(28 days)
The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications 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 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, low adsorption sets, add-on sets, and blood sets.
The provided document is a 510(k) premarket notification for the "Infusomat Space Volumetric Infusion Pump Administration Sets." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for a new clinical claim.
Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details about training sets, is not available in this type of submission. This document describes performance testing conducted to show the new administration sets perform as intended and similarly to the predicate device.
Here's an attempt to extract the relevant information based on the provided text, while acknowledging its limitations for certain aspects of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use." However, specific numerical acceptance criteria and reported performance values for each test are not provided in this summary. The table below represents the types of testing performed and the general conclusion, but not specific pass/fail values or quantitative results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection | Performs as intended |
| Simulated Use | Performs as intended |
| Durability | Performs as intended |
| Flow Rate | Performs as intended |
| Occlusion | Performs as intended |
| Tensile Strength | Performs as intended |
| Pressure Testing | Performs as intended |
| Volumetric Accuracy with Infusomat® Space Volumetric Infusion Pump | Performs as intended |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not provided in the document. The phrase "functional and performance testing" is used, but no specific number of units tested is mentioned.
- Data Provenance: The testing was conducted by B. Braun Medical Inc. as part of their 510(k) submission. It's an internal test, and the data is retrospective in the sense that it was conducted before the submission, but not in the clinical trial sense. Country of origin of data is not specified beyond being part of a U.S. FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable to the type of engineering performance testing described. The "ground truth" for these tests would be established by engineering specifications and standards, not expert medical consensus.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication typically refers to expert review of clinical cases. For engineering tests, results are usually measured against predefined specifications.
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?
- No, an MRMC comparative effectiveness study was not done. This document pertains to an administration set for an infusion pump, which is a hardware device, not an AI-powered diagnostic or decision support system that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical administration set for an infusion pump, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance testing of these administration sets would be based on engineering specifications and established performance standards for such medical devices (e.g., flow rate accuracy within a certain tolerance, pressure resistance, tensile strength). The document does not explicitly list these standards but implies their use through phrases like "perform as intended" and "performs similarly to the predicate device."
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing described is verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the reasons stated above.
§ 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.