The Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural.

The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial.

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user.

The Novum IO LVP is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.

The Novum IQ LVP is intended to be used by trained healthcare professionals.

Device Description

The Novum IQ Large Volume Pump (LVP) is a large volumetric smart pump within the Novum IQ infusion platform. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

Novum IQ LVP provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood and blood products through administration sets at clinician's selectable rates and volumes.

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user. The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities. The Novum IO LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ LVP is intended to be used by trained healthcare professionals.

The Novum IQ LVP employs a feedback controlled, motorized pumping mechanism that works based on peristaltic action and uses inlet and outlet valves for flow control. To deliver medication correctly, the Novum IQ LVP peristaltically compresses the administration set. The pump channel is designed to interface to a Baxter standard administration set. The pumping mechanism interfaces with the keyed slide clamp and tubing to prevent free flow of drug.

The Novum IQ LVP is designed to detect and react to situations that could impact patient safety. When a situation that could impact patient safety is detected. the Novum IO LVP will notify the clinician with a visual alert and an audible alarm tone.

The Novum IQ LVP is designed to operate on Alternating Current (AC) power with an internally mounted rechargeable battery pack to facilitate the continuation of therapy during patient transport or AC power loss.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Novum IQ Large Volume Pump. It primarily discusses the device's substantial equivalence to a predicate device based on non-clinical testing and engineering evaluations. It explicitly states that "No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide information regarding acceptance criteria based on clinical studies, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these would typically be derived from clinical trials, which were not conducted for this submission.

