MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)

K111386 · Smiths Medical MD, Inc. · FRN · Aug 29, 2011 · General Hospital

Device Facts

• Record ID: K111386
• Device Name: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
• Applicant: Smiths Medical MD, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses: . In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. . By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral. . By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. . In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. . Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla. The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version 1.X. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Model 4000 Syringe Infusion Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Model 4000 Syringe Infusion Pump. The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.

Device Story

Medfusion 4000 is a wireless-capable, electro-mechanical syringe infusion pump. It accepts user-defined infusion parameters (drug names, rates, modes) via PharmGuard Toolbox 2 software. The pump delivers fluids (blood, drugs, lipids) via various routes (arterial, epidural, etc.) using modes like continuous, bolus, or body-weight-based. It features plunger force sensing and fast occlusion detection. Used in clinical settings (critical care, anesthesia, neonatal/pediatric) under clinician supervision; also MRI-compatible (up to 1.5 Tesla, outside 150 Gauss line). PharmGuard Toolbox 2 software allows clinicians to create drug libraries, upload configurations, and download infusion/alarm history for process improvement and error reduction. Output is the controlled delivery of therapeutic fluids; clinicians monitor pump status and alarms (e.g., occlusion, near-empty, battery). Benefits include precise fluid administration and reduced medication errors through standardized drug libraries.

Clinical Evidence

No clinical data. Bench testing included accuracy, impact, environmental, magnetic resonance (ASTM-F2052), moisture ingress, chemical compatibility, power management, fault condition, sensor, software validation, drug compatibility, mechanical/electrical safety (EN IEC 60601-1, EN IEC 60601-2-24), EMC (EN IEC 60601-2), and reliability testing. Human Factors Engineering validation studies were conducted in simulated use environments.

Technological Characteristics

Electro-mechanical syringe infusion pump. Materials biocompatible per similarity to existing Smiths Medical devices. Features: plunger force sensing, fast occlusion detection, wireless connectivity. MRI compatible (1.5T, 150 Gauss). Standards: ASTM-F2052, EN IEC 60601-1, EN IEC 60601-2-24, EN IEC 60601-2. Fluid resistance: IPX3.

Indications for Use

Indicated for patients in critical care, anesthesia, neonatal, and pediatric settings requiring precisely controlled infusion of fluids (blood, lipids, drugs, antibiotics, enteral solutions) via arterial, epidural, intrathecal, subcutaneous, or enteral routes.

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

• Medfusion® Model 3500 Syringe Infusion Pump (K040899)
• PharmGuard® Toolbox (K042432)
• ALARIS Medical Systems, Inc. Medley™ Syringe Pump Module (K023264)
• ALARIS Medical Systems Inc. Medley™ System with Medication Management System (K030459)

Submission Summary (Full Text)

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## 510(k) Number: K111386

Date Prepared 24 August, 2011

#### Submitter Information

| Submitter's Name: | Smiths Medical ASD, Inc. |
|-------------------|------------------------------------------|
| Address: | 1265 Grey Fox Road<br>St. Paul, MN 55112 |

Establishment Registration: 2183502

| Contact Person: | James Chapman |
|-----------------|--------------------------------------|
| | Senior Regulatory Affairs Specialist |
| Phone: | [phone] |
| Fax: | [phone] |

#### Device Information

| Trade Name: | Medfusion® Model 4000 Syringe Infusion Pump,<br>PharmGuard® Toolbox 2 Medication Safety Software<br>PharmGuard® Supported Syringes (PSS) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Syringe Infusion Pump, Medication Safety Software |
| Classification Name: | Infusion Pump |
| Product Code: | FRN, MRZ |
| Regulation: | 21 CFR §880.5725 |

#### Predicate Device(s)

The predicate devices are the currently marketed Medfusion® Model 3500 Syringe Infusion Pump (K040899), PharmGuard® Toolbox (K042432), ALARIS Medical Systems, Inc. Medley™ Syringe Pump Module (K023264), and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System (K030459).

#### Device Description

The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechanical syringe infusion pump.

The PharmGuard® Toolbox 2 Medication Safety Software is designed to accommodate the features and capabilities of the 4000 pump with software version 1.X.

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#### Intended Use/Indications for Use

The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:

- . In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- . By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
- . By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- . In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- . Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version 1.X. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Model 4000 Syringe Infusion Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Model 4000 Syringe Infusion Pump.

