(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.
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Traditional 5 I0(k) Premarket Notification
Baxter SIGMA Spectrum Infusion Pump with MDL
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Page 1 of 12 Section 5-510(k) Summary
| 510(K) SUMMARY | K133801 |
|---|---|
| Date: | May 6, 2014 |
| Contact: | Baxter Healthcare Corporation711 Park AvenueMedina, New York 14103Registration No: 1314492 |
| Thomas SampognaSr. Director, Regulatory AffairsPhone: 224-270-4307Fax: 847-786-5116Email: thomas_sampogna@baxter.com | |
| Trade Name: | Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryModel 35700 |
| Common Name: | Infusion Pump |
| Classification Name: | Pump, Infusion |
| Classification: | Infusion Pump as defined in 21 CFR 880.5725, Class II |
| Product Code: | FRN, PHC |
| Predicate Device: | The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is substantially equivalent to the following predicatedevice: |
| SIGMA Spectrum and Spectrum with Master Drug Library,cleared Aug. 26, 2004 (K042121). | |
| Device Description: | The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is a large volume infusion pump system that provides forsafe and effective delivery of fluids into a patient in a controlledmanner, as identified in 21 CFR, 880.5725. The pump is asoftware controlled, electromechanical device used for the infusionof pharmaceutical drugs, blood, blood products and mixtures ofrequired patient therapy through administration sets at userselectable rates and volumes. The feedback-controlled, motorized. |
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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.
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... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..
| Intended Use/Indication for Use: | The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is intended to be used for the controlled administration offluids. These may include pharmaceutical drugs, blood, bloodproducts and mixtures of required patient therapy. The intendedroutes of administration consist of the following clinically acceptedroutes; intravenous, arterial, subcutaneous, epidural or irrigation offluid space. The Baxter SIGMA Spectrum Infusion Pump withMaster Drug Library is intended to be used in conjunction withlegally marketed and compatible intravenous administration setsand medications provided by the user. |
|---|---|
| The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is suitable for a variety of patient care environments suchas, but not limited to hospitals and outpatient care areas. | |
| The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is intended to reduce operator interaction through guidedprogramming, thereby helping to reduce errors. The BaxterSIGMA Spectrum Infusion Pump with Master Drug Library isintended to be used by trained healthcare professionals. | |
| TechnologicalCharacteristics: | The Baxter SIGMA Spectrum Infusion Pump with Master DrugLibrary is substantially equivalent to the predicate device withregards to design, performance and intended use. The followingprovides a comparison summary of the technical characteristics of |
| Characteristic | Proposed Device | Predicate Device (K042121 |
|---|---|---|
| Baxter SIGMA Spectrum Infusion Pump | ||
| Pump Type | Linear peristaltic pump | Linear peristaltic pump |
| Routes ofAdministration | • Intravenous• Arterial• Subcutaneous• Epidural• Irrigation of fluid space | • Intravenous• Arterial• Subcutaneous• Epidural• Irrigation of fluid space• Intrathecal |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| AC Power | Input: 120VAC, 60 Hz / 300 mAOutput (Power Adapter P/N35727): 9VDC/1200 mA, | Input: 100VAC - 240VAC, 50-60 Hz / 200 mAOutput (Power Adapter P/N35714): 9VDC/800 mA |
| Alarm Volume | Variable at three levels: high,medium and low | Variable at three levels: high,medium and low |
