(379 days)
IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration 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 and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.
This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.
Here's an analysis of the provided text in response to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."
Here's a compilation of the tests and the implicit performance:
| Acceptance Criterion (Implied Standard/Test) | Reported Device Performance |
|---|---|
| IV Administration Sets (Proposed K202618 vs. Predicate K170595) | |
| Priming Test / Air Visualization | Verification results confirm no new safety/effectiveness concerns |
| Flow Rate and Occlusion | Verification results confirm no new safety/effectiveness concerns |
| Positive Pressure | Verification results confirm no new safety/effectiveness concerns |
| Negative Pressure (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Dynamic Tensile | Verification results confirm no new safety/effectiveness concerns |
| Static Tensile | Verification results confirm no new safety/effectiveness concerns |
| Leakage (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Clamp Pressure Resistance (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Slide Clamp Pressure (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Stability and Accuracy (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Particulate Contamination (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Microbial Ingress (Additional test performed for proposed device) | Verification results confirm no new safety/effectiveness concerns |
| Y-Connector Injection Site Assembly Pressure and Reseal (Additional test) | Verification results confirm no new safety/effectiveness concerns |
| Biocompatibility (Conformity to ISO 10993-1) | Conformed to ISO 10993-1 (Same as predicate) |
| Sterilization (Ethylene Oxide, SAL 10-6) | Ethylene Oxide, SAL 10-6 (Same as predicate) |
| For Components with Flow Regulators (Applicable to proposed device) | |
| Flow Rate Accuracy Test (ISO 8536-13:2016) | Successfully completed |
| Flow Rate Stability Test (ISO 8536-13:2016) | Successfully completed |
| Positive Pressure Test of Rate Control Device at Various Dial Settings (ISO 8536-13:2016) | Successfully completed |
| Negative Pressure Test of Rate Control Device at Various Dial Settings (ISO 8536-13:2016) | Successfully completed |
| For Clamps and Flow Regulators (Applicable to proposed device) | |
| Clamp Pressure Resistance (ISO 8536-14:2016) | Successfully completed |
| Slide Clamp Pressure (ISO 8536-14:2016) | Successfully completed |
| General Tests | |
| Particulate Matter in Injections (USP) | Successfully completed |
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 tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.
The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, 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 in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on standards.
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
There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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.