Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

K210073 · Fresenius Kabi AG · FRN · Mar 1, 2022 · General Hospital

Device Facts

• Record ID: K210073
• Device Name: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
• Applicant: Fresenius Kabi AG
• Product Code: FRN · General Hospital
• Decision Date: Mar 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets. The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities.

Device Story

Agilia VP Infusion System is a programmable, microcontroller-controlled volumetric linear peristaltic infusion pump. It delivers parenteral fluids, medications, and blood derivatives at programmed rates. Input involves manual programming by trained healthcare professionals in clinical settings. Device features include various infusion modes (continuous, intermittent, primary/secondary, KVO, bolus, loading dose, ramp-up/down, sequential) and mechanical sensors for air, occlusion, temperature, pressure, door status, and set installation. The system includes WiFi connectivity for server communication and is supported by accessories like the Agilia Link stacking rack and Agilia Duo power accessory. Output consists of controlled fluid delivery and system status/alarm notifications (e.g., battery, technical, infusion complete). The device benefits patients by providing precise, automated fluid and medication administration, reducing potential for manual dosing errors through integrated drug library software (Basic Profile). Healthcare providers use the pump interface to manage infusions, with the system providing clinical advisories and alarms to ensure safe operation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, human factors engineering (HFE/UE) studies, electrical safety (IEC 60601-1), EMC testing (IEC 60601-1-2), and cybersecurity assessment. Flow rate and bolus accuracy testing followed AAMI TIR101 2021.

Technological Characteristics

Volumetric linear peristaltic infusion pump; microcontroller-controlled. Dimensions: 5.3 x 7.5 x 6.7 inches; Weight: ~4.4 lbs. Power: 100-240 VAC. Connectivity: WiFi-enabled. Sensors: air, occlusion, temperature, pressure, door, set installation. Standards: IEC 60601-1 (3rd ed), IEC 60601-1-8, IEC 60601-1-2. Software: Basic Profile drug library within pump.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring intermittent or continuous delivery of parenteral fluids, medications, blood, and blood derivatives via intravenous, intra-arterial, subcutaneous, or intraosseous routes in healthcare facilities.

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

• Agilia Infusion System (K121613)

Submission Summary (Full Text)

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March 1, 2022

Fresenis Kabi AG % Keith Dunn Director Regulatory Affairs Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, Illinois 60047

Re: K210073

Trade/Device Name: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ, FPA Dated: January 8, 2021 Received: January 12, 2021

Dear Keith Dunn:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210073

Device Name Agilia VP Infusion System

#### Indications for Use (Describe)

The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.

The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue abstract symbol on the left, resembling three vertical wavy lines. To the right of the symbol, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The text is in a bold, sans-serif font.

# 510(k) SUMMARY

#### Date Prepared

February 28, 2022

#### Owner/Operator

Fresenius Kabi AG 61346 Bad Homburg Germany

Owner/Operator Number: 9027285

#### Contact Person

## Keith Dunn

Director, Regulatory Affairs Fresenius Kabi USA, LLC Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 USA

Phone: [phone] Fax: [phone] E-mail: keith.dunn(@fresenius-kabi.com

## Secondary Contact Person

#### Jason Ma

Sr. Manager, Regulatory Affairs Fresenius Kabi USA, LLC Three Corporate Drive, 2nd Floor Lake Zurich, IL 60047 USA

Phone: [phone] 550 2960 Fax: E-mail: Jason.ma01(@fresenius-kabi.com

#### Device Trade Name

Agilia VP Infusion System

#### Common Name/Usual Name:

Infusion Pump and Accessories

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Image /page/4/Picture/1 description: The image shows the Fresenius Kabi logo. The logo consists of a blue graphic on the left and the words "FRESENIUS KABI" on the right. The graphic is made up of three blue, curved lines. The words "FRESENIUS KABI" are in blue, with "FRESENIUS" on top and "KABI" on the bottom.

