Search Results

The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris System is an interoperable of communicating and exchanging data with compatible information technology systems.

The BD Alaris System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, End-Tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. The EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

The BD Alaris Pump Module, and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

Device Description

The BD Alaris System with Guardrails Suite MX v12 is a modular infusion and monitoring system designed to provide accurate, automated infusion of a broad range of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris System with Guardrails Suite MX v12 has three major components:

System Hardware: a core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with . a distinct function.
. Guardrails Suite MX Software: software applications for support and interaction with the system hardware (BD Alaris System Manager, BD Alaris Guardrails Editor, and BD Alaris System Maintenance).
Interoperability Software: applications for bi-directional communication between the PCU/attached modules and an . electronic medical records (EMR) system. (Care Coordination Engine, Infusion Adapter, and Calculation Services).

The PCU is the core of the BD Alaris System with Guardrails Suite MX v12 and powers, programs, and monitors the attached modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made inter-unit interface connectors built into both sides of the PCU and modules.

The attachable modules are dedicated to infusion of fluids/medication, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

Each system must include a PCU. The rules for attachment of the modules are as follows:

· The PCU is designed to operate a maximum of four infusion or monitoring modules. Modules added in excess of four are not recognized, with the exception of the Auto-ID Module that can be included as a fifth module.
· Up to four Pump or Syringe Modules may be attached to a PCU at one time
Only one PCA and one EtCO2 module can be included within the four attached influsion or monitoring modules, since each BD Alaris System v12 is dedicated to a single patient.
In order to keep the PCU with attached modules well balanced when attached to a pole, it is important to distribute the . modules as evenly as possible on both sides of the PCU unit.

The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, motor control, data processing, power control, keypad processing, and communication.

Communication occurs within the PCU or modules, and between the PCU and attached modules. Communication between the units is by direct electrical connection through the mechanical supports on each side of the PCU and modules.

The PCU with its attached modules is designed to communicate and interact with the BD Alaris System with Guardrails Suite MX v12 software applications including software for interoperability with electronic medical records (EMR) systems. Communication between the PCU and the software application is accomplished through either a direct serial connection with the PCU or through a wireless connection with the PCU. If communication is interrupted, the PCU and modules will continue to function as programmed, but clinicians will need to make changes or inputs manually.

It is important to note that interoperability of the BD Alaris System v12 does not include remote control of the BD Alaris System v12 components. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician before they are activated.

AI/ML Overview

The provided FDA 510(k) summary for the BD Alaris System with Guardrails Suite MX v12 explicitly states a "Summary of Non-Clinical Testing" and "No animal data was generated", and "No clinical data was generated". Therefore, the device performance is reported from non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device K211218)
LVP Flow Rate Accuracy	± 5% flow rate (1 to 999 mL/hr)
± 5.5% flow rate (0.1 to 1 mL/hr)	-19% to + 5.5% system flow rate accuracy (1 to 999 mL/hr)
-8 % to + 5.5% system flow rate accuracy (0.1 to 1 mL/hr)
(Note: These specifications were updated to include "more defined test conditions aligned with the current state of the art standard for flow rate accuracy (AAMI TIR 101:2021 Fluid delivery performance testing for infusion pumps)".)
SYR Flow Rate Accuracy	± 2% linear travel (0.01 to 999 mL/hr)	± 7% system flow rate accuracy (> 10% of the syringe volume per hour)
± 7% system flow rate accuracy (≥ 10% of the syringe volume per hour)
± 10% system flow rate accuracy (≥ 0.1 mL/hr (Syringe sizes 1 mL/hr (Syringe sizes > 12 mL))
± 20% system flow rate accuracy ( 12 mL))
PCA Flow Rate Accuracy	± 2% linear travel (0.1 to 999 mL/hr)	± 7% system flow rate accuracy (> 10% of the syringe volume per hour)
± 10% system flow rate accuracy (> 1 mL/hr)
± 20% system flow rate accuracy ( 0.6 mL and

Ask a Question

Ask a specific question about this device

Page 1 of 1