| Air-In-Line | Air In Line: dual-beam ultrasonicdetector alarms for large bubbles butallows smaller bubbles to pass.Detects air bubbles >2.5 cm (>1in) (approximately 140 µL inBaxter sets)Detects >1 mL of accumulatedair over 15 min., excluding <50µL bubbles, at room temperatureDetects >1.5 mL of accumulatedair over 15 min., excluding <50µL bubbles, at 15.5℃ (60°F) | Inline Air Detection - Air bubbles of>5/8", alarm if >1 ml over 15minutes, <50 µL bubbles are not-summed |
| Anti-Free Flow System | Set-based, utilizing IV set slideclamp | Set-based, utilizing IV set slideclamp |
| Battery Power andCapacity - StandardBattery | Lithium Ion, minimum 1700mA/h, 7.4 VDC nominal.Capacity 8 hrs (at 125 mL/hr atthe highest backlight settings)12 hr recharge time | Lithium Ion, 1800 mA/h, 7.2VDC nominal.Capacity < 11.5hrs (at 115 mL) at10 mL/hr, 14 hrs (1750 mL) at125 mL/hr, 12 hrs (3000mL) at999 mL/hr with backlight off.8 hr. recharge time |
| Battery Power andCapacity - WirelessBattery (802.11b/g) | Lithium Ion, minimum 1700mA/h, 7.4 VDC nominalCapacity 4 hrs (at 125 mL/hr atthe highest backlight settingswith wireless communicationon)16 hr recharge time | N/A - No Wireless Battery Module |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Dose 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 | mL/hr g/hr, mg/hr, mg/kg/hr, mg/min, mg/kg/min, mcg/hr, mg/kg/hr, mcg/min, mcg/kg/min, ng/min, ng/kg/min Units/hr, Units/kg/hr, Units/min, Units/kg/min, mUnits/min mEq/hr, mEq/kg/hr |
| External Interfaces/Communications | Bi-directional IrDA Additional Asynchronous Serial Port expansion bus available at battery terminals (manufacturer use only) and wireless-enabled battery pack | Bi-directional IrDA Additional Asynchronous Serial Port expansion bus available at battery terminals (manufacturer use only) |
| Flow rate | 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 | 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 |
| Infusion Modes | Continuous Primary and Secondary Multi-Step Cyclic TPN Rate Change Bolus Amount/Time (Primary/Secondary) | Continuous Primary and Secondary Titration Ramp/Taper Bolus |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Intended Use/Indications for Use | The Baxter SIGMA SpectrumInfusion Pump with Master DrugLibrary is intended to be used for thecontrolled administration of fluids.These may include pharmaceuticaldrugs, blood, blood products andmixtures of required patient therapy.The intended routes ofadministration consist of thefollowing clinically accepted routes;intravenous, arterial, subcutaneous,epidural or irrigation of fluid space.The Baxter SIGMA SpectrumInfusion Pump with Master DrugLibrary is intended to be used inconjunction with legally marketedand compatible intravenousadministration sets and medicationsprovided by the user.The Baxter SIGMA SpectrumInfusion Pump with Master DrugLibrary is suitable for a variety ofpatient care environments such as,but not limited to hospitals andoutpatient care areas.The Baxter SIGMA SpectrumInfusion Pump with Master DrugLibrary is intended to reduceoperator interaction through guidedprogramming, thereby helping toreduce errors. The Baxter SIGMASpectrum Infusion Pump withMaster Drug Library is intended tobe used by trained healthcare | The Spectrum and Spectrum withMaster Drug Library is intended tobe used for the controlledadministration of intravenous fluids.These may include pharmaceuticaldrugs, blood, blood products andmixtures of required patient therapy.The intended routes ofadministration consist of thefollowing clinically accepted routes;intravenous, arterial, subcutaneous,intrathecal, epidural or irrigation offluid space. The spectrum isintended to be used in conjunctionwith legally marketed intravenousadministration sets and medicationsprovided by the user.The Spectrum and Spectrum withMaster Drug Library is suitable formany user facility applications suchas but not limited to hospitals,outpatient care areas, homecare