(224 days)
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 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.
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 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.
This FDA 510(k) summary for the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software details the device's characteristics and its comparison to a predicate device, focusing on non-clinical testing.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance:
The document states that "Non-Clinical testing of the Spectrum IQ Infusion system with Dose IQ Safety Software met all acceptance criteria". However, it does not explicitly list the quantitative acceptance criteria for each test and its specific performance result in the format of a table you requested. Instead, it broadly states "Per Baxter Test Methods" for several categories of testing. We can infer some performance characteristics from the "Technological Characteristics and Substantial Equivalence" section, which compares the proposed device to the predicate.
Here's an attempt to construct a table based on the provided information, understanding that concrete acceptance criteria and specific numerical performance against those criteria are not explicitly detailed for most points, but rather implied by meeting "Baxter Test Methods" and showing "substantial equivalence":
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (as described or compared) |
|---|---|---|
| Central Management Subsystem | Per Baxter Test Methods | Met |
| Case Works Subsystem | Per Baxter Test Methods | Met |
| Pumping Subsystem | Per Baxter Test Methods | Met (Linear peristaltic design, smooth fluid dynamics, precise volumetric accuracy, uniform flow rate) |
| Power Subsystem | Per Baxter Test Methods | Met |
| System Level Testing | Per Baxter Test Methods | Met |
| Software Testing | Per Baxter Test Methods | Met |
| Reliability Testing | Per Baxter Test Methods | Met |
| Consensus Standards Testing | Specific IEC/ANSI/AAMI standards (e.g., ANSI/AAMI ES60601-1:2005) | Met (Compliance indicated) |
| Human Factors Evaluation | Use errors not greater than minimal risk for critical tasks | Met (Evaluated in simulated environment) |
| Specific Device Performance Characteristics for Substantial Equivalence Comparison: | ||
| Bolus Volume Accuracy (0.5 ml) | Not explicitly stated, predicate is "Identical to proposed" | 0.5 ml ± 20% |
| Bolus Volume Accuracy (999 ml) | Not explicitly stated, predicate is "Identical to proposed" | 999 ml ± 10% |
| Flow Rates | Not explicitly stated, predicate is "Identical to proposed" | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr and 1.0 mL/hr increments from 100 to 999 mL/hr |
| KVO Rate | Not explicitly stated, predicate is "Identical to proposed" | Default 1 mL/hr, configurable 0.5 - 50 mL/hr (primary), Fixed 1 mL/hr (secondary callback) |
| Logging Memory | Minimum 4,500 event capacity | Minimum 4,500 event capacity |
| Low-Flow Continuity | No-flow max 90 seconds @ 0.5 mL/hr, bolus ≤ 15 µL over 5 sec | Maximum period of no-flow is 90 seconds at 0.5 mL/hr with a bolus volume that does not exceed 15 µL over a 5 second sample volume interval. |
| Occlusion Pressure | Adjustable (High, Medium, Low) | High (19 ±9 PSI), Medium (13 ±6 PSI), Low (6 ±4 PSI) |
| Max Allowable Pressure (Downstream Occlusion) | 30 PSI | 30 PSI |
| Single Fault Condition (max bolus) | A maximum bolus of 0.56 mL | A maximum bolus of 0.56 mL |
| Total Drug Delivered | Not explicitly stated, predicate is "Identical to proposed" | 0.1 to 9999 mL with 0.1 mL increments from 0.1 to 99.9 mL and 1.0 mL increments from 100 to 9999 mL |
| Volumetric Accuracy (DEHP Sets 2.0-999 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ± 5% |
| Volumetric Accuracy (DEHP Sets 0.5-1.9 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ± 0.1 mL/hr |
| Volumetric Accuracy (Non-DEHP Sets 10-125 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ±10% ≤ 36 hrs |
| Volumetric Accuracy (Non-DEHP Sets 126-250 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ±10% ≤ 4 hrs |
| Drug Capacity | Up to 5,000 drugs and 32 care areas | Up to 5,000 drugs and 32 care areas |
2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., number of devices tested, number of simulated scenarios).
The data provenance is from non-clinical testing performed by Baxter Healthcare Corporation, including bench testing and human factors evaluation in a simulated environment. There is no mention of country of origin of data beyond Baxter's internal testing as the manufacturer. The tests are prospective in nature, assessing the device's performance against defined requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions a "Human Factors evaluation in a simulated environment" and states it's intended to ensure use errors are not greater than minimal risk. It also mentions "trained healthcare professionals" for intended users.
