(318 days)
The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).
The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.
The provided text describes a 510(k) premarket notification for the NuCath Wedge Pressure Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance results in the way one might expect for a de novo submission or a clinical trial.
However, I can extract the information relevant to acceptance criteria and the study that proves the device meets the acceptance criteria by interpreting the "performance testing" section as the "study" conducted.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with quantitative acceptance criteria values and corresponding quantitative performance values for each test. Instead, it states: "The subject device met all predetermined acceptance criteria as defined in the referenced and internal standards." This implies the tests were conducted with pass/fail criteria, and the device passed all of them.
Below is a table listing the performance tests conducted, with the understanding that the "Reported Device Performance" is implicit as meeting the (unspecified) acceptance criteria for each test.
| Acceptance Criteria (Defined by Referenced and Internal Standards) | Reported Device Performance |
|---|---|
| Visual Inspection | Met criteria |
| Balloon Preparation | Met criteria |
| Diameter and Profile | Met criteria |
| Radio-detectability | Met criteria |
| Catheter Body Maximum Pressure | Met criteria |
| Hubs/Luers | Met criteria |
| Bond Strength (Peak Tensile Force) | Met criteria |
| Tip Pulling and Torquing | Met criteria |
| Minimum Burst Strength | Met criteria |
| Repeated Balloon Inflation (Balloon Fatigue) | Met criteria |
| Balloon Inflation and Deflation | Met criteria |
| Balloon Deflatability | Met criteria |
| Balloon Distensibility (Compliance) | Met criteria |
| Biocompatibility testing (per ISO 10993-1) | Met criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each performance test. It lists the types of tests performed.
- Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (PFM Medical, Inc.). This implies the data is prospective in the sense that the tests were conducted specifically for this submission, and the country of origin would be where the manufacturer's testing facilities are located (implied to be the US based on the Carlsbad, California address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance and design verification testing is established by engineering specifications, recognized standards (e.g., ISO, ASTM), and internal company standards. There are no "experts" in the sense of clinical reviewers establishing ground truth for a test set in this type of submission; rather, the data is compared against predefined technical criteria.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for medical image analysis where multiple readers evaluate cases and a consensus or tie-breaking mechanism is needed. For non-clinical bench testing, the results are objectively measured and compared against established engineering and material specifications.
5. If a Multi Reaser Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation of results, like imaging software) to assess the impact of a device on human reader performance. The NuCath Wedge Pressure Catheter is a physical diagnostic catheter, and its performance evaluation focuses on its physical and functional attributes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described is essentially a "standalone" evaluation of the device itself (algorithm only performance). The tests listed (e.g., burst strength, inflation/deflation, radiodetectability) assess the device's technical specifications and physical integrity without human interaction being part of the primary performance metric for the device's basic function. The device's primary function is to measure pressure, and the tests verify the components that enable this function.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the NuCath Wedge Pressure Catheter is based on:
- Engineering Specifications: Designed values and tolerances for dimensions, material properties, and functional characteristics.
- Referenced Standards: International and national standards such as ISO 10555-1, ISO 10555-4, ASTM F640-12, ISO 80369 series, and ISO 10993-1. These standards define test methods and often acceptable performance ranges for specific aspects of medical devices.
- Internal Standards: Manufacturer's own established quality and performance criteria.
These form the objective criteria against which the device's physical and functional performance is measured.
8. The Sample Size for the Training Set
This question is not applicable. The NuCath Wedge Pressure Catheter is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" of the device involves engineering design, material selection, and manufacturing processes, not data-driven training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" for this physical device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).