Spectrum IQ Infusion System, Dose IQ Safety Software

K173084 · Baxter Healthcare Corporation · FRN · May 11, 2018 · General Hospital

Device Facts

• Record ID: K173084
• Device Name: Spectrum IQ Infusion System, Dose IQ Safety Software
• Applicant: Baxter Healthcare Corporation
• Product Code: FRN · General Hospital
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user. The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas. The Spectrum IO Infusion System with Dose IO Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors. The Spectrum IO Infusion System with Dose IO Safety Software is intended to be used by trained healthcare professionals.

Device Story

Large volume infusion pump system; linear peristaltic mechanism; delivers fluids (drugs, blood) via compatible IV sets. Includes Dose IQ Safety Software for drug library management (limits, advisories, delivery profiles). Operated by trained healthcare professionals in clinical settings. Inputs: manual programming or wireless EMR infusion orders. Outputs: controlled fluid delivery; infusion logs; status alerts. Features auto-programming to populate parameters from EMR; requires clinician verification before start. Benefits: reduces pump programming errors via guided programming and drug library limits; improves documentation accuracy.

Clinical Evidence

No clinical data. Bench testing only, including performance, physical attributes, environmental conditions, software verification, and human factors evaluation in a simulated environment.

Technological Characteristics

Linear peristaltic pump; AC power (100-240VAC) or wireless battery module (Li-ion, 802.11a/b/g/n). Connectivity: IrDA, RS-232, wireless network. Software: Dose IQ Safety Software (Windows 7/10). Standards: ANSI/AAMI ES60601-1, IEC 60601-1-8, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-24.

Indications for Use

Indicated for controlled administration of fluids (pharmaceuticals, blood, blood products) via intravenous, arterial, subcutaneous, or epidural routes in adults, pediatric, and neonatal patients in hospital or 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

• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K133801)

Submission Summary (Full Text)

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May 11, 2018

Baxter Healthcare Corporation Dhiraj Bizzul Manager, Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073

Re: K173084

Trade/Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC Dated: April 11, 2018 Received: April 12, 2018

Dear Dhiraj Bizzul:

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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Tina Kiang
-s

Tina Kiang Ph.D. 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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### Indications for Use

510(k) Number (if known) K173084

#### Device Name

Spectrum IQ Infusion System with Dose IQ Safety Software

#### Indications for Use (Describe)

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The Spectrum IO Infusion System with Dose IO Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors.

The Spectrum IO Infusion System with Dose IO Safety Software is intended to be used by trained healthcare professionals.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ̄ Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### Section 5. 510(k) Summary

May 9, 2018

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

#### CONTACT PERSON:

Dhiraj Bizzul Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

#### IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC

#### Table 1. Baxter Catalog Numbers for Spectrum IQ Infusion System with Dose IQ Safety Software

| Baxter Catalog Number | Name |
|-----------------------|-----------------------------|
| 3570009 | Spectrum IQ Infusion System |
| 35723v090 | Dose IQ Safety Software |

#### PREDICATE DEVICE:

The Spectrum IQ Infusion System with Dose IQ Safety Software is substantially equivalent to the following predicate device:

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| Device | Company | Predicate 510(k) | Clearance Date |
|-----------------------------------------------------------------------|----------------------------------|------------------|----------------|
| Baxter SIGMA<br>Spectrum Infusion<br>Pump with Master Drug<br>Library | Baxter Healthcare<br>Corporation | K133801 | May 7, 2014 |

### Table 2. Predicate Device

### DESCRIPTION OF THE DEVICE:

The proposed device, which is the subject of this Traditional 510(k) premarket notification, is the Spectrum IQ Infusion System with Dose IQ Safety Software. The Spectrum IQ Infusion System with Dose IQ Safety Software is a large volume infusion pump system that provides delivery of fluids into a patient in a controlled manner. The system includes a software controlled, electromechanical pump used for the infusion of fluids such as pharmaceutical drugs, blood, and blood products through intravenous administration sets at user selectable rates and volumes, and a software application that allows the generation, configuration and management of a downloadable drug library into the pump. 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 maintain operation while providing infusion pump capabilities for a wide range of applications.

