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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:

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.

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The Buretrol® Solution Sets with the proposed burette chamber will have the same intended use as sets with the current design of this component. The intended use of these solution administration sets is the administration of fluids from a container into the patient's vascular system through a vascular access device.

Baxter markets a line of Buretrol® solution sets which are intended for the administration of infusion fluids from a container to the patient's vascular system. 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. During intermittent infusion, the main container is shut off above the burette chamber allowing metered (controlled) delivery of the measured volume in the chamber. Some of the Buretrol® sets contain a valve feature which automatically blocks flow after solution has emptied from the burette chamber. The set can be easily converted from the intermittent to the continuous administration mode by closing the air control lever at the top of the burette chamber and allowing continuous infusion from the main container. The subject of this submission is a change in the material composition of the burette chamber housing. The material of the housing will change from cellulose to polyester.

This document describes a 510(k) premarket notification for modified Buretrol® Solution Sets. The modification involves a change in the material composition of the burette chamber housing from cellulose to polyester to reduce product cost. The submission aims to demonstrate that the modified device is substantially equivalent to the currently marketed Buretrol® Solution Sets.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics. However, it broadly states that:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Data regarding the functional performance of the proposed burette chamber have been generated."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The studies mentioned (biological/chemical and functional performance) are likely laboratory-based tests and do not involve human expert interpretation for "ground truth" in the typical sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The studies are not clinical trials requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers provide interpretations, and the AI's impact on their performance is evaluated. The modified Buretrol® Solution Set is an infusion administration device, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, "standalone" testing was performed. The biological, chemical, and functional performance tests evaluate the device itself (the modified burette chamber) without human interaction being a variable in the performance assessment. However, this is not an "algorithm-only" standalone performance as typically described in AI/ML contexts, since the device itself is a physical product, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this type of device modification would be based on:

• Established standards: ISO Standard 10993-1 for biocompatibility and USP Physicochemical tests for material properties.
• Pre-defined functional specifications: The "functional requirements" of the existing Buretrol® Solution Sets against which the modified device's performance was compared. These specifications likely include parameters like flow rate accuracy, drip chamber integrity, connection compatibility, etc.
• Laboratory measurements and observations: Direct measurements and observations from the conducted tests.

8. The Sample Size for the Training Set

This information is not applicable and is not provided in the document. The studies described are not machine learning studies that require a training set. They are engineering and materials science tests.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for the type of device and study described.

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