PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP

K121032 · Hospira, Inc. · FPA · Jun 21, 2012 · General Hospital

Device Facts

• Record ID: K121032
• Device Name: PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
• Applicant: Hospira, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 21, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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. They are 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.

Device Story

Primary Symbiq Set (List 16120) is an intravascular administration set designed for use with the Symbiq Infusion Pump. Components include a MICRODRIP drop former, sight chamber, backcheck valve, two CLAVE Y-sites, distal microbore tubing, and a 0.2-micron filter. The device provides a sterile fluid pathway for administering fluids, drugs, or blood products from a container to a patient's vascular system. Operated by clinicians in hospital or acute care settings, the set facilitates controlled fluid delivery. This submission updates labeling to qualify the set for flow rates between 100 ml/hr and 500 ml/hr, expanding the previously cleared range of 0.1 ml/hr to 100 ml/hr. The device ensures accurate delivery within ±10% at these higher rates, supporting clinical decision-making for high-volume infusion requirements.

Clinical Evidence

Bench testing only. System verification testing confirmed delivery accuracy performance at 500 ml/hr. The device met all acceptance criteria and accuracy claims under standard conditions.

Technological Characteristics

Intravascular administration set; non-DEHP materials; includes MICRODRIP drop former, sight chamber, backcheck valve, 2 CLAVE Y-sites, distal microbore tubing, and 0.2-micron filter. Flow rate range: 0.1 ml/hr to 500 ml/hr. Sterile, single-patient use. Mechanical fluid delivery system.

Indications for Use

Indicated for patients requiring delivery of fluids, drugs, nutritionals, electrolytes, or blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes in hospital, acute, or non-acute care settings.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Primary Symbiq™ Set, MICRODRIP™, Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120 (K110901)

Submission Summary (Full Text)

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Special 510(k)

JUN 2.1 2012

Hospira (

Primary Symbiq ™ Set, MICRODRIP™, Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Dista Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120

# Section 6: 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Primary Symbiq ™ Set, MICRODRIP™, Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120 is provided below.

| Submitter Information | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Hospira, Incorporated |
| Address | 275 North Field Drive |
| | Lake Forest, IL 60045 |
| Phone number | 224-212-4857 |
| Fax number | 224-212-5401 |
| Establishment Registration<br>Number | 3005579246 |
| Name of contact person | Yuliya Matlin, M.S., M.B.A |
| Date prepared | May 23, 2012 |
| Name of Device | |
| Trade or proprietary name | Primary Symbiq™ Set, MICRODRIP™, Piggyback with Backcheck<br>Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter,<br>105 Inch, Non-DEHP, List Number 16120, part of Symbiq Infusion<br>System |
| Common or usual name | Infusion Pump and Administration Sets |
| Classification name | Infusion Pump and Intravascular Administration Set |
| Classification panel | General Hospital |
| Regulation | 21-CFR Part 880.5725 and 21-CFR Part 880.5440 |
| Product Code(s) | 80-FRN, 80-FPA |
| Legally marketed device(s) to<br>which equivalence is claimed | Primary Symbiq™ Set , MICRODRIP™, Piggyback with Backcheck<br>Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter,<br>105 Inch, Non-DEHP, List Number 16120 as cleared in K110901 on<br>March 5, 2012. |
| Reason for 510(k) submission | Labeling updates to reflect the qualifications of Hospira List Number<br>16120 for use at flow rates between 100 ml/hr and 500 ml/hr. |
| Device description | List Number 16120 is a Primary Symbiq™ set that includes<br>MICRODRIP™ Drop Former, Sight Chamber, Backcheck Valve, 2<br>CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch<br>and is non-DEHP . It is designed specifically for use with the<br>Symbiq™ Infusion Pump and is used to administer fluids from a<br>container to a patient's vascular system though a needle or catheter.<br>The set has a sterile fluid pathway and is for single patient use. |

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## Special 510(k)

Primary Symbiq ™ Set, MICRODRIP™, Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Distal
Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120

Hospira Confidentia

| Intended use of the device<br>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. They are 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. | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------|-----------------------|
| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | | | |
| Characteristic | | Subject Device | Predicate™ |
| Intended use | | Same | Same |
| Set Functionality/Principal of Operation | | Same | Same |
| Components | | Same | Same |
| Biocompatibility | | Same | Same |
| Sterilization | | Same | Same |
| Flow rate qualification of List Number 16120 | | 0.1ml/hr to 500 ml/hr | 0.1 ml/hr to 100ml/hr |
| Delivery accuracy of List Number 16120 at flow<br>rates between 0.1ml/hr and 100 ml/hr under<br>standard conditions | | Same | Same |
| Delivery accuracy of List Number 16120 at flow<br>rates between100ml/hr and 500ml/hr under<br>standard conditions | | $±$ 10% | N/A |
| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | | | |
| Performance Test Summary - New Device | | | |
| Characteristic | Test Method | Test Title | Device Performance |
| Delivery Accuracy at<br>Flow Rate of 500ml/hr | System Verification | System Accuracy<br>Performance | Pass |
| Summary Discussion of Bench Performance Data<br>The subject device met all the acceptance criteria and the accuracy performance claims under standard conditions as described in product labeling. Device performance meets the requirements of the testing listed in the "Performance Test Summary – New Devices" table above. The subject device is identical to the predicate with the exception of the label. | | | |
| Statement of Safety and Efficacy | | | |
| The subject device meets the accuracy claims and intended use as described in the product labeling.<br>The safety and effectiveness are substantially equivalent to the predicate Primary Symbiq™ Set, MICRODRIP™, Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120 as cleared in K110901 on March 5, 2012. The claim for substantial equivalence is supported by the information provided in this special 510(k) submission | | | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the logo.

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

JUN 2 1 2012

Ms. Yuliya Matlin, M.S., M.B.A. Associate Director Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Re: K121032

Trade/Device Name: Primary Symbiq™ Set MICRODRIP™ Piggyback with Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter 105 Inch, Non-DEHP, List Number 16120 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 23, 2012 Received: Mav 24, 2012

Dear Ms. Matlin:

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- Ms. Matlin

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), 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Fr. Ostaiz

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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#### 510(k) Number

Primary Symbiq™ Set, MICRODRIP™, Piggyback with Device Name: Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing- 0.2 Micron Filter, 105 Inch, Non-DEHP, List Number 16120

#### Indications for Use:

Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. They are intended primarily for use in the hospital setting and can be used in other acute and nonacute care areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Sub acute Facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.

Over-The-Counter Use AND/OR Prescription Use X_ (Part 21 CFR 807 (Part 21 CFR 801 Subpart D) Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

BRH, Office of Device Evaluation (ODE)

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

510(k) Number: K121032