HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

K041550 · Abbott Laboratories · FRN · Jun 30, 2004 · General Hospital

Device Facts

• Record ID: K041550
• Device Name: HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Abbott Phoenix Infusion System with Abbott MedNet Software is intended for the delivery of fluids, solutions, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers. Long Term Care, Transport and Physician Offices.

Device Story

Electromechanical infusion pump; uses DC motor and in-line cassette to meter I.V. fluids; supports 1-channel or 2-channel configurations; units can be connected (up to 4 channels) via IrDA sensors. Operated by clinicians via LCD-touch screen; programs fluid delivery using weight/surface area-based units. Abbott MedNet software manages drug libraries, configuration, and history logs; data transmitted via cable or optional wireless module to hospital information systems. Provides real-time monitoring of flow parameters, alarms, and program status. Enables standardized drug delivery, reducing medication errors; supports primary and secondary fluid delivery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electromechanical infusion pump; DC motor; in-line cassette; LCD-touch screen interface; IrDA sensors for local pump-to-pump communication; optional wireless communications module; supports 1-4 channel configurations.

Indications for Use

Indicated for delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes. Intended for use in hospital, home care, nursing homes, mobile intensive care, ambulatory infusion centers, hospice, subacute facilities, outpatient/surgical centers, long-term care, urgent care, and physician offices. Prescription use only.

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

• Abbott Plum A+® Infusion Pump with HPL/RS with the plug-and-play Module (K031185)
• Abbott Gemstar™ I.V. Infusion Pump system (K023062)

Submission Summary (Full Text)

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Abbott Laboratories, Inc. Confidential

Original 510(k) Premarket Notification April 2004 Abbott Phoenix Infusion System with Abbott MedNet™ Software

JUN 3 0 2004

K041552

#### 510(k) SUMMARY র্ব

| 1. Submitted by: | Abbott Laboratories, Inc.<br>D-389. Bldg. J-45<br>200 Abbott Park Rd<br>Abbott Park, IL 60064 | Phone: [phone]<br>Fax: [phone]<br>Contact: Patricia Melerski |
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- 2. Date Prepared: April 16, 2004
- 3. Name/Classification Infusion Pump, Class II of Device: 80 FRN - 21 CFR Parts 880.5725

Administration Sets 80 FPA - 21 CFR Reference: 880.5440

- 4. Abbott Phoenix Infusion System with Abbott MedNet™ Trade Name of Proposed Device: Software
- Abbott Pium A+® Infusion Pump with HPL/RS with the 5. Predicate Devices: plug-and-play Module (K031185) Abbott Gemstar™ I.V. Infusion Pump system (K023062)

### 6. Proposed Device Description:

The Abbott Phoenix Infusion System with Abbott MedNet™ Software is comprised of an Abbott Phoenix Infuser and accessories. The accessories consist of dedicated infusion administration sets, an optional wireless communications module and optional software that can manage default settings, drug limit alerts and history logs through the communications connections.

The infuser is an electromechanical infusion pump (hereinafter referred to as a pump) that uses a DC motor along with an in-line cassette to meter intravenous (I.V.) fluids through a dedicated administration set. The pump is manufactured for Abbott Laboratories and distributed by Abbott Laboratories. The administration sets are manufactured by and distributed by Abbott Laboratories.

The pump is manufactured as a one-channel or two-channel fluid delivery device. The clinician can configure the pumps by connecting them together. The two-channel pump can be connected to a one-channel pump to form a three-channel pump. Two two-channel pumps can be connected together to form a four-channel pump. However, two one-channel pumps cannot be connected together, nor can more than two pumps be connected together. When the devices are connected, local communication between the pumps is accomplished through Infrared Data Association® (IrDA) sensors.

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The pump's large LCD-touch screen allows the healthcare practitioner to program fluid delivery in a variety of weight- and surface area-based units such as micrograms/kg/hour, grams/m2/hr, and other delivery specifications.

The display provides visible indication of several functions including active pump operations, alarm and program status, and fluid flow parameters.

Both the bredicate and the proposed devices can be used for primary and secondary fluid delivery.

The pumps can transmit and receive data by using a cable connected to a data port directly or through a wireless communications module. Data handling is accomplished using the Abbott MedNet Software. Data can include downloading customized drug library and/or customized pump configuration, uploading event/alarm logs, triggering a nurse callback, and/or sending current pumping parameters to another computer or device. The wireless communications module allows the pump to be connected to a hospital information system or infusion medication management software system.

The pumps manufactured without a wireless board are enabled for wireless upgrade. The pumps can be converted to have wireless functionality at a later date by inserting an optional wireless communications module in the pump.

### 7. Statement of Intended Use:

The Abbott Phoenix Infusion System with Abbott MedNet Software is intended for the delivery of fluids, solutions, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers. Long Term Care, Transport and Physician Offices.

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

The proposed Abbott Phoenix Infusion System with Abbott MedNet Software and the predicate devices are similar in fundamental technology (fluid delivery), programming options, materials of construction. intended use and labeling. Therefore, the Abbott Phoenix Infusion System with Abbott MedNet Software is substantially equivalent to Abbott Plum A+® Infusion Pump with HPURS with the plug-and-play Module and the Abbott Gemstar® I.V. Infusion Pump. The proposed device does not raise new issues of safety and effectiveness.

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

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 3 0 2004

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

Re: K041550

Trade/Device Name: Hospira Phoenix Infusion System with Hospira MedNet Software Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 22, 2004 Received: June 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 Eederal 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. 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); 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,

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

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## Indications for Use

510(k) Number (if known):

Hospira Phoenix Infusion System with Hospira MedNet Software Device Name:

Indications For Use:

The Hospira Phoenix Infusion System with Hospira MedNet Software has the following indications for use:

The Hospira Phoenix Infusion System with Hospira MedNet Software is intended for the delivery of fluids, solutions, drugs, aqents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.

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

ﺣﯿﺮﺕ

Over-The-Counter Use (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)

Anton Vrons

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

510(k) Number:_人ゆy /SSQ

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