SYMBIQ INFUSION AND ADMINSTRATION SET

K110901 · Hospira, Inc. · FRN · Mar 5, 2012 · General Hospital

Device Facts

• Record ID: K110901
• Device Name: SYMBIQ INFUSION AND ADMINSTRATION SET
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritional, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. It is intended primarily for use the hospital setting and can be used in other acute and non-acute care areas outside of the hospital under the supervision of the healthcare provider. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.

Device Story

Volumetric piston-driven infusion pump; delivers fluids/drugs via dedicated disposable administration sets; plunger cyclically pressurizes cassette pumping chamber through elastomeric diaphragm. Features touchscreen interface for therapy programming; maintains low flow continuity at low rates. Utilizes drug safety software for dosing parameters; supports wired/wireless communication with Hospira MedNet™ server and Hospital Information Systems. Available in one-channel and two-channel configurations. Used in hospital and various acute/non-acute care settings; operated by trained healthcare professionals. Healthcare providers program infusion parameters; system provides alerts for occlusions, air-in-line, and battery status. Benefits include precise fluid delivery and integrated drug safety limits to reduce medication errors.

Clinical Evidence

Clinical evaluations and human factors studies conducted. Human Factors Use Safety Validation study demonstrated 100% task completion accuracy by participants. No clinical performance data (e.g., sensitivity/specificity) reported; safety supported by bench testing, software static analysis, and Safety Assurance Case.

Technological Characteristics

Volumetric piston-driven pump; elastomeric diaphragm cassette. 8.4-inch color LCD touchscreen. AC (100-240 VAC) and rechargeable lithium-ion battery. Wired/wireless network connectivity. Standards: IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), ISO 10993-1 (biocompatibility).

Indications for Use

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

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 Phoenix Infusion System with Hospira MedNet™ Software (K041550)

Submission Summary (Full Text)

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K110901

MAR - 5 2012

# 510(k) SUMMARY Safety and Effectiveness

| Submitter Information | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Inc. |
| Address | 275 North Field Dr, Lake Forest, IL 60045 |
| Phone number | 224-212-4897 |
| Fax number | 224-212-5401 |
| Establishment Registration<br>Number | 3005579246 |
| Name of contact person | Ray Silkaitis/Yuliya Matlin |
| Date prepared | 03/05/2012 |
| Name of device | |
| Trade or proprietary name | Symbiq™ Infusion System |
| Common or usual name | Infusion Pump and Administration sets |
| Classification name | Infusion Pump /Administration Sets |
| Classification panel | 80 |
| Regulation | 880.5725 and 880.5440 |
| Product Code(s) | FRN and FPA |
| Legally marketed device(s) to which equivalence is claimed | Hospira Phoenix Infusion System with Hospira MedNet<br>Software, cleared under K041550 on 06/30/2004 |
| Reason for 510(k) submission | Cumulative changes |
| Device description | Symbiq™ Infusion System includes a volumetric piston-driven<br>infusion pump and utilizes dedicated disposable administration<br>sets for fluid delivery to the patient. The pump's plunger<br>cyclically pressurizes the administration set's cassette<br>pumping chamber through an elastomeric diaphragm to deliver<br>fluid.<br>The device has a touchscreen user interface to program<br>various therapies. At low flow rates the infusion pump is<br>designed to maintain low flow continuity. The infusion pump<br>utilizes drug safety software to set hospital drug dosing<br>parameters.<br>The system can communicate wired or wirelessly over the<br>hospitals network infrastructure through Hospira MedNet™<br>server software with Hospital Information Systems.<br>The pump is available in one-channel and two-channel<br>configurations. |
| Intended use of the device | Symbiq™ Infusion System is intended for the delivery of fluids,<br>solutions, drugs, agents, nutritional, electrolytes, blood and<br>blood products via parenteral, enteral, intravenous, intra-<br>arterial, subcutaneous, epidural or irrigation routes of<br>administration.<br>It is intended primarily for use the hospital setting and can be<br>used in other acute and non-acute care areas outside of the<br>hospital under the supervision of the healthcare provider. All<br>data entry and validation of infusion parameters is performed<br>by a trained healthcare professional according to physician's<br>orders. |
| Indications for use | The Symbiq™ Infusion System is intended for the delivery of<br>fluids, solutions, drugs, agents, nutritionals, electrolytes, blood<br>and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of<br>administration.<br>It is intended primarily for use in the hospital setting and can<br>be used in other acute and non-acute care areas, such as, but<br>not limited to Nursing Homes, Mobile Intensive Care,<br>Ambulatory Infusion Centers, Hospice, Subacute Facilities,<br>Outpatient/Surgical Centers, Long Term Care, Urgent Care,<br>Transport and Physician Offices. |

