K Number
K210074
Device Name
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Manufacturer
Date Cleared
2022-03-01

(413 days)

Product Code
Regulation Number
880.5725
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, 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 SP 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 and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets. It is intended for use by trained healthcare professionals in healthcare facilities
Device Description
The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with 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 SP infusion pump to a PC for serial communication.
More Information

Not Found

No
The summary describes a standard infusion pump with programmable features and accessories. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The testing focuses on traditional medical device performance and safety metrics.

Yes

The device is an infusion system designed to deliver parenteral fluids, medication, blood derivatives, and critical drugs. These actions are directly involved in the treatment or management of a patient's condition, which aligns with the definition of a therapeutic device.

No

This device is an infusion system designed for the delivery of fluids and medication, not for diagnosing conditions. Its purpose is therapeutic/interventional, not diagnostic.

No

The device description explicitly states that the Agilia SP Infusion System includes a "Syringe Infusion Pump," which is a physical hardware component. The description also lists optional hardware accessories.

Based on the provided information, the Agilia SP Infusion System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states the device is for the delivery of fluids, medications, blood derivatives, etc., into the patient's body through various parenteral routes. This is an in vivo application (within a living organism).
  • Device Description: The description details a programmable electronic medical system for administering substances to a patient.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The Agilia SP Infusion System does not perform any such analysis of specimens.

Therefore, the Agilia SP Infusion System is a medical device used for patient treatment, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes

FRN, MRZ

Device Description

The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with 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 SP infusion pump to a PC for serial communication.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric care, neonatal care

Intended User / Care Setting

trained healthcare professionals in healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Testing:

  • Verification testing of product requirements.
  • Human factors engineering testing of product requirements associated with critical tasks.
  • Testing for the reliability goals of the device.

A safety assurance case was provided as recommended in the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014. The goal of the safety assurance case is: The system design is acceptably safe for its intended use by its intended users and in its intended use environment. The supporting assurance arguments covered the following attributes:

  • Residual risks are analyzed and determined to be acceptably low using industry-standard risk analysis practices and regulatory guidance
  • The Agilia SP Infusion System is at least as safe as an equivalent infusion system.
  • The Agilia SP Infusion System is Verified and Validated for its intended use as it relates to safety
  • The Agilia SP Infusion System is reliable over the system's expected lifetime.

Evidence included in the safety assurance case:

  • Risk Management File
  • Design verification and validation testing confirmed the Agilia SP Infusion System met user needs and design inputs. Testing results conformed with acceptance criteria. Flow rate and bolus accuracy testing were conducted by following AAMI TIR 101 2021.
  • Device reliability activities, testing and statistical analysis confirmed the Agilia SP Infusion System met its reliability goal at the system, device subsystem, and subsystem component level.
  • Software verification and validation were performed per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
  • Human factors evaluation conducted to validate the effectiveness of use-related features/functionality and use error-related mitigations in the associated use environments. IEC 62366-1 Edition 1.0 2015 Medical Devices Part 1: Application of usability engineering to medical devices was followed.
  • Electrical and Electromagnetic Compatibility testing were conducted. The Infusion System complies with IEC 60601-1 and IEC 60601-1-2.
  • Cybersecurity testing performed confirmed the system is effective in addressing cybersecurity threats. FDA Cybersecurity Guidance followed include: Content of Premarket Submissions for Management of Cybersecurity, October 2, 2014; Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016.

Clinical Testing:
Clinical evaluation is not required for this submission to support substantial equivalence. Human Factors studies have been conducted on the subject device demonstrating passing results.

Key Metrics

Flow Rate Accuracy: +/- 3% under most conditions

Predicate Device(s)

K133532

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2022

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

Re: K210074

Trade/Device Name: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN. MRZ Dated: January 31, 2022 Received: February 3, 2022

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

1

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 (1-800-638-2041 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) K210074

Device Name Agilia SP Infusion System

Indications for Use (Describe)

The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, 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 SP 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 and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, 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)
Prescription Use (Part 21 CFR 801 Subpart D)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. On the left side of the logo are three blue wavy lines. To the right of the wavy lines is the text "FRESENIUS KABI" in blue. The word "FRESENIUS" is on top of the word "KABI".

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: 224-817-2430 Fax: 847 550 2960 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: 224-817-4100 847 550 2960 Fax: E-mail: jason.ma01(@fresenius-kabi.com

Device Trade Name

Agilia SP 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. On the left side of the logo are three blue wavy lines stacked on top of each other. To the right of the wavy lines is the text "FRESENIUS" on top of the text "KABI". The text is also in blue.

Classification Name

21 CR 880.5725 Infusion Pump

Product Code and Classification Panel

The Agilia SP 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 | Produc
t Code |
|-----------------------------------------|----------------------|-------|---------------------------|-------|------------------|
| Agilia SP MC WiFi Syringe 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 |

Table 1: Device Classification

Legally Marketed Device Under Which Substantial Equivalence is Being Claimed

Alaris System with Guardrails Suite MX (K133532)

Device Description

The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with 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 SP infusion pump to a PC for serial communication.

