The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).

The Plum Duo Infusion System is intended for use in clinical environments in the hospital environment and other outpatient healthcare facilities by licensed healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and neonatal patient populations.

Device Description

The Plum Duo™ Infusion System is the next generation of the Plum™ family of devices that is based on the fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pump design incorporates state-of-the-art features such as dual channel functionality, touch screen display, and lithium iron phosphate battery technology. The pump uses the same volumetric piston type technology with a plunger stepper motor to deliver fluids to a patient as the predicate Plum 360™ Infusion System.
Plum Duo™ Infusion System is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient on up to 4 lines and is designed so that it is possible to use one channel only. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in the speed of programming. Each channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container.

AI/ML Overview

The provided document is a 510(k) Summary for the Plum Duo™ Infusion System, which is an infusion pump. It demonstrates substantial equivalence to a predicate device. This type of regulatory submission focuses on engineering and performance validation rather than clinical studies involving patient data or human interpretation of medical images.

Therefore, the document does not contain the information requested regarding acceptance criteria and study details for an AI/ML-enabled medical device that typically involves:

A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc., which are common for diagnostic or AI algorithms).
Sample size for a test set based on patient data provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication methods for test sets.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance.
Type of ground truth (pathology, outcomes data, expert consensus).
Sample size for the training set and how its ground truth was established.

This document describes a more traditional medical device submission, focusing on the mechanical, electrical, and software safety and performance of an infusion pump. The "Summary of Non-Clinical Testing" section lists various engineering tests (e.g., flow rate accuracy, air in line performance, alarm testing, electrical safety, reliability testing, human factors validation), which are typical for infusion pumps to ensure their safe and effective operation, but these do not align with the criteria for evaluating an AI/ML model for diagnostic or predictive purposes.

The statement "Clinical evaluation is not required for this submission to support substantial equivalence" further confirms that the type of studies and data provenance you are asking about (which often involve clinical data and human interpretation) were not part of this specific submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

August 24, 2023

ICU Medical, Inc. Yuliya Matlin Director, Global Regulatory Affairs 600 N. Field Drive Lake Forest, Illinois 60045

Re: K223607

Trade/Device Name: Plum Duo™ Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: July 27, 2023 Received: July 28, 2023

Dear Yuliya Matlin:

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: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K223607

Device Name Plum Duo™ Infusion System

Indications for Use (Describe)

The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).

The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and neonatal patient populations.

Type of Use ( Select one or both, as applicable )

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 880.5725 for Plum Duo™ Infusion System is provided below.

Submitter Information
Name	ICU Medical, Inc
Address	600 North Field DriveLake Forest, IL. 60045
Phone number	224-706-2419
Fax number	N/A
Establishment RegistrationNumber	3013319212
Name of contact person	Yuliya Matlin, MS., MBAyuliya.matlin@icumed.com
Date prepared	July 27, 2023
Name of device
Trade or proprietary name	Plum Duo™ Infusion System
Common or usual name	Infusion Pump
Classification	II
Classification Reason	21 CFR 880.5725
Panel	80
Product Code(s)	FRN
510(k) Number	K223607
Legally marketed device(s) towhich equivalence is claimed	Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module
Reason for 510(k) submission	The submission is the traditional pre-market notification for the next generation of the Plum family ofDevices: Plum Duo™ Infusion System
Device description	The Plum Duo™ Infusion System is the next generation of the Plum™ family of devices that is based onthe fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pumpdesign incorporates state-of-the-art features such as dual channel functionality, touch screen display,and lithium iron phosphate battery technology. The pump uses the same volumetric piston typetechnology with a plunger stepper motor to deliver fluids to a patient as the predicate Plum 360™Infusion System.Plum Duo™ Infusion System is a large volume pump (LVP) with two independent pump channels thatcan deliver fluid to a patient on up to 4 lines and is designed so that it is possible to use one channelonly. In addition, although the channels can operate independently, patient parameters can be sharedacross the channels to aid in the speed of programming. Each channel accepts a cassette that is part of aPlumSet™ administration set and can connect to a primary and/or secondary container.
Intended Use ofDevice/Indication for Use	The Plum Duo Infusion System is intended for parenteral fluids and medications through clinicallyacceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).The Plum Duo Infusion System is intended for use in clinical environments in the hospital environmentand other outpatient healthcare facilities by licensed healthcare professionals. These healthcareprofessionals are trained in the use of the infusion pump and the administration of therapiesconsistent with the intended use.The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), andneonatal patient populations.