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| | Predicate Device | Subject Device | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------|
| Device Name | Hospira Phoenix Infusion System with<br>Hospira MedNet™ Software K041550 | Symbiq™ Infusion<br>System | |
| Pump Type | Volumetric Piston Type | Same | |
| Number of dosing units | 66 | 91 | |
| Basic Dosing Units | ng/kg/min<br>mcg/kg/min<br>mcg/kg/hr<br>mcg/min<br>mcg/hr<br>mg/kg/hr<br>mg/min<br>mg/hr | grams/hr<br>U/kg/hr<br>U/min<br>U/hr<br>mUn/min<br>mEq/hr<br>mL/hr | Same |
| Routes of Administration | Parenteral, Intravenous, Arterial, Enteral,<br>Subcutaneous, Epidural, Irrigation | Same | |
| Free Flow Protection | Administration set and pump based free<br>flow protection features | Same | |
| Drug Library Feature | Yes | Same | |
| Drug Alerts | Soft and Hard Limits | Same | |
| Power Source | AC: 100-240 VAC and rechargeable<br>lithium ion battery | Same | |
| Battery Life | With a fully charged battery, both one-<br>channel and two-channel infusers deliver<br>four hours of operation at 125 mL/hr with<br>the LCD backlight set to the Power<br>Saving mode | Same | |
| Display | 8.4 in. diagonal; Color LCD | Same | |
| Physical characteristics | Width: 9.9 in.<br>Height: 10.2 in.<br>Depth: 8.6 in.<br>Depth with pole clamp: 13 in.<br>Weight: 10.7 lbs. | Similar<br>Depth increased 1.7 in<br>to add a pole<br>alignment guide | |
| One Channel pump | | | |
| Summary of the technological characteristics of the device compared to the<br>predicate device | | | |
| Device Name | Predicate Device<br>Hospira Phoenix Infusion System with<br>Hospira MedNet™ Software K041550 | Subject Device<br>Symbiq™ Infusion<br>System | |
| Physical characteristics<br>Two channel pump | Width: 10.9 in.<br>Height: 10.2 in.<br>Depth: 8.6 in.<br>Depth with pole clamp: 13 in.<br>Weight: 12.1 lbs.<br>Casing: High-impact plastic | Similar<br>Depth increased 1.7 in<br>to add a pole<br>alignment guide | |
| Low Flow continuity | Yes with Microbore sets | Same | |
| Accuracy | ± 5% for rates > 1 mL/hour.<br>± 10% for rates <=1 mL/hour | ± 5% at all rates | |
| Delivery Rate Ranges | 0.1 to 99.9 mL/hr (in 0.1 mL increments) 100 to 1000 mL/hr (in 1 mL increments) | Same | |
| VTBI (Volume to be Infused)<br>Ranges | 0.1 to 99.9 mL (in 0.1 mL increments) 100 to 9999 mL (in 1 mL increments) | Same | |
| Occlusion Settings | Distal: User specified range in either psi (from 1 to 15 in increments of 0.5) or mmHg (from 50 to 775 in increments of 25) Proximal: -5 psi/250 mmHg | Same | |
| Primary Alarms conditions | Check Cassette, Proximal Occlusion,<br>Distal Occlusion, Air-in-line, Low Battery,<br>Depleted Battery, Service Battery, Power<br>Loss, Callback, End of Infusion,<br>Emergency Stop, Nearing End of Infusion | Same | |

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#### PERFORMANCE DATA

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

#### Performance Test Summary-New Device

System verification and validation activities for Symbig™ Infusion System confirmed that the system meets user needs and design inputs. All the testing met the acceptance criteria.

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 Symbig™ Infusion System.

Risk management as well as verification and validation activities incorporate the principles of applicable FDA guidance such as "Total Product Life Cycle: infusion Pump –Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE)" issued in April 23, 2010 and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," issued January 11, 2002. Human Factors studies have been conducted to validate the effectiveness of use related error mitigations.

| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Electrical and Mechanical Safety | IEC 60601-1 (1988): Medical electrical<br>equipment - Part 1: General<br>requirements for safety, including<br>Amendment 1 (1991) and Amendment<br>2 (1995) for Type B equipment | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2 (2001): Medical<br>Electrical Equipment, Part 1-2:<br>General Requirements for Safety,<br>Collateral Standard: Electromagnetic<br>Compatibility - Requirements and<br>Tests | Pass |
| Alarm Systems | IEC 60601-1-8 Ed.1 (2003-08) Part 1-<br>8: General requirements for safety -<br>Collateral standard: Alarm systems | Pass |
| Sets Biocompatibility | ISO 10993-1:2009: Biological<br>Evaluation of Medical Devices Part 1:<br>Evaluation and Testing | Pass |

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

Clinical evaluations and human factors studies have been conducted for the Symbig™ Infusion System. The Human Factors Use Safety Validation study showed that there were no instances of participants failing to complete tasks correctly during the study. The sum of clinical evaluation and human factors testing support the safety and effectiveness of Symbig™ Infusion System.

# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the verification and validation testing with the results of human factors and clinical evaluations performed supported by static analysis of the software code and the Safety Assurance Case demonstrate that the modifications described in the submission do not introduce any additional issues of safety and effectiveness. The subject device is substantially equivalent to the predicate.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Dr. Ray Silkaitis Director Global Regulatory Affairs, Device Development Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045

MAR - 5 2012

Re: K110901

Trade/Device Name: Symbiq™ Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA Dated: February 28, 2012 Received: February 29, 2012

Dear Dr. Silkaitis:

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 the Federal Pood, Drag, Drag, therefore, market the device, subject to the general approval upprisation (vhe 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 If your de not is classince (so itional controls. Existing major regulations affecting your (1 wirty, it thay be basjon . 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 - Dr. Silkaitis

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you acon 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 Compilance if fication" (21CFR Part 807.97). For questions regarding the reporting of premartevents 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 I ou may betain 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# Indications for Use

510(k) Number (unknown at this time)

Symbiq™ Infusion System Device Name:

#### Indications for Use:

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

lt 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 Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute Facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.

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)

Alil Chyz 3/5/12

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(Division Sign Off)

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

510(k) Number. K110690