BD Alaris Infusion System with Guardrails Suite MX

K243855 · Carefusion 303, Inc. · FRN · Apr 25, 2025 · General Hospital

Device Facts

• Record ID: K243855
• Device Name: BD Alaris Infusion System with Guardrails Suite MX
• Applicant: Carefusion 303, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BD Alaris Infusion 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 2 and 3 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 Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems. The BD Alaris Infusion System with Guardrails Suite MX 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. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

Device Story

Modular infusion and monitoring system; comprises PC Unit (PCU) and attachable modules (Pump, Syringe, PCA, EtCO2, Auto-ID). PCU provides common UI, power, and communication for modules. Pump/Syringe modules use linear peristaltic or syringe-based electromechanical delivery; PCA module adds dose lockout and request cord. EtCO2 module provides capnography; Auto-ID module scans barcodes for patient/clinician/infusate association. Used in professional healthcare environments by clinicians. Guardrails Suite MX software manages drug libraries and profiles; interoperability software enables EMR communication. System supports wireless firmware updates to PCU. Output includes controlled fluid delivery, respiratory monitoring, and clinical event logs. Benefits include standardized drug delivery, reduced medication errors via Guardrails, and integrated patient monitoring.

Clinical Evidence

No clinical data. Bench testing only. Verification/validation included flow rate/bolus accuracy (AAMI TIR 101), alarm detection, respiratory monitoring (ISO 80601-2-55), software/hardware integration, cybersecurity, and human factors/usability engineering (IEC 62366-1).

Technological Characteristics

Modular electromechanical infusion system. PCU (AC/battery powered) with IUI connectors for modules. Materials: Biocompatible. Connectivity: WLAN/Serial. Software: Embedded firmware (bootloader, motor control, UI, networking). Standards: IEC 60601-1, IEC 60601-2-24, ISO 80601-2-55, IEC 60601-1-8, IEC 62133-1, UL 1642.

Indications for Use

Indicated for continuous or intermittent administration of fluids (pharmaceuticals, blood products, nutrition) to adult, pediatric (1 month-21 years), and neonatal (newborn-1 month) patients via IV, IA, subcutaneous, epidural, or irrigation routes. Contraindicated for enteral administration.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• BD Alaris System with Guardrails Suite MX v12 (K211218)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 25, 2025

CareFusion 303, Inc.
Darin Oppenheimer
VP, Regulatory Affairs
10020 Pacific Mesa Blvd
San Diego, California 92121

Re: K243855

Trade/Device Name: BD Alaris Infusion System with Guardrails Suite MX (N/A); BD Alaris PC Unit (PCU) (8015); BD Alaris Pump Module (LVP) (8100); BD Alaris Syringe Module (SYR) (8110); BD Alaris EtCO2 Module (8300); Alaris PCA Module (8120); Alaris Auto-ID Module (8600); BD Alaris System Maintenance (ASM) (8975); BD Guardrails Editor (GRE) (8961); BD Infusion Adapter (IA) (N/A); BD Calculation Services (CS) (N/A); BD Alaris Systems Manager (SM) (9601)

Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: FRN, PHC, MEA, CCK
Dated: March 27, 2025
Received: March 28, 2025

Dear Darin Oppenheimer:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243855 - Darin Oppenheimer
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K243855 - Darin Oppenheimer
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jake K. Lindstrom -S

Jake Lindstrom, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K243855

Device Name
BD Alaris™ Infusion System with Guardrails™ Suite MX

Indications for Use (Describe)

The BD Alaris Infusion 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 2 and 3 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 Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems.

The BD Alaris Infusion System with Guardrails Suite MX 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. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

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

(See attached additional page)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/23)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K243855

Device Name
BD Alaris™ Infusion System with Guardrails™ Suite MX

Indications for Use (Describe)

Attachment

Table 2: Pediatric* and Neonate** Patient Populations

| Module | Route of Administration | Infusates |
| --- | --- | --- |
| BD Alaris™ Pump Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| BD Alaris™ Syringe Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| Alaris™ PCA Module | Intravenous | Pain management drugs approved for intravenous use. |
| | Epidural | Pain management drugs approved for epidural use. |

* Pediatric population: One month to 21 years
** Neonate population: Newborns up to one month – includes preterm or term

Table 3: Adult Patient Population

| Module | Route of Administration | Infusates |
| --- | --- | --- |
| BD Alaris™ Pump Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| | Irrigation of fluid spaces | Fluids approved for irrigation. |
| BD Alaris™ Syringe Module | Intravenous | Pharmaceutical drugs approved for intravenous use. |
| | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| Alaris™ PCA Module | Intravenous | Pain management drugs approved for intravenous use. |
| | Subcutaneous | Pain management drugs approved for subcutaneous use. |
| | Epidural | Pain management drugs approved for epidural use. |

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# 510(k) SUMMARY

## BD Alaris Infusion System with Guardrails Suite MX

This summary of 510(k) information is being submitted in accordance with 21 CFR 807.92.

## General Information

Submitter Name: Becton, Dickinson and Company, on behalf of its wholly owned subsidiary, CareFusion 303, Inc.