Statement of Intended Use/Indications For Use

The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood, and blood derivatives

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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of a stylized blue wave-like graphic on the left, followed by the text "FRESENIUS" stacked above "KABI" in a bold, sans-serif blue font. The wave graphic is composed of three parallel, curved lines that resemble flowing water or a stylized representation of veins, which is relevant to the company's focus on pharmaceuticals and medical technology. The overall design is clean and modern, conveying a sense of innovation and reliability.

through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets.

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

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 contains the logo for Fresenius Kabi. The logo consists of a blue abstract wave-like design on the left, followed by the company name "FRESENIUS" in a bold, sans-serif font. Below "FRESENIUS" is the word "KABI", also in a bold, sans-serif font, and in the same blue color.

CharacteristicPredicate DeviceSubject DeviceComment
K133532K210074
Intended Use /
Indications for
UseThe Alaris® PC Unit is the
main user interface unit and
power supply of the Alaris®
System, a modular system to
be used with Alaris®
System modules intended
for use in today's growing
professional healthcare
environment for facilities
that utilize infusion and/or
monitoring devices. The
specific intended use for
each Alaris® System
module is specified in its
respective submission.

The Alaris System with
Guardrails Suite MX is
intended for use in today's
growing professional
healthcare environment for
facilities that utilize syringe
pumps for the delivery of
fluids, medications, blood
and blood products. It is
indicated for use on adults,
pediatrics and neonates for
continuous or intermittent
delivery through clinically
acceptable routes of
administration such as
intravenous (IV), intra-
arterial (IA), subcutaneous,
epidural, enteral, or
irrigation of fluid spaces. | The Agilia SP Infusion
System is intended for adult
and pediatric care for the
intermittent or continuous
delivery of parenteral fluids,
medication, blood, and
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 SP Infusion
System is also intended for
neonatal care for the
intermittent or continuous
delivery of parenteral fluids
for hydration and nutrition,
medication, blood, and
blood derivatives through
clinically accepted
parenteral routes of
administration and critical
drugs under specific
conditions. These routes of
administration include
intravenous, intra-arterial,
and subcutaneous using
dedicated administration
sets. | Similar
Overall intended
use except the
proposed device
does not include
indications for
epidural or enteral
infusion. |
| Type of Pump | Syringe Infusion Pump | Syringe Infusion Pump | Same |
| Patient
Population | Adults, pediatrics, neonates | Adults, pediatrics, neonates | Same |
| Delivery Modes | Continuous, Intermittent,
KVO, Bolus (Manual and
Programmable), Loading
Dose, Basic infusion | Continuous, Intermittent,
KVO, Bolus (Manual and
Programmable), Loading
Dose, Basic infusion (also
called Basic Profile) | Same |
| Characteristic | Predicate Device | Subject Device | Comment |
| | K133532 | K210074 | |
| Flow Rate
Accuracy | ±5% for flow rates between
1 and 999 mL/h
±5.5% for flow rates less
than 1 mL/h | ±3% under most conditions | Similar
Detailed flow rate
accuracy disclosed
in the labeling |
| WIFI | Yes | Yes | Same |
| Pump Control | Microcontroller controlled | Microcontroller controlled | Same |
| Number of
Channels | 1 | 1 | Same |
| Mechanical
Sensors | occlusion, temperature,
pressure, syringe
installation, force sensor | occlusion, temperature,
pressure, syringe
installation, force sensor | Same |
| Manual
Programming | Yes | Yes | Same |
| Alarms | High pressure / occlusion,
temperature, system
malfunction, empty syringe,
plunger disengages, syringe
unlocked, infusion near end,
infusion complete, low
battery, depleted battery,
technical | High pressure / occlusion,
temperature, system
malfunction, empty syringe,
plunger disengages, syringe
unlocked, infusion near end,
infusion complete, low
battery, depleted battery,
technical | Same |
| Clinical
Advisories | Yes | Yes | Same |
| Infusion Modes | Basic infusion,
continuous/intermittent,
Volume to be infused, Dose
to be infused, KVO, Bolus
(direct and programmed),
Loading Dose | Basic infusion,
continuous/intermittent,
Volume to be infused, Dose
to be infused, KVO, Bolus
(direct and programmed),
Loading Dose | Same |
| Features | Keypad lock/automatic lock,
occlusion auto restart | Keypad lock/automatic lock,
occlusion auto restart | Same |
| Dose Error
Reduction
Software / Drug
Library | Basic Profile (within pump) | Basic Profile (within pump) | Same |
| Wireless Server
Software | Yes | Yes | Same |
| Characteristic | Predicate Device | Subject Device | Comment |
| | K133532 | K210074 | |
| Number of
Compatible
Syringes | 20 | 5 | Similar
Compatibility of
syringes is
dependent on the
pump. |
| Racking /
Organization /
Power | Maximum of 4 | Agilia Link (for 4, 6 or 8
pumps)
Agilia Duo (for 2 pumps) | Similar
Accessories
provide equivalent
functionality. |
| Electrical Safety | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1: 2005
+A1:2012 (3rd edition)
IEC 60601-1-8: 2012
IEC 60601-1-2: 2014 | Similar
State-of-the-art
compliance |
| Mechanical /
Power
Specifications | Pump Size: 8.8 x 6.9 x 9
(PC Unit) 15 x 4.5 x 7.5
(syringe module) inches
Pump Weight: 7.2 lbs. (PC
unit) 4.5 lbs. syringe module
Line Power: 100-240 VAC | Pump Size:
5.3 x 13.6 x 6.7 inches
Pump Weight: App. 4.6 lbs.
Line Power: 100-240 VAC | Similar
System size and
weight considered
moderately small. |
| Operating
Environment | Temperature 41 °F to 104°F
Relative Humidity: 20-90%
w/o condensation | Temperature 41 °F to 104°F
Relative Humidity: 20-90%
w/o condensation | Same |
| Storage
Environment | Temperature: 4 °F to 140°F
Relative Humidity: 5-90%
w/o condensation - | Temperature: 14°F to 140°F
Relative Humidity: 10-90%
w/o condensation | Similar
Functional and
expected life
testing have found
no new issues of
safety or
effectiveness with
this change. |

