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The Infusomat® Space Volumetric Infusion Pump System is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood products through clinically accepted routes of administration. These routes include intravenous, intra-arterial, subcutaneous, and epidural.

The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities.

The Infusomat® Space Volumetric Infusion Pump System includes an external, electronic infusion pump and pump accessories. The pump is transportable within a facility.

The Infusomat® Space pump utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.

The Infusomat® Space is powered by an external power supply or by a rechargeable battery.

Infusomat® Space is capable of wireless communication both inbound and outbound.

SpaceStation with SpaceCom: The B. Braun Space Station is an 115V AC powered flexible docking and communication system for use in a medical facility. It is designed to accommodate multiple Infusomat® Space volumetric infusion pumps. SpaceCom is a communication device that has been integrated into the SpaceStation. SpaceCom supports different interfaces such as Ethernet, PS2-Keyboard, Serial, USB ports and WLAN network card. Data transfer with the pumps is provided via an internal CAN bus. For barcoding, a barcode image reader can be connected to the PS2-Keyboard or USB interface. The pumps are coupled together with connectors on the inner backside of the SpaceStation. These connectors provide the voltage supply, distribute the information in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending.

Drug Library Manager and Drug Upload Manager: The Space OnlineSuite is a server based software system which provides the following applications: Space Server Core, Drug Library Manager (DLM), Upload Manager (ULM).

This document is a 510(k) summary for the Infusomat® Space Volumetric Infusion Pump System, submitted to the FDA. It declares substantial equivalence to a predicate device and outlines performance data for non-clinical testing.

Here's the breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or specific quantifiable performance metrics in a way that can be directly extracted and put into a table. Instead, it describes general compliance with intended use and safety standards.

However, based on the "PERFORMANCE DATA NON-CLINICAL TESTING" section, the following areas were tested to demonstrate substantial equivalence and functionality:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes (e.g., number of units, test runs, or participants) for any of the non-clinical tests (software, delivery accuracy, usability, EMC, functional/electrical safety, human factors).
• Data Provenance: The study was conducted by B. Braun Medical Inc. as part of its regulatory submission. The document doesn't explicitly state the country of origin but implies it's related to the U.S. FDA submission. It is a prospective study in the sense that testing was conducted specifically for this submission to verify and validate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For device performance testing of an infusion pump, "ground truth" would typically refer to established engineering specifications, validated test methods, and industry standards, rather than expert consensus on individual cases. The human factors study involved "intended user population" but the number or specific qualifications of these users aren't detailed, nor are they "experts establishing ground truth" in the diagnostic sense.

4. Adjudication method for the test set:

This concept is not applicable to the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretations (e.g., medical image reading) where multiple experts assess the same cases and a consensus or tie-breaking mechanism is needed. The testing for an infusion pump device focuses on objective performance against engineering specifications and functional requirements.

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:

This is not applicable. The device is an infusion pump, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study or assessment of AI's effect on human reader performance was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document describes performance testing of the device itself, including its software. While the device contains software/algorithms, the performance testing described is of the integrated system, and not an "algorithm only" in the sense of a diagnostic AI standalone study. The device is intended to be used by "trained healthcare professionals," implying a human-in-the-loop operation, but the performance testing focuses on the device's inherent functional capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical and simulated clinical use testing, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• Industry standards and regulatory guidelines (e.g., for safety, EMC).
• Pre-defined pass/fail criteria for various functional tests (e.g., delivery accuracy within a specified tolerance).
• User requirements for human factors studies (i.e., successful completion of tasks by intended users).

There is no mention of expert consensus, pathology, or outcomes data as ground truth for this device's performance evaluation.

8. The sample size for the training set:

This is not applicable. The Infusomat® Space Volumetric Infusion Pump System is not an AI/machine learning model in the sense that it requires a "training set" to learn from data for a diagnostic or predictive task. It is a medical device with pre-programmed functionality. The "Drug Library Manager" creates "drug libraries," which are configuration data, not training data for an algorithm.

9. How the ground truth for the training set was established:

This is not applicable for the same reasons as #8. There is no "training set" for this type of device.

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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 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.

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.

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The Infusomat® Space Volumetric Infusion Pump System is an electrical, external, volumetric infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic infusion pump and pump accessories. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral fluids. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products. The Infusomat® Space Volumetric Infusion Pump System must be housed in a SpaceStation that has SpaceCom software installed in order to accomplish the advanced features of bar coding and out-bound wireless data transmission. The subject device is a computer- controlled electrical, external, lineal peristaltic infusion pump composed of injection molded thermoplastic components.