Address: 10020 Pacific Mesa Blvd.
San Diego, CA 92121

Contact Person: Darin Oppenheimer
Vice President, Regulatory Affairs
Medication Management Solutions
Phone: [phone]
Email: [e-mail]

Date Prepared: April 23, 2025

## Device Name

Proprietary Name: BD Alaris™ Infusion System with Guardrails™ Suite MX

Common Name: Infusion, Pump
Infusion Safety Management Software
Pump, Infusion, PCA
Carbon Dioxide Gas Analyzer

Device Classification: Class II (classification codes are provided in Table 1)

Table 1: BD Alaris™ Infusion System with Guardrails™ Suite MX Product Classification Codes

| 21 CFR Section | Product Code | Description | Components/Module |
| --- | --- | --- | --- |
| 880.5725 | FRN | Pump, Infusion | BD Alaris PC Unit (PCU) |
| | | | BD Alaris Pump Module (LVP) |
| | | | BD Alaris Syringe Module (SYR) |
| | | | Alaris Auto-ID Module (Auto-ID) |
| | | | BD Alaris Systems Maintenance (ASM) |
| | PHC | Infusion safety management software | BD Guardrails Editor (GRE) |
| | | | Systems Manager (SM) |
| | | | Infusion Adapter (IA) |
| | | | Calculation Services (CalcServ) |
| | MEA | Pump, Infusion, PCA | Alaris Patient Controlled Analgesia Module (PCA) |
| 868.1400 | CCK | Analyzer, gas, carbon-dioxide, gaseous-phase | BD Alaris EtCO₂ Module (EtCO₂) |

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# Predicate Device

The predicate device is the BD Alaris System with Guardrails Suite MX v12 cleared under K211218 (July 21, 2023).

# Device Description

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion and monitoring system designed to provide controlled delivery of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris Infusion System with Guardrails Suite MX has three (3) major components:

1. System Hardware: A core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function.
- BD Alaris Pump Module (LVP)
- BD Alaris Syringe Module (SYR)
- Alaris PCA Module (PCA)
- BD Alaris EtCO₂ Module (EtCO₂)
- Alaris Auto-ID Module (Auto-ID)

2. Guardrails Suite MX Software: Software applications for support and interaction with the system hardware
- BD Guardrails Editor (GRE)
- BD Alaris Systems Manager (SM)
- BD Alaris Systems Maintenance (ASM)

3. Interoperability Software: Software applications for facilitating bi-directional communication between the PCU and attached LVP and SYR modules, and an electronic medical records (EMR) system via BD Alaris Infusion Systems Manager (SM) and Care Coordination Engine (CCE), a non-medical device Medical Device Data System (MDDS).
- Calculation Services
- Infusion Adapter (IA)

The PCU is the core of the BD Alaris Infusion System with Guardrails Suite MX and necessary for its operation. It provides a common user interface for programming, and powering and monitoring attached modules. 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 using inter-unit interface (IUI) connectors built into both sides of the PCU and modules, which also serve to provide power to the modules and communication between the PCU and attached modules. The PCU is powered by AC power and has a rechargeable battery to allow for continued therapy during power interruptions.

The attachable modules are dedicated to controlled delivery of fluids, pharmaceutical drugs, parenteral nutrition, and blood and blood products into patients, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system.

- The BD Alaris Pump Module (LVP) delivers fluids accurately over programmed times and can detect and notify the user of situations that could impact patient safety, such as improper set loading, occlusion, and air-in-line. It can deliver fluids continuously or intermittently from any compatible container using a dedicated BD Alaris infusion set. Flow rates range from 0.1 to 999 mL/h and bolus doses can be programmed at the start or during continuous infusion.

- BD Alaris Syringe Module (SYR) is designed for injecting fluids from compatible syringes and can detect and notify the user of situations that could impact patient safety, such as an improperly loaded syringe and occlusion. It can deliver continuous or intermittent volumes from 1 to 50 mL syringes at flow rates of 0.01 to 999 mL/hr.

- The Alaris PCA Module (PCA) is designed for patient-controlled analgesia. It shares core components and functionality with the BD Alaris Syringe Module but includes additional features such as: a dose request cord for self-administering pain medication, software with a dose lockout interval, and a locking syringe enclosure door with a key. When configured for use with the BD Alaris EtCO₂ Module, it can also trigger a pause of the PCA infusion if the respiratory rate of a patient falls outside the limits.

- The BD Alaris EtCO₂ Module (EtCO₂) a capnograph used for continuous, non-invasive monitoring of end-tidal CO₂, fractional inspired CO₂, and respiratory rate. It can be used to monitor respiratory depression in patients when using the Alaris PCA Module.

- The Alaris Auto-ID Module (Auto-ID) features an internal barcode image scanner and an optional handheld scanner. Scanning a clinician ID unlocks the PCU panel in authorized user mode and links clinical event logs with the clinician. Scanning a patient ID band associates logs with the patient, while scanning IV fluid or medication barcodes selects the

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specific item from the drug library for infusion modules.

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

The PCU with its attached modules is designed to be configured to communicate and interact with the Guardrails Suite MX software applications including software for interoperability with Electronic Medical Record (EMR) systems. Communication between the PCU and the software applications is accomplished through either a direct serial connection or through a wireless connection utilize the respective Guardrails Suite MX Software applications.

