(819 days)
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.
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.
The provided FDA 510(k) summary for the BD Alaris System with Guardrails Suite MX v12 explicitly states a "Summary of Non-Clinical Testing" and "No animal data was generated", and "No clinical data was generated". Therefore, the device performance is reported from non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device K211218) |
|---|---|---|
| LVP Flow Rate Accuracy | $\pm$ 5% flow rate (1 to 999 mL/hr) $\pm$ 5.5% flow rate (0.1 to 1 mL/hr) | -19% to + 5.5% system flow rate accuracy (1 to 999 mL/hr) -8 % to + 5.5% system flow rate accuracy (0.1 to 1 mL/hr) (Note: These specifications were updated to include "more defined test conditions aligned with the current state of the art standard for flow rate accuracy (AAMI TIR 101:2021 Fluid delivery performance testing for infusion pumps)".) |
| SYR Flow Rate Accuracy | $\pm$ 2% linear travel (0.01 to 999 mL/hr) | $\pm$ 7% system flow rate accuracy (> 10% of the syringe volume per hour) $\pm$ 7% system flow rate accuracy (≥ 10% of the syringe volume per hour) $\pm$ 10% system flow rate accuracy (≥ 0.1 mL/hr (Syringe sizes < 12 mL), > 1 mL/hr (Syringe sizes > 12 mL)) $\pm$ 20% system flow rate accuracy (< 0.1 mL/hr (Syringe sizes ≤ 12 mL), < 1 mL/hr (Syringe sizes > 12 mL)) |
| PCA Flow Rate Accuracy | $\pm$ 2% linear travel (0.1 to 999 mL/hr) | $\pm$ 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 (< 1 mL/hr) |
| EtCO2 Accuracy | $\pm$ 2 mmHg CO2 Conc (0 to 38 mmHg) 5% of reading + 8% per mmHg (above 38 mmHg) | $\pm$ 2 mmHg CO2 Conc (0-38 mmHg) 5% of reading + 8% per mmHg (39-99 mmHg) |
| Maximum Infusion Pressure (Pump Module) | 525 mmHg | 525 mmHg |
| Maximum Infusion Pressure (Syringe Module) | Without pressure sensing disc: Approximately 800 mmHg With pressure sensing disc: 1060 mmHg | Without pressure sensing disc: Approximately 800 mmHg With pressure sensing disc: 1060 mmHg |
| Programmable Flow Rate Range (Pump & PCA) | 0.1–999 ml/hr | 0.1-999 ml/hr |
| Programmable Flow Rate Range (Syringe) | 0.01-999 mL/hr | 0.01-999 mL/hr |
| Bolus Accuracy (Pump Module) | Not included in predicate submission | Without Rapid Bolus Feature: ≥ 0.2 mL: ±10% < 0.2 mL: 0.2 mL: ±0.02 mL, 0.1 mL: ±0.025 mL With Rapid Bolus Feature: ≥ 1 mL: ±10% > 0.6 mL and < 1 mL: ±15% < 0.6 mL: 0.6 mL: ±0.06 mL, 0.1 mL: 0 mL to +0.055 mL |
| Bolus Accuracy (Syringe Module) | Not included in predicate submission | Full Range: ≥ 0.2 mL: ±10% < 0.2 mL: ±20% |
| Bolus Accuracy (PCA Module) | Not included in predicate submission | Full Range: ≥ 0.2mL: ±10% < 0.2mL: ±20% |
| Post-Occlusion Bolus Volume (Pump Module) | ≤ 0.3 mL at 50 mmHg pressure setting ≤ 0.6 mL at 525 mmHg pressure setting | ≤ 0.3 mL for all pressure settings (under standard operating conditions) |
| Post-Occlusion Bolus Volume (Syringe & PCA Modules) | < 1.1 mL at high pressure setting without pressure sensing disc | ≤ 1.0 mL for all pressure settings (under standard operating conditions) |
| Ingress Protection | IPX1 rated | IPX2 rated |
| Storage/Transport Relative Humidity | 5-85% noncondensing | 5-90% noncondensing |
| Operating Atmospheric Pressure | 525-4560 mmHg (700-6080 hPa) - Predicate also indicated hyperbaric use. | 525 to 795 mmHg (700 - 1060 hPa) - Narrowed range, excluding hyperbaric use, aligned with its use profile. |
| Device Service Life | Not included in predicate submission | 7 Years |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly provide specific sample sizes (e.g., number of infusion pumps, number of tests conducted for each parameter) for each test set. It lists general categories of "non-clinical testing" and indicates that "Verification and validation testing was completed in support of this premarket notification." The data provenance is described as "non-clinical testing," implying internal laboratory testing by the manufacturer. There is no information regarding country of origin or whether the data was retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided about experts used to establish "ground truth" in the context of clinical or diagnostic accuracy. The testing described is non-clinical, focusing on engineering and performance specifications. Therefore, the "ground truth" would be the theoretical or established performance parameters as defined in relevant engineering standards (e.g., AAMI TIR 101:2021).