Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

K161469 · Hospira, Inc. · FRN · Mar 28, 2017 · General Hospital

Device Facts

• Record ID: K161469
• Device Name: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Device Story

Volumetric infusion system for parenteral, enteral, epidural therapies, and blood product administration. Uses dedicated administration sets; features LCD display, alphanumeric keypads, audible/visual indicators, nurse call interface, and network connectivity. Operates via MedNet software for communication between pump, server, and facility systems. Clinicians program therapy via predefined screens; system manages infusion delivery. Updates include bolus functionality, modified dose ranges, and cybersecurity enhancements. Used in clinical settings to deliver precise fluid/medication volumes, improving therapy management and patient safety.

Clinical Evidence

Bench testing only. No clinical data required. Evidence includes system verification and validation, human factors evaluations for the bolus feature, and electrical/electromagnetic compatibility testing per IEC 60601 standards.

Technological Characteristics

Volumetric infusion pump. Connectivity: Networked via MedNet server. Standards: IEC 60601-1 (safety), IEC 60601-2-24 (infusion pump performance), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms). Software: CPU software v15.10, Communication Engine v3.03.

Indications for Use

Indicated for patients requiring parenteral, enteral, or epidural therapies, or administration of whole blood and blood products.

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 (K141789)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2017

Hospira, Inc Keith Dunn Associate Director, Global Regulatory Affairs, Devices 275 North Field Drive Lake Forest, Illinois 60045

Re: K161469

Trade/Device Name: Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN. PHC. FPA Dated: February 22, 2017 Received: February 28, 2017

Dear Keith Dunn:

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. 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.

{1}------------------------------------------------

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 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the name is the letter "s" preceded by a hyphen. The signature is a series of loops and curves.

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K161469

Device Name

Plum 360™ Infusion System with Hospira MedNet™/ Smart Card Plug 'n' Play Module

Indications for Use (Describe)

Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

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

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 [e-mail]

"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}------------------------------------------------

## Section 5: 510(k) Summary

A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | ICU Medical |
| Address | D-393<br>600 North Field Drive<br>Lake Forest, IL. 60045 |
| Phone number | 224-212-4898 |
| Fax number | 224-212-5402 |
| Establishment<br>Registration<br>Number | 3005579246 |
| Name of contact<br>person | Yuliya Matlin |
| Date prepared | March 28, 2017 |
| Name of device | |
| Trade or<br>proprietary<br>name | Plum 360TM Infusion System with MedNet/ Smart Card Plug 'n' Play Module |
| Common or<br>usual name | Infusion Pump |
| Classification<br>name | Infusion Pump |
| Classification panel | 80 |
| Regulation | 21 CFR 880.5725 |
| Product Code(s) | FRN, PHC, FPA |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | Infusion System:<br>Plum 360TM Infusion System with MedNet / Smart Card Plug 'n' Play (K141789) |
| Device description | The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a<br>volumetric Infusion System intended for use in parenteral, enteral and epidural therapies and the<br>administration of whole blood and blood products.<br>Dedicated administration sets are used for delivery of infusion therapy to the patient. The device<br>has a user interface consisting of LCD display, front panel alphanumeric keypads and keys,<br>audible and visual indicators, audible indicator volume control, nurse call interface, network<br>interface connectors, the drug library and software that provides pre-defined display screens for<br>therapy programming.<br>The continued use of the MedNet Software allows communication between the Infusion Pump,<br>MedNet server and the facility's communication systems. |
| Indication for Use | The Plum 360TM Infusion System with Hospira MedNet TM is indicated for use in parenteral,<br>enteral, and epidural therapies and the administration of whole blood and blood products. |

{4}------------------------------------------------

| Summary of<br>Indications for Use<br>Compared to<br>Predicate Device<br>Summary of the | | | With exception to the system name, the Indications for Use is identical to the predicate device.<br>Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play employs the same |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics<br>Compared to<br>Predicate Device | fundamental scientific technology, and principles of operation and intended use as the predicate<br>device. In addition, Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play<br>Module has the following technological characteristic enhancements compared to predicate<br>device with the following changes related to the bolus feature: | | |
| | | Feature | Subject Plum 360 Infusion System with<br>Bolus Feature Compared to Predicate Plum<br>360 Infusion System |
| | | CPU Software | Updated to 15.10<br>Software differences included introduction of<br>bolus functionality and associated user<br>interface modifications, addition of the dosing<br>units and modifications to programmable dose<br>ranges, infusion log updates and cybersecurity<br>enhancements |
| | | Communication Engine (CE) | Updated to 3.03<br>Software differences included Cybersecurity<br>enhancements and changes to support<br>additional bolus functionality |
| | | | |

{5}------------------------------------------------

| Performance Data -<br>Non Clinical Testing | The following standards and associated methods were applied to demonstrate the Plum 360™<br>Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the current device after the historical and subject changes are applied<br>· IEC 60601-1Medical Electrical Equipment-Part 1: General Requirement for Basic<br>Safety and Essential Performance, 2005/(R)2012/C1:2009/(R)2012, Including |
| | Amendment 1:2012 |
| | · IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for<br>the basic safety and essential performance of infusion pumps and controllers, Edition<br>2.0 2012 |
| | · IEC 60601-1-2 Medical electrical equipment- part 1-2: General requirements for basic<br>safety and essential performance- Collateral standard: Electromagnetic compatibility -<br>Requirements and tests, Edition 3:2007 |
| | · IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for alarm<br>systems in medical electrical equipment and medical electrical systems, Edition 2.0<br>2006 |
| | A risk analysis was applied to assess the impact of modifications necessary to include a bolus<br>feature with the system. The analysis demonstrates the changes do not introduce new risks to<br>the patient. All risks which are identified have been mitigated as low as reasobaly possible. |
| | The device safety assurance case was updated to include the bolus feature that is being added to<br>the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module, as<br>recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle |
| | |
| | The assurance case defined the device system, including the indications for use, system<br>specifications, use environments, and user population. The supporting assurance arguments<br>covered the following attributes: |
| | · All potential risks have been mitigated and residual risk is acceptable. |
| | · Design verification and validation of device specifications are adequate. |
| | · Device reliability is adequate. |
| | The following evidence was included in the assurance case: |
| | · Performance Test Summary: System verification and validation activities for Plum 360<br>Infusion System confirmed that the system meets user needs and design inputs. All the<br>testing met the acceptance criteria. |
| | · Human factors evaluations have been conducted to validate the effectiveness of the bolus<br>feature. |
| | · Software verification and validation as recommended in the following FDA guidance<br>documents: |
| | Infusion Pumps Total Product Life Cycle<br>O |
| | Content of Premarket Submissions for Software Contained in Medical Devices<br>O<br>Applying Human Factors and Usability Engineering to Medical Devices<br>O |
| | |
| | Electrical and Electromagnetic Compatibility testing were conducted. Updates due to the bolus<br>feature complies with following standard: |
| | IEC 60601-2-24 Medical Electrical Equipment - Part-24:<br>Infusion Pump Basic<br>Safety and Essential<br>Edition 2.0 2012-10<br>Performance |
| | |
| Performance Data –<br>Clinical Testing | Clinical evaluation is not required for this submission to support substantial equivalence.<br>Human Factors studies have been conducted on subject devices, demonstrating passing results. |

{6}------------------------------------------------

## CONCLUSIONS DRAWN FROM NON-CLINICAL DATA

The conclusions drawn from the non-clinical tests demonstrate that the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to the predicate device.