The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 6 - 2 of 5

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| Parameter | Medfusion 4000<br>Syringe Infusion Pump<br>510(k) K111386 | Medfusion 3500<br>Syringe Infusion Pump<br>510(k) K040899 | ALARIS Medley™<br>Syringe Pump Module<br>510(k) K023264 |
|-----------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|
| System Features® | | | |
| Plunger Force Sensing | Yes | Yes | Unknown |
| MRI Compatibility | ≤ 150 Gauss/1.5 Tesla | ≤ 150 Gauss/1.5 Tesla | Unknown |
| Fluid Resistance | Level IPX 3 | Level IPX 3 | Level IPX 1 |
| Fast Occlusion Detection | Yes | Yes | Yes |
| Minimum Flow Rate | 0.01 mL/hr | 0.01 mL/hr | 0.1 mL/hr |
| Maximum Flow Rate | 1130 mL/hr | 1130 mL/hr | 999 mL/hr |
| Wireless Communications<br>Capabilities | Yes | No | Yes |
| Programming Functions | | | |
| Continuous Mode | Yes | Yes | Yes |
| Volume/Time Mode | Yes | Yes | Yes |
| Dose/Time Mode | Yes | Yes | Yes |
| Mass Mode | Yes | Yes | No |
| Body Weight Mode | Yes | Yes | Yes |
| Body Surface Area Mode | Yes | Yes | Yes |
| Intermittent Mode | Yes | Yes | Yes |
| Dose/Kg/Time Mode | Yes | Yes | No |
| Bolus | Yes | Yes | Yes |
| Alarms | | | |
| KVO Alarm | Yes | Yes | Yes |
| Infusion Complete Alarm | Yes | Yes | Yes |
| Near Empty Alarm | Yes | Yes | No |
| Empty Alarm | Yes | Yes | Yes |
| Invalid Syringe Size<br>Alarm | Yes | Yes | No |
| Syringe Not in Place<br>Alarm | Yes | Yes | Yes |
| Pressure Increasing Alarm | Yes | Yes | No |
| Force Occlusion Alarm | Yes | Yes | Yes |
| Battery Failed Alarm | Yes | Yes | Yes |
| Low Battery Alarm | Yes | Yes | Yes |

### Comparison of Technological Features

.

Traditional 510(k) Tab 6 - 3 of 5

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#### Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the Medfusion® 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software and their ability to achieve their intended use. Bench testing of the Medfusion® 4000 Syringe Infusion Pump confirmed the suitability of the device for its intended use. The following physical tests were performed:

- . Accuracy Testing with All Supported Syringes
- I Impact Testing
- Environmental Testing I
- . Accuracy Testing at Simulated Altitude
- I Magnetic Resonance Testing in Accordance with ASTM-F2052
- . Moisture Ingress Testing
- r Chemical Compatibility Testing
- 트 Power Management
- I Fault Condition Testing
- . Sensor Testing
- . Software Validation Testing
- . Drug Compatibility Testing
- Mechanical and Electrical Safety Testing in Accordance with EN IEC 60601-1 트 and EN IEC 60601-2-24
- 바 EMC Testing in Accordance with EN IEC 60601-2
- Radio Frequency Interference Testing l
- 트 Product Reliability Testing

In addition to the above, Human Factors Engineering validation studies were conducted in a simulated use environment to verify product understanding and pump programming and operation. Human Factors Engineering testing demonstrated that the Medfusion® Model 4000 Syringe Infusion Pump performed as designed and is safe and effective for its intended use.

A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the Medfusion Model 4000 pump. The device is biocompatible based on the similarity of the materials of construction to other devices currently marketed by Smiths Medical ASD, Inc.

#### Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software.

#### Statement of Equivalence

The Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software are substantially equivalent to the currently marketed Medfusion® Model 3500 Syringe Infusion Pump, PharmGuard® Toolbox, ALARIS Medical Systems, Inc. Medley Syringe Pump Module, and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System based on a comparison of the indications for use and the technological characteristics of the devices.

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#### Conclusion

The Medfusion® Model 4000 Syringe Infusion Pump and PharmGuard® Toolbox 2 Medication Safety Software are substantially equivalent to the currently marketed Medfusion® Model 3500 Syringe Infusion Pump, PharmGuard® Toolbox, ALARIS Medical Systems, Inc. Medley Syringe Pump Module, and the ALARIS Medical Systems Inc. Medley™ System with Medication Management System based on the technological characteristics of the devices. Bench tests confirmed the suitability of the devices for their intended uses. .

Traditional 510(k) Tab 6 - 5 of 5

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mr. James Chapman Senior Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

AUG 2 9 2011

Re: K111386

Trade/Device Name: Medfusion® Model 4000 Syringe Infusion System, PharmGuard® Toolbox 2 Medication Safety Software, PharmGuard® Supported Svringes Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ Dated: August 8, 2011 Received: August 10, 2011

Dear Mr. Chapman:

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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson. B.S., M.S., M.B.A. 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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## SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

# Indications for Use Statement

KIII386 510(k) Number:

Device Name: PharmGuard® Supported Syringes

-

Indications for Use:

"The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software."

Prescription Use X (Per 21 CFR 801 .109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

/// C. A
(Division Sign-Off) 8/20/11

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111386

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 5 - 3

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## SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

### Indications for Use Statement

510(k) Number:

Device Name: Medfusion® Model 4000 Syringe Infusion Pump

#### Indications for Use:

"The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:

- . In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, Enteral solutions and other therapeutic fluids.
- . By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
- By the following delivery modes: continuous, volume/time, mass, body weight, custom . dilution, intermittent and bolus.
- . In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- . Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

Prescription Use Over-The Counter Use X AND/OR (Per 21 CFR 801 .109) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chaye 8/25/14

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

510(k) Number: K111386

Medfusion® 4000 Pump and PharmGuard® Toolbox 2 Smiths Medical ASD, Inc.

Traditional 510(k) Tab 5 - 1

{9}------------------------------------------------

## SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

#### Indications for Use Statement

510(k) Number: _ < < 111 386

Device Name: PharmGuard® Toolbox 2 Medication Safety Software

#### Indications for Use:

"The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version V1.0 or higher. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Pump."

Prescription Use x (Per 21 CFR 801 .109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rell C. 8/25/14
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111386

Traditional 510(k) Tab 5 - 2