- The BD Guardrails Editor (GRE) allows for the creation of drug and fluid libraries and guidelines, called 'profiles,' for specific patient populations. GRE also provides a transfer tool to transfer a profile to PCU via serial cable.
- The BD Alaris Systems Manager (SM) manages connectivity and includes a web application, communications server, and database software for managing data, creating reports, connecting with a healthcare facility's network, and storing system configuration, user permissions, and historical data. Use of SM also supports transferring wireless software updates to the PCU during system servicing.
- BD Alaris Systems Maintenance (ASM) is used for standard maintenance tasks, including module calibration and network configurations
- The BD Alaris Interoperable software includes the Infusion Adapter (IA) and Calculation Services to support bidirectional communication between the BD Alaris Infusion System with Guardrails Suite MX and the healthcare facility's EMR. The Infusion Adapter facilitates data exchange ensuring correct message formats and content. Calculation Services performs pre-defined rule-based calculations to obtain infusion duration, body surface area (BSA), and weight-based dose.

It is important to note that interoperability does not include remote control of the BD Alaris Infusion System with Guardrails Suite MX. 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 at the bedside before they are activated.

## Indications for Use

The BD Alaris Infusion 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 2 and 3 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 Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems.

The BD Alaris Infusion System with Guardrails Suite MX 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. EtCO₂ Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO₂), and respiratory rate (RR).

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

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Table 2: Pediatric* and Neonate** Patient Populations

| Module | Route of Administration | Infusates |
| --- | --- | --- |
| BD Alaris™ Pump Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| BD Alaris™ Syringe Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| Alaris™ PCA Module | Intravenous | Pain management drugs approved for intravenous use. |
| | Epidural | Pain management drugs approved for epidural use. |

* Pediatric population: One month to 21 years
** Neonate population: Newborns up to one month – includes preterm or term

Table 3: Adult Patient Population

| Module | Route of Administration | Infusates |
| --- | --- | --- |
| BD Alaris™ Pump Module | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma. |
| | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| | Irrigation of fluid spaces | Fluids approved for irrigation. |
| BD Alaris™ Syringe Module | Intravenous | Pharmaceutical drugs approved for intravenous use. |
| | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. |
| | Epidural | Pharmaceutical drugs approved for epidural use. |
| | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| Alaris™ PCA Module | Intravenous | Pain management drugs approved for intravenous use. |
| | Subcutaneous | Pain management drugs approved for subcutaneous use. |
| | Epidural | Pain management drugs approved for epidural use. |

# Technological Comparison

The subject device has the same general technological characteristics as the predicate device: principle of operation, programmable flow rate range, flow rate accuracy, bolus accuracy, post-occlusion bolus volume, time to occlusion alarm, maximum infusion pressure, alarms and alerts, service life, weight and dimensions, configurable parameters and configurable limits, storage and operating conditions, materials, and power source.

Differences in technological characteristics between the subject device and predicate device include the following:

- LVP Flow Rate Accuracy Reporting: For the LVP module, the statement for flow rate accuracy has been updated to represent only performance at Standard Operating Conditions (SOC), including identifying the tested administration set, as confirmed by Test 1 of the AAMI TIR101, Environment SOC. There have been no changes to the flow rate accuracy requirement under Standard Operating Conditions.
- Other LVP Performance Data Updates: Subject device labeling has been updated for other performance characteristics, such as for post-occlusion bolus and upstream/downstream time to occlusion, to disclose test results from testing of the

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BD Alaris Infusion System with determined worst case administration sets. Disclosure of this data is intended to inform the clinical user of the device performance across the full spectrum of clinical use conditions. As assessed through risk management, differences in disclosed performance data from the predicate device are within the risk acceptability of the predicate device.

- Compatible Administration Sets: Certain BD administration sets have been removed from the BD Alaris System User Manual, Appendix B – Product Compatibility, BD Alaris™ Pump Module Infusion Set Compatibility.
- Compatible Syringes (SYR): Monoject 12, 35, 60 mL syringes have been removed from the compatible syringe list for use with the SYR Module and are also not available as a selection on the device user interface. The 6 mL syringe was also removed as no brand was specified.
- Compatible Syringes (PCA): Monoject 35mL and 60 ml syringes have been removed from the compatible syringe list for use with the PCA Module and are also not available as a selection on the device user interface.
- Device Connectivity (PCU Wireless Software Updates): SM, PCU and GRE software have been updated to provide users the ability to transfer firmware updates to the PCU wirelessly.

The tables on the following pages provide a side-by-side comparison of the subject device to the predicate device, K211218.

