Search Results
Found 1 results
510(k) Data Aggregation
(145 days)
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a large volume infusion pump system that provides for safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR, 880.5725. The pump is a software controlled, electromechanical device used for the infusion of pharmaceutical drugs, blood, blood products and mixtures of required patient therapy through administration sets at user selectable rates and volumes. The feedback-controlled, motorized pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The pump utilizes a primary and secondary processor to assure safe operation while providing infusion pump capabilities for a wide range of applications.
The pump is specifically manufactured and calibrated for the application of a manufacturer's brand of standard gravity administration sets, as indicated in the device labeling. For use, the administration set is loaded into the infusion pump. After acceptance of program parameters, the pump is started and fluid is propelled by the peristaltic action of the pumping mechanism against the outside surface of the administration set tubing. The pump is controlled to create smooth fluid dynamics, precision volumetric accuracy and uniformity of flow rate. None of the pump materials contact the administration set's fluid path.
The infusion pump is small in comparison to the traditional Large Volume Parenteral (LVP) infusion pumps currently on the market. It is designed to be used in a variety of patient care environments such as, but not limited to hospitals and outpatient care areas using an IV pole mounted configuration.
The Master Drug Library (MDL) Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump. The drug library can be loaded directly into the SIGMA Spectrum infusion pump through a wireless network host or through an Infrared Data Association (IrDA) device. The MDL Editor software operates on a Microsoft Windows platform.
Using the MDL Editor software application, a facility can provide preprogrammed delivery profiles, advisories and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus reducing the risk of medication errors. The MDL Editor software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The MDL Editor software application also provides a feature to restrict/limit the access of data to only appropriate personnel, providing additional security and rights to specific users.
This document describes the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) (Model 35700) and its substantial equivalence to a predicate device (K042121). The information provided focuses on the device's technical characteristics, intended use, and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Baxter SIGMA Spectrum Infusion Pump with MDL are primarily established by demonstrating substantial equivalence to the predicate device and meeting various non-clinical testing requirements. The document presents a comparison of characteristics between the proposed device and the predicate. The "Reported Device Performance" column reflects the specifications for the proposed device, which, by satisfying the non-clinical testing criteria, meet the necessary acceptance.
| Characteristic | Acceptance Criteria (Implied by Predicate & Non-Clinical Testing) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Pump Type | Linear peristaltic pump | Linear peristaltic pump |
| Routes of Administration | Intravenous, Arterial, Subcutaneous, Epidural, Irrigation of fluid space (Predicate included Intrathecal, proposed device explicitly lists the others) | Intravenous, Arterial, Subcutaneous, Epidural, Irrigation of fluid space |
| AC Power (Input) | Within acceptable ranges for medical devices | 120VAC, 60 Hz / 300 mA |
| AC Power (Output) | Within acceptable ranges for medical devices | Output (Power Adapter P/N 35727): 9VDC/1200 mA |
| Alarm Volume | Variable at three levels: high, medium, and low | Variable at three levels: high, medium, and low |
| Air-In-Line Detection | Detects air bubbles >5/8", alarms if >1 mL over 15 minutes, <50 µL bubbles not summed (Predicate) | Detects air bubbles >2.5 cm (>1 inch) (approximately 140 µL in Baxter sets); Detects >1 mL of accumulated air over 15 min., excluding <50 µL bubbles, at room temperature; Detects >1.5 mL of accumulated air over 15 min., excluding <50 µL bubbles, at 15.5℃ (60°F) |
| Anti-Free Flow System | Set-based, utilizing IV set slide clamp | Set-based, utilizing IV set slide clamp |
| Battery Power and Capacity (Standard Battery) | Lithium Ion, 1800 mA/h, 7.2 VDC nominal; Capacity < 11.5hrs (at 115 mL) at 10 mL/hr, 14 hrs (1750 mL) at 125 mL/hr, 12 hrs (3000mL) at 999 mL/hr with backlight off; 8 hr. recharge time | Lithium Ion, minimum 1700 mA/h, 7.4 VDC nominal; Capacity 8 hrs (at 125 mL/hr at the highest backlight settings); 12 hr recharge time |
| Battery Power and Capacity (Wireless Battery) | N/A (Predicate had no wireless module) | Lithium Ion, minimum 1700 mA/h, 7.4 VDC nominal; Capacity 4 hrs (at 125 mL/hr at the highest backlight settings with wireless communication on); 16 hr recharge time |
| Dose Modes | Specified dose modes for various drug calculations (Predicate had fewer modes) | mL/hr, mL/kg/min, mL/kg/hr, mL, mL/kg g/hr, mg/hr, mg/kg/hr, mg/min, mg/kg/min, mg/kg/day, mcg/hr, mg/kg/hr, mcg/min, mcg/kg/min, mcg/kg/day, ng/min, ng/kg/min, grams, grams/kg, grams/m², mg, mg/kg, mg/m², mcg, mcg/kg, mcg/m² Units/hr, Units/kg/hr, Units/min, Units/kg/min, mUnits/min, mUnits/kg/hr, mUnits /kg/min, Units, Units/kg, Units/m² mEq/hr, mEq/kg/hr, mEq, mEq/kg mmol/hr, mmol/kg/hr, mmol, mmol/kg |
| External Interfaces/Communications | Bi-directional IrDA; Additional Asynchronous Serial Port expansion bus available at battery terminals (manufacturer use only) | Bi-directional IrDA; Additional Asynchronous Serial Port expansion bus available at battery terminals (manufacturer use only) and wireless-enabled battery pack |
| Flow rate | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr; 1 mL/hr increments thereafter (Predicate) | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr; 1.0 mL/hr increments from 100 to 999 mL/hr |
