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The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump administration sets are sterile, nonpyrogenic, single-use devices for use with the B. Braun Infusomat® Space Volumetric Infusion Pump for pump and gravity administration of fluids.

Each administration set contains a segment of silicone tubing intended to interface with the linear peristaltic mechanism of the pump. There are two connectors at each end of the pump tube segment and a line loading guide to assist the user in loading the pump segment into the pump. Each set also contains a free flow protection clamp. The clamp is specifically designed to interface with a mating receptacle in the pump and is intended to prevent free flow of fluid when the pump door is opened and the set is removed. There are multiple set configurations including basic sets, burette sets, additive sets, filtered sets, epidural sets, low adsorption sets, add-on sets, and blood sets.

This 510(k) is making limited modifications to the predicate device. The subject changes of this 510(k) were related to updates to the tubing length, diameter, and material, as well as component updates to accommodate the changes to the tubing.

This document is a 510(k) clearance letter for the Infusomat® Space Volumetric Infusion Pump Administration Sets. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel device through a comprehensive study meeting specific acceptance criteria.

Therefore, the information requested in your prompt (especially regarding acceptance criteria, study design for proving performance, expert consensus, MRMC studies, etc.) is not applicable to this type of regulatory submission. This 510(k) does not describe a study that "proves the device meets acceptance criteria" in the sense of a clinical trial or performance study against pre-defined thresholds for a new technology. Instead, it relies on demonstrating that the modified device is functionally equivalent and safe compared to an existing, legally marketed device, despite minor changes in materials and specifications.

Here's why each point in your request is not directly extractable or applicable from this 510(k) document:

1. A table of acceptance criteria and the reported device performance: This document lists non-clinical testing (biocompatibility and device performance according to ISO standards, and associated device/pump testing) to demonstrate that the changes implemented do not negatively impact performance compared to the predicate. It does not present specific acceptance criteria in the format of a clinical study endpoint for a novel device. The "performance" is implicitly demonstrated by passing the listed engineering and material tests, showing it functions similarly to the predicate.

2. Sample sized used for the test set and the data provenance: Not specified in detail. The document mentions "non-clinical testing" but does not provide sample sizes for each test or details on data provenance (country of origin, retrospective/prospective). This is typical for 510(k) submissions for accessories or minor modifications where detailed clinical trial data is not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a diagnostic device or an AI/ML algorithm requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and material specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication process described, as it's not a study where human interpretation is the primary outcome.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (infusion set), not an AI/ML diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's safety and performance is based on compliance with established international standards (ISO, USP) for medical devices, material biocompatibility, and functional performance (e.g., flow rates, pressure resistance). This is determined by engineering specifications and laboratory testing, not clinical outcomes or expert consensus on images.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a medical device (infusion set) and demonstrates substantial equivalence through non-clinical performance and biocompatibility testing against established standards. It does not involve the type of acceptance criteria, study design, or ground truth establishment that would be present for software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

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