(64 days)
Acute central venous catheters are indicated to provide short-term access (
A family of power injectable central venous catheters constructed of medical grade polyurethane and is designed for insertion into the central venous system. BD power injectable acute central lines are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories. The maximum pressure injector settings and maximum power injection flow rate are specified in the table below:
| Catheter Length | Lumen(s) | Power Injection Flow Rate | Maximum Power Injector Pressure Setting |
|---|---|---|---|
| 16 cm and 20 cm | Distal | 10 mL/sec | 325 psi |
| Proximal | 10 mL/sec |
This document is an FDA 510(k) Premarket Notification for a medical device: the BD CentroVena™ Acute Central Line (7 French Dual Lumen). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy of a novel AI/software device. Therefore, the questions related to AI/software performance (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance, effect size of human improvement with AI) are not applicable to this type of submission.
Instead, this submission focuses on demonstrating the physical and functional equivalence of a new iteration of an intravascular catheter to existing ones. The "acceptance criteria" here refer to standard performance and safety tests for such medical devices, rather than statistical thresholds for AI model performance.
Here's an analysis of the provided text in the context of the requested information, highlighting what is (and isn't) present:
Context of the Document: This submission seeks 510(k) clearance for a new version of an acute central line catheter. It compares the "subject device" (BD CentroVena™ Acute Central Line) to a "predicate device" (BD Acute Central Line) to argue that it is substantially equivalent, meaning it performs as safely and effectively as existing devices. This is achieved through detailed comparisons of specifications, materials, and comprehensive performance testing.
1. A table of acceptance criteria and the reported device performance:
The document mentions that "All testing passed the predetermined acceptance criteria." However, it does not provide a specific table detailing the numerical acceptance criteria alongside the quantitative results for each test. Instead, it lists the types of performance tests conducted and implicitly states that the outcomes met the necessary standards for substantial equivalence.
Here's a summary of the mentioned tests and their purpose, which serves as a proxy for the acceptance criteria and implied "reported performance" (since they all passed):
| Acceptance Criteria (Measured by Test Purpose) | Reported Device Performance (Implied by "All testing passed") |
|---|---|
| Biocompatibility: Catheter is free from biological hazard. | Confirmed (leveraged from predicate and reference device) |
| Particulate Matter: Compliance with USP . | Tested and confirmed (leveraged from predicate device) |
| Clamp Engagement: Catheter assembly will not leak when clamp is engaged. | Passed |
| Leak Test: Catheter assembly will not leak when distal end is occluded. | Passed |
| Dimensional Test: OD, ID, and lumen area compliance with specifications. | Passed |
| Implantable Length: Useful length compliance with specifications. | Passed |
| Extension Leg Length: Compliance with dimensional specifications. | Passed |
| Burst Test (Catheter & Hydraulic): Catheter burst pressure exceeds peak pressure at max flow. | Passed |
| Power Injection Conditioning: Catheter does not leak or burst as a result of power injections at max flow rate. | Passed |
| Gravity Flow: Performance of a full-length catheter. | Passed |
| Tensile Tests (Luer to Leg, Leg to Trifurcation, Trifurcation to Shaft, Shaft, Tip): Peak tensile force exceeds minimum. | Passed |
| Radiopacity: Catheter radio-detectability. | Passed |
| Catheter Collapse Test: Flow rate of aspiration and no collapse under vacuum. | Passed |
| Suture Wing Integrity Test: Max force catheter junction suture wing can withstand prior to break. | Passed |
| OD Swell: Does not swell beyond twice the labeled OD during power injection. | Passed |
| Tip Stability Test: Tip remains in same orientation during power injection at max flow rate. | Passed |
| Guidewire Drag Test: Guidewire can be removed without difficulty. | Passed |
| Luer Testing (Stress Cracking, Separation from Axial Load/Unscrew Torque, Overriding, Dimensions, Leak): Compliance with ISO 80369-7. | All Luer tests passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify numerical sample sizes for the performance tests conducted. It generally refers to "All testing," "each test piece," implying that appropriate sample sizes were used per industry standards, but the exact numbers are not disclosed.
- Data Provenance: The tests were conducted internally by the manufacturer (Bard Access Systems, Inc. / BD) to demonstrate compliance with standards and equivalence. These are laboratory/bench tests performed on the physical device, not clinical data from patients. The data is prospective in the sense that the tests were specifically performed for this submission. The "country of origin of the data" would be where the tests were performed, presumably within the manufacturer's facilities, likely in the US (Salt Lake City, Utah is the submitter address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. This is a physical device submission, not an AI/software submission. "Ground truth" in the AI sense (e.g., expert labels on medical images) does not apply here. The "ground truth" for the device's performance is established by the specified engineering and material standards (e.g., ISO, ASTM, USP) and the results of laboratory tests.
4. Adjudication method for the test set:
This question is not applicable. There is no "adjudication" in the sense of reconciling disagreements between multiple human readers or comparing AI outputs to human interpretations. Device performance is determined through objective, quantifiable physical tests.
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 question is not applicable, as this is a physical medical device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable, as this is a physical medical device and does not involve an algorithm.
7. The type of ground truth used:
The "ground truth" here is defined by:
- Engineering Standards and Specifications: e.g., ISO 10993-1, USP , ISO 10555-1, ASTM F640-12, ISO 10555-3, ISO 80369-7, and FDA guidance documents.
- Device Design Parameters: The specified dimensional requirements, material properties, and functional performance (e.g., flow rates, pressure resistance).
- Objective Test Measurements: Quantifiable laboratory measurements from performance tests.
8. The sample size for the training set:
This question is not applicable. There is no "training set" in the context of a physical medical device submission.
9. How the ground truth for the training set was established:
This question is not applicable. There is no "training set" or "ground truth" established for it in this context. The "ground truth" for proving substantial equivalence relies on adherence to established engineering standards and validated test methodologies.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).