(265 days)
Not Found
No
The summary describes software for managing infusion pump data, creating drug libraries based on defined best practices, and providing dashboards for viewing historical data. There is no mention of AI or ML being used for analysis, prediction, or decision-making. The software facilitates data management and reporting, but the clinical decisions and treatment pathways are explicitly stated to be the responsibility of trained healthcare professionals.
No
The device is a software suite that manages data for infusion pumps and does not directly provide therapy. It facilitates communication, data management, and drug library creation, but the actual infusion therapy is performed by compatible infusion pumps.
No
The device is a software suite designed to manage data for compatible infusion pumps, create drug libraries, and provide clinical dashboards/reports for quality improvement. It explicitly states it "does not create decisions or treatment pathways" and is not intended to be a substitute for "good clinical management practices," which means it does not diagnose medical conditions or issue diagnostic findings.
Yes
The device is described as a "collection of software products" and a "cloud-based platform provided as a software-as-a-service (SaaS)". While it interacts with compatible infusion pumps, the description explicitly states it "does not remotely control or program the infusion pump or provide the ability to remotely manage pump alarms". The verification and validation activities mentioned are focused on software verification, performance, reliability, compatibility tests, and systems integration tests with the compatible infusion pump, not on the hardware of the infusion pump itself.
Based on the provided information, the LifeShield™ Infusion Safety Software Suite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- LifeShield™ Functionality: The LifeShield™ Infusion Safety Software Suite is designed to manage data for infusion pumps, facilitate communication between systems, create and manage drug libraries, and provide clinical dashboards and reports related to infusion therapy.
- Lack of Specimen Examination: The software does not involve the examination of any specimens derived from the human body. Its function is centered around managing and presenting data related to the operation of infusion pumps and the therapies being delivered.
- Focus on Device Management and Data Presentation: The core functions described are related to device configuration (drug libraries), data collection from the pumps, and presenting that data for review and analysis by healthcare professionals.
- Explicit Statements: The description explicitly states that the Clinical Dashboards & Reports software "is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways." This further reinforces that it is not providing diagnostic information.
In summary, the LifeShield™ Infusion Safety Software Suite is a software platform for managing infusion pump data and related information, not for performing diagnostic tests on patient specimens.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PHC
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 user-defined 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 auto-programming 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonate
Intended User / Care Setting
Trained healthcare professionals, Pharmacists, Clinical administrators; Hospitals, facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hospira MedNet™ Medication Management Suite cleared under K141102
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| Lake Forest, IL. 60045 | |
| Phone number | 224-706-2229 |
| Fax number | N/A |
| Establishment Registration | |
| 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 | |
| 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 |
| LifeShield™ Infusion Safety Software Suite. | |
| 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 |
4
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.
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. |
|-----------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of Device/Indication | | 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
adults, pediatrics and neonates 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 |
| for use | | 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 information collected from compatible infusion pumps.
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. It is not intended to be a substitute for good clinical management
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 | |||
| 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 adults, pediatrics and neonates | |||
| 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 &
| The Hospira MedNet™ Medication
Management Suite (MMS) is intended to
facilitate networked communication
between MMS compatible computer
systems and Hospira Infusion pumps. The
MMS provides trained healthcare
professionals with the capability to send,
receive, report, and store information from
interfaced external systems, and to
configure and edit infusion programming
parameters.
The MMS is intended to provide a way to
automate the programming of infusion
parameters, thereby decreasing the amount
of manual steps necessary to enter infusion
data. All data entry and validation of
infusion parameters is performed by a
trained healthcare professional according to
physician's orders. | Similar
Subject device indications
statement includes clarifying
details on the device purpose.
This does not raise different
questions of safety and
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
capability to view and manage infusion
information collected from compatible
infusion pumps. 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. It is not intended to be a
substitute for good clinical management
practices, nor does its operation create
decisions or treatment pathways. | | |
| Prescription
Device | Yes | | Same |
| Stand-alone
software or
embedded
software | Stand-alone | | Same |
| Application Type | Web-based | Web-based for server software
PC-based Application (drug library) | Similar
This does not raise different
questions of safety and
effectiveness as users require
valid credentials to access and use
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
subject device to manage larger
datasets and maintain system
availability in support of the
device's intended use. This does
not raise different questions of
safety and effectiveness. |
| Compatible
Infusion Pump | Plum Duo (FRN, large volume infusion pump) | Plum 360: (FRN, large volume infusion
pump) | Similar
Both subject and predicate
devices support large volume
infusion pumps to provide drug
libraries, transmit auto-program
orders, and process infusion
information. This does not raise
different questions of safety and
effectiveness. |
| Drug library
Capacity | 40 Clinical Care Areas / 40,000 total rulesets | 40 Clinical Care Areas / 16,000 total rulesets | Similar
The subject device expands its
capacity to support larger
numbers of medication rulesets
within a single drug library. This
does not raise different questions
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
settings | Available with no settings | Similar
The subject device adds settings
for "no drug selected" rulesets to
provide an additional level of
protection when this option is
selected during programming.