However, the document does not specify the number of experts, nor their specific qualifications, who established a "ground truth" or evaluated the human factors test set. It implies user testing with qualified personnel but no detail is provided.
4. Adjudication method for the test set:
The document does not describe any adjudication method for establishing ground truth or resolving discrepancies in any of the testing. The testing is primarily "verification against requirements," implying a pass/fail outcome against predefined specifications rather than a consensus-driven ground truth process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was mentioned or performed. This device is an infusion pump with safety software, not an AI-assisted diagnostic imaging or decision-support tool where "human readers improve with AI" would be a relevant metric. The "Dose IQ Safety Software" automates programming and provides advisories, which is a form of decision support/error reduction, but not in the context of interpreting medical cases like radiologists.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The core device is an infusion pump, which operates independently in its functional delivery of fluids. The "Dose IQ Safety Software" provides automation but "requires a clinician to verify the information before the start of an infusion," indicating a human-in-the-loop system for critical operations. Standalone performance for the pump itself (e.g., flow rate accuracy) was implicitly tested through the "Pumping Subsystem Testing" and "System Level Testing" (which met acceptance criteria), but this is not an "algorithm-only" standalone performance in the typical sense of AI/ML.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is predominantly based on pre-defined engineering and performance requirements and compliance with consensus standards. For the human factors evaluation, the ground truth would be the identification of critical tasks and the assessment of use errors against pre-established risk thresholds, likely based on expert judgment and safety analyses. It's not "pathology" or "outcomes data" in a diagnostic sense.
8. The sample size for the training set:
No training set is mentioned. The document describes a "Dose IQ Safety Software" which allows for the creation and management of a drug library and automated programming. This is a rule-based or reference data-based system, not an AI/ML system that would require a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
As no training set (in the AI/ML sense) is mentioned, this question is not applicable. The "ground truth" for the drug library data would be established by the facility's clinical policies, pharmaceutical guidelines, and expert medical input during the configuration of the drug library itself.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (224) 270-2177 Fax: (224) 270-4119
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 SIGMASpectrum InfusionPump with Master DrugLibrary | Baxter HealthcareCorporation | 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 InfusionSystem with Dose IQ SafetySoftware is intended to be usedfor the controlled administrationof fluids. | Identical to proposed. |
| Indications for Use | The Spectrum IQ InfusionSystem with Dose IQ SafetySoftware is intended to be usedfor the controlled administrationof fluids. These may includepharmaceutical drugs, blood,blood products. | The Baxter SIGMA SpectrumInfusion Pump with Master DrugLibrary is intended to be usedfor the controlled administrationof fluids. These may includepharmaceutical drugs, blood,blood products and mixtures ofrequired patient therapy. |
| Routes of Administration | The intended routes ofadministration consist of thefollowing clinically acceptedroutes; intravenous, arterial,subcutaneous, or epidural. | The intended routes ofadministration consist of thefollowing clinically acceptedroutes; intravenous, arterial,subcutaneous, epidural orirrigation of fluid space. |
| Set Usage | The Spectrum IQ InfusionSystem with Dose IQ SafetySoftware is intended to be usedin conjunction with legallymarketed and compatibleintravenous administration setsand medications provided by theuser. | Identical to proposed. |