However, based on the non-clinical tests and the device comparison provided, I can infer the acceptance criteria relate to meeting the performance, physical attributes, environmental conditions, and safety requirements of relevant international standards and FDA guidance documents. The "reported device performance" would be that the device successfully met these requirements.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Based on the "DISCUSSION OF NONCLINICAL TESTS" and "DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE" sections, the acceptance criteria are primarily derived from regulatory standards and the performance of the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from documentation)	Reported Device Performance (as stated or implied)
General Safety & Performance	Device design is adequately safe for its intended use; potential risks mitigated; residual risk acceptable; design verification and validation acceptable; device reliability acceptable; device meets clinically valid essential performance. (from Safety Assurance Case)	"The Novum IQ LVP has been verified and validated against design input requirements, user needs and intended uses."
Cleaning & Disinfection	Validation according to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).	"Cleaning and Disinfection validation was performed according to FDA Guidance..."
Wireless Functionality	Implementation according to FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013).	"Wireless functionality was implemented according to FDA Guidance..."
Software V&V	According to "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (May 11, 2005) and "Infusion Pumps Total Life Cycle" (December 2, 2014); software considered major level of concern; includes code review, static analysis, unit testing, integration testing, and regression testing.	"Software verification and validation was performed according to Guidance for the Content of Premarket Submission..."
Cybersecurity	Verification and information provided according to FDA's Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 18, 2018) and draft Guidance Postmarket Management of Cybersecurity in Medical Devices (Dec 28, 2016).	"Cybersecurity verification and information was performed and provided according to FDA's Guidance..."
Interoperability	Assessed and tested in accordance with FDA's Guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Device (Sept 6, 2017).	"Interoperability was assessed and tested in accordance with FDA's Guidance..."
Electrical Safety, EMC, Essential Performance	Compliance with IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2, IEC 60601-1-8, AIM 7351731 rev 2: 2017, IEC 62133-2 Ed.1.0 2017-02, UL 2054 2nd Edition, UL 1642 5th Edition.	"Electrical safety, EMC and essential performance testing was successfully completed according to the following standards..."
Human Factors/Usability	Evaluation in a simulated environment with intended user population, use environment, and scenarios, according to IEC 62366-1 ed. 1.0 b:2007 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).	"Baxter conducted a Human Factors evaluation in a simulated environment. Results demonstrated that the Novum IQ LVP is suitable for its intended use."
Flow Rate Accuracy	Accuracy under standard conditions: For primary set material: 0.5 - 0.9 mL/hr: +/-10%; 1 - 1200 mL/hr: +/-5%. (Compared to Predicate: 0.5 - 1.9 mL/hr: +/-0.1 mL/hr; 2- 999 mL/hr: +/-5%)	"Similar. Detailed flow rate accuracy for all sets disclosed in labeling." (Implies meeting or exceeding predicate performance for ranges).
Battery Performance	Smart Battery Pack - Lithium Ion (internal), 10.8 VDC nominal; Max 16 hr recharge time at 23 +/- 2°C; Capacity (medium backlight, wireless enabled): 25-125 mL/hr >=8 hrs; 1200 mL/hr >=6 hrs. (Compared to a predicate with external battery module and different capacity specs).	"The pumps are able to operate independent from AC power during transport situations or interruptions of the voltage supply. Differences do not raise different questions of safety and effectiveness."
Operational Conditions	Operating temperature: 15 to 40°C, 10 to 80% relative humidity non-condensing. (Compared to predicate: 15.6 to 32.2°C, 20 to 90% RH).	"Functional and performance tests support the operational conditions for the subject device."
Storage Conditions	Storage temperature: -10 to 49°C, 10 to 80% relative humidity non-condensing. (Compared to predicate: -10 to 49°C, 10 to 90% RH).	"Functional and performance tests support the storage conditions for the subject device."
Administration Set Loading	Guided administration set loading using visual and audible prompts with automatic ejection of the slide clamp upon door closure. (Compared to predicate: manual removal of slide clamp).	"Functional tests and Human Factors studies support that this difference does not raise different questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any specific component or system-level test. The document refers to "testing" and "verification and validation" efforts, but not the number of units or test cases used.
Data Provenance: Not applicable in the context of clinical data. For non-clinical tests, the data provenance would be internal laboratory testing and controlled simulated environments conducted by Baxter Healthcare Corporation. The document does not specify country of origin for the non-clinical data, but the submission is to the US FDA by Baxter Healthcare Corporation in Deerfield, Illinois.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is typically relevant for studies involving human interpretation (e.g., radiology for AI algorithms). Since no clinical testing was performed and the ground truth for engineering and V&V tests is based on design specifications and standard requirements, this question is not applicable to the provided document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no clinical study involving human readers or interpretation requiring adjudication was performed.

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:

Not applicable, as no clinical testing or studies involving human-in-the-loop performance were conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an infusion pump, not an AI algorithm intended for diagnostic or interpretive tasks. Its performance is measured by its mechanical and electronic functionality, safety features, and accuracy in fluid delivery, not by an independent algorithm's diagnostic output.

7. The type of ground truth used:

For performance, physical attributes, environmental conditions, safety (non-clinical testing): The ground truth was established by adherence to recognized international standards (e.g., IEC 60601 series, UL standards) and FDA guidance documents, as well as internal design specifications and requirements.
For human factors/usability: The ground truth was the ability of intended users to safely and effectively operate the device in simulated clinical scenarios, as evaluated against predefined criteria.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., image datasets for deep learning). The device undergoes design, development, and engineering verification.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 29, 2024

Baxter Healthcare Corporation Dhiraj Bizzul Sr. Manager, Regulatory Affairs, Medication Delivery One Baxter Parkway Deerfield, Illinois 60015

Re: K211122

Trade/Device Name: Novum IQ Large Volume Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: March 10, 2023 Received: March 10, 2023

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211122

Device Name Novum IQ Large Volume Pump

Indications for Use (Describe)

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user.

The Novum IO LVP is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ LVP is intended to be used by trained healthcare professionals.

