Who is the manufacturer of BD Alaris System with Guardrails Suite MX v12.1.2?

Carefusion 303, Inc. filed the 510(k) submission for BD Alaris System with Guardrails Suite MX v12.1.2 (K211218).

What is the FDA product code for BD Alaris System with Guardrails Suite MX v12.1.2?

FRN. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD Alaris System with Guardrails Suite MX v12.1.2?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BD Alaris System with Guardrails Suite MX v12.1.2?

Alaris System with Guardrails Suite MX (K133532).

Who can help prepare an FDA 510(k) submission like BD Alaris System with Guardrails Suite MX v12.1.2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD Alaris System with Guardrails Suite MX v12.1.2

K211218 · Carefusion 303, Inc. · FRN · Jul 21, 2023 · General Hospital

Device Facts

Record ID	K211218
Device Name	BD Alaris System with Guardrails Suite MX v12.1.2
Applicant	Carefusion 303, Inc.
Product Code	FRN · General Hospital
Decision Date	Jul 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The BD Alaris System with Guardrails Suite MX is intended for use by healthcare professionals for the monitoring and controlled delivery of fluids, medications, blood, and blood products into patients.

Device Story

Modular infusion pump and monitoring system; comprises PC Unit (PCU) and attachable modules (Pump, Syringe, EtCO2, Auto-ID, PCA). PCU provides power, user interface, and communication; modules perform fluid delivery or monitoring. System uses linear peristaltic pumping for infusion. Interoperable with EMR systems via wireless or serial connection for data exchange and pre-population of infusion parameters; manual clinician confirmation required for activation. Used in professional healthcare environments by clinicians. Guardrails Suite MX software provides drug libraries with soft/hard dosing limits to reduce medication errors. EtCO2 module monitors respiratory parameters. Benefits include automated, accurate delivery of high-alert medications and integrated patient monitoring.

Clinical Evidence

No clinical data was generated in support of this Premarket Notification. Substantial equivalence is supported by extensive non-clinical bench testing, including flow rate/bolus accuracy, occlusion detection, air-in-line detection, electrical safety, EMC, and software verification/validation.

Technological Characteristics

Modular system; PCU and attachable modules. Materials are biocompatible. Energy source: 100-240 VAC or 12V NiMH battery. Connectivity: WLAN/serial for EMR interoperability. Ingress protection: IPX2. Software: Embedded firmware for motor control, UI, and networking; Guardrails Suite MX for drug library management. Sterilization: Infusion sets sterile; system components non-sterile.

Indications for Use

Indicated for continuous or intermittent administration of fluids to adult, pediatric (1 month to 21 years), and neonatal (newborns up to 1 month) patients via IV, intra-arterial, subcutaneous, epidural, or irrigation routes. Administered fluids include pharmaceutical drugs, red blood cells, platelets, and fresh frozen plasma. 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