andambulatory care services.The Spectrum and Spectrum withMaster Drug Library is intended toreduce operator interaction throughautomated programming, therebyhelping to reduce errors associatedwith complex device programming.Parameter programming requirestrained healthcare professionalconfirmation of limits and drugtherapy to physician's directive. |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Keep Vein Open(KVO) | At the completion of a primaryinfusion, the pump will infuse at theKVO rate configured per drug in theDrug Library or the current infusionrate, whichever is lower.The default KVO rate is set at 1mL/hr, but may be configured tobetween 0.5 - 50 mL/hr.At the completion of a secondaryinfusion program with secondarycallback enabled, the pump will runat a fixed KVO rate of 1 mL/hr. | KVO rate of either 1 mL/hr or theactual rate, whichever is lower atinfusion completion alarm. |
| 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 | With Standard Battery• Operating temperature: 60 to90°F (15.6 to 32.2° C), 20 to90% relative humidity non-condensingWith Wireless Battery Module• Operating temperature: 60 to80°F (15.6 to 26.7° C), 20 to90% relative humidity non-condensing | With Standard Battery• Operating temperature: 60 to90°F (15.6 to 32.2° C), 20 to90% relative humidity non-condensingN/A - No Wireless Battery Module |
| Overall Size (Pump) | With Standard Battery• Without IV pole clamp - 5.8" Hx 4.2" W x 2.5" D• With standard IV pole clamp -5.8" H x 6.4" W x 4.7" DWith Wireless Battery Module• Without IV pole clamp - 6.3" Hx 4.2" W x 2.5" D• With standard IV pole clamp -6.3" H x 6.4" W x 4.7" D | With Standard Battery• Without IV pole clamp - 5.8" Hx 4.2" W x 2.5" D• With standard IV pole clamp -5.8" H x 6.4" W x 4.7" DN/A - No Wireless Battery Module |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Volumetric AccuracyVolumetric accuracy at stated flowrates: | Volumetric accuracy using standardAbbott Sets (now Hospira) | |
| 2.0-999 mL/hr ± 5% | 2-999 mL/hr ± 5% | |
| 0.5-1.9 mL/hr ± 0.1mL/hr | 0.5-1.9 mL/hr ± 0.1mL/hr | |
| Specified accuracy is maintained oncompatible Baxter Standard IVSets for up to 96 hours (maximum12 liters) | ||
| Maximum Allowablepressure while indownstream occlusion | 30 PSI | 36 PSI |
| Weight | With Standard Battery | Without IV pole clamp - 24 oz. |
| Without IV pole clamp - 25.5toz. ± 1.0 oz. | With standard IV pole clamp -32 oz. | |
| · With standard IV pole clamp -33.5 oz. ± 1.0 oz. | ||
| With Wireless Battery Module | N/A - No Wireless Battery Module | |
| Without IV pole clamp – 26.5oz. ± 1.0 oz. | ||
| With standard IV pole clamp -●34.5 oz. ± 1.0 oz. | ||
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Alarms | • AC Applied/Removed | • Air-In-Line |
| • Air Still Detected | • Audio | |
| • Air-In-Line | • Battery Not Detected | |
| • Bag Near Empty | • Dead Battery | |
| • Battery Alert | • Downstream Occlusion | |
| • Battery Depleted | • Infusion Complete | |
| • Battery Missing | • Inactivity Alarm | |
| • Check Flow (unconfirmed) | • In Stop - Load Set | |
| • Clean Load Point #2 | • In Stop - Open Slide Clamp | |
| • Clock Battery Low | • In Stop – Push RUN | |
| • Close Clamp, Reload Set | • Low Battery | |
| • Close Door, Remove Clamp (onpower off) | • Shut Door | |
| • Door Not Fully Latched | • Slide Clamp Closed | |
| • Door Open (Close RollerClamp) | • System Error | |
| • Downstream Occlusion | • Upstream Occlusion | |
| • Improper Shutdown | ||
| • Inactivity Alarm | ||
| • Infusion Complete (Primary,Secondary, Loading Dose andBolus) | ||
| • Load Set (based on set loadingsequence) | ||
| • Low Battery | ||
| • Max Air Detected | ||
| • PIC Alarm (Errors inMicroprocessor) | ||
| • Reload Set | ||
| • Remove Clamp (PrimarySiphoning Callback) | ||
| • Slide Clamp Detected | ||
| • System Error | ||
| • Upstream Occlusion | ||
| • Value Entry Timeout (RateChange Incomplete) | ||
| • Very Low Battery |
each device.