## Classification Name

21 CR 880.5725 Infusion Pump

## Product Code and Classification Panel

The Agilia VP Infusion System (pump, set and accessories) has been classified as Class II under 21 CFR 880.5725, and reviewed by the General Hospital Devices Panel (80). For reference, the product code and classification of each device subsystem is identified in Table 1.

| Device Name | Regulation Number | Class | Description | Panel | Product<br>Code |
|-----------------------------------------------|-------------------|-------|---------------------------|-------|-----------------|
| Agilia VP MC WiFi Volumetric<br>Infusion Pump | 21 CFR 880.5725 | II | Infusion Pump | 80 | FRN |
| Agilia Link | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ |
| Agilia Duo | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ |
| Agilia USB Cable | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | MRZ |
| Volumat Line administration<br>sets | 21 CFR 880.5725 | II | Infusion pump accessories | 80 | FPA |

## Table 1: Device Classification

## Legally Marketed Device Under Which Substantial Equivalence is Being Claimed

Agilia Infusion System (K121613)

## Device Description

The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and optional accessories. The optional accessories are identified as follows:

- Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or ● 8 pumps at the patient bedside.
- Agilia Duo two-channel accessory designed to power two Agilia infusion pumps. ●
- Agilia USB Cable - intended to connect the Agilia VP infusion pump to a PC for serial communication.

## Statement of Intended Use/Indications For Use

The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids. medications, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes

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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a blue graphic on the left, which appears to be three stylized vertical lines. To the right of the graphic are the words "FRESENIUS KABI" in blue, with "FRESENIUS" on top of "KABI". There is a small subscript number 1 next to the letter S in Fresenius.

of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.

The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood and blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities.

#### Technological Comparison as Compared to the Predicate Device

A comparison between the predicate device and the subject device is provided in the Table 2.

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Image /page/6/Picture/1 description: The image shows the Fresenius Kabi logo. The logo consists of a blue abstract symbol on the left and the words "FRESENIUS KABI" in blue on the right. The abstract symbol is made up of three vertical wavy lines.