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

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510(k) Summary

Date: March 18, 2024

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Dhiraj Bizzul Sr. Manager, Global Regulatory Affairs One Baxter Parkway Deerfield, IL 60015 Telephone: (847) 909-6828

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Novum IO Large Volume Pump Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN

PREDICATE DEVICE:

Spectrum IQ Infusion System with Dose IQ Safety Software (K173084)

DESCRIPTION OF THE DEVICE:

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pharmaceutical drugs, parenteral nutrition, blood and blood products through administration sets at clinician's selectable rates and volumes.

INDICATIONS FOR USE:

The Novum IQ LVP is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural. The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial.

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user.

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The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.

The Novum IQ LVP is intended to be used by trained healthcare professionals.

DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE:

Characteristic	Subject Device - Novum IQ LVP	Predicate - SpectrumIQ Infusion System(K173084)	Discussion ofDifferences
Indications forUse and RoutesofAdministration	The Novum IQ LVP is intended foruse on adults and pediatricsubpopulations, except for neonates,for the controlled administration offluids, pharmaceutical drugs,parenteral nutrition, blood and bloodproducts through the followingclinically accepted routes ofadministration: intravenous, arterial,subcutaneous and epidural.The Novum IQ LVP is intended foruse on neonates, for the controlledadministration of fluids andparenteral nutrition through thefollowing clinically accepted routesof administration: intravenous andarterial.	Intended to be used forthe controlledadministration of fluids.These may includepharmaceutical drugs,blood, blood products.The intended routes ofadministration consistof the followingclinically acceptedroutes: intravenous,arterial, subcutaneousor epidural	SimilarParenteral nutritionwas added toprovide additionalclarity on fluidsadministered.Added clarificationto exclude theneonate populationfrom the adult andpediatric clinicallyaccepted routes ofadministration bylimiting theindicated routes tointravenous andarterial.
Characteristic	Subject Device – Novum IQ LVP	Predicate - SpectrumIQ Infusion System(K173084)	Discussion ofDifferences
Set Usage	The Novum IQ LVP is intended tobe used in conjunction with legallymarketed and compatibleadministration sets, and medicationsprovided by the user.	Intended to be used inconjunction withlegally marketed andcompatible intravenousadministration sets andmedications providedby the user.	Similar; removed"intravenous"
UseEnvironment	The Novum IQ LVP is suitable forpatient care in hospitals andoutpatient health care facilities.	Suitable for a variety ofpatient careenvironments such as,but not limited tohospitals and outpatientcare areas.	Same
OtherIndications forUse	The Novum IQ LVP is intended toaid in the reduction of operatorinteraction through guidedprogramming, including a way toautomate the programming ofinfusion parameters anddocumentation of infusion therapieswhen integrated with an ElectronicMedical Record (EMR) system. Thisautomation is intended to aid in thereduction of programming errors.	Intended to reduceoperator interactionthrough guidedprogramming,including a way toautomate theprogramming ofinfusion parameters anddocumentation ofinfusion therapies. Thisautomation is intendedto reduce pumpprogramming errors.	Similar
PumpingMechanism	The Novum IQ LVP is intended tobe used by trained healthcareprofessionals.	Same as subject device.	N/A
	Peristaltic design with activerestoration of administration settubing.	Peristaltic design.	Similar.Performance testsconfirm the activerestoration doesnot raise differentquestions of safetyand effectiveness.
Microprocessor	Multiple processors	Same as subject device.	N/A
User InterfaceDisplay	LCD display with adjustable backlitcapability.	Same as subject device.	N/A
Fluid IngressProtection	IPX2	Same as subject device.	N/A

