(265 days)
Not Found
No
The document describes a standard infusion pump with dual channels and updated hardware features, but makes no mention of AI or ML capabilities.
Yes
The device is an infusion system that delivers parenteral fluids and medications, which are therapeutic interventions.
No
The device description clearly states its purpose is for "parenteral fluids and medications" and acts as a "large volume pump (LVP)". There is no mention of it being used to diagnose conditions, analyze data for diagnostic purposes, or provide information about a patient's health status.
No
The device description explicitly details hardware components like a touch screen display, lithium iron phosphate battery, volumetric piston type technology, plunger stepper motor, and dual pump channels that accept cassettes. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Plum Duo Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for delivering parenteral fluids and medications to patients through clinically acceptable routes (intravenous, intra-arterial, and subcutaneous). This is a direct therapeutic intervention on a living patient.
- Device Description: The description details a pump that delivers fluids to a patient using volumetric piston technology. This is a mechanical device for administering substances, not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The Plum Duo Infusion System is a medical device used for administering treatment directly to a patient.
N/A
Intended Use / Indications for 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 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.
Product codes
FRN
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.
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 (including infants and children), and neonatal patient populations.
Intended User / Care Setting
licensed healthcare professionals; clinical environments in the hospital environment and other outpatient healthcare 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
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 as recommended in the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014. 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 summarized in a table, including:
- Flow Rate Accuracy Testing (Primary and Secondary Delivery, Backpressure Delivery, Concurrent Delivery, Multistep Delivery, Clinically Relevant Combination of Factors, 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)
Key Results:
- 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 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 user-related 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.
- 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 evaluation is not required for this submission to support substantial equivalence.
Key Metrics
Flow Rate Delivery Accuracy:
- 0.1 - 0.9 mL/hr: +/- 5%
- 1 - 999 mL/hr: +/- 5%
0 to 96 hours of cassette service
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
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: 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
2
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 ( Select one or both, as applicable ) |
|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| Lake Forest, IL. 60045 | |
| Phone number | 224-706-2419 |
| Fax number | N/A |
| Establishment Registration | |
| Number | 3013319212 |
| Name of contact person | Yuliya Matlin, MS., MBA |
| yuliya.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) to | |
| 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 |
| 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 |
| 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. | |
| Intended Use of | |
| Device/Indication for 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. |
4
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 | |
| MedNet™ / Smart Card Plug 'n' Play | |||
| Module | N/A | ||
| Type of Pump | Large Volume Infusion Pump | Large Volume Infusion Pump | Same |
| Intended | |||
| Use/Indications for | |||
| 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 healthcareprofessionals 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. | The Plum 360™ Infusion System with | ||
| MedNet™ / Smart Card Plug 'n' Play | |||
| Module is intended for use in | |||
| parenteral, enteral, and epidural | |||
| therapies and the administration of | |||
| whole blood and blood products. | Similar | ||
| Additional details are added to the intended use | |||
| statement of the subject device to clarify patient | |||
| populations and the meaning of parenteral routes of | |||
| administration. Both the predicate device and the | |||
| subject device are prescription devices. They are both | |||
| infusion pump systems indicated for use in parenteral | |||
| therapies. ICU Medical is removing the enteral and | |||
| epidural routes of administration as well as the | |||
| administration of whole blood and blood products from | |||
| the indications for use for the Plum Duo Infusion | |||
| System. The indications are limited to the subset of the | |||
| predicate device indications for use. | |||
| Patient Population | The Plum Duo Infusion System is intended | ||
| for adult, pediatric (including infants and | |||
| children), and neonatal patient populations. | Not Specified | No change in the intended patient population. | |
| Additional details added to the statement to clarify | |||
| the patient population. | |||
| Environment of | |||
| Use | Hospital environments and other | ||
| outpatient healthcare facilities that | |||
| excludes hyperbaric or oxygen-rich | |||
| environments. Not for MRI environment. | |||
| 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 | Hospital environments and other | ||
| outpatient healthcare facilities that | |||
| excludes hyperbaric or oxygen-rich | |||
| environments. Not for MRI | |||
| environment. 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 | Similar | ||
| The subject device is used in the same environment | |||
| (hospitals and other healthcare facilities). The | |||
