BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

K133801 · Baxter Healthcare Corporation · FRN · May 7, 2014 · General Hospital

Device Facts

• Record ID: K133801
• Device Name: BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
• Applicant: Baxter Healthcare Corporation
• Product Code: FRN · General Hospital
• Decision Date: May 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Large volume infusion pump; linear peristaltic mechanism; delivers fluids via compatible administration sets. Controlled by primary/secondary processors; software-driven. Master Drug Library (MDL) Editor software (Windows-based) allows facility-specific drug profiles, limits, and advisories to reduce medication errors. Data loaded via wireless network or IrDA. Used in hospitals/outpatient areas; pole-mounted. Healthcare professionals program delivery parameters; pump provides smooth fluid dynamics and volumetric accuracy. Benefits include reduced operator interaction and error mitigation through preprogrammed drug libraries and safety limits.

Clinical Evidence

No clinical testing performed. Evidence consists of non-clinical bench testing (functional, performance, hardware, software, sensors, alarms, network interface) and human factors evaluation in a simulated environment to ensure minimal risk of use errors.

Technological Characteristics

Linear peristaltic infusion pump; electromechanical; software-controlled. Features dual-beam ultrasonic air-in-line detector, set-based anti-free flow clamp. Power: 120VAC/9VDC adapter or Lithium Ion battery (standard or wireless 802.11b/g). Connectivity: IrDA, wireless network, serial port. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24, UL 60601-1, CAN/CSA C22.2 No 601.1-M90.

Indications for Use

Indicated for controlled administration of fluids (pharmaceuticals, blood, blood products, therapy mixtures) via IV, arterial, subcutaneous, epidural, or irrigation routes. For use by trained healthcare professionals in hospitals and outpatient settings.

Regulatory Classification

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.

Predicate Devices

• SIGMA Spectrum and Spectrum with Master Drug Library (K042121)

Submission Summary (Full Text)