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Table 4: Summary Comparison of Indications for Use

| Characteristic | Predicate Device K211218 Alaris System with Guardrails Suite MX v12 | | | Subject Device BD Alaris Infusion System with Guardrails Suite MX | | |
| --- | --- | --- | --- | --- | --- | --- |
| Indications for Use | 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. Refer the 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 system capable 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. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates. Refer to Table below for the module-specific variations. | | | SAME: 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. Refer the 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 system capable 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. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates. Refer to Table below for the module-specific variations. | | |
| | Pediatric* and Neonate** Patient Population | | | | | |
| | Module | Route of Administration | Infusates | Module | Route of Administration | Infusates |
| | BD Alaris Pump Module (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma | BD Alaris Pump Module (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma |
| | | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use | | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use |
| | | Epidural | Pharmaceutical drugs approved for epidural use | | Epidural | Pharmaceutical drugs approved for epidural use |
| | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use |
| | BD Alaris Syringe Module (SYR) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma | BD Alaris Syringe Module (SYR) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma |
| | | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use | | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use |
| | | Epidural | Pharmaceutical drugs approved for epidural use | | Epidural | Pharmaceutical drugs approved for epidural use |
| | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| | Alaris PCA Module (PCA) | Intravenous | Pain management drugs; for example, opioids | Alaris PCA Module (PCA) | Intravenous | Pain management drugs; for example, opioids |
| | | Epidural | Pain management drugs approved for epidural use | | Epidural | Pain management drugs approved for epidural use |
| | * Pediatric population: One month to 21 years ** Neonate population: Newborns up to one month – includes preterm or term | | | | * Pediatric population: One month to 21 years ** Neonate population: Newborns up to one month – includes preterm or term | |

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| Characteristic | Predicate Device K211218 Alaris System with Guardrails Suite MX v12 | | | Subject Device BD Alaris Infusion System with Guardrails Suite MX | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Adult Patient Population | | | Adult Patient Population | | |
| | Module | Route of Administration | Infusates | Module | Route of Administration | Infusates |
| | BD Alaris Pump Module (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma | BD Alaris Pump Module (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood cells, platelets, and fresh frozen plasma |
| | | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use | | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use |
| | | Epidural | Pharmaceutical drugs approved for epidural use | | Epidural | Pharmaceutical drugs approved for epidural use |
| | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use |
| | | Irrigation of fluid spaces | Fluids approved for irrigation | | Irrigation of fluid spaces | Fluids approved for irrigation |
| | BD Alaris Syringe Module (SYR) | Intravenous | Pharmaceutical drugs approved for intravenous use | BD Alaris Syringe Module (SYR) | Intravenous | Pharmaceutical drugs approved for intravenous use |
| | | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use | | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use |
| | | Epidural | Pharmaceutical drugs approved for epidural use | | Epidural | Pharmaceutical drugs approved for epidural use |
| | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use | | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use |
| | Alaris PCA Module (PCA) | Intravenous | Pain management drugs approved for intravenous use | Alaris PCA Module (PCA) | Intravenous | Pain management drugs approved for intravenous use |
| | | Subcutaneous | Pain management drugs approved for subcutaneous use | | Subcutaneous | Pain management drugs approved for subcutaneous use |
| | | Epidural | Pain management drugs approved for epidural use | | Epidural | Pain management drugs approved for epidural use |
| Contraindications | The BD Alaris System is contraindicated for enteral route of administration. | | | SAME: The BD Alaris System is contraindicated for enteral route of administration. | | |
| Routes of Administration | Continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. | | | SAME: Continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. | | |
| Prescription Only or Over the Counter | Prescription Only | | | SAME: Prescription Only | | |
| Intended Population | Adult, pediatric, neonate | | | SAME: Adult, pediatric, neonate | | |
| Environment of Use | Professional Healthcare Environments | | | SAME: Professional Healthcare Environments | | |

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Table 5: Summary Comparison of Technological Characteristics

