(145 days)
B. Braun Extension Sets are intended for direct injection, intermittent infusion, continuous infusion or aspiration.
B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.
B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. In clinical practice, extension sets are connected to primary IV sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter. An extension set attached to a catheter hub allows the clinician to perform syringe aspirations and injections away from the patient's catheter site.
Extension Sets are widely used in the clinical setting, are available in various lengths and dimensions, and may be comprised of various generic components that are broadly used throughout the industry. Various components such as stopcocks, clamps, injection sites, connectors, manifolds, filters and needleless connectors, previously cleared in 510(k)s, may be included on an Extension Set. B. Braun Extension Sets offer a range of lengths and a variety of tubing dimensions (ie: microbore, standard bore) that provide flexibility in a variety of clinical settings. B. Braun Extension Sets are configured to ensure the intended use of the device is met.
B. Braun's optional stabilization component is a non-removable component that slides on the tubing and may be firmly positioned on the patient connector, secured at the discretion of the clinician at time of use. The optional stabilization component provides additional stabilization to intravascular catheters while firmly positioned on the patient connector of the Extension Set. The optional stabilization component supports the patient connector of the extension set, reducing its contact with the skin. The geometrical design of the stabilization component supports the patient connector maintaining the catheter insertion angle, minimizing the catheter movement in the vessel and the potential for catheter kinking at the insertion site.
Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second.
B. Braun Extension Sets may be used for any patient population.
Extension Sets comprised of a female luer adapter, extension tubing, slide clamp, stabilization component and a male luer adapter with cap are included in this premarket notification. The following Extension Set configurations are subject of this submission.
- Smallbore Extension Set with stabilization component, Spin-Lock connector, removable slide clamp
- Standard Bore Extension Set with stabilization component, Spin-Lock connector, slide clamp
- Extension Set with stabilization component, Spin-Lock connector, slide clamp
This is a 510(k) premarket notification for an Extension Set by B. Braun Medical Inc. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing. It is not a study proving device meeting acceptance criteria in the sense of an effectiveness or clinical trial, but rather a submission for regulatory clearance based on performance standards.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, ground truth for test/training set, training set size) are not applicable as this document details a regulatory submission for a medical device rather than a clinical study of AI performance.
However, I can extract information related to acceptance criteria and performance testing for the physical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All test results met their acceptance criteria" for the performance tests conducted. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The summary lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | |
| Stabilization Component Angular/Axial Stabilization/Performance | Met acceptance criteria |
| Visual | Met acceptance criteria |
| Catheter Angle | Met acceptance criteria |
| Flow Rate No Catheter | Met acceptance criteria |
| Flow Rate - With Catheter | Met acceptance criteria |
| Tape Removal | Met acceptance criteria |
| Occlusion | Met acceptance criteria |
| Negative Pressure | Met acceptance criteria |
| Positive Pressure | Met acceptance criteria |
| Clamp and Positive Pressure | Met acceptance criteria |
| Tensile Strength | Met acceptance criteria |
| Power Injection (up to 400 psi, 15 mL/sec flow rate) | Met acceptance criteria |
| Mechanical Hemolysis Aspiration and Injection | Met acceptance criteria |
| Luer Connection | Met acceptance criteria |
| Gauging | Met acceptance criteria |
| Liquid and Air Leakage | Met acceptance criteria |
| Separation Force | Met acceptance criteria |
| Stress Cracking | Met acceptance criteria |
| Collar Retention | Met acceptance criteria |
| Joint Qualification | Met acceptance criteria |
| Particulate Contamination | Met acceptance criteria |
| Biocompatibility | |
| ISO 10993-4 (Interactions with blood) | Met acceptance criteria (through component and finished product testing) |
| ISO 10993-5 (In vitro cytotoxicity) | Met acceptance criteria (through component and finished product testing) |
| ISO 10993-10 (Irritation & delayed hypersensitivity) | Met acceptance criteria (through component and finished product testing) |
| ISO 10993-11 (Systemic toxicity) | Met acceptance criteria (through component and finished product testing) |
| ISO 10993-17 (Leachable substances) | Met acceptance criteria (through component and finished product testing) |
| ISO 10993-18 (Chemical characterization) | Met acceptance criteria (through component and finished product testing) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. The data provenance is B. Braun's internal testing facilities (implicit, as they performed the tests for their device). These are retrospective tests performed on manufactured devices for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert assessment of a test set for ground truth. The "ground truth" here is compliance with established performance standards and biocompatibility requirements.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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
Not applicable. This device is not an AI algorithm, and no MRMC study was performed or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is established by compliance with recognized international ISO standards for medical devices and performance criteria derived from these standards. For biocompatibility, the ground truth is established by meeting the requirements of the ISO 10993 series.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI or machine learning device requiring a training set.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.