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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 Corporation<br>711 Park Avenue<br>Medina, New York 14103<br>Registration No: 1314492 |
| | Thomas Sampogna<br>Sr. Director, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library<br>Model 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 Drug<br>Library is substantially equivalent to the following predicate<br>device: |
| | SIGMA Spectrum and Spectrum with Master Drug Library,<br>cleared Aug. 26, 2004 (K042121). |
| Device Description: | The Baxter SIGMA Spectrum Infusion Pump with Master Drug<br>Library is a large volume infusion pump system that provides for<br>safe and effective delivery of fluids into a patient in a controlled<br>manner, as identified in 21 CFR, 880.5725. The pump is a<br>software controlled, electromechanical device used for the infusion<br>of pharmaceutical drugs, blood, blood products and mixtures of<br>required patient therapy through administration sets at user<br>selectable 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/<br>Indication for Use: | The Baxter SIGMA Spectrum Infusion Pump with Master Drug<br>Library is intended to be used for the controlled administration of<br>fluids. These may include pharmaceutical drugs, blood, blood<br>products and mixtures of required patient therapy. The intended<br>routes of administration consist of the following clinically accepted<br>routes; intravenous, arterial, subcutaneous, epidural or irrigation of<br>fluid space. The Baxter SIGMA Spectrum Infusion Pump with<br>Master Drug Library is intended to be used in conjunction with<br>legally marketed and compatible intravenous administration sets<br>and medications provided by the user. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Baxter SIGMA Spectrum Infusion Pump with Master Drug<br>Library is suitable for a variety of patient care environments such<br>as, but not limited to hospitals and outpatient care areas. |
| | The Baxter SIGMA Spectrum Infusion Pump with Master Drug<br>Library is intended to reduce operator interaction through guided<br>programming, thereby helping to reduce errors. The Baxter<br>SIGMA Spectrum Infusion Pump with Master Drug Library is<br>intended to be used by trained healthcare professionals. |
| Technological<br>Characteristics: | The Baxter SIGMA Spectrum Infusion Pump with Master Drug<br>Library is substantially equivalent to the predicate device with<br>regards to design, performance and intended use. The following<br>provides 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 of<br>Administration | • Intravenous<br>• Arterial<br>• Subcutaneous<br>• Epidural<br>• Irrigation of fluid space | • Intravenous<br>• Arterial<br>• Subcutaneous<br>• Epidural<br>• Irrigation of fluid space<br>• Intrathecal |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| AC Power | Input: 120VAC, 60 Hz / 300 mA<br>Output (Power Adapter P/N<br>35727): 9VDC/1200 mA, | Input: 100VAC - 240VAC, 50-<br>60 Hz / 200 mA<br>Output (Power Adapter P/N<br>35714): 9VDC/800 mA |
| Alarm Volume | Variable at three levels: high,<br>medium and low | Variable at three levels: high,<br>medium and low |
| Air-In-Line | Air In Line: dual-beam ultrasonic<br>detector alarms for large bubbles but<br>allows smaller bubbles to pass.<br>Detects air bubbles >2.5 cm (>1<br>in) (approximately 140 µL in<br>Baxter sets)<br>Detects >1 mL of accumulated<br>air over 15 min., excluding <50<br>µL bubbles, at room temperature<br>Detects >1.5 mL of accumulated<br>air over 15 min., excluding <50<br>µL bubbles, at 15.5℃ (60°F) | Inline Air Detection - Air bubbles of<br>>5/8", alarm if >1 ml over 15<br>minutes, <50 µL bubbles are not-<br>summed |
| Anti-Free Flow System | Set-based, utilizing IV set slide<br>clamp | Set-based, utilizing IV set slide<br>clamp |
| Battery Power and<br>Capacity - Standard<br>Battery | Lithium Ion, minimum 1700<br>mA/h, 7.4 VDC nominal.<br>Capacity 8 hrs (at 125 mL/hr at<br>the highest backlight settings)<br>12 hr recharge time | Lithium Ion, 1800 mA/h, 7.2<br>VDC nominal.<br>Capacity < 11.5hrs (at 115 mL) at<br>10 mL/hr, 14 hrs (1750 mL) at<br>125 mL/hr, 12 hrs (3000mL) at<br>999 mL/hr with backlight off.<br>8 hr. recharge time |
| Battery Power and<br>Capacity - Wireless<br>Battery (802.11b/g) | Lithium Ion, minimum 1700<br>mA/h, 7.4 VDC nominal<br>Capacity 4 hrs (at 125 mL/hr at<br>the highest backlight settings<br>with wireless communication<br>on)<br>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/<br>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/<br>Indications for Use | The Baxter SIGMA Spectrum<br>Infusion Pump with Master Drug<br>Library is intended to be used for the<br>controlled administration of fluids.<br>These may include pharmaceutical<br>drugs, blood, blood products and<br>mixtures of required patient therapy.<br>The intended routes of<br>administration consist of the<br>following clinically accepted routes;<br>intravenous, arterial, subcutaneous,<br>epidural or irrigation of fluid space.<br>The Baxter SIGMA Spectrum<br>Infusion Pump with Master Drug<br>Library is intended to be used in<br>conjunction with legally marketed<br>and compatible intravenous<br>administration sets and medications<br>provided by the user.<br><br>The Baxter SIGMA Spectrum<br>Infusion Pump with Master Drug<br>Library is suitable for a variety of<br>patient care environments such as,<br>but not limited to hospitals and<br>outpatient care areas.<br><br>The Baxter SIGMA Spectrum<br>Infusion Pump with Master Drug<br>Library is intended to reduce<br>operator interaction through guided<br>programming, thereby helping to<br>reduce errors. The Baxter SIGMA<br>Spectrum Infusion Pump with<br>Master Drug Library is intended to<br>be used by trained healthcare | The Spectrum and Spectrum with<br>Master Drug Library is intended to<br>be used for the controlled<br>administration of intravenous fluids.<br>These may include pharmaceutical<br>drugs, blood, blood products and<br>mixtures of required patient therapy.<br>The intended routes of<br>administration consist of the<br>following clinically accepted routes;<br>intravenous, arterial, subcutaneous,<br>intrathecal, epidural or irrigation of<br>fluid space. The spectrum is<br>intended to be used in conjunction<br>with legally marketed intravenous<br>administration sets and medications<br>provided by the user.<br><br>The Spectrum and Spectrum with<br>Master Drug Library is suitable for<br>many user facility applications such<br>as but not limited to hospitals,<br>outpatient care areas, homecare and<br>ambulatory care services.<br><br>The Spectrum and Spectrum with<br>Master Drug Library is intended to<br>reduce operator interaction through<br>automated programming, thereby<br>helping to reduce errors associated<br>with complex device programming.<br><br>Parameter programming requires<br>trained healthcare professional<br>confirmation of limits and drug<br>therapy to physician's directive. |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Keep Vein Open<br>(KVO) | At the completion of a primary<br>infusion, the pump will infuse at the<br>KVO rate configured per drug in the<br>Drug Library or the current infusion<br>rate, whichever is lower.<br>The default KVO rate is set at 1<br>mL/hr, but may be configured to<br>between 0.5 - 50 mL/hr.<br>At the completion of a secondary<br>infusion program with secondary<br>callback enabled, the pump will run<br>at a fixed KVO rate of 1 mL/hr. | KVO rate of either 1 mL/hr or the<br>actual rate, whichever is lower at<br>infusion completion alarm. |
| Occlusion Pressure | Adjustable:<br>• High (19 ±9 PSI)<br>• Medium (13 ±6 PSI)<br>• Low (6 ±4 PSI) | Adjustable:<br>• High (19 ±9 PSI)<br>• Medium (13 ±6 PSI)<br>• Low (6 ±4 PSI) |
| Operational Conditions | With Standard Battery<br>• Operating temperature: 60 to<br>90°F (15.6 to 32.2° C), 20 to<br>90% relative humidity non-<br>condensing<br>With Wireless Battery Module<br>• Operating temperature: 60 to<br>80°F (15.6 to 26.7° C), 20 to<br>90% relative humidity non-<br>condensing | With Standard Battery<br>• Operating temperature: 60 to<br>90°F (15.6 to 32.2° C), 20 to<br>90% relative humidity non-<br>condensing<br>N/A - No Wireless Battery Module |
| Overall Size (Pump) | With Standard Battery<br>• Without IV pole clamp - 5.8" H<br>x 4.2" W x 2.5" D<br>• With standard IV pole clamp -<br>5.8" H x 6.4" W x 4.7" D<br>With Wireless Battery Module<br>• Without IV pole clamp - 6.3" H<br>x 4.2" W x 2.5" D<br>• With standard IV pole clamp -<br>6.3" H x 6.4" W x 4.7" D | With Standard Battery<br>• Without IV pole clamp - 5.8" H<br>x 4.2" W x 2.5" D<br>• With standard IV pole clamp -<br>5.8" H x 6.4" W x 4.7" D<br>N/A - No Wireless Battery Module |
| Characteristic | Proposed Device | Predicate Device (K042121) |
| Volumetric Accuracy<br>Volumetric accuracy at stated flow<br>rates: | | Volumetric accuracy using standard<br>Abbott Sets (now Hospira) |
| | 2.0-999 mL/hr ± 5% | 2-999 mL/hr ± 5%…