(819 days)
Not Found
No
The summary describes a modular infusion pump and monitoring system with various hardware and software components for fluid administration and respiratory monitoring. It details the system's architecture, communication methods, and performance characteristics related to flow rate, bolus accuracy, and safety features. There is no mention of AI or ML in the intended use, device description, or performance studies. The software components described are for system management, data communication, and basic embedded functions, not for learning or adaptive tasks typically associated with AI/ML.
Yes.
The device administers fluids, including pharmaceutical drugs and blood components, for patient therapy. It also monitors respiratory parameters (EtCO2), which are direct medical interventions and patient monitoring, thus classifying it as a therapeutic device.
Yes
The device includes an EtCO2 Module which is described as a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). Monitoring these physiological parameters is a diagnostic function.
No
The device description explicitly states that the system includes "System Hardware: a core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function." It also mentions that the PCU and attachable modules have "multiple processors running embedded software," indicating the presence of hardware components beyond just software.
Based on the provided information, the BD Alaris System with Guardrails Suite MX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the administration of fluids and monitoring of respiratory parameters to patients through clinically accepted routes. This is a direct interaction with the patient's body, not the examination of specimens derived from the human body.
- Device Description: The description details a modular infusion pump and monitoring system, including hardware for delivering fluids and monitoring physiological parameters like EtCO2. This aligns with medical devices used for patient treatment and monitoring, not laboratory testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The EtCO2 module monitors a physiological parameter directly from the patient's breath.
In summary, the BD Alaris System is a medical device used for patient care (infusion and monitoring), not for performing diagnostic tests on in vitro specimens.
N/A
Intended Use / 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 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.
Product codes
FRN, PHC, MEA, CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric (One month to 21 years), and neonatal (Newborns up to one month – includes preterm or term) patients.
Intended User / Care Setting
healthcare professionals for use in professional healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was completed in support of this premarket notification. The provided table lists various tests/analyses conducted for different modules (PCU, LVP, SYR, PCA, EtCO2, Auto-ID). These tests cover accuracy (flow rate, bolus, syringe, pressure, deliverable volume, critical volume), loading and flow (set misload, syringe loading/misload, free flow protection, retrograde flow, anti-siphon, sympathetic flow, blood set test, mechanical blood compatibility), occlusion detection, air-in-line detection, alarms, battery performance, mechanical durability, displays, packaging, cleaning and disinfection, environmental operating parameters, stress tests (drop, shock and vibration, pressure withstand), fluid ingress, EtCO2 specific analyses, keyboard functionality, communication, memory and clock, biocompatibility, electrical safety and EMC, software verification and validation, user needs validation (simulated testing, clinical assessment, biomedical engineering use), interoperability, human factors/usability engineering, and miscellaneous (available sets, flame retardant, latex requirement, PCA monitoring protocol feature).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
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
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 |
| | | | 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 |
| Contraindications | None | The BD Alaris System is contraindicated for enteral route of administration. | | |
| Routes of
Administration | Continuous/Bolus, Intermittent, Fluids through clinically acceptable routes of
administration such as intravenous (IV), intra-arterial (IA), subcutaneous,
epidural, enteral, or irrigation of fluid spaces. | 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 | Prescription Only | | |
| Intended Population | Adult, pediatric, neonate | Adult, pediatric, neonate | | |
| Environment of Use | Professional Healthcare Environments | Professional Healthcare Environments | | |
11
| Characteristic | Predicate Device
K133532 Alaris System with Guardrails Suite MX | | | Subject Device
BD Alaris System with Guardrails Suite MX v12 | | | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------|--|
| 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. | | | 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 | Module | Accuracy | Condition | Module | Accuracy | Conditions | |
| | | $\pm$ 5% flow rate | 1 to 999 mL/hr | Pump
(LVP) | -19% to + 5.5% system flow rate accuracy | 1 to 999 mL/hr | |
| | LVP | $\pm$ 5.5% flow rate | 0.1 to 1 mL/hr | (LVP) | -8 % to + 5.5% system flow rate accuracy | 0.1 to 1 mL/hr | |
| | | | | | $\pm$ 7% system flow rate accuracy | > 10% of the syringe
volume per hour | |
| | SYR | $\pm$ 2 % linear travel | 0.01 to 999 mL/hr | Syringe
(SYR) | $\pm$ 7% system flow rate accuracy | ≥ 10% of the syringe
volume per hour | |
| | PCA | $\pm$ 2 % linear travel | 0.1 to 999 mL/hr | | $\pm$ 10% system flow rate accuracy | ≥ 0.1 mL/hr
(Syringe sizes 1 mL/hr
(Syringe sizes > 12 mL) | |
| | | $\pm$ 2 mmHg CO2 Conc | 0 to 38 mmHg | | $\pm$ 20% system flow rate accuracy | 12 mL) | |
| | | | | PCA | $\pm$ 7% system flow rate accuracy | > 10% of the syringe
volume per hour | |
| | | | | | $\pm$ 10% system flow rate accuracy | > 1 mL/hr | |
| | | | | | $\pm$ 20% system flow rate accuracy | 0.6 mL and * Actual occlusion pressure varies based on syringe size and manufacturer.
