional difficulties or anomalies. |
| Diameter and Profile Test | The balloon diameter at rated burst pressure shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems. | All catheters met the acceptance criteria. |
| Balloon Distensibility | The results must demonstrate that the balloon diameter is within +/- 10% of the labeled diameter at the RBP and will not be significantly increased at increasingly higher pressures. | All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures. |
| Balloon Minimum Burst Strength | The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure. | All catheters met the established acceptance criteria. |
| Repeated Balloon Inflation (Balloon Fatigue) Test | No breaks allowed. | No Breaks. |
| Balloon Inflation/Deflation Test | Inflation achieved in less than 12 seconds and deflation achieved in less than 20 seconds. | All catheters met the established acceptance criteria. |
| Balloon Deflatability Test | There should be no interference with balloon deflation. | All catheters met the established acceptance criteria. |
| Tip Pull and Torque Test | Must withstand at least 10 turns without breaking. | No breaks. |
| Bond Strength Test | All bonds must withstand at least 3 lbs. of pull strength. | All bonds met the established acceptance criteria. |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400psi). | >30 ATM |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each in-vitro test. Instead, it refers to "all catheters tested" or "all samples," implying that a sufficient number of units were tested to demonstrate compliance with the acceptance criteria. The data provenance is not mentioned, but as this is an in-vitro study, it is likely conducted in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The study described is an in-vitro performance test of a medical device (a catheter), not a diagnostic algorithm that relies on expert interpretation of data. The "ground truth" for these tests is based on objective measurements against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable, as this is an in-vitro performance test, not a study requiring human adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the scope of this device's testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The "Mullins-X PTV Catheter" is a physical medical device, not a software algorithm. The tests performed are standalone performance tests of the physical catheter itself.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on:
- Objective Measurements and Specifications: For criteria like diameter, pressure ratings, and time for inflation/deflation, the ground truth is the predefined numerical specification.
- Absence of Defects: For visual inspection and balloon fatigue tests, the ground truth is the absence of anomalies or breaks.
- Statistical Assurance: For balloon burst strength, the ground truth is a statistical confidence level that a certain percentage of balloons will not burst below the rated pressure.
These are established engineering standards and performance requirements for the device.
8. The Sample Size for the Training Set
Not applicable. This is an in-vitro performance test for a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this device does not involve a training set or 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).