| Characteristic | Predicate Device K211218 Alaris System with Guardrails Suite MX v12 | | | Subject Device BD Alaris Infusion System with Guardrails Suite MX | | |
| --- | --- | --- | --- | --- | --- | --- |
| Principle of Operation | The PC Unit provides the power source and the common user interface for programming all attached modules which helps reduce complexity at the point of care. The PC Unit is responsible for all communication to the modules and is the basis for the modular platform that the healthcare facility can build on to customize infusion delivery to meet individual patient needs by adding or subtracting associated modules. The system utilizes modular electromechanical componentry to infuse fluids, medications, blood and blood products when used in conjunction with the dedicated infusion sets. Controlled delivery is achieved through the linear peristaltic pumping action of the pumping chamber section of the infusion set. | | | SAME: The PC Unit provides the power source and the common user interface for programming all attached modules which helps reduce complexity at the point of care. The PC Unit is responsible for all communication to the modules and is the basis for the modular platform that the healthcare facility can build on to customize infusion delivery to meet individual patient needs by adding or subtracting associated modules. The system utilizes modular electromechanical componentry to infuse fluids, medications, blood and blood products when used in conjunction with the dedicated infusion sets. Controlled delivery is achieved through the linear peristaltic pumping action of the pumping chamber section of the infusion set. | | |
| Accuracy | | | | SIMILAR: For the LVP module, the claim for flow rate accuracy has been updated to represent only performance at Standard Operating Conditions. There have been no changes to the actual flow rate accuracy performance requirements of the LVP. The full range of flow rate accuracy at non-SOC based on AAMI TIR:101 test data is presented in the User Manual. | | |
| | Module | Accuracy* | Conditions | Module | Accuracy† | Conditions |
| | Pump (LVP) | -19% to + 5.5% system flow rate accuracy | 1 to 999 mL/hr | Pump (LVP) | ±5% system flow rate accuracy | 1 to 999 mL/hr |
| | | -8 % to + 5.5% system flow rate accuracy | 0.1 to 1 mL/hr | | -8 % to + 5.5% system flow rate accuracy | 0.1 to 1 mL/hr |
| | Syringe (SYR) | ± 7% system flow rate accuracy | ≥ 10% of the syringe volume per hour | Syringe (SYR) | ± 7% system flow rate accuracy | ≥ 10% of the syringe volume per hour |
| | | ± 10% system flow rate accuracy | ≥ 0.1 mL/hr (Syringe sizes ≤ 12 mL) | | ± 10% system flow rate accuracy | ≥ 0.1 mL/hr (Syringe sizes ≤ 12 mL) |
| | | | ≥ 1 mL/hr (Syringe sizes > 12 mL) | | | ≥ 1 mL/hr (Syringe sizes > 12 mL) |
| | | ± 20% system flow rate accuracy | < 0.1 mL/hr (Syringe sizes ≤ 12 mL) | | ± 20% system flow rate accuracy | < 0.1 mL/hr (Syringe sizes ≤ 12 mL) |
| | | | < 1 mL/hr (Syringe sizes > 12 mL) | | | < 1 mL/hr (Syringe sizes > 12 mL) |
| | PCA | ± 7% system flow rate accuracy | ≥ 10% of the syringe volume per hour | PCA | ± 7% system flow rate accuracy | ≥ 10% of the syringe volume per hour |
| | | ± 10% system flow rate accuracy | ≥ 1 mL/hr | | ± 10% system flow rate accuracy | ≥ 1 mL/hr |
| | | ± 20% system flow rate accuracy | < 1 mL/hr | | ± 20% system flow rate accuracy | < 1 mL/hr |
| | EtCO2 | ± 2 mmHg CO2 Conc | 0–38 mmHg | EtCO2 | ± 2 mmHg CO2 Conc | 0–38 mmHg |
| | | 5% of reading + 8% per mmHg (above 38 mmHg) | 39–99 mmHg | | 5% of reading + 8% per mmHg (above 38 mmHg) | 39–99 mmHg |

* Flow Rate Accuracy data is generated in compliance to AAMI TIR 101 standard. Flow Rate Accuracy data for standard and non-standard operating condition is provided in the BD Alaris System with Guardrails Suite MX User Manual.
† Flow Rate Accuracy data is generated in compliance to AAMI TIR 101 standard. Flow Rate Accuracy data for standard and non-standard operating condition is provided in the BD Alaris System with Guardrails Suite MX User Manual.

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| Characteristic | Predicate Device K211218 Alaris System with Guardrails Suite MX v12 | | | | Subject Device BD Alaris Infusion System with Guardrails Suite MX | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Maximum Infusion Pressure | Pump Module: 525 mmHg Syringe Module: • Without pressure sensing disc: Approximately 800 mmHg‡ • With pressure sensing disc: 1060 mmHg | | | | SAME: Pump Module: 525 mmHg Syringe Module: • Without pressure sensing disc: Approximately 800 mmHg§ • With pressure sensing disc: 1060 mmHg | | |
| Programmable Flow Rate Range | Pump and PCA Modules: 0.1–999 ml/hr Syringe Module: 0.01–999 mL/hr | | | | SAME: Pump and PCA Modules: 0.1–999 ml/hr Syringe Module: 0.01–999 mL/hr | | |
| Bolus Accuracy (Pump) | Pump Module | | | | Pump Module | | |
| | Rate Range (mL/hr) | Bolus Volume Range (mL) | | Accuracy | Rate Range (mL/hr) | Bolus Volume Range (mL) | Accuracy |
| | Full Range (Without Rapid Bolus Feature) | ≥ 0.2 mL | | ±10% | Full Range (Without Rapid Bolus Feature) | ≥ 0.2 mL | ±10% |
| | | < 0.2 mL* | 0.2 mL: 0.1 mL: | ±0.02 mL ±0.025 mL | | < 0.2 mL* | 0.2 mL: 0.1 mL: |
| | Full Range (With Rapid Bolus Feature) | ≥ 1 mL | | ±10% | Full Range (With Rapid Bolus Feature) | ≥ 1 mL | |
| | | ≥ 0.6 mL and < 1 mL | | ±15% | | ≥ 0.6 mL and < 1 mL | |
| | | < 0.6 mL* | 0.6 mL: 0.1 mL: | ±0.06 mL 0 mL to +0.055 mL | | < 0.6 mL* | 0.6 mL: 0.1 mL: |
| | *Recommended minimum bolus volume is > 0.2 mL without rapid bolus feature and ≥ 0.6 ml with rapid bolus feature | | | | *Recommended minimum bolus volume is ≥ 0.2 mL without rapid bolus feature and ≥ 0.6 ml with rapid bolus feature | | |
| Bolus Accuracy (Syringe and PCA Modules) | Syringe Module | | | | SAME: Syringe Module | | |
| | Rate Range (mL/hr) | Bolus Volume Range (mL) | | Accuracy | Rate Range (mL/hr) | Bolus Volume Range (mL) | Accuracy |
| | Full Range | ≥ 0.2 mL | | ±10% | Full Range | ≥ 0.2 mL | ±10% |
| | | < 0.2 mL* | | ±20% | | < 0.2 mL* | ±20% |
| | *Recommended minimum bolus volume is ≥ 0.2 mL | | | | *Recommended minimum bolus volume is ≥ 0.2 mL | | |
| | PCA Module | | | | PCA Module | | |
| | Rate Range (mL/hr) | Bolus Volume Range (mL) | | Accuracy | Rate Range (mL/hr) | Bolus Volume Range (mL) | Accuracy |
| | Full Range | ≥ 0.2mL | | ±10% | Full Range | ≥ 0.2mL | ±10% |
| | | < 0.2mL* | | ±20% | | < 0.2mL* | ±20% |
| | *Recommended minimum bolus volume is ≥ 0.2 mL | | | | *Recommended minimum bolus volume is ≥ 0.2 mL | | |