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The reported tests are non-clinical and objective measurements based on engineering specifications and standards, not subjective assessments requiring adjudication by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The BD Alaris System with Guardrails Suite MX v12 is an infusion pump and monitoring system, not a diagnostic imaging device typically associated with MRMC studies or AI assistance for human readers. No mention of AI assistance for human readers is made in the document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical infusion pump system with embedded software. While it has "Guardrails Suite MX Software" for safety management and "Interoperability Software" for communication, its primary function is direct fluid delivery and monitoring. Standalone algorithm-only performance as typically understood in AI/ML medical devices is not relevant here. The performance metrics are for the integrated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be established by:
- Engineering Specifications: The defined parameters and tolerances for fluid delivery, pressure, flow rate, alarms, and environmental conditions.
- International and Industry Standards: Compliance with relevant standards like ISO 80601-2-55 (for EtCO2 module) and AAMI TIR 101:2021 (for flow rate accuracy).
- Objective Measurement Devices: Calibrated equipment used to measure the physical outputs of the device (e.g., volume of fluid delivered, pressure readings).
8. The sample size for the training set
Not applicable. This is a traditional medical device (infusion pump) with embedded software, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The software functions based on programmed logic and established parameters rather than learning from data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning for this device. The system's "knowledge" or operational parameters are pre-defined by engineering design and validated against established standards and specifications.
{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 ofAdministration | Infusates |
|---|---|---|
| BD Alaris PumpModule (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; redblood cells, platelets and fresh frozen plasma. |
| BD Alaris PumpModule (LVP) | Subcutaneous | Fluids and pharmaceutical drugs approved for subcutaneous use. |
| BD Alaris PumpModule (LVP) | Epidural | Pharmaceutical drugs approved for epidural use. |
| BD Alaris PumpModule (LVP) | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use |
| BD Alaris SyringeModule (SYR) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; redblood cells, platelets and fresh frozen plasma. |
| BD Alaris SyringeModule (SYR) | Subcutaneous | Pharmaceutical drugs approved for subcutaneous use. |
| BD Alaris SyringeModule (SYR) | Epidural | Pharmaceutical drugs approved for epidural use. |
| BD Alaris SyringeModule (SYR) | Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. |
| Alaris PCAModule (PCA) | Intravenous | Pain management drugs approved for intravenous use |
| Alaris PCAModule (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 ofAdministration | Infusates |
|---|---|---|
| BD Alaris PumpModule (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alert medications, chemotherapy, and parenteral nutrition; redblood 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 fluidspaces | Fluids approved for irrigation. | |
| BD Alaris SyringeModule (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 PCAModule (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 CartwrightSenior Director, Regulatory AffairsPhone: 858-987-4203Email: laurie.cartwright@bd.com |
| Date Prepared: | July 19, 2023 |
| Device Name | |
| Proprietary Name: | BD Alaris System with Guardrails Suite MX v12 |
| Common Name: | Infusion, PumpInfusion Safety Management Software Pump, Infusion, PCACarbon 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 managementsoftware | 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 ofAdministration | 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 subcutaneoususe. | |
| 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™ PCAModule | 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 ofAdministration | 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 subcutaneoususe. | |
| Epidural | Pharmaceutical drugs approved for epidural use. | |