The pump is specifically manufactured and calibrated for use with Baxter's standard 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. The pump is designed to create smooth fluid dynamics, precise volumetric accuracy, and a uniform flow rate. None of the pump materials contact the fluid path of the administration set.

The Dose IQ Safety Software is a software application that allows for the generation, configuration, and management of a downloadable drug library into a selected Spectrum pump. The drug library can be loaded directly into the pump through a wireless network host or through an Infrared Data Association (IrDA) device. The Dose IQ Safety Software operates on a standard software, Microsoft Windows®, platform.

Using the Dose IQ Safety Software application, a facility can develop preprogrammed delivery profiles, advisories, and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus aiding in the reduction of medication

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errors. The Dose IO Safety Software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The Dose IQ Safety 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.

The Spectrum IQ Infusion System with Dose IQ Safety Software is also capable of automatically populating infusion parameters based on an infusion order that is wirelessly received from a facility's electronic medical record (EMR) system. Although the pump can accept remote orders and populate the infusion parameters, it requires a clinician to verify the information before the start of an infusion.

#### INDICATIONS FOR USE:

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Spectrum IO Infusion System with Dose IO Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This is intended to aid in the reduction of pump programming errors.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Spectrum IQ Infusion System with Dose IO Safety Software is substantially equivalent to the predicate device with regards to design, performance, and intended use. The following provides a comparison summary of technical characteristics.

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| Characteristic | Proposed Device | Predicate Device (K133801) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| Intended Use | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is intended to be used<br>for the controlled administration<br>of fluids. | Identical to proposed. |
| Indications for Use | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is intended to be used<br>for the controlled administration<br>of fluids. These may include<br>pharmaceutical drugs, blood,<br>blood products. | The Baxter SIGMA Spectrum<br>Infusion Pump with Master Drug<br>Library is intended to be used<br>for the controlled administration<br>of fluids. These may include<br>pharmaceutical drugs, blood,<br>blood products and mixtures of<br>required patient therapy. |
| Routes of Administration | The intended routes of<br>administration consist of the<br>following clinically accepted<br>routes; intravenous, arterial,<br>subcutaneous, or epidural. | The intended routes of<br>administration consist of the<br>following clinically accepted<br>routes; intravenous, arterial,<br>subcutaneous, epidural or<br>irrigation of fluid space. |
| Set Usage | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is intended to be used<br>in conjunction with legally<br>marketed and compatible<br>intravenous administration sets<br>and medications provided by the<br>user. | Identical to proposed. |
| Use Environment | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is suitable for a variety<br>of patient care environments<br>such as, but not limited to<br>hospitals and outpatient care<br>areas. | Identical to proposed. |
| Other Indications for Use | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is intended to reduce<br>operator interaction through<br>guided programming, including<br>a way to automate the<br>programming of infusion<br>parameters and documentation<br>of infusion therapies. This is<br>intended to aid in the reduction<br>of pump programming errors. | The Baxter SIGMA Spectrum<br>infusion pump with Master Drug<br>Library is intended to reduce<br>operator interaction through<br>guided programming, thereby<br>helping to reduce errors. |

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| | | ( |
|--------|------|-----|
| 1<br>r | able | . . |

