LifeShield™ Infusion Safety Software Suite

K223606 · Icu Medical, Inc. · PHC · Aug 24, 2023 · General Hospital

Device Facts

• Record ID: K223606
• Device Name: LifeShield™ Infusion Safety Software Suite
• Applicant: Icu Medical, Inc.
• Product Code: PHC · General Hospital
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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 Story

Cloud-based SaaS platform (AWS-hosted) for infusion pump data management; interfaces with Plum Duo infusion pumps and hospital HIS/EHR systems. Components: Drug Library Management (DLM) for pharmacist configuration of drug libraries/rulesets; Device Manager/Data Flow Management for library deployment; Clinical Dashboards & Reports (CDR) for near real-time monitoring of infusion status, asset tracking, and historical analytics. Supports auto-programming (receiving pharmacy-validated orders from EHR) and infusion documentation (forwarding pump data to EHR). Operated by pharmacists and clinical administrators; does not remotely control pumps or manage alarms. Enhances clinical safety via digital signatures for drug libraries, multi-factor authentication, and expanded ruleset capacity. Output used by clinicians for quality improvement and trend analysis; does not create treatment pathways.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including design verification, software verification (IEC 62304:2015), cybersecurity evaluation, risk management (ISO 14971:2019), and human factors studies (IEC 62366-1:2015, ANSI/AAMI HE75).

Technological Characteristics

Cloud-based SaaS platform hosted on AWS. Stand-alone software. Connectivity: Networked interface with infusion pumps and HIS/EHR. Features: Digital signing of drug libraries, multi-factor authentication, role-based access control. Supports 40 clinical care areas and 40,000 rulesets. Software development follows IEC 62304:2015.

Indications for Use

Indicated for adult, pediatric, and neonate patients undergoing infusion therapy with connected compatible infusion pumps.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Hospira MedNet™ Medication Management Suite (K141102)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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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 Drive<br>Lake Forest, IL. 60045 |
| Phone number | 224-706-2229 |
| Fax number | N/A |
| Establishment Registration<br>Number | 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) to<br>which 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 device<br>LifeShield™ Infusion Safety Software Suite. |
| Device description | The LifeShield™ Infusion Safety Software Suite is a cloud-based platform<br>provided as a software-as-a-service (SaaS) designed to be compatible with<br>the Plum Duo™ infusion pump. The LifeShield Infusion Safety Software<br>Suite is hosted by Amazon Web Services (AWS) as its cloud provider.<br>LifeShield™ Infusion Safety Software Suite consists of a collection of<br>software services which, when used together, provide a comprehensive set<br>of data management capabilities for trained healthcare professionals when<br>working with infusion pumps. LifeShield™ Infusion Safety Software Suite<br>does not remotely control or program the infusion pump or provide the |

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Image /page/4/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the text "icu medical" in a sans-serif font. Below the text "icu medical" is the text "human connections" in a smaller, lighter font. The logo is simple and modern.

