HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE

K141102 · Hospira, Inc. · FRN · Jul 8, 2014 · General Hospital

Device Facts

• Record ID: K141102
• Device Name: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira Infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.

Device Story

Hospira MedNet™ Medication Management Suite (MMS) is an optional software product for healthcare facilities; facilitates bi-directional networked communication (wired/wireless) between hospital information systems and compatible infusion pumps. Inputs include infusion parameters, pump configurations, location data, history, events, trending, alarms, and status. System enables sending, receiving, reporting, and storing pump data; automates infusion parameter programming to reduce manual data entry steps. Operated by trained healthcare professionals; cannot remotely start, modify, or terminate ongoing infusions. Healthcare providers use output to manage pump configurations and infusion data; supports clinical decision-making by ensuring accurate, physician-ordered infusion programming. Benefits include reduced manual entry errors and improved infusion management efficiency.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by non-clinical verification and validation testing, risk management activities, and human factors studies validating error mitigation effectiveness.

Technological Characteristics

Software-based infusion pump management system. Features include Drug Library Editor (DLE), server-based download/upload management, pump configuration, log management, multiple drug entries per Clinical Care Area (CCA), and bi-directional wireless/wired communication. Operates on networked PC/server infrastructure.

Indications for Use

Indicated for use by trained healthcare professionals in healthcare facilities to facilitate networked communication between hospital information systems and Hospira infusion pumps, including configuration, infusion parameter programming, and data management.

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

• Hospira MedNet™ Medication Management Suite (MMS) (K042609)

Submission Summary (Full Text)

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# JUL 0882014

1

#### K141102 510(k) SUMMARY

## A summary of 510(k) safety and effectiveness information in accordance with the requirements ` of 21 CFR 807.92.

| Submitter Information | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Inc |
| Address | 275 North Field Dr, Lake Forest, IL 60045 |
| Phone number | 858-391-1142 |
| Fax number | 224-212-5401 |
| Establishment<br>Registration<br>Number | 3005579246 |
| Name of contact<br>person | Tom Gutierrez |
| Date prepared | April 28, 2014 |
| Name of device | |
| Trade or<br>proprietary name | Hospira MedNet™ Medication Management Suite |
| Common or<br>usual name | Infusion Pump Accessory Software |
| Classification<br>name | Infusion Pump |
| Classification panel | General Hospital |
| Regulation | 880.5725 |
| Product Code(s) | FRN |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Hospira MedNet™ Medication Management Suite (MMS), cleared<br>under K042609. |
| Reason for 510(k)<br>submission | Software Changes |
| Device description | The Hospira MedNet™ Medication Management Suite (MMS) is<br>an optional software product intended for use in healthcare<br>facilities by trained healthcare professionals to facilitate<br>networked communications (wired or wireless) between MMS<br>compatible hospital information systems and compatible infusion<br>pumps.<br>The MMS provides healthcare professionals with the capability to<br>send, receive, and store information from infusion pumps. The bi-<br>directional communication includes infusion parameters, pump<br>default configurations, pump location, history, events, trending,<br>alarms and status. The MMS cannot remotely start, modify, or |
| | terminate ongoing infusions. |
| Intended use/<br>Indications for use of<br>the device | The Hospira MedNet™ Medication Management Suite (MMS) is<br>intended to facilitate networked communication between MMS<br>compatible computer systems and Hospira Infusion pumps. The<br>MMS provides trained healthcare professionals with the<br>capability to send, receive, report, and store information from<br>interfaced external systems, and to configure and edit infusion<br>programming parameters. |
| | The MMS is intended to provide a way to automate the<br>programming of infusion parameters, thereby decreasing the<br>amount of manual steps necessary to enter infusion data. All<br>data entry and validation of infusion parameters is performed by<br>a trained healthcare professional according to physician's<br>orders. |

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Summary of the technological characteristics of the device compared to the predicate device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Characteristic | Subject Device<br>Hospira MedNet™<br>Medication Management<br>Suite | Predicate Hospira MedNet™<br>Medication Management Suite<br>K042609 |
|---------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| Drug Library Editor (DLE) | Yes | Yes |
| DLE on PC | | |
| Manage Download and<br>Uploading via server | Yes | Yes |
| Configure Pumps | Yes | Yes |
| Manage Pump Logs | Yes | Yes |
| Multiple Drug entries per<br>CCA | Yes | Yes |
| Multiple CCAs | Yes | Yes |
| Pre-populating pump | Yes | Yes |
| Wireless Communications | Yes | Yes |
| Bi-directional<br>Communications | Yes | Yes |

i

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CN A THE SERVER A SPERFORMANCE DATA - CATAL - CATAL CARA - C

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*

#### Non-Clinical Performance Test Summary

Verfication and validation activities for Hospira MedNet™ software confirmed that the software meets user needs and design inputs.

Verification and validation testing was conducted and confirmed that the new feature design requirements were met. Additionally, pre-existing design requirements were re-tested. It was reconfirmed that Hospira MedNet™ continued to meet all pre-existing design requirements.

Risk management activities are incorporated in to the design and development process and a Safety Assurance Case has been generated to demonstrate the safety of the Hospira MedNet™ Medication Management Suite.

Human Factors studies have been conducted to validate the effectiveness of use related error mitigations.

## SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

#### Clinical Performance Data/Information

No clinical trials have been performed. The modifications described in the submission do not meet the clinical testing criteria outlined in the FDA guidance "Total Product Life Cycle: infusion Pump –Premarket Notification {510(k)} Submissions (DRAFT GUIDANCE) issued in April 23, 2010, given:

- Hospira MedNet is not a new device
- there were no changed or modification in the intended use of the device
- the modifications were not intended to correct problems with the design of the user interface or usability of the product

A CONCLUSIONS DRAWNIFROM NON-CLINICAL AND CLINICAL DATA

The results of the verification and validation testing as well as the risk analysis applied, supported by the Human Factors studies, demonstrate that the modifications described in the submission met design specifications and the device as a whole continues to be safe and effective.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 8, 2014

Hospira, Incorporated Mr. Tom Gutierrez Associate Director Global Regulatory Affairs 275 North Field Drive Lake Forest, IL 60045

Re: K141102

Trade/Device Name: Hospira MedNet™ Medication Management Suite Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 6, 2014 Received: June 9, 2014

Dear Mr. Gutierrez:

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.

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Page 2 - Mr. Gutierrez

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 (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.

510(k) Number (if known)

## 241102

#### Device Name

Hospira MedNet™ Medication Management Suite

#### Indications for Use (Describe)

The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS computer systems and Hospira Infusion pumps. The MMS provides trained healtheare professionals with the capability to send, receive, report, and store interfaced external systems, and to configure and edit infusion programming parameters.

The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the arnount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | |
|--------------------------------------------------------------------------------------|--|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Digitally signed by<br>Richard C. Chapman -S<br>Date: 2014.07.08<br>10:04:40 -04'00' | |

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