| Use Environment | The Spectrum IQ InfusionSystem with Dose IQ SafetySoftware is suitable for a varietyof patient care environmentssuch as, but not limited tohospitals and outpatient careareas. | Identical to proposed. |
| Other Indications for Use | The Spectrum IQ InfusionSystem with Dose IQ SafetySoftware is intended to reduceoperator interaction throughguided programming, includinga way to automate theprogramming of infusionparameters and documentationof infusion therapies. This isintended to aid in the reductionof pump programming errors. | The Baxter SIGMA Spectruminfusion pump with Master DrugLibrary is intended to reduceoperator interaction throughguided programming, therebyhelping to reduce errors. |
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| ( | ||
|---|---|---|
| 1r | able | . . |
| Characteristic | Proposed Device | Predicate Device (K133801) |
|---|---|---|
| The Spectrum IQ InfusionSystem with Dose IQ SafetySoftware is intended to be usedby trained healthcareprofessionals. | 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 ModuleSoftware 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 fromPersonal Computer (PC)through network host toselected pump(s) usingwireless battery module(802.11 set of standards)Wireless infrared signal transferfrom Personal Computer (PC) tothe pump through an IrDA | • Wireless transfer fromPersonal Computer (PC)through network host toselected pump(s) usingwireless battery module(802.11 set of standards)Wireless infrared signal transferfrom Personal Computer (PC) toa mobile Personal DigitalAssistant (PDA) and by infraredfrom the PDA to a selectedpump |
| Communication protocols | Proprietary communicationprotocol INTCOM andEXTCOM version 2.0 | Proprietary communicationprotocol INTCOM andEXTCOM 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, 50-60 Hz / 300 mA• Output (P/N 30205):9VDC/1000 mA, shortcircuit protectedCord length | • Input: 120VAC, 60 Hz /300 mA• Output (P/N 35727):9VDC/1200 mA, shortcircuit protectedCord length - Identical toproposed |
| Alarm Volume | Variable (three levels: high,medium and low) | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| Air-In-Line | Air In Line: dual-beamultrasonic detector alarms forlarge bubbles but allows smallerbubbles to pass. Detects air bubbles >2.5cm (>1 in) (approximately140 µL in Baxter sets) Detects >1 mL ofaccumulated air over 15min., excluding <10 µLbubbles, at roomtemperature Detects >1.5 mL of accumulatedair over 15 min., excluding <10µL bubbles, at 15.5°C (60°F) | Identical to proposed. |
| Anti-Free Flow System | Set-based, utilizing IV set slideclamp | Identical to proposed. |
| Battery Power and Capacity -Standard Battery | Not Applicable | Lithium Ion, minimum1700 mA/h, 7.4 VDCnominal. Capacity 8 hrs (at 125mL/hr at the highestbacklight settings) 12 hr. recharge timeCharging occurs if AC PowerAdaptor is plugged in whetherpump is ON or OFF |
| Battery Power and Capacity –Wireless Battery | Lithium Ion, minimum1700 mA/h, 7.4 VDCnominal Capacity 4 hours (at 125mL/hr at the highestbacklight settings) 16 hour recharge time Charging occurs if ACPower Adaptor is pluggedin, whether pump is ONor OFF 802.11 a/b/g/nconnectivity | 802.11 b/g connectivityRemaining specs – identical toproposed |
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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,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, ng,ng/kg, 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/kg/min, mmol/hr,mmol/kg/hr,mmol/kg/min | Identical to proposed. | ||||||
| External Interfaces | IrDA (SIR EncodingProtocol. SupportsIrOBEX).Additional Asynchronous SerialPort expansion bus available atbattery terminals supports a RS-232 connector (manufacturer useonly) and wireless enabledbattery module. | Identical to proposed. | ||||||
| Flow Rates | 0.5 to 999 mL/hr with 0.1 mL/hrincrements from 0.5 to 99.9mL/hr and 1.0 mL/hr incrementsfrom 100 to 999 mL/hr | Identical to proposed. | ||||||
| Infusion Modes | Continuous (Primary andSecondary), Multi-Step, CyclicTPN, Bolus, Amount/Time(Primary/Secondary) andVolume/Time | Continuous (Primary andSecondary), Multi-Step, CyclicTPN, Bolus, and Amount/Time(Primary/Secondary) |
Table 3.