| 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 | |||
| administration of therapies consistent | |||
| with the intended use. | healthcare professionals are trained in | ||
| the use of the infusion pump and the | |||
| administration of therapies consistent | |||
| with the intended use. In addition, the | |||
| healthcare professionals are trained in | |||
| the administration of whole blood and | |||
| blood products. | |||
| Route of | |||
| Administration | Parenteral, limited to intravenous, | ||
| subcutaneous, and intra-arterial. | Parenteral, enteral and epidural | Similar | |
| The subject device routes of administration are a | |||
| subset of the predicate device routes of | |||
| administration and are consistent with the predicate. | |||
| Set Compatibility | Compatible with currently marketed Plum™ Administration Sets | Same | |
| ICU Medical Safety | |||
| Software/Drug | |||
| Library | Compatible with LifeShield™ Infusion | ||
| Safety Software Suite | Compatible with ICU Medical MedNet™ | ||
| Safety Software | Similar | ||
| Both products are compatible with Infusion Safety | |||
| 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) | ||
| No Default Drug Library (DDL) | Custom Drug Library and Default Drug | ||
| Library | Similar | ||
| Removing the option of default drug library increases | |||
| compliance with the usage of the hospital created | |||
| drug library. | |||
| Delivery Methods/ | |||
| Therapies | 1. Continuous |
- Multistep
- Loading Dose (standalone or with
underlying continuous therapy) - Bolus (standalone or with underlying
continuous therapy) | 1. Continuous - Multistep
- Loading Dose (with underlying
continuous therapy) - Bolus (with underlying continuous
therapy) | Similar
The ability to deliver a loading dose and/or bolus
without an underlying continuous therapy allows the
clinician additional flexibility in administering therapy. |
| Therapy Modes | 1. Piggyback (with flush feature) - Concurrent
- Deliver alone (primary delivery only) | 1. Piggyback
- Concurrent | Similar
The addition of the piggyback flush feature
automates the existing manual workflow and ensures
the patient receives the piggyback medication in its
entirety at the piggyback delivery rate for the
duration of the therapy.
The addition of deliver alone provides an additional
option for the medications that should not be
interrupted or delivered concurrently with another
medication 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) | Similar
The extended range provides greater flexibility to the
clinician to tailor the therapy to meet the patient's
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
Accuracy | • 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 | Similar
Detailed flow rate accuracy disclosed in the labeling |
| WiFi | Yes | | Same |
| Pump Operation | Volumetric Piston Type | | Same |
| Number of
Channels | 2 Channels: Left and Right Channel. Each
channel has primary (Line 1) and
secondary (Line 2) | Single channel with primary (Line A) and
secondary (Line B) | Similar
The addition of the second channel enables the
clinician to infuse four therapies simultaneously on
one device. The ability to add additional infusion lines
on the same device allows more efficiency in space
management and ease of line management with
tracing to one device. |
| Sensors | Air Detection, Occlusion, Temperature,
Cassette Detection, Ambient light sensors | Air Detection, Occlusion, Cassette
Detection sensors | Similar
Additional sensor functionality optimizes system
performance. |
| Alarm Summary | Check cassette alarms, proximal (upstream) and distal (downstream) occlusion, door
open, air detection, callback, lockout, low battery, and internal system monitor
alarms. | | Same |
| Clinical Advisories | Addition of the clinical advisory
field/message on the pump interface | Not available | Different
This feature provides an additional field for the
pharmacy to enter any applicable precautions or
instructions |
| Summary of the technological characteristics of the device compared to the predicate device | | | |
| Characteristic | Subject Device (K223607) | Predicate (K161469) | Comparison |
| Operating
Environment and
Storage
Specifications | Operating Temperature 41°F to 104°F (5°C to 40°C) | | Same
Details 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) | | |
| Physical
Specifications | Dimensions: Approximately 9 H x 11.75
W x 6.5 D inches (23 cm H x 30 cm W x 17
cm D) (excluding pole clamp extrusion
and power cord storage) | Dimensions: Approximately 8" H x 8" W
x 6" D (20 cm H x 20 cm W x 15 cm D),
excluding pole clamp extrusion
and power cord storage. | Similar
The differences in physical dimensions do not impact
ergonomics or user experience. |
| | Mass: Approximately 10.6 lbs (4.8
kilograms) 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 power
supply acceptable for 120v and 240v
mains supply | ICU Medical design: Separate power
supplies for US (120v) and international
(240v) configurations | Similar
Universal power supply provides customer
convenience to use uniform power source. |
| Battery | Lithium Iron Phosphate Battery with battery
management electronics | Sealed Lead Acid Battery | Different
Updated battery technology to improve power
density, battery capacity reporting, and safety
monitoring reliability and life cycle for optimization of
performance. |
| Display | 10" color touchscreen display with WXGA
resolution | Custom 4" QVGA Monochromatic display | Different
Full color touchscreen display with increased
resolution enhances the user experience. |
5
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
6
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.
7
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.
8
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.
9
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 |
10
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.
11
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
12
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. ●
13
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.