The provided 510(k) summary for the B. Braun Infusomat® Space Volumetric Infusion Pump System (K083689) does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm.

This document is a premarket notification for an infusion pump system, focusing on its substantial equivalence to previously cleared devices and new functionalities like barcode scanning, wireless data transmission, and PCA. The performance aspects discussed generally relate to the device's mechanical operation and its ability to administer fluids, blood, and medications, as expected from an infusion pump.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific, quantifiable acceptance criteria (e.g., accuracy percentages, error rates) for new features like barcode reading or wireless data transmission, nor does it present the results of a primary study demonstrating performance against such criteria. The submission largely relies on predicate device equivalence for demonstrating safety and effectiveness.
2. Sample size used for the test set and the data provenance: Not applicable as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 document pertains to a medical device (infusion pump), not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance (as inferred from the document's purpose):

The document asserts the device's performance through:

• Substantial Equivalence: The Infusomat® Space Volumetric Infusion Pump System is considered substantially equivalent to the original cleared Infusomat® Space (K062700). Its new features (barcode, wireless, PCA) are deemed substantially equivalent to the B. Braun Outlook® Safety Infusion System (K011975) and the MEDLEY™ PCA Module (K032233). This implies that the performance of the new features is expected to be comparable to these cleared predicate devices.
• Intended Use: The device is intended to provide infusions of parenteral fluids/medications, blood, and blood products with accuracy and control, as would be expected from any volumetric infusion pump.
• Error Reduction: The document highlights that the barcode, wireless, and PCA features are designed to "enhance the administration of infusions" and are "tools in the development of medication error reduction programs while ensuring the validity of transferred data." This is a goal and intended outcome rather than a quantified performance metric from a study within the document.
• Customization: The system can be customized to meet institutional needs (e.g., enabling/disabling features, assigning dose/rate limits). This speaks to its flexibility and control rather than a specific performance metric.
• Mechanical Integrity: "The mechanics of the Infusomat Space have not changed since the original submission," implying its core pumping mechanism maintains its established performance.

In conclusion, this 510(k) summary describes a traditional medical device and its enhanced functionalities through substantial equivalence arguments, rather than presenting a performance study with detailed acceptance criteria that would typically be found for an AI/ML-based device.

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The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is 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 system is 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 System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The Infusomat® Space is a 12V DC or battery powered external, transportable, volumetric infusion pump. The Infusomat® Space utilizes a linear peristaltic pumping mechanism and is intended to provide infusions of parenteral and enteral fluids. The Infusomat® Space is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system created by using the administration sets with the Infusomat® Space is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Infusomat® Space Volumetric Infusion Pump System, based on the requested categories.

It's important to note that the provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices and describes the device's components and intended use. It does not contain specific acceptance criteria, detailed study designs, or performance metrics in a quantitative manner that would be typically found in a full efficacy study report. Therefore, many sections of your request cannot be fully answered from this document.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to existing predicate devices, implying that its performance meets the generally accepted safety and effectiveness standards for infusion pumps. However, no specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, duration of battery life, etc.) or corresponding performance data are listed.

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

This information is not provided in the document. The 510(k) summary does not describe any specific clinical or performance testing that would involve a "test set" in the context of efficacy or diagnostic accuracy. The substantial equivalence argument relies on comparing features and intended use with predicate devices.

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

This information is not applicable/provided. As there's no described "test set" for performance evaluation against a ground truth in the document, there's no mention of experts or their qualifications for establishing such truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No "test set" or adjudication method is described.

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

This information is not applicable. The device described is a volumetric infusion pump, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study related to human reading improvement with AI is irrelevant to this device.

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

This information is not applicable. The Infusomat® Space is a physical medical device (an infusion pump), not an algorithm that performs standalone analysis. Its performance is inherent in its electromechanical function.

7. The Type of Ground Truth Used

This information is not applicable/provided. No specific ground truth, in the context of diagnostic accuracy or similar, is described as being used for performance evaluation in this 510(k) summary. The "ground truth" for an infusion pump would typically be its physical accuracy and safety parameters, which are assessed through engineering and bench testing, but specifics are not detailed here.

8. The Sample Size for the Training Set

This information is not applicable/provided. The document does not describe the use of machine learning or AI, and therefore, there is no "training set" in this context. The pump's design and engineering would be based on established medical device standards and principles, not statistical data training sets.

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

This information is not applicable/provided. As there is no training set for an AI/ML algorithm described, the method for establishing its ground truth is also not mentioned.

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