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

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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.<br>Infusion data includes infusion status (e.g. volume change) and events (e.g.<br>infusion start, stop, complete). LifeShield™ Infusion Safety Software Suite<br>does 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 software<br>products that facilitates networked communication between compatible<br>systems. The Infusion Safety Software Suite provides trained healthcare<br>professionals the ability to manage data for compatible infusion pumps. All<br>data entry and validation of infusion parameters on compatible infusion<br>pumps is performed by a trained healthcare professional. LifeShield™<br>Infusion Safety Software Suite is indicated for use in patients including<br>adults, pediatrics and neonates undergoing infusion therapy with<br>connected compatible infusion pumps (as per the indications for use<br>specified for the compatible infusion pump).<br>The LifeShield™ Drug Library Management (DLM) software product is<br>intended to be used by pharmacists to create, configure, edit, and manage |
| for use | | drug library data, including infusion pump settings, for use with compatible<br>infusion pumps. Drug library contents are constructed based on the<br>healthcare provider's defined best practices. |
| | | The LifeShield™ Clinical Dashboards & Reports (CDR) software product<br>provides trained healthcare professionals with the capability to view and<br>manage infusion information collected from compatible infusion pumps.<br>Healthcare professionals may choose to use the collected infusion<br>information to support continuous quality improvement programs, or to<br>analyze and trend various aspects of the infusion pumps and therapies<br>used. It is not intended to be a substitute for good clinical management<br>practices, 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 for<br>Use | The LifeShield™ Infusion Safety Software<br>Suite is a collection of software products that<br>facilitates networked communication<br>between compatible systems. The Infusion<br>Safety Software Suite provides' trained<br>healthcare professionals the ability to<br>manage data for compatible infusion pumps.<br>All data entry and validation of infusion<br>parameters on compatible infusion pumps is<br>performed by a trained healthcare<br>professional. LifeShield™ Infusion Safety<br>Software Suite is indicated for use in patients<br>including adults, pediatrics and neonates<br>undergoing infusion therapy with connected<br>compatible infusion pumps (as per the<br>indications for use specified for the<br>compatible infusion pump).<br><br>The LifeShield™ Drug Library Management<br>(DLM) software product is intended to be<br>used by pharmacists to create, configure,<br>edit, and manage drug library data, including<br>infusion pump settings, for use with<br>compatible infusion pumps. Drug library<br>contents are constructed based on the<br>healthcare provider's defined best practices.<br><br>The LifeShield™ Clinical Dashboards &<br> | The Hospira MedNet™ Medication<br>Management Suite (MMS) is intended to<br>facilitate networked communication<br>between MMS compatible computer<br>systems and Hospira Infusion pumps. The<br>MMS provides trained healthcare<br>professionals with the capability to send,<br>receive, report, and store information from<br>interfaced external systems, and to<br>configure and edit infusion programming<br>parameters.<br><br>The MMS is intended to provide a way to<br>automate the programming of infusion<br>parameters, thereby decreasing the amount<br>of manual steps necessary to enter infusion<br>data. All data entry and validation of<br>infusion parameters is performed by a<br>trained healthcare professional according to<br>physician's orders. | Similar<br><br>Subject device indications<br>statement includes clarifying<br>details on the device purpose.<br>This does not raise different<br>questions of safety and<br>effectiveness. |
| Summary of the technological characteristics of the device compared to the predicate device | | | |
| Characteristic | Subject Device | Predicate K141102 | Comparison |
| | trained healthcare professionals with the<br>capability to view and manage infusion<br>information collected from compatible<br>infusion pumps. Healthcare professionals<br>may choose to use the collected infusion<br>information to support continuous quality<br>improvement programs, or to analyze and<br>trend various aspects of the infusion pumps<br>and therapies used. It is not intended to be a<br>substitute for good clinical management<br>practices, nor does its operation create<br>decisions or treatment pathways. | | |
| Prescription<br>Device | Yes | | Same |
| Stand-alone<br>software or<br>embedded<br>software | Stand-alone | | Same |
| Application Type | Web-based | Web-based for server software<br>PC-based Application (drug library) | Similar<br>This does not raise different<br>questions of safety and<br>effectiveness as users require<br>valid credentials to access and use<br>the 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 the<br>subject device to manage larger<br>datasets and maintain system<br>availability in support of the<br>device's intended use. This does<br>not raise different questions of<br>safety and effectiveness. |
| Compatible<br>Infusion Pump | Plum Duo (FRN, large volume infusion pump) | Plum 360: (FRN, large volume infusion<br>pump) | Similar<br>Both subject and predicate<br>devices support large volume<br>infusion pumps to provide drug<br>libraries, transmit auto-program<br>orders, and process infusion<br>information. This does not raise<br>different questions of safety and<br>effectiveness. |
| Drug library<br>Capacity | 40 Clinical Care Areas / 40,000 total rulesets | 40 Clinical Care Areas / 16,000 total rulesets | Similar<br>The subject device expands its<br>capacity to support larger<br>numbers of medication rulesets<br>within a single drug library. This<br>does not raise different questions<br>of 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 mode<br>settings | Available with no settings | Similar<br>The subject device adds settings<br>for "no drug selected" rulesets to<br>provide an additional level of<br>protection when this option is<br>selected during programming.<br>This does not raise different<br>questions of safety and<br>effectiveness. |
| Drug Library List | Available with dashboard | Available with no dashboard | Similar<br>The addition of the dashboard in<br>the subject device provides a<br>convenient way for users to access<br>drug libraries in the system. This<br>does not raise different questions<br>of safety and effectiveness. |
| Drug Library<br>Report | Single printable report | Multiple printable reports…