(162 days)
The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
The BD Saf-T PRN Luer Activated Valve is a closed system that opens when a standard male luer taper is inserted and closes automatically when the male luer taper is disconnected. The BD Saf-T PRN valve permits injection, gravity flow or withdrawal of fluids. It is compatible with standard luer slip and luer lock adapters.
Here's an analysis of the provided text regarding the BD Saf-T PRN Luer Activated Valve, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail manner. Instead, it states that the BD Saf-T PRN Luer Activated Valve was shown to be substantially equivalent to the predicate device (Clave® Connector C-1000) based on comparison of several characteristics. The reported performance refers to this determination of substantial equivalence.
| Acceptance Criteria (Implicit by Equivalence) | Reported Device Performance (Comparative Equivalence) |
|---|---|
| Actuation Force | Found to be substantially equivalent to predicate |
| Luer Torque and Pull Forces | Found to be substantially equivalent to predicate |
| Flow Rate | Found to be substantially equivalent to predicate |
| Back Pressure | Found to be substantially equivalent to predicate |
| Insertion Force to Access the Device | Found to be substantially equivalent to predicate |
| Leak Testing | Found to be substantially equivalent to predicate |
| Hemolysis | Found to be substantially equivalent to predicate |
| Microbial Ingress | Found to be substantially equivalent to predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on the sample sizes used for the nonclinical tests (e.g., number of devices tested for flow rate, leak testing, etc.). It also does not specify the country of origin of the data or whether the tests were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable in this context. The study is a nonclinical, bench-top comparison of physical and functional characteristics of a medical device to a predicate device. It does not involve human interpretation or subjective assessment that would require expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable. As this is a nonclinical, bench-top study, there is no need for an adjudication method for human interpretations. The tests likely involved standardized methods and measurements.
5. If a Multi-Reader 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 or screening tools where human readers (e.g., radiologists) interpret images or data. The BD Saf-T PRN Luer Activated Valve is an accessory to an intravascular administration set, and its performance is evaluated based on physical and functional characteristics, not human interpretive effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable in the traditional sense of AI algorithms. The "device" itself is a mechanical component. The nonclinical tests evaluate the standalone performance of the device and compare it to a predicate device, which is essentially an "algorithm-only" approach if we consider "algorithm" to mean the device's inherent mechanical function. There is no human interaction in the performance metrics mentioned (actuation force, flow rate, etc.).
7. The Type of Ground Truth Used:
The "ground truth" for this study was established by objective, standardized measurements and tests of the physical and functional characteristics of both the subject device (BD Saf-T PRN Luer Activated Valve) and the predicate device (Clave® Connector C-1000). For example, a flow rate "ground truth" would be the actual measured flow rate through the device using a calibrated flow meter.
8. The Sample Size for the Training Set:
This information is not applicable. This is a traditional medical device submission based on substantial equivalence, not a machine learning or AI-based device that would require a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason 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.