The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump).

The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices.

The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion collected from compatible infusion pumps. Healthcare professionals may choose to use the collected information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

Device Description

The LifeShield™ Infusion Safety Software Suite is a cloud-based platform provided as a software-as-a-service (SaaS) designed to be compatible with the Plum Duo™ infusion pump. The LifeShield Infusion Safety Software Suite is hosted by Amazon Web Services (AWS) as its cloud provider. LifeShield™ Infusion Safety Software Suite consists of a collection of software services which, when used together, provide a comprehensive set of data management capabilities for trained healthcare professionals when working with infusion pumps. LifeShield™ Infusion Safety Software Suite does not remotely control or program the infusion pump or provide the ability to remotely manage pump alarms such as real-time monitoring, clearing and silencing alarms.

The LifeShield™ Drug Library Management (DLM) software product is used by pharmacists to create approved drug libraries that can be downloaded by the infusion pumps. Drug libraries contain information on medications along with rulesets and associated clinical care areas (CCA) defined by pharmacists in accordance to their facility's best practices. Certain infusion pump parameters are also defined in the drug library. The LifeShield™ Device Manager (DM) and LifeShield™ Data Flow Management (DFM) are used to make the drug libraries available for the infusion pump to download and install. Download and installation of a drug library to the infusion pump establishes alert parameters for a medication that is being programmed for infusion. Additionally, the infusion pump applies the userdefined drug library settings for the configurable features of the pump.

The LifeShield™ Clinical Dashboards & Reports (CDR) software is used by clinical administrators to view infusion or device-related information received from the Plum Duo™ infusion pump via the LifeShield™ DFM. It provides a near real-time view of ongoing infusions and their status; a view of all infusion pumps with their asset information and operational status; dashboards that provides easy navigation of key infusion or asset metrics; and an analytics viewer that users can use to view historical infusion and/or asset information. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. The information presented by the software does not create decisions or treatment pathways for patients. LifeShield™ CDR is able to display infusion and infusion pump information from a single or multiple facilities within the customer account.

LifeShield™ Infusion Safety Software Suite can be configured to interface with a facility's Hospital Information System (HIS) / EHR system to support auto-programming and infusion documentation. When the autoprogramming feature license is enabled, the LifeShield™ Infusion Safety Software Suite can receive a pharmacy-validated order (also referred as auto-program order) from the HIS/EHR and route it to the infusion pump where the therapy program is pre-populated with physician-prescribed medication and infusion parameters, helping to reduce manual entry by the clinician when programming the pump. LifeShield™ Infusion Safety Software Suite does not modify the contents of the auto-program order received from the HIS/EHR.

When the infusion documentation feature license is enabled, the LifeShield™ Infusion Safety Software Suite forwards the infusion data it receives from the infusion pump to the HIS/EHR system to support the facility's documentation of infusion information and HIS/EHR dashboards. Infusion data includes infusion status (e.g. volume change) and events (e.g. infusion start, stop, complete). LifeShield™ Infusion Safety Software Suite does not modify the contents of the infusion data sent to the HIS/EHR.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the LifeShield™ Infusion Safety Software Suite based on the provided document:

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

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and device performance metrics in a direct table format. However, it implicitly states that the device met acceptance criteria through various tests.

Here's an interpreted table based on the non-clinical testing summary:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Design Requirements Met	Design verification tests passed established acceptance criteria, confirming the subject device meets design requirements.
Software Verification	Software verification followed the software development process outlined in IEC 62304:2015.
Performance, Reliability, Compatibility	Verification activities also included performance, reliability, compatibility tests, and systems integration tests with the compatible infusion pump, which were passed.
System Integration	Systems integration tests with the compatible infusion pump were passed.
Cybersecurity	Cybersecurity evaluation and testing demonstrate that the software is reasonably secure.
User Needs Met (Design Validation)	Design validation tests passed established acceptance criteria, confirming the subject device meets all intended users' needs.
Risk Management	Risk mitigations have been incorporated into the design and have been tested for correct implementation and effectiveness as part of design verification and validation.
User Interface Effectiveness (Human Factors)	Human Factors studies demonstrate the effectiveness of the user interface design for key features and their associated critical tasks.

