(35 days)
The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors.
The proposed devices, which are the subject of this Special 510(k) Premarket Notification. consist of a power injectable extension set without the One-Link Needle-free IV connector, extension set codes with the One-Link Needle-free IV connector bonded to the rest of the set, standard bore power injectable extension sets, and a power injectable extension set with a one piece male Luer. They are single use disposable devices intended for use with a vascular access device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids.
The provided document describes a Special 510(k) Premarket Notification for updated configurations of the Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K120443) by adding new set configurations, rather than introducing a completely new device or technology. Therefore, the "study" described focuses on non-clinical performance testing to ensure the new configurations maintain the safety and effectiveness of the predicate device.
Here's a breakdown of the requested information based on the provided text, recognizing that some points are not fully applicable or explicitly detailed for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All test results meet their acceptance criteria," but does not explicitly list the specific quantitative acceptance criteria for each test. For instance, for the "Tubing bond strength test," the document doesn't specify what minimum bond strength (e.g., in pounds-force) was considered acceptable.
| Test Conducted | Reported Device Performance | Acceptance Criteria (Not explicitly quantified in text) |
|---|---|---|
| ISO Luer tests on male Luer lock connectors | Met acceptance criteria | Not explicitly quantified |
| Tubing bond strength test on solvent bonds | Met acceptance criteria | Not explicitly quantified |
| Solvent bond pressure test | Met acceptance criteria | Not explicitly quantified |
| Clamp shut-off test | Met acceptance criteria | Not explicitly quantified |
| Power injector compatibility test | Met acceptance criteria (specifically, compatible with 325 psi, 10 mL/s) | Not explicitly quantified, but device features specify compatibility with 325 psi (2241 kPa) and 10 mL/s |
| Connector disengagement test | Met acceptance criteria | Not explicitly quantified |
| Post sterilization lipid stress test | Met acceptance criteria | Not explicitly quantified |
| Pressure failure mode simulation | Met acceptance criteria | Not explicitly quantified |
| Burst pressure test | Met acceptance criteria | Not explicitly quantified |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the individual non-clinical tests. It simply states that "all test results meet their acceptance criteria."
- Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the data beyond the company's location (Deerfield, Illinois, USA). The tests are inherently non-clinical (laboratory/bench testing) rather than clinical retrospective or prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of regulatory submission. The "ground truth" for non-clinical performance tests is typically established by engineering specifications, recognized industry standards (like ISO standards mentioned for Luer tests), and risk analysis, rather than expert consensus on medical images or patient outcomes. The performance is measured against predefined engineering and safety benchmarks.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where expert review and consensus are needed to determine an outcome (e.g., presence of a disease). For non-clinical bench testing, the results are typically quantitative measurements compared against predefined acceptance criteria, and thus do not require an adjudication process involving multiple human experts in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting data (e.g., medical images). The submitted device is an IV connector and extension set, which is a medical device for fluid administration, not a diagnostic or AI-assisted interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical product, not an AI algorithm.
7. The Type of Ground Truth Used
For this submission, the "ground truth" is based on engineering specifications, recognized industry standards (e.g., ISO Luer tests), and design verification tests derived from risk analyses. It's about demonstrating that the physical device components (connections, bonds, materials) perform as expected under specified conditions (pressure, flow rate, stress) to ensure safety and effectiveness for its intended use, rather than comparing against pathology, clinical outcomes, or expert consensus on a diagnostic finding.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, this submission is for a physical medical device, not an AI model requiring a training set.
§ 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.