12
13
| Characteristic | Predicate Device
K133532 Alaris System with Guardrails Suite MX | Subject Device
BD Alaris System with Guardrails Suite MX v12 |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 | Not included in predicate submission | 7 Years |
| Weight | 28.3 lbs (13 kg) maximum-weight supported configuration | 28.3 lbs (13 kg) maximum-weight supported configuration |
| Dimensions | PCU: 6.9" W x 8.9" H x 9.0" D (including pole clamp) | 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 | 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 | 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 | 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 | 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 | Auto-ID Module: 2.0" W x 7.25" H x 5.0" D |
| Materials
Biocompatibility | Not included in predicate submission | Biocompatible |
| Ingress Protection | IPX1 rated | 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 | 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 | Supported |
| Real Time Clock | Supported | Supported |
| | Atmospheric Pressure: 375 to 760 mmHg (500-1013 hPa) | Atmospheric Pressure: 375 to 760 mmHg (500-1013 hPa) |
| Storage/Transport | Relative humidity: 5-85% noncondensing | Relative humidity: 5-90% noncondensing |
| Conditions | Temperature: 4°F-140°F (-20°C~60°C) | Temperature: -4°F-140°F (-20°C-60°C) |
| Operating
Conditions | Atmospheric pressure: 525-4560 mmHg (700-6080 hPa) | Atmospheric Pressure: 525 to 795 mmHg (700 - 1060 hPa) |
| | Relative humidity: 20 – 90% Noncondensing | Relative humidity: 20 – 90% Noncondensing |
| | Temperature: 41°F - 104°F (5°C-40°C) | 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. | 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 | Guardrails parameter |
| 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 hospital—
determined monitoring modules (EtCO2 or SPO2) are not attached. | The PCA/Monitoring Protocol is based on hospital-configured monitoring limits. The
Protocol will not be enabled and will not activate if EtCO2 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 monitoring modules
(EtCO2 or SPO2) are attached. | Automatic pause when hospital-configured PCA/Monitoring Protocol limits are exceeded.