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| Characteristic | Proposed Device | Predicate Device (K133801) |
|---|---|---|
| Keep Vein Open (KVO) | At the completion of a primaryinfusion, the pump will infuse atthe KVO rate configured perdrug in the Drug Library or thecurrent infusion rate, whicheveris lower. The default KVO rateis set at 1 mL/hr, but may beconfigured to between 0.5 - 50mL/hr.At the completion of a secondaryinfusion program with secondarycallback enabled, the pump willrun at a fixed KVO rate of 1mL/hr. | Identical to proposed. |
| Logging Memory | ●24 hr memory of all set upscreens except formultistep and cyclicmodes that are retaineduntil using the clearprogram soft key●A pump history logMinimum 4,500 event capacity.Once the maximum number oflog entries is reached, the datafor each new event replaces thedata for the oldest event (thedata for oldest event is lost) | ●24 hr memory of all set upscreens except formultistep and cyclicmodes that are retaineduntil using the clearprogram soft key●Separate pump history logand drug error logMinimum 4,500 event capacity.Once the maximum number oflog entries is reached, the datafor each new event replaces thedata for the oldest event (thedata for oldest event is lost) |
| Low-Flow Continuity | The maximum period of no-flowis 90 seconds at a flow rate of0.5 mL/hr with a bolus volumethat does not exceed 15 µL overa 5 second sample volumeinterval. | Identical to proposed. |
| Occlusion Pressure | Adjustable:●High (19 ±9 PSI)●Medium (13 ±6 PSI)●Low (6 ±4 PSI) | Identical to proposed. |
| Operational Conditions | With Wireless Battery Module●Operating temperature: 60to 90°F (15.6 to 32.2° C),20 to 90% relativehumidity non-condensing. | With Standard Battery●Operating temperature: 60to 90°F (15.6 to 32.2° C),20 to 90% relativehumidity non-condensing. |
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| nC | |||
|---|---|---|---|
| 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 Pressurewhile in Downstream Occlusion | 30 PSI | Identical to proposed. |
| Single Fault Condition | A maximum bolus of 0.56 mLmay be generated as a result of aSingle Fault Condition (a failureof the Spectrum IQ, which stopsthe Pump motor and results in analarm). | Identical to proposed. |
| Storage Temperature | Storage temperature: 14 to120°F (-10 to 49°C), 10 to 90%relative humidity non-condensing. | Identical to proposed. |
| Timekeeping | Real Time Clock, batterybacked, 7-year life | Real Time Clock, batterybacked, 10-year life |
| Total Drug Delivered | 0.1 to 9999 mL with 0.1 mLincrements from 0.1 to 99.9 mLand 1.0 mL increments from 100to 9999 mL | Identical to proposed. |
| Volumetric Accuracy | Accuracy is based on volumecollected over one hour usingcompatible Baxter Standard IVSets.DEHP Sets:2.0-999 mL/hr ± 5% | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| 0.5-1.9 mL/hr ± 0.1mL/hrSpecified accuracy is maintainedon Baxter Standard IV Sets forup to 96 hours (maximum 12liters) when tested at 72 +/-2 F.Non-DEHP Sets:10-125 mL/hr ±10% ≤ 36 hrs126-250 mL/hr ±10% ≤ 4 hrs | ||
| Weight | Wireless Battery ModuleWithout 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(802.11a/b/g/n), SIGMA PartNumber 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(802.11b/g), SIGMA PartNumber 35162 Standard: IEEE 802.11b/gTransmit Power: 12 dBm typical |
| Wireless Security | WEP (Wired EquivalentPrivacy) Encryption: 64/128-bit (RC4) WPA/WPA2/802.11i Encryption: TKIP, CCMP (AES) WPA-PSK 802.1X authentication LEAP (WEP only) | WEP (Wired EquivalentPrivacy) 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) |
| ●EAP-TLS | ●EAP-TLS | |
| ●EAP-FAST | ||
| ●EAP-TTLS/PAPEAP-TTLS/MSCHAPv2SHA-2 | ||
| Lettering | Tall Man lettering | Identical to proposed. |
| Dose IQ Safety Software | ||
| Infusion Modes | Continuous (Primary andSecondary), Multi-Step, CyclicTPN, Bolus, Amount/Time(Primary/Secondary) andVolume/Time | Continuous (Primary andSecondary), Multi-Step, CyclicTPN, Bolus, and Amount/Time(Primary/Secondary) |
| System Basis | Microsoft Windows® 7 (32 or64-bit) and MicrosoftWindows® 10 (64-bit) operatingsystem compatibility. | Microsoft Windows® 7operating system compatibility. |
| Drug Capacity | Up to 5,000 drugs and 32 careareas | Identical to proposed. |
| Available Limits | ●Upper Hard Limit must begreater than or equal toUpper Soft Limit. | Identical to proposed. |
| ●Upper Soft Limit must begreater than or equal to aStarting Rate. | ||
| ●Starting Rate must begreater than or equal to aLower Soft Limit. | ||
| ●Lower Soft Limit must begreater than or equal to aLower Hard Limit. | ||
| Lower Hard Limit mustbe less than or equal to aLower Soft Limit | ||
| All Rates and Drug LibraryLimits must fall within SpectrumPump operational range of 0.5 to999 mL/hr. | ||
| Security Roles | ●Read-Only Access | Identical to proposed. |
| ●Limited Access | ||
| ●Full Access | ||
| Characteristic | Proposed Device | Predicate Device (K133801) |
| Reports | ●Standard and customDrug and Fluid Report forDrugs/Fluids,Concentration Limits,Configurations, etc.Audit reports for a list ofchanges made to the DrugLibrary along with the date thechange was performed | Identical to proposed. |
