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.

Device Description

List Number 16120 is a Primary Symbiq™ set that includes MICRODRIP™ Drop Former, Sight Chamber, Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch and is non-DEHP . It is designed specifically for use with the Symbiq™ Infusion Pump and is used to administer fluids from a container to a patient's vascular system though a needle or catheter. The set has a sterile fluid pathway and is for single patient use.

AI/ML Overview

This document describes a Special 510(k) submission for a labeling update to an existing medical device, the Primary Symbiq™ Set. It is not a study proving the device meets acceptance criteria through rigorous clinical trials or AI performance evaluations as would be typical for a new diagnostic or prognostic device. Instead, it demonstrates continued performance for an expanded use case compared to a previously cleared version of the same device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Delivery accuracy at flow rates between 100 ml/hr and 500 ml/hr under standard conditions	±10% (Implicitly met as the device passed System Accuracy Performance for 500 ml/hr and a general statement of meeting all acceptance criteria and accuracy performance claims is made.)
Delivery Accuracy at Flow Rate of 500 ml/hr	Pass (tested under "System Verification" method with "System Accuracy Performance" title)
Meet all acceptance criteria and accuracy performance claims under standard conditions as described in product labeling.	Met all acceptance criteria and accuracy performance claims.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set used for the "Delivery Accuracy at Flow Rate of 500ml/hr" test. It only mentions the test method ("System Verification") and title ("System Accuracy Performance").
The data provenance is not specified beyond being "Non-Clinical Tests Conducted." Given the nature of a 510(k) submission for a label update on an existing device, these would likely be internal lab tests performed by Hospira (the manufacturer), and thus retrospective from the perspective of the submission, but the tests themselves are performed on manufactured units.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of submission. The "ground truth" here is the physical performance of the infusion set, measured by engineering and quality control tests, not by human expert interpretation of data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically relevant for human interpretation or consensus-based ground truth establishment, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

This information is not applicable. The device is an infusion set, not an AI-powered diagnostic or therapeutic tool that involves human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.

This information is not applicable. The device is an infusion set, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is the physical measurement of fluid delivery accuracy under controlled laboratory conditions, against predefined engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable. The device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no training set for this type of medical device.

Summary

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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 RegistrationNumber	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 BackcheckValve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter,105 Inch, Non-DEHP, List Number 16120, part of Symbiq InfusionSystem
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) towhich equivalence is claimed	Primary Symbiq™ Set , MICRODRIP™, Piggyback with BackcheckValve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter,105 Inch, Non-DEHP, List Number 16120 as cleared in K110901 onMarch 5, 2012.
Reason for 510(k) submission	Labeling updates to reflect the qualifications of Hospira List Number16120 for use at flow rates between 100 ml/hr and 500 ml/hr.
Device description	List Number 16120 is a Primary Symbiq™ set that includesMICRODRIP™ Drop Former, Sight Chamber, Backcheck Valve, 2CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inchand is non-DEHP . It is designed specifically for use with theSymbiq™ Infusion Pump and is used to administer fluids from acontainer to a patient's vascular system though a needle or catheter.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 deviceSymbiq 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 flowrates between 0.1ml/hr and 100 ml/hr understandard conditions		Same	Same
Delivery accuracy of List Number 16120 at flowrates between100ml/hr and 500ml/hr understandard 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 atFlow Rate of 500ml/hr	System Verification	System AccuracyPerformance	Pass
Summary Discussion of Bench Performance DataThe 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.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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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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.