| Infusion Modes | Continuous Primary and Secondary, Titration, Ramp/Taper, Bolus (Predicate) | Continuous Primary and Secondary, Multi-Step, Cyclic TPN, Rate Change, Bolus Amount/Time (Primary/Secondary) |
| Keep Vein Open (KVO) | KVO rate of either 1 mL/hr or the actual rate, whichever is lower at infusion completion alarm (Predicate) | At the completion of a primary infusion, the pump will infuse at the KVO rate configured per drug in the Drug Library or the current infusion rate, whichever is lower. Default KVO is 1 mL/hr (configurable 0.5-50 mL/hr). Secondary infusion with callback: fixed KVO of 1 mL/hr. |
| Occlusion Pressure | Adjustable: High (19 ±9 PSI), Medium (13 ±6 PSI), Low (6 ±4 PSI) | Adjustable: High (19 ±9 PSI), Medium (13 ±6 PSI), Low (6 ±4 PSI) |
| Operational Conditions (Standard Battery) | Operating temperature: 60 to 90°F (15.6 to 32.2° C), 20 to 90% relative humidity non-condensing | Operating temperature: 60 to 90°F (15.6 to 32.2° C), 20 to 90% relative humidity non-condensing |
| Operational Conditions (Wireless Battery) | N/A (Predicate had no wireless module) | Operating temperature: 60 to 80°F (15.6 to 26.7° C), 20 to 90% relative humidity non-condensing |
| Overall Size (Pump) - Standard Battery (Without IV pole clamp) | 5.8" H x 4.2" W x 2.5" D | 5.8" H x 4.2" W x 2.5" D |
| Overall Size (Pump) - Wireless Battery (Without IV pole clamp) | N/A (Predicate had no wireless module) | 6.3" H x 4.2" W x 2.5" D |
| Volumetric Accuracy | 2-999 mL/hr ± 5%; 0.5-1.9 mL/hr ± 0.1mL/hr (Predicate) | 2.0-999 mL/hr ± 5%; 0.5-1.9 mL/hr ± 0.1mL/hr; Specified accuracy maintained on compatible Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) |
| Maximum Allowable Pressure while in downstream occlusion | 36 PSI (Predicate) | 30 PSI |
| Weight (Standard Battery, Without IV pole clamp) | 24 oz. (Predicate) | 25.5 oz. ± 1.0 oz. |
| Weight (Wireless Battery, Without IV pole clamp) | N/A (Predicate had no wireless module) | 26.5 oz. ± 1.0 oz. |
| Master Drug Library Editor - Drug capacity | Up to 1,000 drugs and 32 care areas (Predicate) | Up to 5,000 drugs and 32 care areas |
| Master Drug Library Editor - Available Limits | Upper Hard Limit, Upper Soft Limit, Starting Rate, Lower Soft Limit, Lower Hard Limit | Upper Hard Limit, Upper Soft Limit, Starting Rate, Lower Soft Limit, Lower Hard Limit |
| Master Drug Library Editor - Security Roles | Read-Only Access, Limited Access, Full Access | Read-Only Access, Limited Access, Full Access |
| Master Drug Library Editor - MDL Reports | Standard Drug and Fluid Report, Audit reports | Standard and custom Drug and Fluid Report, Audit reports |
Study Proving Device Meets Acceptance Criteria:
A "Non-clinical Testing" study was conducted to prove the device meets acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size in terms of a number of devices or data points used for testing. It describes broad categories of testing such as "Functional and Performance," "System Hardware," "Administration Set Compatibility," "Power," "Environmental and Physical," "Reliability," "System Software," "Network Interface," "Labeling," and "Consensus Standards."
The provenance of the data is retrospective, as it refers to testing performed by Baxter against requirements and standards. The country of origin of the data is not specified, but the submission is to the US FDA, implying testing was conducted to US and international standards relevant to the US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" for a test set in the traditional sense of medical image analysis or diagnostic AI. Instead, the testing was performed against established engineering requirements, performance specifications, and consensus standards for medical electrical equipment and infusion pumps (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24, UL 60601-1, CAN/CSA C22.2 No 601.1-M90, IEC 62366). The "ground truth" here is adherence to these predefined technical and safety standards. The individuals involved would be engineers and testing personnel qualified to interpret and execute these standards.
4. Adjudication Method for the Test Set:
No adjudication method (like 2+1 or 3+1) is mentioned, as this is not a study involving human interpretation of medical data for ground truth establishment. Deviations from expected performance would be rectified through standard engineering debugging and re-testing processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed in support of this premarket Assessment of Clinical Testing notification." This type of study is not relevant for the regulatory submission of an infusion pump, which focuses on device safety and performance according to engineering specifications and non-clinical use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The "MDL Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump." The functionality of the MDL editor software itself, which could be considered an "algorithm," was assessed through "System Software" testing, including "User Interface," "Processing," and "Sensors and Alarms." The non-clinical testing performed is effectively a standalone performance assessment of the device's hardware and software against its design specifications and external standards. It is "algorithm only" in the sense that the device's programmed functions and algorithms for infusion delivery, alarm logic, and MDL management were tested independently to ensure they met their design requirements.
7. The Type of Ground Truth Used:
The "ground truth" used for this submission is adherence to established engineering requirements, performance specifications, and consensus standards. This is explicitly stated in the "Assessment of Non-Clinical Testing" section, which outlines testing against "requirements for performance, physical attributes, environmental conditions and safety." Additionally, the Master Drug Library Editor's capabilities (drug capacity, available limits, security roles, reports) are compared to the predicate device, implying that the predicate's capabilities serve as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable as the submission is for an infusion pump, not a machine learning or AI model trained on a dataset. The device's software is developed through traditional software engineering processes, not machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1