(24 days)
The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.
The Buretrol Solution Sets are sterile, single use disposable devices indicated for use in the administration of fluids from a container into the patient's vascular system through a vascular access device. The sets contain a burette chamber which can be used to mix supplementary medication in a measured amount of diluent from the main container. The sets can be adjusted for either metered volume solution administration (intermittent) or continuous solution administration. The sets can be converted from intermittent to continuous administration by closing the air vent at the top of the burette and allowing continuous infusion from the main container. There are different configurations of the burette, based on presence of and differences in valve type.
This document describes the acceptance criteria and study for the Special 510(k) Premarket Notification for Buretrol Solution Sets.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spike Leakage Test Over Time | Not specified, but implied to meet functional requirements | All tests met the acceptance criteria |
| Burette Squeeze Test | Not specified, but implied to meet functional requirements | All tests met the acceptance criteria |
| Burette Pressure Test | Not specified, but implied to meet functional requirements | All tests met the acceptance criteria |
| Burette Scale Legibility | Not specified, but implied to ensure clear and accurate reading | All tests met the acceptance criteria |
| Roller Clamp Immediate Shut-Off | Not specified, but implied to ensure immediate cessation of fluid flow | All tests met the acceptance criteria |
| Roller Clamp Shut-Off Over Time | Not specified, but implied to ensure sustained cessation of fluid flow | All tests met the acceptance criteria |
| Check Valve Backflow Evaluation | Not specified, but implied to prevent backflow | All tests met the acceptance criteria |
| Regulating Roller Clamp Cold Flow Test | Not specified, but implied to ensure proper flow regulation at low temperatures | All tests met the acceptance criteria |
| Regulating Roller Clamp Shut-Off Test | Not specified, but implied to ensure complete shut-off | All tests met the acceptance criteria |
| Air Vent Air Flow Test | Not specified, but implied to ensure proper air flow for burette function | All tests met the acceptance criteria |
| ISO Luer Tests on Male Luer Lock | Not specified, but implied to meet ISO Luer standards for secure and leak-free connections | All tests met the acceptance criteria |
| Biocompatibility (for new materials) | Meeting ISO 10993 standards and Blue Book Memorandum G95-1 for "Biological Evaluation of Medical Devices" | No new materials were introduced; previous assessments apply |
2. Sample Size Used for the Test Set and Data Provenance:
The document reviews manufacturing changes rather than a new device; thus, it relies on design verification tests. The specific sample sizes for each performance test (e.g., Spike Leakage, Burette Squeeze) are not explicitly stated in the provided text. The data provenance is presumed to be from Baxter Healthcare Corporation's internal testing. The study is a retrospective analysis of the device's functional and biocompatibility performance based on existing designs and materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device, not a diagnostic algorithm that requires expert ground truth for interpretation (e.g., image analysis). The "ground truth" here is the pass/fail result of engineering and materials science tests against pre-defined acceptance criteria.
4. Adjudication Method for the Test Set:
This information is not applicable for the type of non-clinical device testing described. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation by multiple human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms with and without AI assistance in a clinical setting, which is not the subject of this 510(k) summary.
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 administration set, not an AI or software-based medical device.
7. The Type of Ground Truth Used:
The "ground truth" used for these tests is engineering specifications and recognized standards (e.g., ISO Luer tests, ISO 10993 for biocompatibility). The tests verify that the physical characteristics and functional performance of the Buretrol Solution Sets meet these established criteria.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
§ 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.