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

The document does not specify the sample size used for any of the test sets (design verification, design validation, cybersecurity, human factors). It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their specific qualifications for establishing ground truth for any of the tests. It refers to "trained healthcare professionals" for the intended use and "pharmacists" for drug library creation but does not detail their involvement in formal ground truth establishment for testing.

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

The document does not describe any adjudication method used for establishing ground truth or evaluating test results.

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:

The document states, "A Clinical Study is not required for this submission to support substantial equivalence." Therefore, no MRMC comparative effectiveness study was done, and there is no information on human reader improvement with or without AI assistance. This device is a software suite for managing infusion pump data, not an AI-powered diagnostic or assistive tool for human interpretation.

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

The device is described as a "software-as-a-service (SaaS)" that facilitates data management and communication for infusion pumps. It explicitly states that "All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional." While portions of the software may operate automatically (e.g., routing data), the core functionality involves human interaction and oversight. Therefore, a purely standalone algorithm-only performance study as typically understood for AI algorithms would not be applicable or detailed here. The "non-clinical testing" and "design verification" cover its functional performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of "ground truth" used for its internal verification and validation studies. Given the nature of the device (infusion safety software), the "ground truth" would likely involve:

Design requirements and specifications: For design verification, the software's output and functionality are compared against its documented requirements.
User needs: For design validation, the software's ability to meet the needs of trained healthcare professionals (pharmacists, clinical administrators) for tasks like drug library management, data viewing, and auto-programming would be assessed.
Industry standards: Adherence to standards like IEC 62304 for software and ISO 14971 for risk management implies these standards served as a form of "ground truth" for compliance.

8. The sample size for the training set:

As this is not an AI/ML device that requires a training set in the conventional sense, the document does not mention a training set or its sample size. The software development process aligns with IEC 62304, focusing on verification and validation of designed functionality.

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

Not applicable, as there is no mention of a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

August 24, 2023

ICU Medical, Inc. Pernell Abrantes Senior Manager, Global Regulatory Affairs 600 N. Field Drive Lake Forest, Illinois 60045

Re: K223606

Trade/Device Name: LifeShield™ Infusion Safety Software Suite Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PHC Dated: July 24, 2023 Received: July 28, 2023

Dear Pernell Abrantes:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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).

Sincerely,

Juliane C. Lessard -S

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

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Indications for Use

510(k) Number (if known)

Device Name

LifeShield Infusion Safety Software Suite

Indications for Use (Describe)

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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Image /page/3/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and consists of the word "icumedical" in a sans-serif font. Below the word "icumedical" are the words "human connections" in a smaller, lighter blue font. The logo is simple and modern, and the use of blue gives it a clean and professional look.

Section 5: 510(k) Summary

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 880.5725 for LifeShield™ Infusion Safety Software Suite.

Submitter Information
Name	ICU Medical, Inc.
Address	600 North Field DriveLake Forest, IL. 60045
Phone number	224-706-2229
Fax number	N/A
Establishment RegistrationNumber	3013319212
Name of contact person	Pernell Abrantes
Date prepared	November 11, 2022
Name of device
Trade or proprietary name	LifeShield™ Infusion Safety Software Suite
Common or usual name	Infusion Safety Management Software
Classification	Class II
Classification Reason	21 CFR 880.5725
Panel	General Hospital
Product Code(s)	PHC
Legally marketed device(s) towhich equivalence is claimed	Hospira MedNet™ Medication Management Suite cleared under K141102
Reason for 510(k) submission	The submission is a traditional pre-market notification for a new deviceLifeShield™ Infusion Safety Software Suite.
Device description	The LifeShield™ Infusion Safety Software Suite is a cloud-based platformprovided as a software-as-a-service (SaaS) designed to be compatible withthe Plum Duo™ infusion pump. The LifeShield Infusion Safety SoftwareSuite is hosted by Amazon Web Services (AWS) as its cloud provider.LifeShield™ Infusion Safety Software Suite consists of a collection ofsoftware services which, when used together, provide a comprehensive setof data management capabilities for trained healthcare professionals whenworking with infusion pumps. LifeShield™ Infusion Safety Software Suitedoes not remotely control or program the infusion pump or provide the

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ability to remotely manage pump alarms such as real-time monitoring, clearing and silencing alarms.

