The Agilia Infusion System is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonates human patients to administer via a single channel or mounted on a multiple channels rack accessory:
· Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration.
· Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required.

Device Description

The Agilia Infusion System is composed of the following components:

· Volumat MC Agilia infusion pump
· Volumat Lines administration sets
- 16 sterile administration sets, including 2 for transfusions and 1 auxiliary line
· Link+ Agilia racks, three options:
- Link4+
- Link6+
- · Link8+
· Vigilant Drug'Lib Agilia: dose error reduction software (DERS)
- · Accessories:
  - . Agilia Duo
  - Agilia USB cable .
. Link+ Agilia Nurse Call cable
Agilia RS232 cable
Link+ Agilia Ethernet cross-over cable .
Link+ Agilia USB Cable .

The Volumat MC Agilia infusion pump is a peristaltic infusion pump which can be installed on a rail or pole, or on a flat surface. The system is configurable by the user, ranging from a configuration with a single Volumat MC Agilia infusion pump to multiple-pump configurations utilizing Link+ racks connected to a Hospital Information System (HIS). A series of two pumps may be configured using the Agilia DUO accessory, or a series of 4, 6, or 8 pumps may be mounted on the Link+ Agilia rack to centralize power supply and data communication. Vigilant Drug'Lib Agilia dose error reduction software (DERS) (optional) is installed on a PC platform for communication with the pump via a USB cable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Fresenius Kabi Agilia Infusion System (K121613), based on the provided text:

Important Note: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting de novo acceptance criteria and performance data for a novel device. Therefore, the "acceptance criteria" here are largely implied by the equivalence demonstration to the predicate. The document states that the proposed and predicate devices have "equivalent accuracies and infusion volume capacities, as well as similar rate ranges." However, specific numerical acceptance criteria (e.g., "accuracy must be within ±X%") and directly corresponding reported performance values are not explicitly provided in this document. The provided text primarily summarizes the non-clinical testing performed to support the safety and performance claims by adhering to industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence & Standards Adherence)	Reported Device Performance
Accuracy and Infusion Volume Capacity: Equivalent to predicate device (Infusomat® Space Volumetric Infusion System).	Stated as "equivalent accuracies and infusion volume capacities" to the predicate device. No specific numerical values provided in the summary.
Rate Ranges: Similar to predicate device.	Stated as "similar rate ranges" to the predicate device. No specific numerical values provided in the summary.
Occlusion Detection: Detects upstream and downstream occlusion.	Both pumps detect upstream and downstream occlusion by means of specific sensors.
DERS Safety: Assures safety in an equivalent way to predicate DERS.	Both offer the possibility to limit the same drug parameters in DERS mode and assure safety in an equivalent way.
Biocompatibility: Complies with ISO 10993-1, ISO 8536, ISO 594 for Volumat Lines.	Biocompatibility testing performed according to ISO 10993-1, ISO 8536, ISO 594. (Implies compliance)
Hardware & Software V&V: Complies with relevant industry standards (e.g., IEC 60601-2-24, ISO 60601-1-8, IEC 62304, ISO 8536, ISO 594).	Hardware and software verification and validation testing performed, including testing to relevant industry standards. (Implies compliance)
Electrical Safety & EMC: Complies with IEC 60601-1, IEC 60601-1-2.	Testing to industry standards for electrical safety and electromagnetic compatibility (e.g., IEC 60601-1, IEC 60601-1-2) performed. (Implies compliance)
Sterilization Validation, Shelf Life, Packaging & Transport: Validated.	Sterilization validation, shelf life testing, packaging and transport validation performed. (Implies successful validation)
Usability: Design optimized for safety and validated usability in simulated use environment (per IEC 62366).	Usability assessments conducted in a simulated use environment in accordance with IEC 62366 to optimize the safety of the device design and validate the usability of the system. (Implies successful validation)

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

The document does not explicitly specify a "test set" in the context of clinical data for performance evaluation. Instead, it refers to:

Non-clinical testing: This would involve various engineering and laboratory tests on discrete components and the integrated system. Specific sample sizes for these individual tests are not mentioned in this summary.
Usability Assessments: These were conducted in a simulated use environment. The sample size of participants for these assessments is not specified.
Data Provenance: The studies are described as "non-clinical testing" and "usability assessments." This implies the data were laboratory-generated or simulated-environment generated, rather than from live patient data. The country of origin for these studies is not explicitly stated, but the submitter (Fresenius Kabi AG) is based in Bad Homburg, Germany.