Actual occlusion pressure varies based on syringe size and manufacturer.

Actual occlusion pressure varies based on syringe size and manufacturer.

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| Characteristic | Predicate Device
K211218 Alaris System with Guardrails Suite MX v12 | Subject Device
BD Alaris Infusion System with Guardrails Suite MX |
| --- | --- | --- |
| Post-occlusion Bolus Volume | Pump Module:
• ≤ 0.3 mL for all pressure settings (under standard operating conditions)
Syringe and PCA Module:
• ≤ 1.0 mL for all pressure settings (under standard operating conditions) | SAME:
Pump Module:
• ≤ 0.3 mL for all pressure settings (under standard operating conditions)
Syringe and PCA Module:
• ≤ 1.0 mL for all pressure settings (under standard operating conditions) |
| Compatible Administration Sets | Compatible Administration Sets as stated in BD Alaris System User Manual. | DIFFERENT:
Certain BD administration sets have been removed from the BD Alaris System User Manual, Appendix B – Product Compatibility, BD Alaris™ Pump Module Infusion Set Compatibility. |
| Compatible Syringes (Syringe Module) | No Brand Specified (6 mL)
BD Luer Lok (1, 3, 5, 10, 20, 30, 50 mL)
Monoject Luer Lock (12, 35, 60 mL)
Terumo (10 mL) | DIFFERENT:
BD Luer Lok (1, 3, 5, 10, 20, 30, 50 mL)
Terumo (10 mL)
Monoject 12, 35, 60 mL syringes have been removed from the compatible syringe list and are also not available as a selection on the device user interface. The 6 mL syringe was also removed as no brand was specified. |
| Compatible Syringes (PCA Module) | BD Luer Lok (20, 30, 50 mL)
Monoject Luer Lock (35mL including the 35 mL empty barrel syringe and 60mL) | DIFFERENT:
BD Luer Lok (20, 30, 50 mL)
Monoject empty barrel (35 mL)
Monoject 35 and 60 mL syringes have been removed from the compatible syringe list and are also not available as a selection on the device user interface. Monoject 35 mL empty barrel syringe remains compatible. |
| Alarms and Alerts | The subject device contains the following categories of audio and visual alarms, errors, and messages.
• Advisory/Message
• Alarm
• Alert
• Audio Characteristics
• Clinical Advisory
• Error
• Maintenance Reminder
• Prompt | SAME:
The subject device contains the following categories of audio and visual alarms, errors, and messages.
• Advisory/Message
• Alarm
• Alert
• Audio Characteristics
• Clinical Advisory
• Error
• Maintenance Reminder
• Prompt |
| Alarm Handler | Alarm conditions are detected by the Sensor/Actuator and Fluid Delivery Subsystem and reported to the Audio/Visual Alarm subsystem, which prioritizes the alarms and ensures proper enunciation utilizing the user interfaces of the PCU and Modules. | SAME:
Alarm conditions are detected by the Sensor/Actuator and Fluid Delivery Subsystem and reported to the Audio/Visual Alarm subsystem, which prioritizes the alarms and ensures proper enunciation utilizing the user interfaces of the PCU and Modules. |
| Device Service Life | 7 Years | SAME:
7 Years |