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Image /page/5/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and consists of the text "icu medical" in a sans-serif font. Below the text is the phrase "human connections" in a smaller, lighter blue font. The logo is simple and modern.

		facility's documentation of infusion information and HIS/EHR dashboards.Infusion data includes infusion status (e.g. volume change) and events (e.g.infusion start, stop, complete). LifeShield™ Infusion Safety Software Suitedoes not modify the contents of the infusion data sent to the HIS/EHR.
Intended Use of Device/Indication		The LifeShield™ Infusion Safety Software Suite is a collection of softwareproducts that facilitates networked communication between compatiblesystems. The Infusion Safety Software Suite provides trained healthcareprofessionals the ability to manage data for compatible infusion pumps. Alldata entry and validation of infusion parameters on compatible infusionpumps is performed by a trained healthcare professional. LifeShield™Infusion Safety Software Suite is indicated for use in patients includingadults, pediatrics and neonates undergoing infusion therapy withconnected compatible infusion pumps (as per the indications for usespecified for the compatible infusion pump).The LifeShield™ Drug Library Management (DLM) software product isintended to be used by pharmacists to create, configure, edit, and manage
for use		drug library data, including infusion pump settings, for use with compatibleinfusion pumps. Drug library contents are constructed based on thehealthcare provider's defined best practices.
		The LifeShield™ Clinical Dashboards & Reports (CDR) software productprovides trained healthcare professionals with the capability to view andmanage infusion information collected from compatible infusion pumps.Healthcare professionals may choose to use the collected infusioninformation to support continuous quality improvement programs, or toanalyze and trend various aspects of the infusion pumps and therapiesused. It is not intended to be a substitute for good clinical managementpractices, nor does its operation create decisions or treatment pathways.

