Plum Duo™ Infusion System

K223607 · Icu Medical, Inc. · FRN · Aug 24, 2023 · General Hospital

Device Facts

• Record ID: K223607
• Device Name: Plum Duo™ Infusion System
• Applicant: Icu Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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. These 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 Story

Large volume infusion pump (LVP) with two independent channels; delivers fluids/medications via volumetric piston technology with plunger stepper motor. Inputs: user-programmed infusion parameters via 10-inch color touchscreen; compatible with PlumSet administration sets. Outputs: controlled fluid delivery; visual/audible alarms (occlusion, air-in-line, etc.). Used in hospitals/outpatient facilities by trained licensed healthcare professionals. Features: dual-channel, WiFi connectivity, lithium iron phosphate battery, drug library integration (LifeShield Infusion Safety Software). Enhances clinical workflow via piggyback flush automation, concurrent delivery, and shared patient parameters across channels. Benefits: precise medication administration, improved space/line management, and flexible therapy options (continuous, multistep, loading dose, bolus).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including flow rate/bolus accuracy (AAMI TIR101), alarm functionality, mechanical/electrical safety (IEC 60601 series), cybersecurity, and human factors validation.

Technological Characteristics

Large volume infusion pump; volumetric piston/plunger stepper motor; lithium iron phosphate battery; 10-inch WXGA color touchscreen; WiFi enabled. Materials: high-impact plastic. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software), IEC 62366-1 (usability), ISO 14971 (risk management).

Indications for Use

Indicated for parenteral fluid and medication delivery via intravenous, intra-arterial, or subcutaneous routes in adult, pediatric, and neonatal patients within hospital and outpatient healthcare settings.

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

• Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module (K161469)

Submission Summary (Full Text)