Opioid medications must be programmed and EtCO2 module is attached. |
| Characteristic | Predicate Device
K133532 Alaris System with Guardrails Suite MX | Subject Device
BD Alaris System with Guardrails Suite MX v12 |
| 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. | 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 | Guardrails parameter |
14
15
Infusion Management System Comparison
| Characteristic | Predicate Device
K133532 Alaris System with Guardrails Suite MX | Subject Device
BD Alaris System with Guardrails Suite MX v12 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Local server | Local server |
| Pump Data Transmission | WLAN | WLAN |
| Dashboard
(clinical, biomedical, pharmacy) | Available on the hospital health information technology (HIT) network | 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) | 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 | Available; customizable with an editor |
| Drug Library Updates | Available with connectivity | Available with connectivity |
| Drug Library Validation | Available with Guardrails Suite | Available with Guardrails Suite |
| Set Usage | The Alaris System is used in conjunction with dedicated infusion sets. | The Alaris System is used in conjunction with dedicated infusion sets. |
| Dosing Limits | Soft and Hard Limits | Soft and Hard Limits |
| Dose Error Reduction | Alaris Guardrails | Alaris Guardrails |
16
Summary of Non-Clinical Testing
Verification and validation testing was completed in support of this premarket notification. The following table provides a summary of the testing:
| Test/Analysis | Module |
|---|---|
| Accuracy | |
| Flow Rate Accuracy | |
| Flow Rate Accuracy (SOC and AAMI TIR 101 Compliance) | LVP, SYR, PCA |
| Flow Rate Accuracy (Non-SOC) | LVP, SYR, PCA |
| Bolus Accuracy | |
| Bolus Accuracy (SOC and AAMI TIR 101 Compliance) | LVP, SYR, PCA |
| Bolus Accuracy (Non-SOC) | LVP, SYR, PCA |
| Bolus After Set Up - Volume on Door Closure (SOC) | LVP |
| Bolus Volume, Post-Occlusion (SOC) | LVP, SYR, PCA |
| Bolus Volume, Post-Occlusion (Non-SOC) | LVP, SYR, PCA |
| Bolus Volume, Post-Occlusion (SOC + High Pressure) | PCA |
| Syringe Accuracy | |
| Syringe Instrument Accuracy (SOC) | SYR, PCA |
| Pressure Accuracy | SYR, PCA |
| Deliverable Volume | SYR, PCA |
| Visually Verifying Syringe Volume | SYR, PCA |
| Critical Volume Accuracy (SOC) | LVP, SYR |
| Loading and Flow | |
| Set Misload | LVP |
| Syringe Loading | PCA |
| Syringe Misload | SYR, PCA |
| Free Flow Protection | LVP |
| Retrograde Flow | LVP |
| Anti-Siphon feature Infusion Sets | SYR, PCA |
| Sympathetic Flow | LVP |
| Blood Set Test Without Nuisance Occlusion Alarms | LVP |
| Mechanical Blood Compatibility Test | LVP, SYR |
| Occlusion Detection | |
| Occlusion Time-to-Alarm (SOC) | LVP, SYR, PCA |
| Occlusion Time-to-Alarm (Non-SOC) | LVP, SYR, PCA |
| Partial Upstream Occlusion Detection | LVP |
| Midstream Occlusion (Stuck Silicone Tubing) Detection | LVP |
| Upstream and Downstream Occlusion Time-to-Alarm with Aged Sets | LVP |
| Air-in-Line Detection | |
| Single Air Bolus (AIL) | LVP |
| Accumulated Air-in-Line (SOC) | LVP |
| Air-in-Line Detection (Non-SOC) | LVP |
| Air-In-Line (AIL) Engineering Analysis | LVP |
| Test/Analysis | Module |
| Alarms | |
| Alarm and Backup Alarm Test | PCU |
| Alarm Ability Upon Watchdog Timeout | PCU |
| Fixed Volume Alarm | PCU |
| Low Battery Alarm | PCU |
| Visual Alarm Flash Rate | PCU |
| Loudness Test | PCU, LVP, SYR, PCA |
| Battery | |
| AC to Battery Switchover Test | PCU |
| Battery Runtime Test | PCU |
| Battery Storage | PCU |
| Battery Physical Requirement Inspection Test | PCU |
| Automatically Condition Battery Analysis | PCU |
| Mechanical | |
| Securing PCA Module Engineering Analysis/Report | PCA |
| Modules Attachment and Removal Inspection Test | PCU, LVP, SYR, PCA, EtCO2 |
| Handle Strength Test | PCU |
| Pole Clamp Inspection Test | PCU |