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Characteristic	Subject Device – Novum IQ LVP	Predicate - SpectrumIQ Infusion System(K173084)	Discussion ofDifferences
AC Power	Input: 100-240VAC, 50/60 Hz / 500 mAOutput: 16 VDC/1.25 A, shortcircuit protected	Input: 100-240VAC,50/60 Hz / 300 mAOutput: 9VDC/1000mA, short circuitprotected	The differences inpower ratings donot raise differentquestions of safetyand effectiveness.
Battery	Smart Battery Pack-Lithium Ion (internal battery unit),10.8 VDC nominal-Maximum 16 hour recharge time at$23 \pm 2°$ C ( $73.4 \pm 3.6°$ F)-Battery capacity for a new fullycharged Smart Battery Pack, at themedium backlight setting andwireless enabled use is as follows:Flow Rate (mL/hr) Capacity (hrs) 25-125 ≥8 1200 ≥6 Charging occurs if the AC poweradapter is plugged in, whether thepump is on or off.			Lithium Ion (externalWireless BatteryModule)- 7.4 VDC nominalCapacity 5 hours (atintermediate rate (25ml/hr) at highestbacklight settings).Capacity 4 hours (at125 mL/hr at the defaultbacklight setting andwireless ON)Capacity 3.1 hours (at999 ml/hr with highestbacklight setting withwireless ON).16 hour recharge time$22.2 \pm 1.1°$ C ( $72 \pm 2 °$F)Charging occurs if ACPower Adaptor isplugged in, whetherpump is ON or OFF.	The pumps areable to operateindependent fromAC power duringtransport situationsor interruptions ofthe voltagesupply. Differencesdo not raisedifferent questionsof safety andeffectiveness.
Alarms	Per IEC 60601-1-8	Same as subject device.	N/A
LoggingCapability	Yes	Same as subject device.	N/A
InfusionDelivery Modes	Continuous (Primary andSecondary), Multi-Step, Bolus,Amount/Time (Primary andSecondary) and Volume/Time(Primary and Secondary)	Continuous (Primaryand Secondary), Multi-Step, Cyclic TPN,Bolus, Amount/Time(Primary/Secondary)and Volume/Time	SimilarCyclic TPN modenot needed as itcan beadministered usingMulti-Stepprogramming.

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Characteristic	Subject Device – Novum IQ LVP	Predicate - SpectrumIQ Infusion System(K173084)	Discussion ofDifferences
Flow Rate	0.5 to 1200 mL/hr with 0.1 mL/hrincrements from 0.1 to 99.9 mL/hrand 1.0 mL/hr increments from 100to 1200 mL/hr	0.5 to 999 mL/hr with0.1 mL/hr incrementsfrom 0.5 to 99.9 mL/hrand 1.0 mL/hrincrements from 100 to999 mL/hr	SimilarPerformance testsconfirm that theflow rate range forthe subject devicedoes not raisedifferent questionsof safety andeffectiveness.
Volumetric /Flow RateAccuracy understandardconditions	Accuracy depends on set materialunder standard conditions:For primary set material:0.5 - 0.9 ml/hr: +/-10%1 - 1200 ml/hr: +/-5%	Accuracy depends onset material.For primary setmaterial:0.5 - 1.9 ml/hr: +/-0.1ml/hr2- 999 ml/hr: +/-5%For other compatible setmaterials:5 - 999 ml/hr: +/-10%	SimilarDetailed flow rateaccuracy for allsets disclosed inlabeling
Drug LibraryCapacity	Number of Care Areas: 32Number of Drugs: 5000Number of Clinical Advisories: 800Number of Modifiers: 1000	Number of Care Areas:32Number of Drugs: 5000Number of ClinicalAdvisories: 400Number of Modifiers:500	Subject devicesupports increasedcapacity in theareas of ClinicalAdvisories andModifiers.
OperationalConditions	Operating temperature: 59 to 104°F(15 to 40° C), 10 to 80% relativehumidity non-condensing.	Operating temperature:60 to 90°F (15.6 to32.2° C), 20 to 90%relative humidity non-condensing.	Functional andperformance testssupport theoperationalconditions for thesubject device.
StorageConditions	Storage temperature: 14 to 120°F (-10 to 49°C), 10 to 80% relativehumidity non-condensing.	Storage temperature: 14to 120°F (-10 to 49°C),10 to 90% relativehumidity non-condensing.	Functional andperformance testssupport the storageconditions for thesubject device.
Characteristic	Subject Device – Novum IQ LVP	Predicate - SpectrumIQ Infusion System(K173084)	Discussion ofDifferences
Approximate Size (Pump)	4.1"h x 9.8"w x 6.7"d	7.4"h x 5.2"w x 3.3"d	Human Factorsstudies support thePhysicalDimensions andForm Factor forthe subject device.
Approximate Weight (Pump)	2.8 kg (5.5 lbs)	1.4 kg (3 lbs)	Human Factorsstudies support theWeight of thesubject device.
Auto-programming	Yes	Same as subject device.	N/A
Wireless	Yes	Same as subject device.	N/A
Administration Set Loading	Guided administration set loadingusing visual and audible promptswith automatic ejection of the slideclamp upon door closure.	Guided administrationset loading using visualand audible prompts,requiring removal ofslide clamp by userupon door closure.	The proposeddevice isautomating aprocess which wasmanual in thepredicate device bythe use of ahardware designchange.Functional testsand Human Factorsstudies support thatthis difference doesnot raise differentquestions of safetyand effectiveness.