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Image /page/4/Picture/0 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 word "medical" are the words "human connections" in a smaller, light gray font.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device (K223607)	Predicate (K161469)	Comparison
Device Name	Plum Duo™ Infusion System	Plum 360™ Infusion System withMedNet™ / Smart Card Plug 'n' PlayModule	N/A
Type of Pump	Large Volume Infusion Pump	Large Volume Infusion Pump	Same
IntendedUse/Indications forUse	The Plum Duo Infusion System is intendedfor parenteral fluids and medicationsthrough clinically acceptable routes (limitedto intravenous, intra-arterial, andsubcutaneous therapies).The Plum Duo Infusion System is intendedfor use in clinical environments in thehospital environment and other outpatienthealthcare facilities by licensed healthcareprofessionals are trained in the use of theinfusion pump and the administration oftherapies consistent with the intended use.The Plum Duo Infusion System is intended foradult, pediatric (including infants andchildren), and neonatal patient populations.	The Plum 360™ Infusion System withMedNet™ / Smart Card Plug 'n' PlayModule is intended for use inparenteral, enteral, and epiduraltherapies and the administration ofwhole blood and blood products.	SimilarAdditional details are added to the intended usestatement of the subject device to clarify patientpopulations and the meaning of parenteral routes ofadministration. Both the predicate device and thesubject device are prescription devices. They are bothinfusion pump systems indicated for use in parenteraltherapies. ICU Medical is removing the enteral andepidural routes of administration as well as theadministration of whole blood and blood products fromthe indications for use for the Plum Duo InfusionSystem. The indications are limited to the subset of thepredicate device indications for use.
Patient Population	The Plum Duo Infusion System is intendedfor adult, pediatric (including infants andchildren), and neonatal patient populations.	Not Specified	No change in the intended patient population.Additional details added to the statement to clarifythe patient population.
Environment ofUse	Hospital environments and otheroutpatient healthcare facilities thatexcludes hyperbaric or oxygen-richenvironments. Not for MRI environment.The Plum Duo Infusion System is intendedfor use in clinical environments in thehospital environment and otheroutpatient healthcare facilities bylicensed healthcare professionals. Thesehealthcare professionals are trained in	Hospital environments and otheroutpatient healthcare facilities thatexcludes hyperbaric or oxygen-richenvironments. Not for MRIenvironment. The Plum Duo InfusionSystem is intended for use in clinicalenvironments in the hospitalenvironment and other outpatienthealthcare facilities by licensedhealthcare professionals. These	SimilarThe subject device is used in the same environment(hospitals and other healthcare facilities). Thestatement has been aligned with the intended use.
Summary of the technological characteristics of the device compared to the predicate device			Human Connections
	the use of the infusion pump and theadministration of therapies consistentwith the intended use.	healthcare professionals are trained inthe use of the infusion pump and theadministration of therapies consistentwith the intended use. In addition, thehealthcare professionals are trained inthe administration of whole blood andblood products.
Route ofAdministration	Parenteral, limited to intravenous,subcutaneous, and intra-arterial.	Parenteral, enteral and epidural	SimilarThe subject device routes of administration are asubset of the predicate device routes ofadministration and are consistent with the predicate.
Set Compatibility	Compatible with currently marketed Plum™ Administration Sets		Same
ICU Medical SafetySoftware/DrugLibrary	Compatible with LifeShield™ InfusionSafety Software Suite	Compatible with ICU Medical MedNet™Safety Software	SimilarBoth products are compatible with Infusion SafetySoftware.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device (K223607)	Predicate (K161469)	Comparison
Drug Library	Custom Drug Library (CDL)No Default Drug Library (DDL)	Custom Drug Library and Default DrugLibrary	SimilarRemoving the option of default drug library increasescompliance with the usage of the hospital createddrug library.