| Minimizing Inadvertent Dislodgement Inspection Test | SYR, PCA |
| Door and Latch Mechanism Interaction with Adjacent Modules Test | LVP |
| Service Life Testing (SLT) Engineering Analysis | PCU, LVP, SYR, PCA |
| Service Life Study Plan Test | PCU, LVP, SYR |
| Gunk Test | IUI, PCU, LVP, SYR, PCA, EtCO2 |
| Door Gunk Test | LVP |
| Inspection-Communications Connector Connect/Disconnect & System Power | PCU, LVP, SYR, PCA, Auto-ID |
| Carrying/Door Handle and Project Tamper Resistant Key Test | PCU |
| Disposables Interaction with LVP Door and Latch Mechanism Inspection | LVP, EtCO2 |
| Dose Request Cord Inspection Test | PCA |
| Spallation Test (SOC) | LVP |
| Push Test | PCU, LVP, SYR, PCA, Auto-ID |
| Maximum System Weight, Modules Size and Weight | PCU, LVP, SYR, PCA, EtCO2, Auto-ID |
| Displays | |
| Display Viewability Test | PCU, LVP, SYR, PCA, EtCO2 |
| Module Channel Display Engineering Analysis | PCU, LVP, SYR, PCA, EtCO2 |
| Operating in Sunlight and Photo Flash Test | PCU, LVP, SYR, PCA, Auto-ID |
| Segment Display Replacement | LVP, PCA, SYR, EtCO2 |
| Packaging Test | |
| Cleaning and Disinfection | PCU, LVP, SYR, PCA, EtCO2 |
| Cleaning and Disinfection | |
| Environmental Operating Parameters | |
| Storage Temperature and Humidity Tests | PCU, LVP, SYR, PCA, EtCO2 |
| Storage Pressure Test | PCU, LVP, SYR, PCA, EtCO2 |
| Operating Pressure Test | PCU, LVP, SYR, PCA, EtCO2 |
| Keypad with Gasket Storage Temperature and Humidity Test | PCU |
| Operating on Different Surfaces | PCU, LVP, SYR, PCA, EtCO2 |
| Test/Analysis | Module |
| Stress Test | |
| Drop Test | PCU, LVP, SYR, PCA, EtCO2 |
| Shock and Vibration Test | PCU, LVP, SYR, PCA, EtCO2 |
| Pressure Withstand Test | LVP |
| Fluid Ingress | |
| IPX2 and Spillage Test | PCU, LVP, SYR, PCA, EtCO2 |
| Spillage Test | Auto-ID |
| EtCO2 | |
| Leak Down | EtCO2 |
| Exhaust Port | EtCO2 |
| Auto Zero Engineering Analysis | EtCO2 |
| Auto Zero per ISO 80601-2-55 Engineering Analysis | EtCO2 |
| Respiratory Rate Accuracy Engineering Analysis | EtCO2 |
| Measurement Accuracy Engineering Analysis | EtCO2 |
| Power Supply Engineering Analysis | PCU |
| Keyboard | |
| Keypad Press and Audio Verification | PCU, LVP, SYR, PCA |
| Vented Keypad Analysis | PCU, LVP, SYR, PCA, EtCO2 |
| Communication - RJ-45 and RS-232 Capability | PCU |
| Memory and Clock | |
| Memory Retention | PCU |
| Real-Time Clock Drift | PCU |
| Biocompatibility-Cytotoxicity, Irritation, and Sensitization | ALL |
| Electrical Safety and EMC | |
| Immunity to Electrostatic Discharge | ALL |
| Immunity to Radiated RF, Magnetic Fields, and Proximity RF Wireless | |
| Communication Equipment | ALL |
| Electrical Safety | ALL |
| Software Verification and Validation-Code Inspection, Static Analysis, Unit | |
| Testing, Black and Gray Box | Software |
| User Needs | |
| Validation by Simulated Testing | PCU, LVP, SYR, PCA |
| Validation by Clinical Assessment | PCU, LVP, SYR, PCA |
| Validation of Biomedical Engineering Use | PCU, LVP, SYR, PCA |
| Interoperability | PCU, LVP, Auto-ID |
| Human Factors/Useability Engineering | PCU, LVP, SYR, PCA, EtCO2, Auto-ID |
| and LVP for Anesthesia | |
| Miscellaneous | |
| Available Sets Engineering Analysis | LVP, SYR, PCA |
| Flame Retardant Engineering Analysis | PCU, LVP, SYR, PCA, EtCO2, |
| Auto-ID | |
| Latex Requirement Engineering Analysis | PCU, LVP, SYR, PCA, EtCO2 |
| PCA Monitoring Protocol Feature | PCU, PCA, EtCO2 |
17
18
Animal Data
No animal data was generated in support of this Premarket Notification.
Clinical Data
No clinical data was generated in support of this Premarket Notification.
19
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The BD Alaris System with Guardrails Suite MX v12 is substantially equivalent to the Alaris System with Guardrails Suite MX cleared under K133532 with respect to the indications for use, target populations, treatment method, and technological characteristics.