Alaris System with Guardrails Suite MX (K133532)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. September 27, 2023 CareFusion 303 Inc. Laurie Cartwright Senior Director, Regulatory Affairs 10020 Pacific Mesa Blvd. San Diego, California 92121 Re: K211218 Trade/Device Name: BD Alaris System with Guardrails Suite MX v12 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC, MEA, CCK Dear Laurie Cartwright: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 21, 2023. Specifically, FDA is updating this SE Letter to change the trade name, which was originally requested in your 510(k) submission, as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jake Lindstrom, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-5716, Jake.Lindstrom(@fda.hhs.gov. > Sincerely, Digitally signed by Jake K. Jake K. Lindstrom -S Lindstrom -S Date: 2023.09.27 10:24:33 > 10:24:33 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out in a sans-serif font. July 21, 2023 CareFusion 303 Inc. Laurie Cartwright Senior Director, Regulatory Affairs 10020 Pacific Mesa Blvd. San Diego, California 92121 Re: K211218 Trade/Device Name: BD Alaris System with Guardrails Suite MX v12.1.2 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC, MEA, CCK Dated: June 21, 2023 Received: June 21, 2023 Dear Laurie Cartwright: 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 (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 located 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {2}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Juliane C. Lessard -S Juliane C. Lessard, Ph.D. Division Director DHT3C: Drug Delivery and General Hospital Devices & 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 {3}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K211218 Device Name BD Alaris System with Guardrails Suite MX v12 #### Indications for Use (Describe) 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. (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 ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K211218 #### Device Name BD Alaris System with Guardrails Suite MX v12 Indications for Use (Describe) #### Attachment | 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) | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. | | BD Alaris Pump Module (LVP) | Epidural | Pharmaceutical drugs approved for epidural use. | | BD Alaris Pump Module (LVP) | 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) | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. | | BD Alaris Syringe Module (SYR) | Epidural | Pharmaceutical drugs approved for epidural use. | | BD Alaris Syringe Module (SYR) | 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) | 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 #### Adult Patient Population | 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. | | | 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 (SYR) | 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 (PCA) | Intravenous | Pain management drugs approved for intravenous use. | | | Subcutaneous | Pain management drugs approved for subcutaneous use. | | | Epidural | Pain management drugs approved for epidural use. | Page 2 of 2 Pediatric* and Neonate** Patient Populations {5}------------------------------------------------ # 510(k) SUMMARY BD Alaris System with Guardrails Suite MX v12 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 | |------------------------|--------------------------------------------------------------------------------------------------------------------| | Address: | 10020 Pacific Mesa Blvd. San Diego, CA 92121 | | Contact Person: | Laurie Cartwright Senior Director, Regulatory Affairs Phone: 858-987-4203 Email: laurie.cartwright@bd.com | | Date Prepared: | July 19, 2023 | | Device Name | | | Proprietary Name: | BD Alaris System with Guardrails Suite MX v12 | | Common Name: | Infusion, Pump Infusion Safety Management Software Pump, Infusion, PCA Carbon Dioxide Gas Analyzer | | Device Classification: | Class II (classification codes are provided in the following table) | | 21 CFR Section | Product Code | Description | Components/Module | |----------------|--------------|----------------------------------------|---------------------------------------| | 880.5725 | FRN | Pump, Infusion | Point of Care Unit (PCU) | | | | | Large Volume Pump Module (LVP Module) | | | | | Syringe Module (Syringe Module) | | | | | Auto-ID Module | | | | | System Maintenance (ASM) | | | PHC | Infusion safety management software | Calculation Services (CalcServ) | | | | | Systems Manager (SM) | | | | | Infusion Adaptor (IA) | | | | | Guardrails Editor (GRE) | | | MEA | Pump, Infusion, PCA | Patient Controlled Analgesia Module | | | | | (PCA Module) | | 868.1400 | CCK | Carbon dioxide gas analyzer | EtCO2 Module (EtCO2 Module) | ## BD Alaris System Product Classification Codes {6}------------------------------------------------ ### Predicate Device The predicate device is the Alaris System with Guardrails Suite MX cleared under K133532 (August 21, 2014). #### 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. ### Intended Use The BD Alaris System with Guardrails Suite MX is intended for use by healthcare professionals for the monitoring and controlled delivery of fluids, medications, blood, and blood products into patients. {7}------------------------------------------------ #### 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. See Pediatrio*, 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 with Guardrails Suite MX is an interoperable of communicating and exchanging data with compatible information technology systems. The BD Alaris System with Guardrails Suite MX includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO) Module, Auto-ID Module, Patient-Controlled Analgessia (PCA) Module, and associated software applications. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractonal 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. | 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. | | | | | Table 1: Pediatric* and Neonate** Patient Populations | |--|--|--|-------------------------------------------------------| | | | | | * Pediatric population: One month to 21 years ** Neonate population: Newborns up to one month – includes preterm or term #### Table 2: 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. | {8}------------------------------------------------ #### Comparison of Technological Characteristics with the Predicate Device Comparison of the predicate and proposed device technological characteristics demonstrates that the majority of the devices' technological characteristics are the characteristics that are the same include: principle of operation, maximum infusion pressure, programmable flow rate range, weight and dimensions, and power source. Differences exist relating to flow rate accuracy, post-occlusion bolus volume, ingress protection, storage/transport relative humidity, and operating condition atmospheric pressure: - Flow rate and post-occlusion bolus volume specifications for the BD Alaris System v12 have been 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). - · The predicate device had an ingress protection of IPX1 (protected against falling drops of water) whereas the modified BD Alaris System v12 has been demonstrated to meet the higher IPX2 rating (protected against dripping water, tilted at a 15-degree angle). - Storage/transport relative humidity has been verified to a wider range than that for the predicate device; this change is . associated with the wider range of relative humidity that may be experienced during transport. - · The operating atmospheric pressure range for the BD Alaris System v12 has been changed from a range of 525 to 4560 mmHg to a range of 525 to 795 mmHg. It now excludes hyperbaric use, as the System is not indicated for use in a hyperbaric chamber. The narrowed range for operating atmospheric pressure is aligned with its use profile. The tables on the following pages provide a side-by-side comparison of the subject device, K133532. {9}------------------------------------------------ | Characteristic | Predicate Device K133532 Alaris System with Guardrails Suite MX | Subject Device BD Alaris System with Guardrails Suite MX v12 | |-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Alaris System with Guardrails Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Alaris System with Guardrails Suite MX 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 Alaris System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings; and exchanging data such that the clinical or operational purpose and meaning of the data are preserved and unaltered. | 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 inspire 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 | | 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 | | | Epidural | Pharmaceutical drugs approved for epidural 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 calls, 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 (PCA) | Intravenous | Pain management drugs; for example, opioids | | | 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 | | | # Comparison of Indications for Use and Intended Use {10}------------------------------------------------ | Characteristic | Predicate Device K133532 Alaris System with Guardrails Suite MX | Subject Device BD Alaris System with Guardrails Suite MX v12 | | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Adult Patient Population | | | | | | Module | Route of Administration | Infusates | | | | BD Alaris Pump Module (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; red blood calls, 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 | | |…

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