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

This information is not provided in the document. For non-clinical and usability testing, "ground truth" would be established by test protocols, established industry standards, and expert engineering judgment, but the report doesn't detail the involvement of specific experts for this purpose beyond general statements about adherence to standards.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where multiple human readers or evaluators assess patient cases, which was not the primary focus of this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC comparative effectiveness study was done. The device is an infusion pump, not an AI-powered diagnostic or assistive tool for human readers in the traditional sense. The "DERS" (Dose Error Reduction Software) is a safety feature, but its integration is described as equivalent to the predicate, and no study measuring human improvement with or without this specific DERS is mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself (the infusion pump system) is a standalone piece of medical equipment designed to perform infusions. The performance testing primarily assessed the function of the device itself (e.g., accuracy, occlusion detection) in a non-clinical setting, which can be considered a standalone assessment of the algorithm/hardware's ability to perform its intended function. However, "standalone" in the context of diagnostic AI algorithms usually refers to the algorithm making a decision without human input, which is not directly applicable here.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing and usability assessments would be:

Engineering Specifications and Industry Standards: For performance metrics like accuracy, flow rate, and occlusion detection, the ground truth is defined by the device's design specifications and the requirements of standards like IEC 60601-2-24.
Simulated Use Environment Outcomes: For usability, the ground truth is established by observing user interaction in a simulated environment and identifying potential use errors or safety concerns according to principles outlined in IEC 62366.
Biocompatibility Standards: For material safety, compliance with ISO 10993 standards constitutes the ground truth.

8. The Sample Size for the Training Set

The document does not describe the development of an AI algorithm that would require a "training set" in the typical sense (e.g., for machine learning). The DERS software is configurable but its development doesn't appear to be based on a machine learning model that requires a training set of data.

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

As no training set (for a machine learning model) is described, this information is not applicable. For the DERS, the "ground truth" for its functionality (e.g., drug limits) would be established by clinical protocols, pharmaceutical guidelines, and expert medical judgment during its configuration for hospital use, but this is not a training set for an algorithm.

Summary

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K121613

510(k) Summary for the Fresenius Kabi Agilia Infusion System

MAY 0-1 2013

SUBMITTER/510(K) HOLDER 1.

Fresenius Kabi AG Else-Kröner-Strasse 1 61352 Bad Homburg, Germany

Michel MONIER, michel.monier@fresenius-kabi.com Contact Name: Telephone Number: +33 476 671 010

May 31, 2012 Date Prepared:

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

Agilia Infusion System Infusion pump system Infusion pumps Intravascular administration sets

PREDICATE DEVICES 3.

K062700/K083689 B. Braun Medical, Inc., Infusomat® Space Volumetric � Infusion Pump System

DEVICE DESCRIPTION 4.

The Agilia Infusion System is composed of the following components:

· Volumat MC Agilia infusion pump
· Volumat Lines administration sets
- 16 sterile administration sets, including 2 for transfusions and 1 auxiliary line
· Link+ Agilia racks, three options:
- Link4+
- Link6+
- · Link8+
· Vigilant Drug'Lib Agilia: dose error reduction software (DERS)
- · Accessories:
  - . Agilia Duo
  - Agilia USB cable .

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. Link+ Agilia Nurse Call cable
Agilia RS232 cable
Link+ Agilia Ethernet cross-over cable .
Link+ Agilia USB Cable .

INDICATION FOR USE/INTENDED USE 5.

Intermittent or continuous delivery of parenteral fluids (solutions, colloids, . parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration.
Transfusion of blood and blood derivatives products. ◆

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE 6. PREDICATE DEVICE/S

Both the proposed Agilia Infusion System and the predicate Infusomat® Space Volumetric Infusion System have a similar overall design, consisting of an external and transportable infusion pump with accessories including dedicated administration sets, DERS, and a rack for mounting several individual pumps to provide centralized power and alarms replication.