Delivery Methods/Therapies	1. Continuous2. Multistep3. Loading Dose (standalone or withunderlying continuous therapy)4. Bolus (standalone or with underlyingcontinuous therapy)	1. Continuous2. Multistep3. Loading Dose (with underlyingcontinuous therapy)4. Bolus (with underlying continuoustherapy)	SimilarThe ability to deliver a loading dose and/or boluswithout an underlying continuous therapy allows theclinician additional flexibility in administering therapy.
Therapy Modes	1. Piggyback (with flush feature)2. Concurrent3. Deliver alone (primary delivery only)	1. Piggyback2. Concurrent	SimilarThe addition of the piggyback flush featureautomates the existing manual workflow and ensuresthe patient receives the piggyback medication in itsentirety at the piggyback delivery rate for theduration of the therapy.The addition of deliver alone provides an additionaloption for the medications that should not beinterrupted or delivered concurrently with anothermedication or fluid.
Rate Ranges	0.1 to 99.9 mL/hr (in 0.1 mL/hr increments)100 to 999 mL/hr (in 1 mL/hr increments)		Same
Bolus Rate Ranges	0.1 to 99.9 mL/hr (in 0.1 mL/hr increments)100 to 999 mL/hr (in 1 mL/hr increments)	1.0 to 99.9 mL/hr (in 0.1 mL/hr increments)100 to 999 mL/hr (in 1 mL/hr increments)	SimilarThe extended range provides greater flexibility to theclinician to tailor the therapy to meet the patient'sspecific medical needs.
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device (K223607)	Predicate (K161469)	Comparison
Flow Rate DeliveryAccuracy	• 0.1 - 0.9 mL/hr: +/- 5%,• 1 - 999 mL/hr: +/- 5%0 to 96 hours of cassette service	• 0.1 - 0.9 mL/hr: +/- 10%,• 1 - 999 mL/hr: +/- 5%0 to 48 hours of cassette service	SimilarDetailed flow rate accuracy disclosed in the labeling
WiFi	Yes		Same
Pump Operation	Volumetric Piston Type		Same
Number ofChannels	2 Channels: Left and Right Channel. Eachchannel has primary (Line 1) andsecondary (Line 2)	Single channel with primary (Line A) andsecondary (Line B)	SimilarThe addition of the second channel enables theclinician to infuse four therapies simultaneously onone device. The ability to add additional infusion lineson the same device allows more efficiency in spacemanagement and ease of line management withtracing to one device.
Sensors	Air Detection, Occlusion, Temperature,Cassette Detection, Ambient light sensors	Air Detection, Occlusion, CassetteDetection sensors	SimilarAdditional sensor functionality optimizes systemperformance.
Alarm Summary	Check cassette alarms, proximal (upstream) and distal (downstream) occlusion, dooropen, air detection, callback, lockout, low battery, and internal system monitoralarms.		Same
Clinical Advisories	Addition of the clinical advisoryfield/message on the pump interface	Not available	DifferentThis feature provides an additional field for thepharmacy to enter any applicable precautions orinstructions
Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Subject Device (K223607)	Predicate (K161469)	Comparison
OperatingEnvironment andStorageSpecifications	Operating Temperature 41°F to 104°F (5°C to 40°C)		SameDetails are located in the product labeling
	Storage Temperature: -4°F to 140°F (-20°C to 60°C);
	Atmospheric Pressure: 0 to 10,000 feet (0 to 3000 meters) or equivalent
	Relative Humidity: 10% to 90% (maximum dew point of 30°C)
PhysicalSpecifications	Dimensions: Approximately 9 H x 11.75W x 6.5 D inches (23 cm H x 30 cm W x 17cm D) (excluding pole clamp extrusionand power cord storage)	Dimensions: Approximately 8" H x 8" Wx 6" D (20 cm H x 20 cm W x 15 cm D),excluding pole clamp extrusionand power cord storage.	SimilarThe differences in physical dimensions do not impactergonomics or user experience.
	Mass: Approximately 10.6 lbs (4.8kilograms) with battery	Mass: Approximately 10 lbs. (4.5 kg)with battery
	Casing: High-impact plastic.	Casing: High-impact plastic.	Similar
Power Requirements	Off the Shelf (OTS) universal powersupply acceptable for 120v and 240vmains supply	ICU Medical design: Separate powersupplies for US (120v) and international(240v) configurations	SimilarUniversal power supply provides customerconvenience to use uniform power source.
Battery	Lithium Iron Phosphate Battery with batterymanagement electronics	Sealed Lead Acid Battery	DifferentUpdated battery technology to improve powerdensity, battery capacity reporting, and safetymonitoring reliability and life cycle for optimization ofperformance.
Display	10" color touchscreen display with WXGAresolution	Custom 4" QVGA Monochromatic display	DifferentFull color touchscreen display with increasedresolution enhances the user experience.