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| Characteristic | Predicate Device
K211218 Alaris System with Guardrails Suite MX v12 | Subject Device
BD Alaris Infusion System with Guardrails Suite MX |
| --- | --- | --- |
| Weight | 28.3 lbs (13 kg) maximum-weight supported configuration | SAME:
28.3 lbs (13 kg) maximum-weight supported configuration |
| Dimensions | PCU: 9.0" W x 8.9" H x 9.0" D (including pole clamp)
Pump Module: 3.3" W x 8.9" H x 5.5" D
Syringe Module: 4.75" W x 15.0" H x 7.5" D
PCA Module: 4.75" W x 15.0" H x 7.5" D
EtCO2 Module: 3.3" W x 8.9" H x 5.5" D
Auto-ID Module: 2.0" W x 7.25" H x 5.0" D | SAME:
PCU: 9.0" W x 8.9" H x 9.0" D (including pole clamp)
Pump Module: 3.3" W x 8.9" H x 5.5" D
Syringe Module: 4.75" W x 15.0" H x 7.5" D
PCA Module: 4.75" W x 15.0" H x 7.5" D
EtCO2 Module: 3.3" W x 8.9" H x 5.5" D
Auto-ID Module: 2.0" W x 7.25" H x 5.0" D |
| Materials
Biocompatibility | Biocompatible | SAME:
Biocompatible |
| Ingress Protection | IPX2 rated | SAME:
IPX2 rated |
| Power Source | Power Requirement: 100–240 VAC, 50/60 Hz, 150 VA MAX
Battery Pack: Rechargeable 12 V, 4000 mAh nickel metal hydride battery | SAME:
Power Requirement: 100–240 VAC, 50/60 Hz, 150 VA MAX
Battery Pack: Rechargeable 12 V, 4000 mAh nickel metal hydride battery |
| Watchdog Timer | Supported | SAME:
Supported |
| Real Time Clock | Supported | SAME:
Supported |
| Storage/Transport
Conditions | Atmospheric Pressure: 375 to 760 mmHg (500–1013 hPa) | SAME:
Atmospheric Pressure: 375 to 760 mmHg (500–1013 hPa) |
| | Relative humidity: 5-90% noncondensing | SAME:
Relative humidity: 5-90% noncondensing |
| | Temperature: -4°F–140°F (-20°C–60°C) | SAME:
Temperature: -4°F–140°F (-20°C–60°C) |
| Operating
Conditions | Atmospheric Pressure: 525 to 795 mmHg (700 - 1060 hPa) | SAME:
Atmospheric Pressure: 525 to 795 mmHg (700 - 1060 hPa) |
| | Relative humidity: 20 – 90% Noncondensing | SAME:
Relative humidity: 20 – 90% Noncondensing |
| | Temperature: 41°F – 104°F (5°C–40°C) | SAME:
Temperature: 41°F – 104°F (5°C–40°C) |
| Sterilization | Only the infusion sets are provided sterile. The remaining components are provided non-sterile and are not intended to be sterilized. | SAME:
Only the infusion sets are provided sterile. The remaining components are provided non-sterile and are not intended to be sterilized. |
| PCA Monitoring Protocol Functionality: | | |
| PCA/Monitoring
Protocol | Guardrails parameter | SAME:
Guardrails parameter |

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| Characteristic | Predicate Device
K211218 Alaris System with Guardrails Suite MX v12 | Subject Device
BD Alaris Infusion System with Guardrails Suite MX |
| --- | --- | --- |
| PCA Required Monitoring Modules | The PCA/Monitoring Protocol is based on hospital-configured monitoring limits. The Protocol will not be enabled and will not activate if EtCO_{2} module is not attached. | SAME:
The PCA/Monitoring Protocol is based on hospital-configured monitoring limits. The Protocol will not be enabled and will not activate if EtCO_{2} module is not attached. |
| Pause of PCA infusion due to potential unsafe state | Automatic pause when hospital-configured PCA/Monitoring Protocol limits are exceeded. Opioid medications must be programmed and EtCO_{2} module is attached. | SAME:
Automatic pause when hospital-configured PCA/Monitoring Protocol limits are exceeded. Opioid medications must be programmed and EtCO_{2} module is attached. |
| PCA Monitoring Protocol Alarms, Errors, Messages, Advisories | When the PCA/Monitoring protocol is enabled and a specific opioid medication is selected during programming, the clinician will receive a pop-up message to attach an appropriate monitoring module as per established hospital protocol.
When the PCA Module is paused as a result of patient monitoring limits exceeding hospital-configured PCA/Monitoring Protocol limits, the clinician will be alerted by a high-priority alarm and a visual message. | SAME:
When the PCA/Monitoring protocol is enabled and a specific opioid medication is selected during programming, the clinician will receive a pop-up message to attach an appropriate monitoring module as per established hospital protocol.
When the PCA Module is paused as a result of patient monitoring limits exceeding hospital-configured PCA/Monitoring Protocol limits, the clinician will be alerted by a high-priority alarm and a visual message. |
| PCA/Monitoring Protocol | Guardrails parameter | SAME:
Guardrails parameter |

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Table 5: Summary Comparison Infusion Management System

| Characteristic | Predicate Device K211218 Alaris System with Guardrails Suite MX v12 | Subject Device BD Alaris System with Guardrails Suite MX |
| --- | --- | --- |
| Technology | Local server | SAME: Local server |
| Pump Data Transmission | WLAN | SAME: WLAN |
| Wireless software updates to PCU | N/A | Subject device includes additional feature for wireless software updates to PCU via SM. Performance testing confirms the subject device with this added feature does not raise different questions of safety and effectiveness. |
| Dashboard (clinical, biomedical, pharmacy) | Available on the hospital health information technology (HIT) network | SAME: Available on the hospital health information technology (HIT) network |
| Autoprogramming | Supports interfaces to a bar code medication administration (BCMA); supports remote IV orders from EMR system (available with connectivity) | SAME: Supports interfaces to a bar code medication administration (BCMA); supports remote IV orders from EMR system (available with connectivity) |
| Drug Libraries | Available; customizable with an editor | SAME: Available; customizable with an editor |
| Drug Library Updates | Available with connectivity | SAME: Available with connectivity |
| Drug Library Validation | Available with Guardrails Suite | SAME: Available with Guardrails Suite |
| Set Usage | The Alaris System is used in conjunction with dedicated infusion sets. | SAME: The Alaris System is used in conjunction with dedicated infusion sets. |
| Dosing Limits | Soft and Hard Limits | SAME: Soft and Hard Limits |
| Dose Error Reduction | Alaris Guardrails | SAME: Alaris Guardrails |