| Characteristic | Proposed Device | Predicate Device (K133801) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Spectrum IQ Infusion<br>System with Dose IQ Safety<br>Software is intended to be used<br>by trained healthcare<br>professionals. | Identical to proposed. |
| Intended Treatment Population | Adults, Pediatric, and Neonates | Identical to proposed |
| | Design Attributes | |
| Pump Software Version | V9.00.01 | V8.00.00 |
| MDL Software Version | V9.0.1 | V8.0.0 |
| Wireless Battery Module<br>Software Version | V9 | V8 |
| Pumping Mechanism | Linear peristaltic design | Identical to proposed. |
| Number of Available Models | One (1) | Identical to proposed. |
| Drug Library Transfer | • Wireless transfer from<br>Personal Computer (PC)<br>through network host to<br>selected pump(s) using<br>wireless battery module<br>(802.11 set of standards)<br>Wireless infrared signal transfer<br>from Personal Computer (PC) to<br>the pump through an IrDA | • Wireless transfer from<br>Personal Computer (PC)<br>through network host to<br>selected pump(s) using<br>wireless battery module<br>(802.11 set of standards)<br>Wireless infrared signal transfer<br>from Personal Computer (PC) to<br>a mobile Personal Digital<br>Assistant (PDA) and by infrared<br>from the PDA to a selected<br>pump |
| Communication protocols | Proprietary communication<br>protocol INTCOM and<br>EXTCOM version 2.0 | Proprietary communication<br>protocol INTCOM and<br>EXTCOM version 1.0 |
| Modes of Delivery | Continuous and Intermittent | Identical to proposed. |
| Features/Functions/Performance Specification | | |
| Spectrum IQ Infusion System | | |
| AC Power | • Input: 100-240VAC, 50-<br>60 Hz / 300 mA<br><br>• Output (P/N 30205):<br>9VDC/1000 mA, short<br>circuit protected<br><br>Cord length ~3.0 m (~ 9.75 feet) | • Input: 120VAC, 60 Hz /<br>300 mA<br><br>• Output (P/N 35727):<br>9VDC/1200 mA, short<br>circuit protected<br><br>Cord length - Identical to<br>proposed |
| Alarm Volume | Variable (three levels: high,<br>medium and low) | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| Air-In-Line | Air In Line: dual-beam<br>ultrasonic detector alarms for<br>large bubbles but allows smaller<br>bubbles to pass. Detects air bubbles >2.5<br>cm (>1 in) (approximately<br>140 µL in Baxter sets) Detects >1 mL of<br>accumulated air over 15<br>min., excluding <10 µL<br>bubbles, at room<br>temperature Detects >1.5 mL of accumulated<br>air over 15 min., excluding <10<br>µL bubbles, at 15.5°C (60°F) | Identical to proposed. |
| Anti-Free Flow System | Set-based, utilizing IV set slide<br>clamp | Identical to proposed. |
| Battery Power and Capacity -<br>Standard Battery | Not Applicable | Lithium Ion, minimum<br>1700 mA/h, 7.4 VDC<br>nominal. Capacity 8 hrs (at 125<br>mL/hr at the highest<br>backlight settings) 12 hr. recharge time<br>Charging occurs if AC Power<br>Adaptor is plugged in whether<br>pump is ON or OFF |
| Battery Power and Capacity –<br>Wireless Battery | Lithium Ion, minimum<br>1700 mA/h, 7.4 VDC<br>nominal Capacity 4 hours (at 125<br>mL/hr at the highest<br>backlight settings) 16 hour recharge time Charging occurs if AC<br>Power Adaptor is plugged<br>in, whether pump is ON<br>or OFF 802.11 a/b/g/n<br>connectivity | 802.11 b/g connectivity<br>Remaining specs – identical to<br>proposed |