| Upstream Occlusion Suspension | Optional feature to allow theuser to temporarily suspend theupstream occlusion alarm afteraddressing two successiveupstream occlusion alarms withonscreen troubleshootingprompts and confirming flow. | Identical to proposed. |
| Clinical Advisory | Clinical advisory (optional); canbe entered for any drug or fluidand will be displayed on thepump during initialprogramming. In addition, thepump provides the followingnotifications/pump messaging tothe user for additional errorprotection:●Check flow at Run -prompts the clinician atthe start of the infusion toensure that there are noclosed clamps or kinks inthe tubing that mightprevent flowSecondary ErrorPrevention - prompts theclinician to verify thesecondary VTBI (VolumeTo Be Infused) equals thesecondary bag volumeand also prompts theclinician to verify dropsare falling in thesecondary drip chamberand not in the primary | Identical to proposed. |
| Rate or Dose Change Limits | Programmable limit for thepercentage of a dose or ratechange made in oneprogramming step for each | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| specific drug. A 500% fixedalert limit for single step ratetitration in OR/Anesthesia careareas. | ||
| Auto-Programming | Auto-programming is the abilityto populate infusion parametersfrom the patient's order in theelectronic medical record (EMR)into the Spectrum IQ InfusionPump | N/A |
| Back-association (An EMRfunction related to the handlingof auto-documentation ofmanually programmedinfusions. It enables users toassign un-associated infusiondocumentation data for properdispositioning within the EMR) | Yes – Barcode placement onPump and Image on screen | Yes – Barcode placement onpump |
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Table 3.
With the exception of autoprogrmaming, the changes identified above are incremental in natural such that they reflect the natural progression of the device design and continuous improvement.
The introduction of auto-programming does not change the intended use or the fundamental scientific technology and performance specifications (i.e., same principles of operation, pumping mechanism, materials, design, energy source, manufacturing process, etc.) as compared to the predicate device. The auto-programming feature, for infusion orders, builds on the capabilities of the predicate's existing communication pathways through use of the wireless technology and interface architecture.
As a result, these changes do not raise new questions of safety and effectiveness.
DISCUSSION OF NONCLINICAL TESTS:
Non-Clinical testing of the Spectrum IO Infusion System with Dose IO Safety Software has been verified against requirements for performance, physical attributes, and environmental conditions, and to provide objective evidence that the device intended use is met. Verification was performed through bench testing in the following areas:
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| Testing | Acceptance Criteria |
|---|---|
| Central Management Subsystem Testing | Per Baxter Test Methods |
| Case Works Subsystem Testing | Per Baxter Test Methods |
| Pumping Subsystem Testing | Per Baxter Test Methods |
| Power Subsystem Testing | Per Baxter Test Methods |
| System Level Testing | Per Baxter Test Methods |
| Software Testing | Per Baxter Test Methods |
| Reliability Testing | Per Baxter Test Methods |
| Consensus Standards Testing | Per the following Consensus Standards:ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R) 2012IEC 60601-1-8:2006 +A1:2012 (edition 2.1)IEC 60601-1-2:2014IEC 60601-1-6 Ed. 3.1 b:2013IEC 60601-2-24:2012 |
Table 4. Verification Testing Summary
In addition to the above, and in consideration of IEC 62366-1ed. 1.0 b:2015, Medical devices - Part 1: Application of usability engineering to medical devices as well as FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016, Baxter conducted a Human Factors evaluation in a simulated environment to ensure that use of the Spectrum IQ Infusion System with Dose IQ Safety Software would not exhibit use errors associated with critical tasks that are greater than the minimal risk. User needs and intended uses were evaluated through simulated testing of use, labeling evaluation, and blood and blood product testing.
In compliance to FDA guidance, "Infusion Pumps Total Product Life Cycle" issued December 2, 2014, Baxter has developed a Safety Assurance Case considering the risks associated with the changes covered under this submission 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 Spectrum IQ Infusion system with Dose IQ Safety Software met all acceptance criteria, demonstrating that the device is substantially equivalent to the predicate.
DISCUSSION OF CLINICAL TESTS:
No clinical testing was performed in support of this premarket notification.
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CONCLUSION:
The Spectrum IQ Infusion System with Dose IQ Safety Software has been verified and validated against design input requirements, user needs and intended uses. The nonclinical data demonstrate that the subject device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device.
§ 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).