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Image /page/6/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in a sans-serif font. Below the word "icumedical" are the words "human connections" in a smaller, lighter blue font. The logo is simple and modern.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
Indications forUse	The LifeShield™ Infusion Safety SoftwareSuite is a collection of software products thatfacilitates networked communicationbetween compatible systems. The InfusionSafety Software Suite provides' trainedhealthcare professionals the ability tomanage data for compatible infusion pumps.All data entry and validation of infusionparameters on compatible infusion pumps isperformed by a trained healthcareprofessional. LifeShield™ Infusion SafetySoftware Suite is indicated for use in patientsincluding adults, pediatrics and neonatesundergoing infusion therapy with connectedcompatible infusion pumps (as per theindications for use specified for thecompatible infusion pump).The LifeShield™ Drug Library Management(DLM) software product is intended to beused by pharmacists to create, configure,edit, and manage drug library data, includinginfusion pump settings, for use withcompatible infusion pumps. Drug librarycontents are constructed based on thehealthcare provider's defined best practices.The LifeShield™ Clinical Dashboards &	The Hospira MedNet™ MedicationManagement Suite (MMS) is intended tofacilitate networked communicationbetween MMS compatible computersystems and Hospira Infusion pumps. TheMMS provides trained healthcareprofessionals with the capability to send,receive, report, and store information frominterfaced external systems, and toconfigure and edit infusion programmingparameters.The MMS is intended to provide a way toautomate the programming of infusionparameters, thereby decreasing the amountof manual steps necessary to enter infusiondata. All data entry and validation ofinfusion parameters is performed by atrained healthcare professional according tophysician's orders.	SimilarSubject device indicationsstatement includes clarifyingdetails on the device purpose.This does not raise differentquestions of safety andeffectiveness.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
	trained healthcare professionals with thecapability to view and manage infusioninformation collected from compatibleinfusion pumps. Healthcare professionalsmay choose to use the collected infusioninformation to support continuous qualityimprovement programs, or to analyze andtrend various aspects of the infusion pumpsand therapies used. It is not intended to be asubstitute for good clinical managementpractices, nor does its operation createdecisions or treatment pathways.
PrescriptionDevice	Yes		Same
Stand-alonesoftware orembeddedsoftware	Stand-alone		Same
Application Type	Web-based	Web-based for server softwarePC-based Application (drug library)	SimilarThis does not raise differentquestions of safety andeffectiveness as users requirevalid credentials to access and usethe devices.
Database	Amazon Web Services Cloud	Local Server	Different
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
provider			The use of the cloud allows thesubject device to manage largerdatasets and maintain systemavailability in support of thedevice's intended use. This doesnot raise different questions ofsafety and effectiveness.
CompatibleInfusion Pump	Plum Duo (FRN, large volume infusion pump)	Plum 360: (FRN, large volume infusionpump)	SimilarBoth subject and predicatedevices support large volumeinfusion pumps to provide druglibraries, transmit auto-programorders, and process infusioninformation. This does not raisedifferent questions of safety andeffectiveness.
Drug libraryCapacity	40 Clinical Care Areas / 40,000 total rulesets	40 Clinical Care Areas / 16,000 total rulesets	SimilarThe subject device expands itscapacity to support largernumbers of medication rulesetswithin a single drug library. Thisdoes not raise different questionsof safety and effectiveness.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
No Drug Selected	Available with program and delivery modesettings	Available with no settings	SimilarThe subject device adds settingsfor "no drug selected" rulesets toprovide an additional level ofprotection when this option isselected during programming.This does not raise differentquestions of safety andeffectiveness.
Drug Library List	Available with dashboard	Available with no dashboard	SimilarThe addition of the dashboard inthe subject device provides aconvenient way for users to accessdrug libraries in the system. Thisdoes not raise different questionsof safety and effectiveness.
Drug LibraryReport	Single printable report	Multiple printable reports	SimilarConsolidation of drug library datain a single report by the subjectdevice does not raise differentquestions of safety andeffectiveness.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
Facility support	Multiple facilities for drug library and datareporting	Single facility for drug library and datareporting	SimilarThe subject device enhancespredicate functionality by allowingdeployment of a drug library tomultiple facilities, as well asprocessing infusion data frommultiple facilities. This does notraise different questions of safetyand effectiveness.
Drug LibrarySettings	General Pump Settings for Plum Duo™Program Delivery ModeCCA settings for Patient weight, height andBSAConcentration TypeTherapy-based medication limitsNon-Therapy based medication limitsClinical Use and Clinical AdvisoryHigh-Alert medication designation	General Pump Settings for Plum 360™Program Delivery ModeCCA settings for Patient weight, height andBSAConcentration TypeTherapy-based medication limitsClinical Use	SimilarThe subject device enhancesexisting drug library settings byaligning with configurable pumpfeatures, adding additional limits,clinical advisory, and a way forusers to flag medications that arehigh-alert. This does not raisedifferent questions of safety andeffectiveness.
Therapy modeSettings	Continuous, Bolus, Loading Dose, Multistep	Continuous	SimilarThe subject device enhances thedrug library by supportingadditional therapy mode settings,allowing users to provide
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
			additional rules for those modes.This does not raise differentquestions of safety andeffectiveness.
Medication UnitFamily	grams, mL, Units, mmol, mEq		Same
Number ofmedication units	119	98	SimilarThe subject device addsmedication units to provide awider range of units that can beselected when creating a druglibrary. This does not raisedifferent questions of safety andeffectiveness.
Infusion andDevice StatusDisplay		Near-real time	Same
Infusion StatusInformation	Displays details of infusions active within 1 hrwith added information pertaining to theinfusion	Displays details of infusions active within 1hr	SimilarThe subject device providesadditional information associatedwith the displayed ongoinginfusions. The added informationdoes not affect the purpose of thenear real-time display. This does
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
			not raise different questions ofsafety and effectiveness.
HistoricalReports	Reports imported from external tool. Reportavailability is configurable	Reports generated from built-in reporttemplates. Report availability notconfigurable	SimilarThe subject device allowsflexibility in what historical reportsare made available to the accountin accordance with the customerneeds. This does not raisedifferent questions of safety andeffectiveness.
Auto-programming	Routes digitally-signed pharmacy-validatedorders from the HIS/EHR system to the pump	Routes pharmacy-validated orders from theHIS/EHR system to the pump	SimilarThe subject device improves thisfeature by digitally signing theauto program order to ensureintegrity of the order ismaintained when received by thepump. The difference does notaffect the purpose of the auto-programming feature. This doesnot raise different questions ofsafety and effectiveness.
InfusionDocumentation	Routes infusion data with added details onwireless connectivity to the HIS/EHR systemto support documentation	Routes infusion data to the HIS/EHR systemto support documentation	SimilarThe subject device provides
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
			additional information in theinfusion data that is sent to theHIS/EHR. The added informationdoes not affect the purpose of theinfusion documentation feature.This does not raise differentquestions of safety andeffectiveness.
AssetManagement	Supports Drug Library UpdateSupports Pump Software UpdateDisplay of Device Status		Same
User access	Requires login for system access (withadditional password requirements)Requires Role-base access	Requires login for system accessRequires Role-base access	SimilarThe subject device enhancessystem security by requiring usersto use stronger passwords. Thisdoes not raise different questionsof safety and effectiveness.
Multi-factorAuthentication	Yes	No	DifferentThe subject device provides anadditional layer of security toaccess the device. This does notraise different questions of safetyand effectiveness.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device	Predicate K141102	Comparison
Digitally-signedDrug Library	Yes	No	DifferentThe subject device employs digitalsigning of drug libraries, ensuringthe integrity of the drug librariesfiles. This does not raise differentquestions of safety andeffectiveness.