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| Characteristic | Proposed Device | Predicate Device (K133801) | | | | | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--|--|--|--|--|-----------------------|
| Bolus Volume Accuracy | Bolus Volume Volume Error 0.5 ml $\pm$ 20% 999 ml $\pm$ 10% | | | | | | | Identical to proposed |
| Dose Modes | mL/hr, mL/kg/min,<br>mL/kg/hr, mL, mL/kg g/hr, mg/hr, mg/kg/hr,<br>mg/min, mg/kg/min,<br>mg/kg/day, mcg/hr,<br>mg/kg/hr, mcg/min,<br>mcg/kg/min, mcg/kg/day,<br>ng/min, ng/kg/min, ng,<br>ng/kg, grams, grams/kg,<br>grams/m2, mg, mg/kg,<br>mg/m2, mcg, mcg/kg,<br>mcg/m2 Units/hr, Units/kg/hr,<br>Units/min, Units/kg/min,<br>mUnits/min,<br>mUnits/kg/hr, mUnits<br>/kg/min, Units, Units/kg,<br>Units/m2 mEq/hr, mEq/kg/hr,<br>mEq/kg/min, mmol/hr,<br>mmol/kg/hr,<br>mmol/kg/min | Identical to proposed. | | | | | | |
| External Interfaces | IrDA (SIR Encoding<br>Protocol. Supports<br>IrOBEX).<br>Additional Asynchronous Serial<br>Port expansion bus available at<br>battery terminals supports a RS-<br>232 connector (manufacturer use<br>only) and wireless enabled<br>battery module. | Identical to proposed. | | | | | | |
| Flow Rates | 0.5 to 999 mL/hr with 0.1 mL/hr<br>increments from 0.5 to 99.9<br>mL/hr and 1.0 mL/hr increments<br>from 100 to 999 mL/hr | Identical to proposed. | | | | | | |
| Infusion Modes | Continuous (Primary and<br>Secondary), Multi-Step, Cyclic<br>TPN, Bolus, Amount/Time<br>(Primary/Secondary) and<br>Volume/Time | Continuous (Primary and<br>Secondary), Multi-Step, Cyclic<br>TPN, Bolus, and Amount/Time<br>(Primary/Secondary) | | | | | | |

Table 3.

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| Characteristic | Proposed Device | Predicate Device (K133801) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Keep Vein Open (KVO) | At the completion of a primary<br>infusion, the pump will infuse at<br>the KVO rate configured per<br>drug in the Drug Library or the<br>current infusion rate, whichever<br>is lower. The default KVO rate<br>is set at 1 mL/hr, but may be<br>configured to between 0.5 - 50<br>mL/hr.<br>At the completion of a secondary<br>infusion program with secondary<br>callback enabled, the pump will<br>run at a fixed KVO rate of 1<br>mL/hr. | Identical to proposed. |
| Logging Memory | ●<br>24 hr memory of all set up<br>screens except for<br>multistep and cyclic<br>modes that are retained<br>until using the clear<br>program soft key<br>●<br>A pump history log<br>Minimum 4,500 event capacity.<br>Once the maximum number of<br>log entries is reached, the data<br>for each new event replaces the<br>data for the oldest event (the<br>data for oldest event is lost) | ●<br>24 hr memory of all set up<br>screens except for<br>multistep and cyclic<br>modes that are retained<br>until using the clear<br>program soft key<br>●<br>Separate pump history log<br>and drug error log<br>Minimum 4,500 event capacity.<br>Once the maximum number of<br>log entries is reached, the data<br>for each new event replaces the<br>data for the oldest event (the<br>data for oldest event is lost) |
| Low-Flow Continuity | The maximum period of no-flow<br>is 90 seconds at a flow rate of<br>0.5 mL/hr with a bolus volume<br>that does not exceed 15 µL over<br>a 5 second sample volume<br>interval. | Identical to proposed. |
| Occlusion Pressure | Adjustable:<br>●<br>High (19 ±9 PSI)<br>●<br>Medium (13 ±6 PSI)<br>●<br>Low (6 ±4 PSI) | Identical to proposed. |
| Operational Conditions | With Wireless Battery Module<br>●<br>Operating temperature: 60<br>to 90°F (15.6 to 32.2° C),<br>20 to 90% relative<br>humidity non-condensing. | With Standard Battery<br>●<br>Operating temperature: 60<br>to 90°F (15.6 to 32.2° C),<br>20 to 90% relative<br>humidity non-condensing. |

