HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE

K042609 · Hospira, Inc. · FRN · Oct 6, 2004 · General Hospital

Device Facts

• Record ID: K042609
• Device Name: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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 a software product for healthcare facilities; facilitates bi-directional networked communication (wired/wireless) between hospital information systems and Hospira infusion pumps (e.g., Plum A+). MMS enables sending, receiving, reporting, and storing infusion parameters, pump configurations, location, history, events, trending, alarms, and status. Core function: pre-populating infusion parameters to reduce manual programming steps. Operated by trained healthcare professionals; MMS cannot remotely start, modify, or terminate infusions. Data entry and validation remain the responsibility of the clinician per physician orders. Benefits include reduced manual data entry errors and improved workflow efficiency through automated parameter configuration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological comparison to predicate devices.

Technological Characteristics

Software-based infusion pump accessory; facilitates networked communication (wired/wireless) between hospital information systems and infusion pumps. Enables data transfer for infusion parameters, pump configurations, and status monitoring. Operates as a networked software suite.

Indications for Use

Indicated for use by trained healthcare professionals in healthcare facilities to facilitate networked communication between hospital information systems and infusion pumps, and to automate the programming of infusion parameters based on physician orders.

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 A+/A+3 Infusion Systems with Hospira MedNet™ Software (K042081)
• Medley™ with Medication Management System (Medley™ System MMS) (K030459)
• Horizon Outlook™ with DoseCom™ (K011975)

Submission Summary (Full Text)

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K042609

## 1 A - 2004

#### 510(k) SUMMARY বা

| 1. Submitted by: | Hospira, Inc.<br>D-040B Bldg. H2<br>275 N. Field Drive<br>Lake Forest, IL 60045<br>Contact: Ray Silkaitis, RPh Ph.D. | Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 2. Name/Classification of Device: | Infusion Pump Accessory; Class II; 80 FRN<br>21 CFR Parts 880.5725 | |
| 3. Trade Name of Proposed Device: | Hospira MedNet™ Medication Management Suite | |
| 5. Predicate Devices | K 042081 Plum A+/A+3 Infusion Systems with Hospira MedNet™ Software<br>K030459 Medley™ with Medication Management System (Medley™ System MMS)<br>K011975 Horizon Outlook™ with DoseCom™ | |

#### 5. Proposed Device Description:

The Hospira MedNet™ Medication Management Suite is an optional software product intended for use in healthcare facilities by trained healthcare professionals to facilitate networked communications (wired or wireless) between MMS compatible hospital information systems and Hospira infusion pumps, such as the Plum A+ 9. The feature of pre-populating infusion parameters is being added to reduce the number of manual steps to program an external infusion pump.

The MMS provides healthcare professionals with the capability to send, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pump default configurations, pump location, history, events, trending, alarms and status. The MMS cannot remotely start, modify, or terminate ongoing infusions.

## 6. Statement of 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.

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K042609

## 7. Summary of Technological Characteristics of New Device Compared to Predicate Device

The subject and predicate devices were compared and are similar in design, components and intended use. The proposed modifications do not raise new issues of safety and/or effectiveness. Therefore, the software is substantially equivalent to the predicate devices.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

Hospira, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K042609

Trade/Device Name: Hospira MedNet™ Medication Management Suite Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 22, 2004 Received: September 24, 2004

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Devine

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. or the revolved with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K042609

# Indications for Use

510(k) Number (if known)

Hospira MedNet™ Medication Management Suite Device Name:

### Indications for 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.

Curt Thompson

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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