(69 days)
The BD Posiflow Positive Displacement Valve is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. The BD Positive Displacement Valve can be used by itself or as a component on an extension/infusion set, a vial adapter, or as a connector to convert a standard access site to a needleless access site.
The BD Posiflow Positive Displacement Valve is a needleless alternative to an IV set injection port. It is accessed by a standard luer taper connection for continuous or intermittent infusion or withdrawal of fluids. The positive displacement feature is intended to eliminate fluid retrograde, which normally results when disconnecting a connector from an IV injection site.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, specific details about study methodology for clinical performance (like expert consensus, sample sizes for training sets in AI, etc.) are unlikely to be present.
It's important to note that this document concerns a physical medical device (a valve), not an AI/software device. Therefore, many of the questions related to AI-specific study details (like multi-reader multi-case studies, AI model performance metrics, training set details) are not applicable in this context. The "acceptance criteria" here refer to the performance standards for the physical device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Nonclinical Tests) |
|---|---|
| Flow Rate | The current and modified devices were compared. |
| Backpressure Leakage | The current and modified devices were compared. |
| Vacuum Leakage | The current and modified devices were compared. |
Overall Conclusion: Based on the nonclinical tests for flow rate, backpressure leakage, and vacuum leakage, the current and modified BD Posiflow Positive Displacement Valves are substantially equivalent. This implies that the modified device met the performance standards demonstrated by the predicate device for these parameters. The document does not specify quantitative acceptance thresholds for these categories, but rather indicates that the modified device performed equivalently to the predicate.
Study Details (for a physical medical device)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "the current and modified devices" being compared, implying a number of units of each were tested, but no specific sample size (N) is provided for these nonclinical tests.
- Data Provenance: Not explicitly stated, but these would be laboratory-based nonclinical tests, likely conducted at Becton Dickinson's facilities in the USA (based on their address).
- Context: These are nonclinical (bench) tests, not clinical trials involving patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As these are nonclinical physical device performance tests (flow rate, leakage), there's no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The ground truth here would be derived from physical measurements against scientific principles and engineering standards.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1) are typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiologists diagnosing images). These nonclinical tests involve objective physical measurements, not subjective interpretations requiring adjudication.
-
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:
- No. This is a physical medical device (a valve), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device. The concept of an "algorithm only" or "human-in-the-loop" performance is not applicable to a physical valve.
-
The type of ground truth used:
- For the nonclinical tests (flow rate, backpressure leakage, vacuum leakage), the "ground truth" is established through physical measurements and engineering standards/specifications. The comparison is against the performance of the predicate device, which itself would have met certain engineering and safety standards.
-
The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.
-
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, this question is not relevant.
§ 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.