| Intra-arterial | Pharmaceutical drugs approved for intra-arterial use. | |
| Irrigation of fluidspaces | 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™ PCAModule | 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 DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 |
|---|---|---|
| Indications for Use | The Alaris System with Guardrails Suite MX is intended for use in professionalhealthcare facilities that utilize infusion devices for the delivery of fluids,medications, blood and blood products. The Alaris System with Guardrails SuiteMX is intended to provide trained healthcare caregivers a way to automate theprogramming of infusion parameters, thereby decreasing the amount of manualsteps necessary to enter infusion data. All data entry and validation of infusionparameters is performed by the trained healthcare professional according to aphysician's order. The Alaris System with Guardrails Suite MX is aninteroperable system capable of communicating and exchanging data accurately,effectively, securely, and consistently with different information technologysystems, software applications, and networks, in various settings; and exchangingdata such that the clinical or operational purpose and meaning of the data arepreserved and unaltered. | The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoringsystem for the continuous or intermittent administration of fluids to adult, pediatric, andneonatal 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 bloodcomponents (platelets and fresh frozen plasma) as required for patient therapy. The BD AlarisSystem is an interoperable system capable of communicating and exchanging data withcompatible information technology systems.The BD Alaris System includes the PC Unit (PCU) and one or more of the following: PumpModule, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. EtCO2 Module isa capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspirecarbon dioxide (FiCO2), and respiratory rate (RR).BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated forvarying patient populations, routes of administration, and infusates. Refer to Table below forthe module-specific variations. |
| Pediatric* and Neonate** Patient Population | ||
| Module | Route of Administration | Infusates |
| BD Alaris PumpModule (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alertmedications, chemotherapy, and parenteral nutrition;red blood cells, platelets and fresh frozen plasma |
| Subcutaneous | Fluids and pharmaceutical drugs approved forsubcutaneous use | |
| Epidural | Pharmaceutical drugs approved for epidural use | |
| Intra-arterial | Pharmaceutical drugs approved for intra-arterial use | |
| BD Alaris SyringeModule (SYR) | Intravenous | Fluids, pharmaceutical drugs including high-alertmedications, 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 PCAModule (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 DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 | ||
|---|---|---|---|---|
| Adult Patient Population | ||||
| Module | Route ofAdministration | Infusates | ||
| BD Alaris PumpModule (LVP) | Intravenous | Fluids, pharmaceutical drugs including high-alertmedications, chemotherapy, and parenteral nutrition;red blood calls, platelets and fresh frozen plasma | ||
| Subcutaneous | Fluids and pharmaceutical drugs approved forsubcutaneous use | |||
| Epidural | Pharmaceutical drugs approved for epidural use | |||
| Intra-arterial | Pharmaceutical drugs approved for intra-arterial use | |||
| Irrigation of fluidspaces | Fluids approved for irrigation | |||
| BD Alaris SyringeModule (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 PCAModule (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 ofAdministration | Continuous/Bolus, Intermittent, Fluids through clinically acceptable routes ofadministration 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 suchas intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. | ||
| Prescription Only orOver 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 DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 | |||||
|---|---|---|---|---|---|---|---|