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DISCUSSION OF NONCLINICAL TESTS:

Non-Clinical testing of the Novum IQ LVP has been performed against requirements for performance, physical attributes, environmental conditions and safety, and to provide objective evidence that the device's intended use is met.

As recommended by FDA guidance, "Infusion Pumps Total Product Life Cycle" issued December 2, 2014, Baxter has developed a Safety Assurance Case (SAC) to demonstrate that hazardous situations resulting from the design, intended use, and reasonably foreseeable misuse of the device have been appropriately mitigated.

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The stated goal of the safety assurance case is to document that the design of the Novum IQ LVP is adequately safe for its intended use. The assurance case defined the device system, including the indications for use, patient population, use environments, and system specifications. The supporting assurance arguments confirmed that:

. potential risks have been mitigated and the residual risk is acceptable,
design verification and validation of the device is acceptable,
device reliability is acceptable,
the device meets clinically valid essential performance. ●

Performance testing of the Novum IQ LVP was verified against requirements for performance, physical attributes, environmental conditions, safety, and to provide objective evidence that the device intended use is met.

. Verification and validation demonstrated that design inputs and user needs were met. Verification involves testing of both system and subsystem level requirements against pre-defined and approved protocols containing validated test methods and established acceptance criteria.
. Cleaning and Disinfection validation was performed according to FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2015.
. Wireless functionality was implemented according to FDA Guidance Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013.
. Software verification and validation was performed according to Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, issued May 11, 2005 and Infusion Pumps Total Life Cycle, issued December 2, 2014. The software is considered a major level of concern. Software testing included code review, static analysis, unit testing, integration testing, and regression testing.
. Cybersecurity verification and information was performed and provided according to FDA's Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 18, 2018, and FDA's draft Guidance Postmarket Management of Cybersecurity in Medical Devices, issued December 28th 2016.

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. Interoperability was assessed and tested in accordance with FDA's Guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Device, issued September 6, 2017.
Electrical safety, EMC and essential performance testing was successfully completed according to the following standards and associated methods:
. IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirement for Basic Safety and Essential Performance
. IEC 60601-2-24 Medical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
. IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
. IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems.
. AIM 7351731 rev 2: 2017, Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
. IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
. UL 2054 2nd Edition Household and Commercial Batteries
UL 1642 5th Edition Lithium Batteries

In addition to the above, and in consideration of IEC 62366-1 ed. 1.0 b:2007, 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. The human factors study was conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results demonstrated that the Novum IQ LVP is suitable for its intended use.

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DISCUSSION OF CLINICAL TESTS:

No clinical testing was performed in support of this premarket notification.

CONCLUSION:

The Novum IQ LVP has been verified and validated against design input requirements, user needs and intended uses. The subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).