Search Results

The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley™ System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

The Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology.

This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS.

As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley System to transmit and receive messages with the ALARIS® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA's), hospital monitoring systems and Hospital Information Management Systems (HIMS).

The provided text is a 510(k) Premarket Notification for the ALARIS Medical Systems, Inc. Medley System with MMS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of typical AI/ML device evaluations.

Here's a breakdown based on the information provided and what is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document states "performance data" was used but doesn't detail the nature or size of the dataset.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. This device is an infusion pump system with communication capabilities, not an AI/ML diagnostic or prognostic device that typically requires expert-established ground truth for performance evaluation.
• Qualifications of Experts: Not applicable. The "ground truth" for this type of device would likely involve functional testing against specifications and comparison to the predicate device's operational characteristics, rather than expert interpretation of medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. As noted above, this is not an AI/ML diagnostic device requiring expert adjudication.

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

• MRMC Study: No. An MRMC study is typically for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This device is an infusion pump system, which does not involve "human readers" in this context.

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

• Standalone Performance: The performance data assessed the device's ability to "meet specified requirements" and be "substantially equivalent to the predicate device." This implies an evaluation of the system's functionalities, including its communication capabilities and automation features, as a standalone entity in relation to its intended purpose. However, the exact methodology is not detailed. The automation of programming infusion parameters is a key function described.

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

• Type of Ground Truth: Not explicitly stated as "ground truth" in the AI/ML sense. For this device, the "ground truth" would likely be based on:
  • Functional specifications: Whether the device performs as designed (e.g., transmits and receives data correctly, automates programming accurately).
  • Comparison to predicate device: Demonstrating that its technological characteristics and performance are equivalent to the legally marketed predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™).
  • Safety standards: Adherence to relevant safety and performance standards for infusion pumps.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a hardware/software system for infusion and communication, not an AI/ML model that undergoes a "training" phase with a dataset in the typical sense.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set with associated ground truth for model development.

In summary: The provided 510(k) document focuses on establishing substantial equivalence for an infusion pump system with added communication capabilities. It references "performance data" indicating the device meets "specified requirements" and is "substantially equivalent" to a predicate device. However, it does not provide the detailed quantitative acceptance criteria, study design, or AI/ML-specific evaluation metrics (like sample sizes for test/training sets, expert adjudication, or MRMC studies) that would typically be found in a submission for an AI/ML-enabled diagnostic or prognostic device. The nature of this device means these AI/ML-specific questions often do not directly apply.

Ask a specific question about this device

The intended use of the Vista™ basic with fm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Vista™ basic and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.

The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.

The Vista™ basic with fm system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting.

The Vista™ basic is an electrical external infusion pump intended to provide accurate infusions of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Vista™ basic by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Vista™ basic with fm system introduces some additional features to aid the clinician in fluid delivery and maintenance.

These features include the addition of a barcode reader to minimize the potential for programming errors, an external power source to reduce the number of electrical outlets required at the bedside, and the convenience of a large interactive monitor that displays the status of all Vista™ basics being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input.

The infusion pump contains the following hardware assemblies: linear peristaltic pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord can be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of a 12V rechargeable battery. The display subassembly contains an LCD display and a kevpad used to input data into the pump as well as to present pump status and information to the user.

The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems.

The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data.

The software also provides communication abilities from external devices to the pump. This feature is only accessible by a trained Biomedical Technician. Programming of the pump is to be performed by trained Biomedical professionals.

This 510(k) submission describes the B. Braun Medical Inc. Vista™ basic with fm system, an infusion pump. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics beyond a general claim of substantial equivalence to predicate devices.

Instead, the document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The clinical applications of the device.
• Predicate Device Comparison: How this device is similar to existing, legally marketed devices (Horizon Outlook™ and Alaris Medley™ Patient Care System). This comparison focuses on design, material composition, components, manufacturing process, intended use, and labeling, as well as specific features.
• Claim of Substantial Equivalence: The primary purpose of the 510(k) submission, asserting that the new device is as safe and effective as predicate devices.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text.

Here's what I can extract from the provided text regarding the device and its comparison to predicate devices, noting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on claims of "substantial equivalence" to predicate devices without listing specific performance metrics or acceptance criteria for the new device.

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

This information is not provided. The document makes no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to predicate devices rather than a de novo performance study with a test set.

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

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test set or study is detailed, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.

This information is not provided. The document does not describe any MRMC comparative effectiveness study.

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

This information is not applicable/not provided. The device in question is an infusion pump with a "fm system" (which includes features like a barcode reader and drug library for programming) and is not described as an AI algorithm that would have standalone performance in that context. Its "performance" would relate to factors like flow accuracy and safety alarms.

7. The Type of Ground Truth Used

This information is not provided. No specific test for performance against a ground truth is described. The basis for safety and effectiveness is stated as "substantial equivalence" to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not provided. Since no specific development or validation study with a "training set" (common for AI/machine learning devices) is described, this is not applicable. The device's software is mentioned, but its development process in terms of data sets is not detailed.

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

This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also not mentioned.

Summary of what is present:

The document serves as a 510(k) submission, asserting the "substantial equivalence" of the Vista™ basic with fm system infusion pump to two predicate devices: the Horizon Outlook™ and the Alaris Medley™ Patient Care System. The claim of equivalence is based on similarities in:

• Design
• Material composition (Injection Molded Thermoplastics for non-solution contact parts)
• Components
• Manufacturing process
• Intended use (accurate and continuous flow of parenteral and enteral fluids, medication error reduction)
• Labeling
• Specific features like control pump activities from a monitor, drug calculation abilities, drug library, dosing limits, communication ports, and visual displays (Digital LCD).

The submission explicitly states: "There are no new issues of safety or effectiveness raised by the Vista™ basic with fm system." and "There are technological differences between the subject and predicate device, however, these differences do not raise new issues of safety and effectiveness." This indicates that the device's acceptable performance is implicitly demonstrated by its similarity to already cleared devices, rather than through independent studies with specific performance criteria.

Ask a specific question about this device