(88 days)
The Bard PTV Dilatation Catheters are 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.
The Bard PTV Dilatation Catheter is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over the wire catheter is compatible with 0.035" guidewire and is available in 75 and 100 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard PTV Dilatation Catheter, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Predicate Mullins-X Test / Attribute | Predicate Mullins-X Acceptance Criteria | Subject Bard PTV Dilatation Catheter Acceptance Criteria | Test Result |
|---|---|---|---|
| Visual Inspection | Free from contamination, discoloration, damage that could impact function. | Inspection for damage prior to testing; no abnormalities observed, confirmed by functional testing. Included in biocompatibility section. | PASS |
| Balloon Preparation Test | Prepped per procedure without functional difficulties or anomalies. | Guidewire lumen flushable with saline (10mL syringe or equivalent). | PASS |
| Diameter and Profile Test | Balloon diameter at rated burst pressure within +/- 10% of labeled diameter; fit through selected introducer. | Balloon Outer Diameter: +.04/-.03mm across all diameters (more robust than +/- 10% for 12mm balloon). | PASS |
| Balloon Inflatability Test (Deflation) | No interference with balloon deflation. | Deflation: Ability to deflate evaluated; no abnormalities, all samples fully deflated. | PASS |
| Tip Pull and Torque Test | Withstand at least 10 turns without breaking. | Tip Tensile: Minimum tensile force of 2 pounds-force (follows ISO10555-1). | PASS |
| Bond-Strength Test | All bonds must withstand at least 3 lbs of pull strength. | Joint Tensile: Minimum tensile force of 5 pounds-force (more robust). | PASS |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400psi). | Catheter Shaft Leak and Catheter Shaft Burst: Highest rated burst pressure for Atlas Gold is 18atm, proposed specification set to +5atm (23atm minimum). | PASS |
| Balloon Burst Pressure | Results must show statistically (at least 95% confidence) at least [criteria not fully visible in provided text, but implies burst pressure must be met]. | Labeled rated burst pressure are higher; passed specified criteria (more robust). | PASS |
| Repeated Balloon Inflation (Fatigue Test) | [Criteria not fully visible in provided text, but implies withstand cycles to burst pressure.] | Catheter must be capable of withstanding 20 cycles to ≥ labeled rated burst pressure. | PASS |
| Balloon Distensibility | [Criteria not fully visible in provided text, but implies diameter change within a range]. | ≤ 5% across diameters (more robust). | PASS |
| Inflation/Deflation Time | Inflation achieved in less than 12 seconds; deflation achieved in less than 20 seconds. | [Not explicitly mentioned as a subject device acceptance criteria in the summary table, but 'Inflation Time' and 'Simulated Use Deflation Time' are listed as in-vitro tests performed.] | PASS (implied by "Inflation Time" and "Simulated Use Deflation Time" being performed and leading to overall PASS) |
| Trackability | [Not explicitly mentioned as a predicate criteria in the summary table, but listed as an in-vitro test performed on the subject device]. | [Not explicitly mentioned in the summary table]. | PASS (implied by "Trackability" being performed and leading to overall PASS) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size for each individual test. It refers to "All results showed the subject device passed the specified criteria" and "all samples were able to be fully deflated," suggesting multiple units were tested for each criterion.
- Data Provenance: The data is from in vitro testing conducted by Bard Peripheral Vascular, Inc. The document does not specify the country of origin of the data beyond the company's location (Tempe, Arizona, USA). It is prospective in the sense that these tests were performed on the device to demonstrate equivalence for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" here is the performance specifications of the device, which are determined through engineering principles, regulatory standards (e.g., ISO10555-1 mentioned for Tip Tensile), and comparison to predicate devices. There is no expert review or consensus process for establishing the "ground truth" of mechanical performance metrics like burst pressure or tensile strength in the way there would be for image analysis or clinical diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective, quantitative mechanical and functional assessments (e.g., measuring diameter, forces, times), there is no need for expert adjudication of results. The results are Pass/Fail based on comparison to pre-defined numerical criteria.
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
This information is not applicable. This submission is for a medical device (dilatation catheter), not an AI diagnostic or assistance system that would involve human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This refers to an algorithm's performance, which is not relevant for a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria and performance evaluation is based on:
- Engineering specifications and design requirements: Derived from the intended use and safety considerations.
- Regulatory standards: Such as ISO10555-1 mentioned for the Tip Tensile test.
- Performance of predicate devices: The "Predicate Mullins-X Acceptance Criteria" serve as a benchmark, and in some cases, the subject device's criteria are "more robust."
Essentially, the ground truth is established by a combination of relevant standards and established performance benchmarks for similar devices.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device. It does not involve a training set as would be used in machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 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).