(105 days)
Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10ml/s, in state of connection.
Carefusion NeutraClear™ Needle-free connector is a bidirectional needleless injection valve. The Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Carefusion NeutraClear™ Needle-free connector is intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.
This document describes the regulatory submission (510k) for the Carefusion NeutraClear™ Needle-free connector. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive independent clinical effectiveness studies typical for novel devices.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing performed to demonstrate that the modified device (with minor changes compared to the predicate) performs as intended and is as safe and effective as the predicate. The document doesn't detail a traditional clinical study but rather a series of performance and safety tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" alongside "reported device performance" in a quantitative table for each test. Instead, it states that various tests were performed and that the device met the acceptance criteria for all of them. The "reported device performance" is summarized as having met these criteria.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Functional Performance | Met all functional performance criteria. |
| Microbial Ingress | Met microbial ingress criteria. |
| Hemolysis | Met hemolysis criteria. |
| Priming Volume/Flow Rate | Met priming volume/flow rate criteria. |
| Sterility | Met sterility criteria (Ethylene oxide sterilization in accordance with ISO 11135-1:2007 and ISO 10993-7:2008). |
| Biocompatibility | Met biocompatibility criteria (in accordance with ISO 10993-1:2009). |
| Other Performance Criteria | Met other performance criteria. |
(Note: The specific quantitative results or acceptance thresholds for each test are not detailed in this summary.)
2. Sample sizes 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 sample sizes used for the individual performance tests (microbial ingress, hemolysis, priming volume/flow rate, etc.). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) summary for minor device modifications, these details are often kept in the full submission, not the summary.
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 type of information (experts, ground truth for test sets) is typically relevant for studies evaluating diagnostic or AI-driven devices, where human expertise is used to define a "correct" answer against which the device is measured. For a medical device like a needle-free connector, which undergoes performance and safety testing, "ground truth" is established by adherence to recognized standards and objective measurements performed in a laboratory setting, not by human expert interpretation. Therefore, this information is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Similar to point 3, adjudication methods are relevant for subjective assessments or when discrepancies arise in human interpretation (e.g., in reading medical images). Performance testing of a physical medical device against predefined standards does not involve an adjudication method by human experts. Therefore, this information is not applicable and not provided in the document.
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
MRMC studies and the concept of "human readers improving with AI assistance" are specific to AI/CAD devices. The Carefusion NeutraClear™ Needle-free connector is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed, and this information is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is also specific to AI/algorithm performance. The device in question is a physical needle-free connector. Therefore, a standalone algorithm performance study was not performed, and this information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the performance of this device is based on objective measurements and adherence to recognized performance standards and guidance, such as ISO 8536-4:2010, ISO 594-2:1998, ISO 8536-10:2004, ISO 10993-1:2009, ISO 11135-1:2007, and ISO 10993-7:2008. These standards define the acceptable physical, mechanical, and biological properties and performance characteristics of such devices. For example, for microbial ingress, the ground truth is whether microorganisms can penetrate the device under specific test conditions, as defined and measured by the test method.
8. The sample size for the training set
The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, not an AI system. Therefore, there is no training set, and this information is not applicable.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
§ 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.