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Image /page/5/Picture/0 description: The image shows the logo for ICU Medical. The word "icu" is in a bold, blue font, while the word "medical" is in a lighter blue, thinner font. The logo is simple and modern.

human connections

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Image /page/6/Picture/0 description: The image shows the logo for ICU Medical. The word "icu" is in a bold, dark blue font, while the word "medical" is in a lighter blue font. Below the company name are the words "human connections" in a smaller, light blue font.

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Image /page/7/Picture/0 description: The image shows the logo for ICU Medical. The text "icu" is in bold blue font, while "medical" is in a lighter blue and a thinner font. Below the word "medical" is the phrase "human connections" in a smaller, lighter blue font.

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Image /page/8/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is written in a sans-serif font, with "icu" in a darker blue than "medical". Below the company name, the tagline "human connections" is written in a smaller, lighter font.

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Image /page/9/Picture/0 description: The image shows the logo for ICU Medical. The logo consists of the word "icumedical" in blue font, with the "icu" portion being a darker shade of blue. Below the word "icumedical" is the phrase "human connections" in a smaller, lighter blue font. The logo is simple and modern, with a focus on the company's name and its mission.

Summary of Non-Clinical Testing

To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed:

. Verification testing of product requirements
. Human factors validation testing of product requirements associated with critical tasks
Testing for the reliability goals of the device

The safety assurance case was provided for the Plum Duo™ Infusion System as recommended in the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014.

The safety assurance case is used to build a robust argument that the Plum Duo™ Infusion System Pump is safe for its intended use in its intended environment. The argument is made by mitigating the following three arguments wherein risk may be produced within the context of the device's intended use.

The assurance case defines the device system, including the operational description, system definition, indications for use, patient population, intended users and use environments. The supporting assurance arguments covered the following attributes:

. Plum Duo™ Infusion System hazards are adequately identified and addressed.
Plum Duo™ Infusion System design is adequately reliable.
Plum Duo™ Infusion System design requirements are adequate and are adequately verified and validated.

Verification and validation testing was completed in support of this premarket submission. The following table provides a summary of the testing:

Flow Rate Accuracy Testing
Flow Continuity
Flow Rate Accuracy (Primary and Secondary Delivery)
Backpressure Delivery
Concurrent Delivery
Multistep Delivery
Clinically Relevant Combination of Factors (non-standard operating conditions)
AAMI TIR 101 Testing
Start Up Delay Time and Flow Rate Accuracy
Loading Dose Volumetric Accuracy
Bolus Volumetric Accuracy
Flow Reduction due to Inline Resistance
Air In Line Performance Testing
Upstream Single Air Bolus
Downstream Single Air Bolus
Upstream Cumulative Air-In-Line
Downstream Cumulative Air-in-Line
Cassette Performance Testing
Free Flow Protection
Cassette loading and unloading
Backpriming
Cassette Integrity Check
Occlusion Performance Testing
Time to Detect Downstream Occlusion
Maximum Unintended Bolus after Occlusion resolved
Downstream Occlusion Auto Restart
Upstream/Downstream Occlusion
Alarms Testing
Functional, Audio, Visual, Software testing of system's alarms
Mechanical/Hardware Testing
Touchscreen Display Functionality
Door Functionality
Infuser Sound Levels
IV Pole Configuration and Stability
Physical Attributes (power cord, grip handle, pump dimensions/weight)
Pole Clamp Functionality
Fluid Ingress Testing
Environmental conditions testing
Operating Temperature
Storage Temperature
Atmospheric Pressure
Relative Humidity
Packaging
Shipping and Packaging
Shock and Vibration
Electrical Platform Testing
Electrical Design Analysis
Electrical Subsystem Functional
Electrical Subsystem Performance
Battery Testing
Battery System Design Analysis
Battery Functionality and Performance
Battery Run Time
Battery Certification
Material Compatibility (Cleaning and Disinfection Agents) Testing
Functional/ Cleaning and Disinfection
Validation of Reprocessing Instructions Testing
Functional/ Cleaning and Disinfection
Certifications
IEC 60601 Series Certification (IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 62304, IEC 62366-1)
CE Performance Testing
CE Subsystem Design Analysis
CE Functionality
FCC Certification
EMI / EMC Testing
Radiated and Conducted Emissions/ Immunity
Voltage Variation Immunity
Magnetic Field Immunity
Surge, ESD, RFID, Electrical Fast Transient (EFT) Immunity
Multiple Pump EMI and Wireless Coexistence Evaluation
Cybersecurity Testing
Software Verification and Validation: code inspection, unit testing, static analysis, black / grey box
testing, system integration testing
Reliability Testing
Cassette Loader Reliability
Battery Reliability
Pressure Sensor Reliability
Pole Clamp Reliability
Power Button Reliability
Display Reliability
Circuit Board Reliability
Power Supply Reliability
Haptics Reliability
Speaker Reliability
Battery Cell Storage Reliability
Backup Piezo Reliability
Mechanism Reliability
Preventive Maintenance Analysis
HALT (Highly Accelerated Life Test) Reliability
Free Fall Drop Abuse
Display Impact Reliability
AC Power Cord and Retainer Abuse
Thermal Margin Analysis
Software Reliability
Human Factors Validation Testing
Interoperability
Auto-programming and Auto-documentation