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|--------|-----|---|--|
| a | .01 | e | |
| | | | |

| Characteristic | Proposed Device | Predicate Device (K133801) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | With Wireless Battery Module |
| | | Operating temperature: 60 to 80°F (15.6 to 26.7° C), 20 to 90% relative humidity non-condensing. |
| Overall Size (Pump) | Wireless Battery Module: | With Standard Battery |
| | Without IV pole clamp – 7.4"h x 5.2"w x 3.3"d | Without IV pole clamp – 5.8" H x 4.2" W x 2.5" D |
| | With standard IV pole clamp - 7.4"h x 7.7"w x 5.5"d | With standard IV pole clamp - 5.8" H x 6.4" W x 4.7" D |
| | | With Wireless Battery Module: |
| | | Without IV pole clamp – 6.3" H x 4.2" W x 2.5" D |
| | | With standard IV pole clamp -6.3" H x 6.4" W x 4.7" D |
| Maximum Allowable Pressure<br>while in Downstream Occlusion | 30 PSI | Identical to proposed. |
| Single Fault Condition | A maximum bolus of 0.56 mL<br>may be generated as a result of a<br>Single Fault Condition (a failure<br>of the Spectrum IQ, which stops<br>the Pump motor and results in an<br>alarm). | Identical to proposed. |
| Storage Temperature | Storage temperature: 14 to<br>120°F (-10 to 49°C), 10 to 90%<br>relative humidity non-<br>condensing. | Identical to proposed. |
| Timekeeping | Real Time Clock, battery<br>backed, 7-year life | Real Time Clock, battery<br>backed, 10-year life |
| Total Drug Delivered | 0.1 to 9999 mL with 0.1 mL<br>increments from 0.1 to 99.9 mL<br>and 1.0 mL increments from 100<br>to 9999 mL | Identical to proposed. |
| Volumetric Accuracy | Accuracy is based on volume<br>collected over one hour using<br>compatible Baxter Standard IV<br>Sets.<br>DEHP Sets:<br>2.0-999 mL/hr ± 5% | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| | 0.5-1.9 mL/hr ± 0.1mL/hr<br>Specified accuracy is maintained<br>on Baxter Standard IV Sets for<br>up to 96 hours (maximum 12<br>liters) when tested at 72 +/-2 F.<br>Non-DEHP Sets:<br>10-125 mL/hr ±10% ≤ 36 hrs<br>126-250 mL/hr ±10% ≤ 4 hrs | |
| Weight | Wireless Battery Module<br>Without IV pole clamp – 45.6 oz.± 1.0 oz. With standard IV pole clamp – 51.6 oz. ± 1.0 oz. | With Standard Battery Without IV pole clamp – 25.5 oz. ±1.0 oz. With standard IV pole clamp – 33.5oz. ± 1.0 oz. With Wireless Battery Module Without IV pole clamp – 26.5 oz. ±1.0 oz. With standard IV pole clamp – 34.5oz. ± 1.0 oz. |
| Wireless Network Interface | Wireless Battery Module<br>(802.11a/b/g/n), SIGMA Part<br>Number 35223 Standard: IEEE 802.11a Standard: IEEE 802.11b Standard: IEEE 802.11g Standard: IEEE 802.11n Transmit Power: 12 dBm typical | Wireless Battery Module<br>(802.11b/g), SIGMA Part<br>Number 35162 Standard: IEEE 802.11b/g<br>Transmit Power: 12 dBm typical |
| Wireless Security | WEP (Wired Equivalent<br>Privacy) Encryption: 64/128-bit (RC4) WPA/WPA2/802.11i Encryption: TKIP, CCMP (AES) WPA-PSK 802.1X authentication LEAP (WEP only) | WEP (Wired Equivalent<br>Privacy) Encryption: 64/128-bit (RC4) WPA/WPA2/802.11i Encryption: TKIP, CCMP (AES) WPA-PSK 802.1X authentication LEAP (WEP only) PEAP/MSCHAPv2 |
| | | PEAP/MSCHAPv2 |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| | ●<br>EAP-TLS | ●<br>EAP-TLS |
| | ●<br>EAP-FAST | |
| | ●<br>EAP-TTLS/PAP<br>EAP-TTLS/MSCHAPv2SHA-2…