Table 2: Predicate Comparison

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Image /page/7/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, stylized waves on the left side. To the right of the waves, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The logo is simple and modern, with a focus on the company name and a visual representation of movement or flow.

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Image /page/8/Picture/1 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. The word "FRESENIUS" is on top of the word "KABI".

To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed:

  • Verification testing of product requirements. ●

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Image /page/9/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. The words "FRESENIUS" and "KABI" are stacked on top of each other.

  • Human factors engineering testing of product requirements associated with critical tasks.
  • Testing for the reliability goals of the device. .

Non-Clinical Testing

A safety assurance case was provided for the Agilia SP Infusion System as recommended in the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014.

The stated goal of the safety assurance case is:

  • The system design is acceptably safe for its intended use by its intended users and in . its intended use environment.
    The assurance case defines the device system, including the operational description, system definition, indications for use, patient population, intended users and use environments. The supporting assurance arguments covered the following attributes:

  • Residual risks are analyzed and determined to be acceptably low using industrystandard risk analysis practices and regulatory guidance

  • The Agilia SP Infusion System is at least as safe as an equivalent infusion system.

  • The Agilia SP Infusion System is Verified and Validated for its intended use as it relates to safety

  • The Agilia SP Infusion System is reliable over the system's expected lifetime.

The following evidence was included in the safety assurance case:

  • Risk Management File
  • . Design verification and validation testing confirmed the Agilia SP Infusion System met user needs and design inputs. Testing results conformed with acceptance criteria. Flow rate and bolus accuracy testing were conducted by following AAMI TIR 101 2021.
  • . Device reliability activities, testing and statistical analysis confirmed the Agilia SP Infusion System met its reliability goal at the system, device subsystem, and subsystem component level.

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Image /page/10/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of two parts: a graphic element on the left and the company name on the right. The graphic element is composed of three blue, stylized, vertical lines that resemble waves or streams. To the right of the graphic, the words "FRESENIUS" and "KABI" are stacked vertically, also in blue.

  • Software verification and validation were performed per FDA Guidance for the ● Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
  • Human factors evaluation conducted to validate the effectiveness of use-related features/functionality and use error-related mitigations in the associated use environments. IEC 62366-1 Edition 1.0 2015 Medical Devices Part 1: Application of usability engineering to medical devices was followed.
  • Electrical and Electromagnetic Compatibility testing were conducted. The Infusion System complies with the following standards:
    • Electrical Safety per IEC 60601-1 O
    • o EMC testing per IEC 60601-1-2
  • Cybersecurity testing performed confirmed the system is effective in addressing ● cybersecurity threats. FDA Cybersecurity Guidance followed include:
    • Content of Premarket Submissions for Management of Cybersecurity, October 2, O 2014
    • O Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016

Clinical Testing

Clinical evaluation is not required for this submission to support substantial equivalence. Human Factors studies have been conducted on the subject device demonstrating passing results.

Conclusion

The results of software, electrical safety, system verification and validation testing conclude that the Agilia SP Infusion System is safe and effective for the intended users, uses, and use environments, and that no further clinical investigation or testing is needed. The methods and results described in the verification and human factors evaluation (HFE/UE) reports support this conclusion.

Results of verification and validation activities demonstrate that the Agilia SP Infusion System is substantially equivalent to the predicate Alaris System with Guardrails Suite MX (K133532).