This does not raise different
questions of safety and
effectiveness. |
| Drug Library List | Available with dashboard | Available with no dashboard | Similar
The addition of the dashboard in
the subject device provides a
convenient way for users to access
drug libraries in the system. This
does not raise different questions
of safety and effectiveness. |
| Drug Library
Report | Single printable report | Multiple printable reports | Similar
Consolidation of drug library data
in a single report by the subject
device does not raise different
questions of safety and
effectiveness. |
| 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 data
reporting | Single facility for drug library and data
reporting | Similar
The subject device enhances
predicate functionality by allowing
deployment of a drug library to
multiple facilities, as well as
processing infusion data from
multiple facilities. This does not
raise different questions of safety
and effectiveness. |
| Drug Library
Settings | General Pump Settings for Plum Duo™
Program Delivery Mode
CCA settings for Patient weight, height and
BSA
Concentration Type
Therapy-based medication limits
Non-Therapy based medication limits
Clinical Use and Clinical Advisory
High-Alert medication designation | General Pump Settings for Plum 360™
Program Delivery Mode
CCA settings for Patient weight, height and
BSA
Concentration Type
Therapy-based medication limits
Clinical Use | Similar
The subject device enhances
existing drug library settings by
aligning with configurable pump
features, adding additional limits,
clinical advisory, and a way for
users to flag medications that are
high-alert. This does not raise
different questions of safety and
effectiveness. |
| Therapy mode
Settings | Continuous, Bolus, Loading Dose, Multistep | Continuous | Similar
The subject device enhances the
drug library by supporting
additional 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 different
questions of safety and
effectiveness. |
| Medication Unit
Family | grams, mL, Units, mmol, mEq | | Same |
| Number of
medication units | 119 | 98 | Similar
The subject device adds
medication units to provide a
wider range of units that can be
selected when creating a drug
library. This does not raise
different questions of safety and
effectiveness. |
| Infusion and
Device Status
Display | | Near-real time | Same |
| Infusion Status
Information | Displays details of infusions active within 1 hr
with added information pertaining to the
infusion | Displays details of infusions active within 1
hr | Similar
The subject device provides
additional information associated
with the displayed ongoing
infusions. The added information
does not affect the purpose of the
near 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 of
safety and effectiveness. |
| Historical
Reports | Reports imported from external tool. Report
availability is configurable | Reports generated from built-in report
templates. Report availability not
configurable | Similar
The subject device allows
flexibility in what historical reports
are made available to the account
in accordance with the customer
needs. This does not raise
different questions of safety and
effectiveness. |
| Auto-
programming | Routes digitally-signed pharmacy-validated
orders from the HIS/EHR system to the pump | Routes pharmacy-validated orders from the
HIS/EHR system to the pump | Similar
The subject device improves this
feature by digitally signing the
auto program order to ensure
integrity of the order is
maintained when received by the
pump. The difference does not
affect the purpose of the auto-
programming feature. This does
not raise different questions of
safety and effectiveness. |
| Infusion
Documentation | Routes infusion data with added details on
wireless connectivity to the HIS/EHR system
to support documentation | Routes infusion data to the HIS/EHR system
to support documentation | Similar
The 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 the
infusion data that is sent to the
HIS/EHR. The added information
does not affect the purpose of the
infusion documentation feature.
This does not raise different
questions of safety and
effectiveness. |
| Asset
Management | Supports Drug Library Update
Supports Pump Software Update
Display of Device Status | | Same |
| User access | Requires login for system access (with
additional password requirements)
Requires Role-base access | Requires login for system access
Requires Role-base access | Similar
The subject device enhances
system security by requiring users
to use stronger passwords. This
does not raise different questions
of safety and effectiveness. |
| Multi-factor
Authentication | Yes | No | Different
The subject device provides an
additional layer of security to
access the device. This does not
raise different questions of safety
and effectiveness. |
| Summary of the technological characteristics of the device compared to the predicate device | | | |
| Characteristic | Subject Device | Predicate K141102 | Comparison |
| Digitally-signed
Drug Library | Yes | No | Different
The subject device employs digital
signing of drug libraries, ensuring
the integrity of the drug libraries
files. This does not raise different
questions of safety and
effectiveness. |
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Image /page/7/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in lowercase letters. Below the word "icumedical" are the words "human connections" in a smaller font size and a lighter shade of blue. The logo is simple and modern.
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Image /page/8/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 is the tagline "human connections" in a smaller font.
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Image /page/9/Picture/1 description: The image shows the logo for ICU Medical. The text "icumedical" is written in a sans-serif font, with "icu" in a bold, darker blue and "medical" in a lighter blue. Below the main text, in a smaller font, are the words "human connections".
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Image /page/10/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in lowercase letters. Below the word "icumedical" is the phrase "human connections" in a smaller font size.
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Image /page/11/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in lowercase letters. Below the word "icumedical" are the words "human connections" in a smaller font size.
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Image /page/12/Picture/1 description: The image shows the ICU Medical logo. The words "icu" are in bold blue font, while the word "medical" is in a lighter blue and thinner font. Below the logo, the words "human connections" are written in a smaller, light blue font.
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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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Image /page/14/Picture/1 description: The image shows the logo for ICU Medical. The word "icu" is in bold blue font, while "medical" is in a lighter blue and a thinner font. Below the logo is the phrase "human connections" in a smaller, light blue font.
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Image /page/15/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and consists of the words "icu medical" in a sans-serif font. Below the company name are the words "human connections" in a smaller, lighter blue font. The logo is simple and modern.
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.