The proposed Volumat MC Agilia and Infusomat® Space infusion pumps are both microprocessor-controlled, linear peristaltic pumps that achieve infusion in an identical manner and have similar operational features, alarms, and indicators. The technological and performance characteristics of the proposed and the predicate device are also similar. The two systems have equivalent accuracies and infusion

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volume capacities, as well as similar rate ranges. Both pumps detect upstream and downstream occlusion by means of specific sensors. In addition, both pumps offer the possibility to limit the same drug parameters in DERS mode and assure safety in an equivalent way.

The Link+ Agilia and SpaceStation from B. Braun are both rack systems that are intended to power mounted IV pumps and ensure infusion data communication to external HIS. Link+ Agilia and B. Braun SpaceStation support hospital wired network connection using Ethernet standard and to export patient infusion data to third party systems. Link+ Agilia does not support RF wireless network connection in order to limit radio frequency emissions at the bedside.

Both the Vigilant Drug'Lib Agilia DERS and B. Braun Drug List Editor software applications are intended to secure the administration of drugs with configurable drug limits according to clinical practice. Vigilant Drug'Lib Agilia can upload up to 19 different drug libraries to pumps. The drug library of the Agilia Infusion System can be adapted to a specific care area (association of a drug library and a set of device configurations). Vigilant Drug'Lib Agilia manages up to 19 Care Areas. The predicate device manages up to 15 drug categories that serve to classify the drugs from a drug pool or to create a subset of drugs with different concentrations.

The administration sets provided for use with the proposed and predicate infusion systems have equivalent technological characteristics, with various component combinations and materials for specific medical applications. Both the proposed and predicate administration sets include tubing sets, connectors, filters, etc. that comply with industry requirements and standards. Technological characteristics such as tubing diameter and length, filter sizes, Luer Lock connectors, etc., are comparable for the proposed and predicate devices and conform to industry standards.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Nonclinical testing performed to support the performance and safety claims for the Agilia Infusion System includes, but is not limited to, the following:

· Biocompatibility testing according to ISO 10993-1, ISO 8536, ISO 594 for Volumat Lines
· Hardware and software verification and validation testing including testing to relevant industry standards (e.g. IEC 60601-2-24, ISO 60601-1-8, IEC 62304, ISO 8536, ISO 594)

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· Testing to industry standards for electrical safety and electromagnetic compatibility (e.g., IEC 60601-1, IEC 60601-1-2)
Sterilization validation, shelf life testing, packaging and transport validation

Usability assessments were conducted in a simulated use environment in accordance with IEC 62366 to optimize the safety of the device design and validate the usability of the system.

SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8.

No clinical testing was performed in support of this premarket notification.

SUMMARY OF OTHER INFORMATION 9.

Per the Guidance for Industry and FDA Staff, Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (April 23, 2010) (TPLC Infusion Pump Guidance), a safety assurance case is provided for the Agilia Infusion System.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Non-clinical testing, as well as a detailed clinical evaluation involving an extensive series of usability tests, supports the performance and safety claims for the Agilia Infusion System. The similarities in intended use, operational characteristics, technological characteristics, and performance characteristics between the proposed Agilia Infusion System and the predicate Infusomat Space Volumetric Infusion Pump System lead to a conclusion of substantial equivalence between the proposed and predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

May 1, 2013

Fresenius Kabi AG C/O Ms. Cheryl Roscher Three Corporate Drive LAKE ZURICH Illinois 60047

Re: K121613

Trade/Device Name: Agilia Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 26, 2013 Received: April 29, 2013

Dear Ms. Roscher:

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.

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

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Page 2 - Ms. Roscher

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Image /page/5/Picture/8 description: The image contains a logo or emblem with stylized text and geometric shapes. The text appears to read "for" on the top left, and "with" and "ufowits" in the center. The right side of the image features a triangular shape with multiple lines, creating a layered effect. The overall design is intricate and appears to be hand-drawn or stylized.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K121613

Device Name:

Agilia Infusion System

Indication(s) for Use:

· Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but not limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration.

· Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required.

Prescription Use: X

AND/OR

Over-the-counter Use:

(21 CFR 801 Subpart D)

(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)

Sajjad H. Syed
----------------

signed by Sailad H. Sved U.S. Government, ou=HHS. People, cn=Saijad H. Sved. 0300 100.1.1=2000601742 2013.04.30 14:17:40 -04'00

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

510(k) Number: K121613

Page 1 of 1

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).