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

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
| |

|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 Drive<br>Lake Forest, IL. 60045 |
| Phone number | 224-706-2419 |
| Fax number | N/A |
| Establishment Registration<br>Number | 3013319212 |
| Name of contact person | Yuliya Matlin, MS., MBA<br>[e-mail] |
| 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) to<br>which 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 of<br>Devices: Plum Duo™ Infusion System |
| Device description | The Plum Duo™ Infusion System is the next generation of the Plum™ family of devices that is based on<br>the fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pump<br>design incorporates state-of-the-art features such as dual channel functionality, touch screen display,<br>and lithium iron phosphate battery technology. The pump uses the same volumetric piston type<br>technology with a plunger stepper motor to deliver fluids to a patient as the predicate Plum 360™<br>Infusion System.<br>Plum Duo™ Infusion System is a large volume pump (LVP) with two independent pump channels that<br>can deliver fluid to a patient on up to 4 lines and is designed so that it is possible to use one channel<br>only. In addition, although the channels can operate independently, patient parameters can be shared<br>across the channels to aid in the speed of programming. Each channel accepts a cassette that is part of a<br>PlumSet™ administration set and can connect to a primary and/or secondary container. |
| Intended Use of<br>Device/Indication for Use | The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically<br>acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies).<br>The Plum Duo Infusion System is intended for use in clinical environments in the hospital environment<br>and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare<br>professionals are trained in the use of the infusion pump and the administration of therapies<br>consistent with the intended use.<br>The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and<br>neonatal 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 with<br>MedNet™ / Smart Card Plug 'n' Play<br>Module | N/A |
| Type of Pump | Large Volume Infusion Pump | Large Volume Infusion Pump | Same |
| Intended<br>Use/Indications for<br>Use | The Plum Duo Infusion System is intended<br>for parenteral fluids and medications<br>through clinically acceptable routes (limited<br>to intravenous, intra-arterial, and<br>subcutaneous therapies).<br>The Plum Duo Infusion System is intended<br>for use in clinical environments in the<br>hospital environment and other outpatient<br>healthcare facilities by licensed healthcareprofessionals are trained in the use of the<br>infusion pump and the administration of<br>therapies consistent with the intended use.<br>The Plum Duo Infusion System is intended for<br>adult, pediatric (including infants and<br>children), and neonatal patient populations. | The Plum 360™ Infusion System with<br>MedNet™ / Smart Card Plug 'n' Play<br>Module is intended for use in<br>parenteral, enteral, and epidural<br>therapies and the administration of<br>whole blood and blood products. | Similar<br>Additional details are added to the intended use<br>statement of the subject device to clarify patient<br>populations and the meaning of parenteral routes of<br>administration. Both the predicate device and the<br>subject device are prescription devices. They are both<br>infusion pump systems indicated for use in parenteral<br>therapies. ICU Medical is removing the enteral and<br>epidural routes of administration as well as the<br>administration of whole blood and blood products from<br>the indications for use for the Plum Duo Infusion<br>System. The indications are limited to the subset of the<br>predicate device indications for use. |
| Patient Population | The Plum Duo Infusion System is intended<br>for adult, pediatric (including infants and<br>children), and neonatal patient populations. | Not Specified | No change in the intended patient population.<br>Additional details added to the statement to clarify<br>the patient population. |
| Environment of<br>Use | Hospital environments and other<br>outpatient healthcare facilities that<br>excludes hyperbaric or oxygen-rich<br>environments. Not for MRI environment.<br>The Plum Duo Infusion System is intended<br>for use in clinical environments in the<br>hospital environment and other<br>outpatient healthcare facilities by<br>licensed healthcare professionals. These<br>healthcare professionals are trained in | Hospital environments and other<br>outpatient healthcare facilities that<br>excludes hyperbaric or oxygen-rich<br>environments. Not for MRI<br>environment. The Plum Duo Infusion<br>System is intended for use in clinical<br>environments in the hospital<br>environment and other outpatient<br>healthcare facilities by licensed<br>healthcare professionals. These | Similar<br>The subject device is used in the same environment<br>(hospitals and other healthcare facilities). The<br>statement 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 the<br>administration of therapies consistent<br>with the intended use. | healthcare professionals are trained in<br>the use of the infusion pump and the<br>administration of therapies consistent<br>with the intended use. In addition, the<br>healthcare professionals are trained in<br>the administration of whole blood and<br>blood products. | |
| Route of<br>Administration | Parenteral, limited to intravenous,<br>subcutaneous, and intra-arterial. | Parenteral, enteral and epidural | Similar<br>The subject device routes of administration are a<br>subset of the predicate device routes of<br>administration and are consistent with the predicate. |
| Set Compatibility | Compatible with currently marketed Plum™ Administration Sets | | Same |
| ICU Medical Safety<br>Software/Drug<br>Library | Compatible with LifeShield™ Infusion<br>Safety Software Suite | Compatible with ICU Medical MedNet™<br>Safety Software | Similar<br>Both products are compatible with Infusion Safety<br>Software. |
| 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)<br>No Default Drug Library (DDL) | Custom Drug Library and Default Drug<br>Library | Similar<br>Removing the option of default drug library increases<br>compliance with the usage of the hospital created<br>drug library. |
| Delivery Methods/<br>Therapies | 1. Continuous<br>2. Multistep<br>3. Loading Dose (standalone or with<br>underlying continuous therapy)<br>4. Bolus (standalone or with underlying<br>continuous therapy) | 1. Continuous<br>2. Multistep<br>3. Loading Dose (with underlying<br>continuous therapy)<br>4. Bolus (with underlying continuous<br>therapy) | Similar<br>The ability to deliver a loading dose and/or bolus<br>without an underlying continuous therapy allows the<br>clinician additional flexibility in administering therapy. |
| Therapy Modes | 1. Piggyback (with flush feature)<br>2. Concurrent<br>3. Deliver alone (primary delivery only) | 1. Piggyback<br>2. Concurrent | Similar<br>The addition of the piggyback flush feature<br>automates the existing manual workflow and ensures<br>the patient receives the piggyback medication in its<br>entirety at the piggyback delivery rate for the<br>duration of the therapy.<br>The addition of deliver alone provides an additional<br>option for the medications that should not be<br>interrupted or delivered concurrently with another<br>medication or fluid. |
| Rate Ranges | 0.1 to 99.9 mL/hr (in 0.1 mL/hr increments)<br>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)<br>100 to 999 mL/hr (in 1 mL/hr increments) | 1.0 to 99.9 mL/hr (in 0.1 mL/hr increments)<br>100 to 999 mL/hr (in 1 mL/hr increments) | Similar<br>The extended range provides greater flexibility to the<br>clinician to tailor the therapy to meet the patient's<br>specific medical needs. |
| Summary of the technological characteristics of the device compared to the predicate device | | | |
| Characteristic | Subject Device (K223607) | Predicate (K161469) | Comparison |
| Flow Rate Delivery<br>Accuracy | • 0.1 - 0.9 mL/hr: +/- 5%,<br>• 1 - 999 mL/hr: +/- 5%<br>0 to 96 hours of cassette service | • 0.1 - 0.9 mL/hr: +/- 10%,<br>• 1 - 999 mL/hr: +/- 5%<br>0 to 48 hours of cassette service | Similar<br>Detailed flow rate accuracy disclosed in the labeling |
| WiFi | Yes | | Same |
| Pump Operation | Volumetric Piston Type | | Same |
| Number of<br>Channels | 2 Channels: Left and Right Channel. Each<br>channel has primary (Line 1) and<br>secondary (Line 2) | Single channel with primary (Line A) and<br>secondary (Line B) | Similar<br>The addition of the second channel enables the<br>clinician to infuse four therapies simultaneously on<br>one device. The ability to add additional infusion lines<br>on the same device allows more efficiency in space<br>management and ease of line management with<br>tracing to one device. |
| Sensors | Air Detection, Occlusion, Temperature,<br>Cassette Detection, Ambient light sensors | Air Detection, Occlusion, Cassette<br>Detection sensors | Similar<br>Additional sensor functionality optimizes system<br>performance. |
| Alarm Summary | Check cassette alarms, proximal (upstream) and distal (downstream) occlusion, door<br>open, air detection, callback, lockout, low battery, and internal system monitor<br>alarms. | | Same…