(260 days)
The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.
The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The quidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Three radiopaque markers are embedded in the balloon wall. These bands are positioned at the proximal and distal balloon shoulders, and in the middle. These bands are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the True™ Flow Valvuloplasty Perfusion Catheter:
Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report proving a device meets specific clinical acceptance criteria in a human population. Therefore, many of the requested items related to human studies (sample sizes, expert qualifications, adjudication, MRMC) cannot be directly extracted from this document, as the "studies" mentioned are primarily non-clinical (in vitro) performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance data categories and concludes that the device "met all predetermined acceptance criteria of design verification and validation." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test or the exact numerical performance results. It merely states that the criteria were met.
Therefore, the table below reflects what is reported in the document:
| Performance Characteristic | Acceptance Criteria (as reported) | Reported Device Performance |
|---|---|---|
| Dimensional Testing | Predetermined criteria | Met criteria |
| Marker Band Alignment | Predetermined criteria | Met criteria |
| Dye Penetration | Predetermined criteria | Met criteria |
| Visual Inspection (Product) | Predetermined criteria | Met criteria |
| Visual Inspection (Packaging) | Predetermined criteria | Met criteria |
| Tip Morphology | Predetermined criteria | Met criteria |
| Trackability | Predetermined criteria | Met criteria |
| Sheath Compatibility | Predetermined criteria | Met criteria |
| Media Interaction | Predetermined criteria | Met criteria |
| Luer Interface | Predetermined criteria | Met criteria |
| Hub Stress | Predetermined criteria | Met criteria |
| Inflation/Deflation Time | Predetermined criteria | Met criteria |
| Fatigue to Failure | Predetermined criteria | Met criteria |
| Tip to Balloon Tensile | Predetermined criteria | Met criteria |
| Balloon Burst | Predetermined criteria | Met criteria |
| Catheter Leak | Predetermined criteria | Met criteria |
| Failure Mode | Predetermined criteria | Met criteria |
| Shaft Burst | Predetermined criteria | Met criteria |
| Catheter Elongation | Predetermined criteria | Met criteria |
| Hub to Shaft Tensile | Predetermined criteria | Met criteria |
| Balloon to Shaft Tensile | Predetermined criteria | Met criteria |
| Radiopacity | Predetermined criteria | Met criteria |
| Balloon Distensibility | Predetermined criteria | Met criteria |
| Perfusion Test | Predetermined criteria | Met criteria |
| Radial Force Test | Predetermined criteria | Met criteria |
| MEM Elution Test | Predetermined criteria | Met criteria |
| Kligman Maximization Test | Predetermined criteria | Met criteria |
| Intracutaneous Injection | Predetermined criteria | Met criteria |
| Systemic Injection Test | Predetermined criteria | Met criteria |
| Rabbit Pyrogen Test | Predetermined criteria | Met criteria |
| Hemolysis Rabbit Blood Contact | Predetermined criteria | Met criteria |
| Complement Activation Test | Predetermined criteria | Met criteria |
| Prothrombin Time Assay | Predetermined criteria | Met criteria |
| In Vitro Thrombogenicity | Predetermined criteria | Met criteria |
| In Vivo Thrombogenicity | Predetermined criteria | Met criteria |
| (Leveraged from Predicate) | ||
| Pouch Tensile | Predetermined criteria | Met criteria (by predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the sample sizes used for each individual non-clinical (in vitro) test. It simply lists the types of tests performed.
- Data Provenance: The tests are described as "in vitro tests," meaning they were conducted in a lab environment, not on human subjects. They are non-clinical studies. The country of origin of the data is not specified, but the applicant is "Bard Peripheral Vascular, Inc" located in Tempe, Arizona, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in this document. Ground truth, in the context of expert consensus, typically refers to clinical data or interpretations by medical professionals. The studies described are primarily engineering and biocompatibility tests, not studies requiring expert clinical interpretation to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in this document. Adjudication methods (like 2+1 or 3+1) are usually for resolving discrepancies in expert opinions on clinical test data. Since the tests are in vitro performance tests, such a method is not relevant.
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
An MRMC comparative effectiveness study was not done. This document describes a medical device (a catheter), not an artificial intelligence (AI) system or a diagnostic imaging tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the in vitro performance and biocompatibility tests, the "ground truth" would be established by:
- Engineering specifications and design requirements: For mechanical, dimensional, and functional tests (e.g., balloon burst, trackability, inflation/deflation time).
- Standardized test methods and validated analytical techniques: For chemical, material interaction, and biological safety tests (e.g., MEM Elution, Rabbit Pyrogen Test, Thrombogenicity tests).
- Comparison to predicate device performance benchmarks: The overall conclusion relies on demonstrating "substantial equivalence" to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This document describes a physical medical device and its non-clinical testing, not an AI or machine learning product.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, there is no "training set" in the context of this device's evaluation.
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.