(442 days)
The nPulse™ neutral displacement connector is a single patient use, sterile, nonpyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse™ connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
The nPulse K150 Neutral Displacement Needle Free Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The nPulse K150 Neutral Displacement Needle Free Connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. The nPulse K150 valve is a normally closed, luer-activated, valved connector which has an open mode that permits bi-directional fluid flow and a closed mode that prevents fluid flow.
The provided text describes a medical device, the NP Medical nPulse™ K150 Neutral Displacement Needle Free Connector, and its substantial equivalence to a predicate device (NP Medical K100 Neutral Displacement Needle Free Connector) for FDA 510(k) clearance.
The document highlights performance testing conducted to support this equivalence. Here's extraction of relevant information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside performance data in a direct row-by-row comparison. Instead, it lists the performance tests conducted and generally states that the device "has been evaluated using the appropriate methodology as specified in the FDA recognized consensus standards and in conjunction with NP Medical established test protocols" and that differences from the predicate "demonstrated applicable performance" or "aligns with current best practices."
However, specific performance claims and how they relate to the predicate and established standards are mentioned for certain differences:
| Performance Characteristic | Acceptance Criteria (Implied / Achieved) | Reported Device Performance (Subject Device - NP Medical nPulse K150) |
|---|---|---|
| Multiple Activations | Applicable performance following 200 activations based on Gland Height and Integrity, Back Pressure, and Activated Pressure Resistance. | Demonstrated applicable performance following 200 activations. |
| Use Days | Microbial ingress performance supporting a 7-day change protocol with 0 CFU recovered. | Aligning with current best practices for 7-day use; 0 CFU recovered for all test device replicates. |
| Shelf Life | Performance after 5 years of aging, including microbial ingress testing with 0 CFU recovered. | Demonstrated performance after 5 years of aging; 0 CFU recovered for all test device replicates. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of devices tested for Air Bolus, Repeat Insertion, etc.). It mentions "all test device replicates" for microbial ingress testing but doesn't quantify this.
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. It implies internal testing by NP Medical, Inc., located in Clinton, MA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The testing for the NP Medical nPulse™ K150 connector involves technical performance benchmarks (e.g., flow rates, pressure resistance, sterility) rather than clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when interpreting subjective data or reaching consensus on diagnoses, which is not the nature of the bench testing described here.
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 information is not applicable. MRMC studies and AI assistance are relevant to diagnostic tools or image analysis, not to a needle-free connector's performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests conducted on the NP Medical nPulse™ K150 connector and its predicate device is established by specified functional requirements and consensus standards. For example:
- Microbial ingress testing: The ground truth is the absence of microbial growth (0 CFU recovered), demonstrating sterility barrier integrity.
- Pressure ratings, flow rates, etc.: The ground truth is compliance with pre-defined engineering specifications and relevant FDA recognized consensus standards (e.g., ISO standards) for intravascular administration sets.
8. The sample size for the training set
This information is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As in point 8, this device does not utilize machine learning or AI requiring a training set with established ground truth.
§ 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.