(90 days)
The K100 Neutral Displacement 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 K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
The K100 Neutral Displacement Needleless Connector is a sterile, single patient use, swabable, normally closed, luer-activated, valved connector. The K100 valve is comprised of a: a housing (inlet and outlet), a fluid channel, a translating member (or lower gland) secured to a longitudinal wall of the housing and bounding a variable volume region of the fluid channel, a post having a lumen terminating at a distal head of the post and biased in the proximal direction by the lower gland when in the closed mode, and an upper seal having a sealing ring and secured to the longitudinal wall of the housing, the sealing ring contacting the distal head of the post when in the closed mode to prevent flow through the fluid channel, Moving components within the assembly are lubricated with silicone oil.
The provided text is a 510(k) summary for the K100 Neutral Displacement Needle Free Connector. It outlines the device's description, intended use, comparison to a predicate device, and performance testing. However, it does not contain acceptance criteria for specific performance metrics nor detailed study results that prove the device meets these criteria in a quantitative manner.
Instead, it states that "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." without providing the criteria themselves or the specific data showing compliance.
Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I provide specific details on sample sizes, ground truth establishment, or clinical study types (like MRMC or standalone) because this information is not present in the provided document.
Here's an overview of what is available in the document related to performance claims:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in a quantifiable manner. The document lists the tests performed and states that "All test results meet the acceptance criteria." without detailing what those criteria are or the specific results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified beyond "Pass" |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the performance tests.
- Data Provenance: The tests were "conducted by NP Medical," indicating internal testing. The country of origin and whether the data is retrospective or prospective are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. These are bench tests, not involving human interpretation or subjective assessments typically requiring expert consensus as ground truth.
4. Adjudication method for the test set:
- Not applicable/Not specified. This pertains to expert review of ambiguous cases, which is not relevant for bench testing of medical devices like this connector.
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:
- No. This type of study is for evaluating AI systems in diagnostic imaging or similar fields. This document describes a medical device (needle-free connector) and its mechanical/physical performance, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This question is relevant for AI algorithms. The document describes a physical medical device. The "standalone" performance here refers to the device's functional integrity as a component.
7. The type of ground truth used:
- For the bench tests listed (e.g., Air Bolus, Flow Rate, Hydraulic Burst Leak), the "ground truth" would be established by physical measurement against a predefined engineering specification or standard. The document states that "All test results meet the acceptance criteria," implying such specifications were used.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm that requires a "training set."
Summary of available performance claims:
The document lists the following bench tests that were conducted, and for each, it explicitly states that "All tests met acceptance criteria."
- Air Bolus and Bubble Free Priming
- Repeat Insertion
- Blood Flushing Evaluation
- Bolus Back Pressure
- Docking Stability
- Flow Rate
- Fluid Displacement
- Gland Height Determination
- Hydraulic Burst Leak
- ISO 594 Test Methods
- Lipid Resistance
- Priming Volume
- Residual Volume
- Stress Resistance to Swabbing Chemicals (IPA and CHG).
- Torque Testing
- Microbial Ingress testing
- Sterilization Validation
- Packaging/Shelf Life Validation
The comparison to the predicate device also highlights some performance aspects:
- Multiple Activations: K100 (96 intermittent) vs. Predicate (96 intermittent)
- Indwell: K100 (96 hours) vs. Predicate (96 hours)
- Pressure Rating: K100 (325 psi) vs. Predicate (> 60 psi)
- Priming Volume: K100 (0.12 mL) vs. Predicate (0.25 mL)
- Microbial Ingress Test: K100 (Pass) vs. Predicate (Pass)
The document concludes that "The K100 Neutral Displacement Needle Free Connector is substantially equivalent to the identified predicate system based on the indication for use, design features, operating principles, performance tests and material composition."
§ 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.