(25 days)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices, which are the subject of this Special 510(k) premarket notification, consist of IV administration sets, some of which include a needle-accessed injection site (y-site). They are single use disposable devices intended for use for the administration of fluids from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, including extension sets and solution sets. The extension sets have been previously cleared under 510(k) premarket notification K811078 (cleared on July 2. 1981) and the solution sets have been previously cleared under 510(k) premarket notification K961225 (cleared on June 21, 1996).
The basis for this premarket notification is a proposed design change to the y-site component currently used in Baxter IV administration sets. The design change is intended to eliminate latex in the current y-site as well as to optimize the manufacturing process. This proposed change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device, update the description to comply with Baxter's labeling standard, update the statement regarding latex, and update references to pump devices.
This document describes the 510(k) premarket notification for Baxter Healthcare Corporation's Solution Sets and Extension Sets. The core of the submission revolves around a proposed design change to the y-site component of these intravenous administration sets.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All test results meet their acceptance criteria". However, the specific acceptance criteria values for each test are not explicitly provided in the text. Only the type of tests conducted and the general outcome (meeting criteria) are stated.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Specific Pass/Fail Thresholds for each test (e.g., minimum burst pressure, maximum leakage rate, acceptable coring percentage) | All tests met the (unspecified) acceptance criteria. |
| Tests Conducted: | |
| Puncture Test | Met acceptance criteria |
| 7-Day Indwell Test | Met acceptance criteria |
| Burst Test | Met acceptance criteria |
| Vacuum Leakage Test | Met acceptance criteria |
| Solvent Bond Tensile Strength Test | Met acceptance criteria |
| Solvent Bond Air Pressure Test | Met acceptance criteria |
| Coring Test | Met acceptance criteria |
| Insertion Force Test | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the bench tests (e.g., how many y-sites were subjected to the Puncture Test or Burst Test).
- Data Provenance: The tests are described as non-clinical bench tests. The data was generated by Baxter Healthcare Corporation to evaluate the effect of a design modification. There is no mention of country of origin for test data, but it can be inferred the testing was conducted internally by Baxter. These are prospective tests conducted to validate the new design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: For non-clinical bench tests of an IV administration set, the "ground truth" is defined by predefined engineering specifications and performance standards rather than expert consensus on medical images or clinical outcomes. The tests evaluate the physical and functional properties of the device against these objective criteria. Therefore, no medical experts are required to establish ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable: Since these are objective bench tests against engineering specifications, there is no need for an adjudication method by human observers. The tests produce quantifiable results that are either within or outside the predetermined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: An MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve interpretation by human readers. The current submission is for an IV administration set, which is a therapeutic/delivery device, and its safety and effectiveness are assessed through bench testing and biocompatibility rather than reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This product is a physical medical device (IV administration set), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- The ground truth for these tests is based on predefined engineering specifications, performance standards, and regulatory guidelines (e.g., ISO-10993-1 for biocompatibility). The tests objectively measure parameters like puncture resistance, burst pressure, and leakage, which are then compared against these established technical requirements.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI/ML algorithm involved, this question is not relevant.
§ 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.