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Traditional 510(k) Premarket Notification
Baxter SIGMA Spectrum Infusion Pump with MDL
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Traditional 510(k) Premarket Notification
Baxter SIGMA Spectrum Infusion Pump with MDL
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| Characteristic | Proposed Device | Predicate Device (K042121) |
|---|---|---|
| Master Drug Library Editor | ||
| Drug capacity | Up to 5,000 drugs and 32 care areas | Up to 1,000 drugs and 32 care areas |
| 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 |
| Security Roles for MDL | Read-Only Access Limited Access Full Access | Read-Only Access Limited Access Full Access |
| MDL Reports | Standard and custom Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc. Audit reports for a list of changes made to the Drug Library along with the date the change was preformed | Standard Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc. Audit reports for a list of changes made to the Drug Library along with the date the change was preformed |
The device labeling contains Warning statements that identify Deviations from Flow Rate Accuracy deviations in the stated flow rate accuracy and performance limitations for specific system configurations. These system configurations relate to variations of fluid viscosity, fluid temperature, head height or back pressure, or any combination thereof, that exceed stated conditions needed to achieve the device flow rate accuracy and performance claims. In addition, there are specific IV set Warnings that relate to certain design attributes of the set, such as use of sets with vents, burettes, minidrip chambers and backcheck valves, and set materials (i.e., non-DEHP). The Operators Manual contains complete information regarding these Warning statements. No clinical testing was performed in support of this premarket Assessment of Clinical Testing notification.
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| Assessment ofNon-Clinical Testing | Non-clinical testing of the Baxter SIGMA Spectrum InfusionPump with Master Drug Library has been performed againstrequirements for performance, physical attributes, environmentalconditions and safety, and to provide objective evidence that thedevice intended use is met. Verification was performed throughbench testing and assured the following requirement attributeswere met: | |
|---|---|---|
| • Functional and Performance | ||
| • System Hardware | ||
| • Administration Set Compatibility | ||
| • Power | ||
| • Environmental and Physical | ||
| • Reliability | ||
| • System Software | ||
| o User Interface | ||
| o Processing | ||
| o Sensors and Alarms | ||
| • Network Interface | ||
| o Wireless Battery Module | ||
| o Serial Communication | ||
| • Labeling | ||
| • Consensus Standards | ||
| o IEC 60601-1 (1988), "Medical ElectricalEquipment, Part 1: General Requirements forSafety" with Amendment 1 (1991) and Amendment2 (1995) | ||
| o IEC 60601-1-2:2001, "Medical ElectricalEquipment-Part 1-2 Edition 2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements andTests with Amendment 1 (2004), Section 36,Deviation per IEC 60601-2-24:1998 | ||
| o UL 60601-1 (2003), 1st Edition "Medical ElectricalEquipment, Part 1: General Requirements forSafety" | ||
| o CAN/CSA C22.2 No 601.1-M90 (1990), "MedicalElectrical Equipment, Part 1: General Requirementsfor Safety" | ||
:
.
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- IEC 60601-2-24 (1998), "Medical Electrical O Equipment Part 2-24: Particular Requirements for the Safety of Infusion Pumps and Controllers"
- . Master Drug Library
In addition to the above, and in consideration of IEC 62366:2007. Medical devices -- Application of usability engineering to medical devices", Baxter conducted a Human Factors evaluation in a simulated environment to ensure that use of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library would not exhibit use errors that are greater than minimal risk. User needs and intended uses were evaluated through clinical assessment of use, industry literature, labeling evaluation and blood and blood component testing.
Lastly, in complying with the requirements in FDA draft guidance, "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] April 23, 2010", Baxter has developed a Safety Assurance Case to demonstrate that hazardous situations resulting from the design, intended use and reasonably foreseeable misuse of the device have been appropriately mitigated.
Non-clinical testing of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library met all acceptance criteria, demonstrating that the device is safe and effective for its intended use.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library has been verified and validated against design input requirements, user needs and intended uses. Based on testing and the comparison of design, performance, and intended use, the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library raises no new questions concerning safety and effectiveness and is, thus, substantially equivalent to the predicate device.
Conclusion:
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Image /page/12/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
Baxter Healthcare Corporation Thomas Sampogna Senior Director, Regulatory Affairs 32650 N. Wilson Street Round Lake, Illinois 60073
Re: K133801
Trade/Device Name: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library,
Model 35700 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC Dated: April 30, 2014 Received: May 1, 2014
Dear Mr. Sampogna:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Sampogna
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, .
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K 133801
Device Name
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Indications for Use (Describe)
The Baxter SIGMA Spectrum Infusion Purn with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, 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 administrations 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. ChapmanDate: 2014.05.06 17:00:22 -04'00' |
FORM FDA 3881 (1/14)
shing Services (301) 443-6740
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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:
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§ 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).