(73 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biological and Chemical Reactivity | "The materials were found to be acceptable for their intended use," based on ISO Standard 10993-1 and USP Physicochemical tests. |
| Functional Performance | "The data indicate that the proposed burette chamber meets or exceeds all functional requirements and support its suitability for use in Buretrol® Solution Sets." |
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.
§ 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.