| Characteristic | Predicate Device | Subject Device | Comment |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K121613 | K210073 | |
| Intended Use /<br>Indications for<br>Use | The Agilia Infusion System is<br>a transportable equipment<br>intended for use by trained<br>healthcare professionals in<br>healthcare facilities and<br>homecare environments on<br>adults, pediatrics and<br>neonate's human patients to<br>administer via a single<br>channel or mounted on a<br>multiple channels rack<br>accessory:<br>• Intermittent or continuous<br>delivery of parenteral fluids<br>(solutions, colloids,<br>parenteral nutrition) and<br>medications (including but<br>not limited to diluted drugs,<br>chemotherapy) through<br>clinically accepted IV routes<br>of administration.<br>• Transfusion of blood and<br>blood derivatives products. | The Agilia VP Infusion<br>System is intended for adult<br>and pediatric care for the<br>intermittent or continuous<br>delivery of parenteral fluids,<br>medications, blood and blood<br>derivatives through clinically<br>accepted parenteral routes of<br>administration. These routes<br>of administration include<br>intravenous, intra-arterial,<br>subcutaneous and<br>intraosseous using dedicated<br>administration sets.<br>The Agilia VP Infusion<br>System is also intended for<br>neonatal care for the<br>intermittent or continuous<br>delivery of parenteral fluids<br>for hydration and nutrition,<br>blood and blood derivatives<br>through clinically accepted<br>parenteral routes of<br>administration. These routes<br>of administration include<br>intravenous, intra-arterial,<br>and subcutaneous using<br>dedicated administration sets.<br>It is intended for use by<br>trained healthcare<br>professionals in healthcare<br>facilities. | Similar<br>The intended use<br>between the predicate<br>and proposed device<br>are the same in terms<br>of intended patient,<br>route of<br>administrations, and<br>treatment. Per FDA<br>guidance, the<br>statement was revised<br>to specifically name<br>the intended routes of<br>administration and to<br>differentiate the<br>intended patient<br>population . |
| Type of Pump | Volumetric, Linear Peristaltic<br>Pump | Volumetric, Linear Peristaltic<br>Pump | Same |
| Patient<br>Population | Adults, pediatrics, neonates | Adults, pediatrics, neonates | Same |
| Delivery<br>Modes | Continuous, Intermittent,<br>Primary, Secondary, KVO,<br>Bolus (Manual and<br>Programmable), Loading<br>Dose | Continuous, Intermittent,<br>Primary, Secondary, KVO,<br>Bolus (Manual and<br>Programmable), Loading<br>Dose, Ramp-up / Ramp<br>down, Sequential | Similar<br>Performance testing<br>demonstrates the<br>additional modes do<br>not introduce any new<br>issues of safety or<br>effectiveness. |
| Characteristic | Predicate Device | Subject Device | Comment |
| | K121613 | K210073 | |
| Infusion<br>Accuracy | $\pm$ 5% | $\pm$ 5% under most conditions | Similar<br>Detailed flow rate<br>accuracy disclosed in<br>the labeling |
| WIFI | No | Yes | Similar<br>Performance testing<br>demonstrates the<br>addition of WIFI<br>functionality does not<br>introduce any new<br>issues of safety or<br>effectiveness. |
| Pump Control | Microcontroller controlled | Microcontroller controlled | Same |
| Number of<br>Channels | 1 | 1 | Same |
| Mechanical<br>Sensors | air, occlusion, temperature,<br>pressure, door, set installation | air, occlusion, temperature,<br>pressure, door, set installation | Same |
| Barcoding | No | No | Same |
| Automated<br>Programming | No | No | Same |
| Manual<br>Programming | Yes | Yes | Same |
| Piggy back /<br>secondary | Yes | Yes | Same |
| Alarms | Air, occlusion, temperature,<br>system malfunction,<br>set installation, door,<br>low drug reservoir volume,<br>infusion complete, battery,<br>technical | Air, occlusion, temperature,<br>system malfunction,<br>set installation, door,<br>low drug reservoir volume,<br>infusion complete, battery,<br>technical | Same |
| Clinical<br>Advisories | Yes | Yes | Same |
| Infusion<br>Modes | Basic, continuous,<br>intermittent, primary /<br>secondary, KVO, Bolus<br>(direct and programmed),<br>Loading Dose | Basic, continuous,<br>intermittent, primary /<br>secondary, KVO, Bolus<br>(direct and programmed),<br>Loading Dose, Ramp-up /<br>Ramp Down, Sequential | Similar<br>Performance testing<br>demonstrates the<br>additional infusion<br>modes do not<br>introduce any new<br>issues of safety or<br>effectiveness. |
| Characteristic | Predicate Device | Subject Device | Comment |
| | K121613 | K210073 | |
| Features | Keypad lock | Keypad lock/automatic lock,<br>occlusion auto restart | Similar<br>Performance testing<br>demonstrates the<br>additional keypad<br>features do not<br>introduce any new<br>issues of safety or<br>effectiveness. |
| Dose Error<br>Reduction<br>Software /<br>Drug Library<br>Software<br>Compatibility | Basic Profile (within pump) | Basic Profile (within pump) | Same |
| Wireless<br>Server<br>Software | No | Yes | Similar<br>Performance testing<br>demonstrates the<br>addition of wireless<br>server software does<br>not introduce any new<br>issues of safety or<br>effectiveness. |
| Administration<br>Sets | Volumat Line administration<br>sets | Volumat Line administration<br>sets | Same |
| Racking /<br>Organization /<br>Power | Link+ Agilia | Agilia Link | Similar<br>Simpler, non-<br>communicating<br>accessory for proposed<br>device |
| | Agilia Duo | Agilia Duo | Same |
| Electrical<br>Safety | IEC 60601-1: 1998 +A1:1995<br>(2nd edition)<br>IEC 60601-1-8: 2003<br>+A1:2006<br>IEC 60601-1-2: 2007<br>ANSI/AAMI ID26:<br>2004/(R)2009 | IEC 60601-1: 2005<br>+A1:2012 (3rd edition)<br>IEC 60601-1-8: 2012<br>IEC 60601-1-2: 2014<br>ANSI/AAMI ID26:<br>2004/(R)2009 | Similar<br>Performance testing<br>demonstrates the<br>application of state-of-<br>the-art standards does<br>not introduce any new<br>issues of safety or<br>effectiveness. |
| Mechanical /<br>Power<br>Specifications | Pump Size: 5.3 x 7.5 x 6.7<br>inches<br>Pump Weight: App. 4.4 lbs.<br>Line Power: 100-240 VAC | Pump Size: 5.3 x 7.5 x 6.7<br>inches<br>Pump Weight: App. 4.4 lbs.<br>Line Power: 100-240 VAC | Same |
| Operating<br>Environment | Temperature: 41° F to 104° F<br>Relative Humidity: 20-90% | Temperature: 41° F to 104° F<br>Relative Humidity: 20-90% | Same |
| Characteristic | Predicate Device<br>K121613 | Subject Device<br>K210073 | Comment…