| Principle ofOperation | The PC Unit provides the power source and the common user interface forprogramming all attached modules, which helps reduce complexity at the pointof care. The PC Unit is responsible for all communication to the modules and isthe basis for the modular platform that the healthcare facility can build on tocustomize infusion delivery to meet individual patient needs by adding orsubtracting associated modules.The system utilizes modular electromechanical componentry to infuse fluids,medications, blood, and blood products when used in conjunction with thededicated infusion sets. Controlled delivery is achieved through the linearperistaltic 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 allattached modules which helps reduce complexity at the point of care. The PC Unit isresponsible for all communication to the modules and is the basis for the modular platformthat the healthcare facility can build on to customize infusion delivery to meet individualpatient 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 pumpingchamber 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 syringevolume per hour | ||||||
| SYR | $\pm$ 2 % linear travel | 0.01 to 999 mL/hr | Syringe(SYR) | $\pm$ 7% system flow rate accuracy | ≥ 10% of the syringevolume 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 < 12 mL) | |||
| > 1 mL/hr(Syringe sizes > 12 mL) | |||||||
| $\pm$ 2 mmHg CO2 Conc | 0 to 38 mmHg | $\pm$ 20% system flow rate accuracy | < 0.1 mL/hr(Syringe sizes ≤ 12 mL) | ||||
| EtCO2 | 5% of reading + 8% per mmHg(above 38 mmHg) | 39 to 99 mmHg | < 1 mL/hr(Syringe sizes > 12 mL) | ||||
| PCA | $\pm$ 7% system flow rate accuracy | > 10% of the syringevolume per hour | |||||
| $\pm$ 10% system flow rate accuracy | > 1 mL/hr | ||||||
| $\pm$ 20% system flow rate accuracy | < 1 mL/hr | ||||||
| EtCO2 | $\pm$ 2 mmHg CO2 Conc | 0-38 mmHg | |||||
| 5% of reading + 8% per mmHg(above 38 mmHg) | 39-99 mmHg | ||||||
| Maximum | Pump Module: 525 mmHg | Pump Module: 525 mmHg | |||||
| Infusion Pressure | Syringe Module: | Syringe Module: | |||||
| • Without pressure sensing disc: Approximately 800 mmHg* | • Without pressure sensing disc: Approximately 800 mmHg* | ||||||
| • With pressure sensing disc: 1060 mmHg | • With pressure sensing disc: 1060 mmHg | ||||||
| ProgrammableFlow RateRange | Pump and PCA Modules: 0.1–999 ml/hr | Pump and PCA Modules: 0.1-999 ml/hr | |||||
| Syringe Module: 0.01-999 mL/hr | Syringe Module: 0.01-999 mL/hr | ||||||
| Characteristic | Predicate DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 | |||||
| BolusAccuracy(Pump) | Not included in predicate submission | Pump Module | |||||
| Rate Range(mL/hr) | Bolus Volume Range (mL) | Accuracy | |||||
| Full Range(Without RapidBolus Feature) | ≥ 0.2 mL | ±10% | |||||
| < 0.2 mL* | 0.2 mL:0.1 mL: | ±0.02 mL±0.025 mL | |||||
| ≥ 1 mL | ±10% | ||||||
| Full Range(With Rapid BolusFeature) | > 0.6 mL and < 1 mL | ±15% | |||||
| < 0.6 mL* | 0.6 mL:0.1 mL: | ±0.06 mL0 mL to +0.055 mL | |||||
| *Recommended minimum bolus volume is ≥ 0.2 mL without rapid bolus feature and ≥ 0.6 mlwith rapid bolus feature | |||||||
| BolusAccuracy(Syringe andPCA Modules) | Not included in predicate submission | Syringe Module | |||||
| Rate Range(mL/hr) | Bolus Volume Range (mL) | Accuracy | |||||
| Full Range | ≥ 0.2 mL | ±10% | |||||
| < 0.2 mL* | ±20% | ||||||
| *Recommended minimum bolus volume is ≥ 0.2 mL | |||||||
| PCA Module | |||||||
| Rate Range(mL/hr) | Bolus Volume Range (mL) | Accuracy | |||||
| Full Range | ≥ 0.2mL | ±10% | |||||
| < 0.2mL* | ±20% | ||||||
| *Recommended minimum bolus volume is ≥ 0.2 mL | |||||||
| Post-occlusionBolus Volume | Pump Module:• ≤ 0.3 mL at 50 mmHg pressure setting• ≤ 0.6 mL at 525 mmHg pressure settingSyringe and PCA Modules:• < 1.1 mL at high pressure setting without pressure sensing disc | Pump Module:• ≤ 0.3 mL for all pressure settings (under standard operating conditions)Syringe and PCA Module:• ≤ 1.0 mL for all pressure settings (under standard operating conditions) | |||||
| Alarms andAlerts | The predicate device contains the following categories of audio and visualalarms, errors, and messages. | The subject device contains the following categories of audio and visual alarms, errors, andmessages. | |||||
| • Advisory/Message | • Advisory/Message | ||||||
| • Alarm | • Alarm | ||||||
| • Alert | • Alert | ||||||
| • Audio Characteristics | • Audio Characteristics | ||||||
| • Clinical Advisory | • Clinical Advisory | ||||||
| • Error | • Error | ||||||
| • Maintenance Reminder | • Maintenance Reminder | ||||||
| • Prompt | • Prompt |
Comparison of Technological Characteristics
* Actual occlusion pressure varies based on syringe size and manufacturer.