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Non-Clinical and/or Clinical Test Summary &amp; Conclusion

Non-clinical testing was performed to verify requirements for essential performance, physical attributes, reliability, and safety, and to provide objective evidence that the device intended use is met. The following verification and validation testing was completed in support of this subject device:

Essential performance requirement verification

○ Accurate Delivery – Testing for flow rate and bolus accuracy based on AAMI TIR 101, Fluid delivery performance testing for infusion pumps compliance.
Protection against Inadvertent Delivery – Testing demonstrating critical volume has been adequately established, protection against free flow, protection against bolus during set loading, protection against post-occlusion bolus, and means to pause an infusion for BD Alaris Pump Module (LVP), BD Alaris Syringe Module (SYR), and Alaris Patient Controlled Analgesia (PCA) Module.
○ Alarm detection/notification – Testing demonstrating the device ability to detect and alarm for conditions adverse to safe administration of fluids (such as interrupted delivery/occlusions, air in line, battery status, and device malfunction.
○ Accurate measurement of a patient's End-tidal $\mathrm{CO}_{2}$ levels based on ISO 80601-2-55, Particular requirements for the basic safety and essential performance of respiratory gas monitors compliance and Respiratory Rate (RR) – Testing demonstrating alarm functionality, support of PCA infusion pause functionality, and accuracy of $\mathrm{EtCO}_{2}$ monitoring parameters and respiratory rate.

- Requirements verification - Testing demonstrating that design inputs were met at both system and subsystem level utilizing test protocols containing validated test methods, statistical methods in sample size determination and data analysis, and established acceptance criteria.

○ Software requirements via code review, static analysis, unit testing, integration testing, and regression testing.
Hardware requirements.
Hardware/Software compatibility requirements.
System operational requirements.
System interoperability requirements.
Blood and blood component delivery requirements.
Biocompatibility requirements.
System reliability requirements utilizing testing and statistical analysis at the system, device subsystem, and subsystem/component level.

- Electrical safety, Electromagnetic Compatibility (EMC) and essential performance - Testing was successfully completed according to the following standards and associated methods listed in the Table 6:

Table 6: List of Safety and Electromagnetic Compatibility (EMC) Standards

| Standard | Edition/Date | Title |
| --- | --- | --- |
| ANSI/AAMI ES 60601-1(FDA Number: 19-46) | 2005/2012 & AMD:2021Consolidated Version | "Medical electrical equipment-Part 1: General requirements for basic safety and essential performance(AAMI ES60601-1: 2005 & A1:2012 & A2:2021)" |
| IEC 60601-1(FDA Number: 19-49) | 3.2 Edition 2020Consolidated Version | Medical electrical equipment-Part 1: General requirements for basic safety and essential performanceIEC 60601-1 Edition 3.2 2020 Consolidated Version |
| IEC 60601-1-2(FDA Number: 19-36) | 4.1 Edition 2020Consolidated Version | Collateral Standard: EMC - Requirements and tests |
| IEC 60601-2-24 | Edition 2.0 2012 | Medical electrical equipment-Part 2.24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers. |
| UL 1642(FDA Number: 19-10) | 5th Edition 2009 | Lithium Batteries |

{19}

| Standard | Edition/Date | Title |
| --- | --- | --- |
| IEC 62133-1
(FDA Number: 19-32) | Edition 1.0 2017 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems |
| ISO 80601-2-55
(FDA Number: 1-140) | Edition 2.0 2018 | Medical electrical equipment-Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| IEC 60601-1-8
(FDA Number: 5-131) | 2.2 Edition 2020
Consolidated Version | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| ANSI/IEEE USEMCSC
C63.27
(FDA Number: 19-48) | 2021 | American National Standard for Evaluation of Wireless Coexistence |

- System cleaning and disinfection validation - Cleaning and Disinfection validation was performed according to FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
- Design validation – Design validation was performed utilizing clinical assessment, simulated testing, and biomedical engineering use. In addition, using use-related risk analysis and IEC 62366-1, Edition 1.1 2020-06 Consolidated Version, Medical devices – Part 1: Application of usability engineering to medical devices as well as reference to FDA guidance, “Applying Human Factors and Usability Engineering to Medical Devices”, Human Factors evaluation for the BD Alaris Infusion System was performed under simulated clinical conditions. Results demonstrate that the subject device through the design of its user interface is safe and effective for the intended use, intended users, and use environments.

Additionally, assessment and verification of implemented cybersecurity controls was performed and provided according to FDA’s Guidance for Industry and Food and Drug Administration Staff, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued September 27, 2023.

Clinical test data or animal test data is not applicable for this Premarket Notification.

## Conclusions

Verification and validation testing was successfully completed and demonstrates that the subject devices are as safe and effective as the legally marketed predicate device. The BD Alaris Infusion System with Guardrails Suite MX is substantially equivalent to the Alaris System with Guardrails Suite MX v12 cleared under K211218 with respect to the indications for use, target populations, treatment method, and technological characteristics.