(247 days)
The IV Administration Sets with Hand Pump are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. When the hand pump component is activated to deliver only crystalloid and colloid resuscitative fluids. These devices may patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
The IV Administration Sets with Hand Pump are single use, disposable, intravenous administration sets with a pressure pump and air guard filter used to deliver fluids from a container into a patient's vascular system rapidly through the use of the pressure pump and/or gravity flow. These sets may be comprised of various generic components which are broadly used throughout the industry such as a bag spike, drip chamber, slide clamp, roller clamp, luer access device, stopcocks, manifolds, tubing, and luer connections. Each of these needleless components have already been cleared through the 510(k) process either individually or as part of a B. Braun IV pump 510(k) which included sets. The unique components to these sets include the manual hand pump and a 15um filter integrated within the drip chamber to reduce the potential for bubble formation within the set during use. The addition of the hand pressure pump provides the capability for delivering IV fluids more rapidly by compressing the pump by hand.
This document describes a 510(k) premarket notification for the B. Braun IV Administration Set with Hand Pump and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present specific acceptance criteria or reported device performance in a quantitative manner that can be organized into a table. The performance testing section broadly states that functional performance testing was completed to demonstrate that the sets perform as intended and that results of testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use. This is a qualitative conclusion rather than a presentation of specific metrics against predefined thresholds.
Based on the provided text, here is an attempt to address your request, acknowledging the limitations of the input:
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not specify quantitative acceptance criteria or precise performance metrics, the table below reflects the qualitative statements provided.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Qualitative) | Reported Device Performance (Inferred/Qualitative) |
|---|---|---|
| Functional Performance | Device performs as intended for fluid delivery, including gravity flow and increased flow with hand pump. | "Results of testing demonstrate that the proposed device performs similarly to the predicate device and can be use safety and effectively according to its intended use." |
| Material Biocompatibility | Materials are safe for clinical application. | "Biocompatibility test results verify that the IV Administration Sets with Hand Pump materials of construction are safe for their clinical application." |
| Adherence to Standards | Conformance to relevant ISO standards (e.g., fluid path integrity, luer connections, sterilization). | The device was evaluated against ISO 594-1, ISO 594-2, ISO 8536-4, ISO 10993-1, and ISO 11135-1. (Implies conformance was met to achieve substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance or biocompatibility testing. It only mentions that "Functional performance testing was completed" and "The materials of construction...were tested."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The testing described is primarily engineering/laboratory-based functional and biocompatibility testing, not clinical studies involving expert interpretation of results to establish a "ground truth" in the way one might for diagnostic devices.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the testing (functional and biocompatibility), an adjudication method in the context of expert consensus on clinical findings is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through functional performance and biocompatibility testing against predicate devices and relevant industry standards, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is an IV administration set with a hand pump, not an AI or algorithm-driven device.
7. The Type of Ground Truth Used
For the functional performance testing, the "ground truth" would be the expected physical and mechanical performance of an IV administration set as defined by engineering specifications and industry standards (e.g., flow rates, luer connection integrity, pressure resistance). For biocompatibility, the "ground truth" is that the materials do not elicit adverse biological responses, as determined by ISO 10993-1 standard tests.
8. The Sample Size for the Training Set
This question is not applicable as the device is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable.
§ 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.