{12}------------------------------------------------
{13}------------------------------------------------
| Characteristic | Predicate DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 |
|---|---|---|
| Alarm Handler | Alarm conditions are detected by the Sensor/Actuator and Fluid DeliverySubsystem and reported to the Audio/Visual Alarm subsystem, which prioritizesthe alarms and ensures proper enunciation utilizing the user interfaces of the PCUand Modules. | Alarm conditions are detected by the Sensor/Actuator and Fluid Delivery Subsystem andreported to the Audio/Visual Alarm subsystem, which prioritizes the alarms and ensuresproper enunciation utilizing the user interfaces of the PCU and Modules. |
| Device ServiceLife | 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 | |
| MaterialsBiocompatibility | Not included in predicate submission | Biocompatible |
| Ingress Protection | IPX1 rated | IPX2 rated |
| Power Source | Power Requirement: 100-240 VAC, 50/60 Hz, 150 VA MAXBattery Pack: Rechargeable 12 V, 4000 mAh nickel metal hydride battery | Power Requirement: 100-240 VAC, 50/60 Hz, 150 VA MAXBattery 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) |
| OperatingConditions | 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 areprovided 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/MonitoringProtocol | Guardrails parameter | Guardrails parameter |
| PCA RequiredMonitoring Modules | The PCA/Monitoring Protocol is based on hospital-configured monitoringlimits. 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. TheProtocol will not be enabled and will not activate if EtCO2 module is not attached. |
| Pause of PCAinfusion due topotential unsafe state | Automatic pause when hospital-configured PCA/Monitoring Protocol limits areexceeded. 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 DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD Alaris System with Guardrails Suite MX v12 |
| PCA MonitoringProtocol Alarms,Errors, Messages,Advisories | When the PCA/Monitoring protocol is enabled and a specific opioid medicationis selected during programming, the clinician will receive a pop-up message toattach an appropriate monitoring module as per established hospital protocol.When the PCA Module is paused as a result of patient monitoring limitsexceeding hospital-configured PCA/Monitoring Protocol limits, the clinicianwill be alerted by a high-priority alarm and a visual message. | When the PCA/Monitoring protocol is enabled and a specific opioid medication is selectedduring programming, the clinician will receive a pop-up message to attach an appropriatemonitoring 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-priorityalarm and a visual message. |
| PCA/MonitoringProtocol | Guardrails parameter | Guardrails parameter |
{14}------------------------------------------------
{15}------------------------------------------------
Infusion Management System Comparison
| Characteristic | Predicate DeviceK133532 Alaris System with Guardrails Suite MX | Subject DeviceBD 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 WirelessCommunication Equipment | ALL |
| Electrical Safety | ALL |
| Software Verification and Validation-Code Inspection, Static Analysis, UnitTesting, 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-IDand 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.
§ 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).