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510(k) Data Aggregation
(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.
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(20 days)
Pressure Rated: The MaxZero™ Extension Set with Needle-Free Connector(s) is for single use only. The MaxZero™ Extension Set with Needle-Free Connector(s) may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
The MaxZero™ Extension Set with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics (neonates, infants, children, adolescents) and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids, All MaxZero™ Extension Set with Needle-Free Connector(s) include the previously cleared zero reflux MZ1000 needleless Connector bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needle stick injuries. The MaxZero™ needleless connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
The provided document is a 510(k) summary for the MaxZero™ Extension Set with Needle-Free Connector(s). It details the device's technical characteristics, its substantial equivalence to a predicate device, and the non-clinical testing performed to support its safety and effectiveness.
Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results met their acceptance criteria and support that the MaxZero™ Extension Set with Needle-Free Connector(s) are appropriately designed for their intended use." However, specific numerical acceptance criteria and the exact reported performance results for each test are not provided in this summary. The summary only lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Standards | Met acceptance criteria per ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010, ISO 8536-8:2004, ISO 8536-9:2004, ISO 8536-10:2004, and FDA Guidance for Intravascular Administration Sets. |
| Biocompatibility | Met acceptance criteria per ISO-10993-1:2009, ISO 10993-2:2006, ISO 10993-4:2002, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-12:2012. |
| Sterilization & Shelf Life | Met acceptance criteria per ISO 11137-1:2006, ISO 11137-2:2006, ISO 11607:2003, ASTM F1980-07:2002, ASTM F1140:2000, ASTM D4169:1998, ASTM-F1929-98(04):1998. |
| Additional Performance Data | Met acceptance criteria for Microbial Ingress and Barrier testing, High-Pressure Testing, Air Water Interface Visibility, Set Internal Excess Pressure Testing, Clamps - Internal Excess Pressure and Tubing Open Fluid Path Testing, Bond Pull Testing, Priming Volume and Flow Rate Testing, and Harsh Infusates Testing. |
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 state the sample sizes for the individual non-clinical tests. It refers to "design verification performance testing" and lists various standards and additional tests. The data provenance is not specified, but the submission is from CareFusion, Inc., located in San Diego, CA, USA. The testing would have been conducted by or for a US-based company, likely in the US or in a facility adhering to international standards for medical device testing. The data is prospective, as these are engineering and laboratory tests conducted to qualify the device.
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)
This section is not applicable as the document is discussing a non-clinical evaluation of a medical device (intravascular administration set) rather than diagnostic or imaging software requiring expert interpretation for ground truth establishment. The "ground truth" here is defined by engineering specifications and recognized performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or evaluations of diagnostic systems where there might be disagreement in expert interpretations.
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
There is no MRMC comparative effectiveness study mentioned. The submission is for a physical medical device (extension set) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device, the "ground truth" is established through:
- Engineering specifications and design requirements: The device must meet specific physical and performance parameters (e.g., pressure resistance, flow rates, bond strength).
- Recognized consensus standards: The device performance is evaluated against international standards such as ISO and ASTM for medical devices, luer connectors, sterilization, packaging, and biocompatibility.
- Biocompatibility guidelines: Specific ISO standards define acceptable biological responses and toxicity.
- Regulatory guidance: Adherence to FDA guidance documents for intravascular administration sets.
8. The sample size for the training set
This section is not applicable as there is no machine learning or AI component requiring a training set. The device is a physical product.
9. How the ground truth for the training set was established
This section is not applicable as there is no machine learning or AI component requiring a training set and its associated ground truth establishment.
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