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Image /page/13/Picture/1 description: The image shows the ICU Medical logo. The words "icu medical" are written in a sans-serif font, with "icu" in a darker blue than "medical". Below the company name, the words "human connections" are written in a smaller, lighter blue font. The logo is simple and modern.

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Summary of Non-Clinical Testing

Non-clinical verification of LifeShield™ Infusion Safety Software Suite has been conducted to evaluate the safety, performance and functionality. The results of these tests have demonstrated the overall safety and effectiveness of the subject device, supporting a substantial equivalence determination of LifeShield Infusion Safety Software Suite to the predicate device Hospira MedNet™ Medication Management Suite. A summary of the testing conducted is presented below.

Design verification tests passed established acceptance criteria, confirming the subject device meets design requirements. Verification activities also included software verification, performance, reliability, compatibility tests, and systems integration tests with the compatible infusion pump. Software verification followed the software development process outlined in IEC 62304:2015.
Cybersecurity evaluation and testing demonstrate that the software is reasonably secure.
Design validation tests passed established acceptance criteria, confirming the subject device meets all intended users' needs.
Risk management activities are performed in accordance to ISO 14971:2019, and risk mitigations have been incorporated into the design and have been tested for correct implementation and effectiveness as part of design verification and validation.
. Human Factors studies demonstrate the effectiveness of the user interface design for key features and their associated critical tasks. Human Factors studies were conducted in accordance to IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018.

Summary of Clinical Testing

Not applicable. A Clinical Study is not required for this submission to support substantial equivalence.

Conclusion

The LifeShield™ Infusion Safety Software Suite is as safe and effective for its intended use as the currently marketed predicate device Hospira MedNet™ Management Suite. Verification, validation, cybersecurity and human factors testing conducted demonstrate that LifeShield™ Infusion Safety Software Suite meet all acceptance criteria requirements, and confirm that no different questions and safety and effectiveness are raised. Therefore, the subject device – LifeShield™ Infusion Safety Software Suite is substantially equivalent to the currently marketed predicate device – Hospira MedNet™ Medication Management Suite.

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).