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Image /page/10/Picture/0 description: The image shows the logo for ICU Medical. The logo consists of the text "icumedical" in a blue sans-serif font. Below the word "icumedical" is the text "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.

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Image /page/11/Picture/0 description: The image shows the logo for ICU Medical. The word "icu" is in bold, blue font, while "medical" is in a lighter blue, thinner font. Below the word "medical" are the words "human connections" in a smaller, light blue font.

Design verification and validation testing confirmed the Plum Duo™ Infusion System met user needs, risk controls, and design inputs. Testing results conformed with acceptance criteria.
Flow rate and bolus accuracy testing were conducted by following AAMI TIR101.
Device reliability activities, testing and statistical analysis confirmed the Plum Duo™ Infusion System met its reliability goal at the system, device subsystem, and subsystem component level.
Software verification and validation were performed per FDA Guidance for the Content of

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Image /page/12/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is displayed in two lines, with "icu" in bold blue and "medical" in a lighter blue. Below the company name, the tagline "human connections" is written in a smaller, lighter blue font.

Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005, and Content of Premarket Submissions for Device Software Functions Draft Guidance for Industry and Food and Drug Administration Staff, issued November 4, 2021.

Human factors evaluations were conducted to validate the effectiveness of safety critical userelated features/functionality and use error-related mitigations in the associated use environments. IEC 62366-1 Medical Devices Part 1: Application of usability engineering to medical devices was followed.
Electrical and Electromagnetic Compatibility testing were conducted. The Plum Duo™ Infusion System complies with the following standards:
Electrical Safety per IEC 60601-1 and Electromagnetic Compatibility per IEC 60601-1-2. ●

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Image /page/13/Picture/0 description: The image shows the logo for ICU Medical. The word "icu" is in bold blue letters, and the word "medical" is in a lighter blue color. Below the company name is the phrase "human connections" in a smaller, lighter blue font.

Cybersecurity testing performed the system is effective in addressing cybersecurity threats. FDA Cybersecurity Guidance followed during development include Content of Premarket Submissions for Management of Cybersecurity, issued October 2, 2014 and Postmarket Management of Cybersecurity in Medical Devices, issued December 28, 2016.

Risk management activities have been incorporated into the design in accordance with ISO 14971:2019 and have been tested for correct implementation and effectiveness as part of design verification and validation

Clinical Testing

Clinical evaluation is not required for this submission to support substantial equivalence.

Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Plum Duo™ Infusion System is substantially equivalent to the Plum 360™ Infusion System with MedNet™ / Smart Card Plug 'n' Play Module cleared under K161469 with respect to the indications for use, target populations, treatment method, and technological characteristics.

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).