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.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Agilia SP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic or clinical outcomes.

Therefore, many of the requested detailed points regarding acceptance criteria and performance against a test set (especially those related to AI/MRMC studies, ground truth establishment, and expert adjudication) are not applicable directly to this type of device clearance and the information provided in this document.

However, I can extract information related to the acceptance criteria for the non-clinical performance of the infusion pump and the methods used to prove that performance.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating equivalence in technical specifications and safety/performance characteristics. The most direct mention of a performance criterion is for flow rate accuracy.

Characteristic	Acceptance Criterion (Predicate Device)	Reported Device Performance (Subject Device)	Comment/Comparison
Flow Rate Accuracy	±5% for 1-999 mL/h; ±5.5% for <1 mL/h	±3% under most conditions	Similar (Subject device reports better accuracy)

Note: The document states "Detailed flow rate accuracy disclosed in the labeling." This implies the acceptance criteria for the subject device are met by its reported performance of ±3% under most conditions, which is presented as being "similar" to the predicate, with the subject device apparently exceeding the predicate's reported accuracy.

2. Sample size used for the test set and the data provenance

The document specifies non-clinical testing for product requirements, human factors, and reliability. It mentions "Design verification and validation testing" and "Device reliability activities, testing and statistical analysis."

Sample Size: The specific sample sizes for these non-clinical tests (e.g., number of pumps tested for flow rate accuracy, number of reliability tests) are not detailed in this summary document.
Data Provenance: The tests are described as "non-clinical testing" and performed by the manufacturer (Fresenius Kabi AG, Germany/USA). This indicates they were prospective, laboratory-based tests conducted by the company for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device clearance. Infusion pumps are mechanical/electronic devices, and their performance is evaluated against engineering specifications, not human expert interpretation of data like in an AI/imaging device. The "ground truth" for flow rate, for example, is established by precise measurement equipment and engineering standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions (e.g., in radiology studies). This documentation describes non-clinical engineering and performance testing.

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

This question is not applicable. The Agilia SP Infusion System is an infusion pump, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study is irrelevant to its clearance.

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

This question is not applicable. There is no "algorithm" in the sense of an AI or diagnostic algorithm being evaluated for standalone performance. The device's "standalone" performance refers to its functional operation as an infusion pump, which was verified through non-clinical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-clinical performance (e.g., flow rate accuracy, alarms, mechanical sensors, electrical safety), the "ground truth" is established by:

Engineering Specifications and Standards: Compliance with recognized standards such as AAMI TIR 101 2021 (for flow rate and bolus accuracy), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8 (for electrical safety and EMC), and IEC 62366-1 (for human factors/usability).
Design Inputs and User Needs: The device was tested to confirm it "met user needs and design inputs."
Risk Analysis: Residual risks were determined to be acceptably low using "industry-standard risk analysis practices."

8. The sample size for the training set

This question is not applicable. As a physical infusion pump (not an AI/machine learning device), there is no "training set." The device is designed, manufactured, and verified/validated against engineering principles and standards, not trained on data.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this device.

Summary of what the document does describe regarding proving device performance:

The document outlines a comprehensive set of non-clinical tests performed to demonstrate the safety and effectiveness of the Agilia SP Infusion System and its substantial equivalence to the predicate device (Alaris System with Guardrails Suite MX). These tests primarily involved:

Verification testing of product requirements: Ensuring the device meets its specified design inputs.
Human factors engineering testing: Evaluating the user interface and safety for critical tasks according to IEC 62366-1.
Reliability testing: Confirming the device meets its reliability goals over its expected lifetime.
Flow rate and bolus accuracy testing: Conducted following AAMI TIR 101 2021.
Software verification and validation: Per FDA guidance (May 2005).
Electrical Safety (IEC 60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) testing.
Cybersecurity testing: Adhering to FDA Cybersecurity Guidance (October 2014, December 2016).

The "acceptance criteria" for these tests are implicitly that the device performs according to its design specifications, meets relevant international standards (e.g., IEC, AAMI), and demonstrates safety and effectiveness comparable to the predicate device (or better, as seen with flow rate accuracy). The safety assurance case framework provides an overarching structure for these demonstrations.

Summary

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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

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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 (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)

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	RegulationNumber	Class	Description	Panel	Product 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

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.

Characteristic	Predicate Device	Subject Device	Comment
	K133532	K210074
Intended Use /Indications forUse	The Alaris® PC Unit is themain user interface unit andpower supply of the Alaris®System, a modular system tobe used with Alaris®System modules intendedfor use in today's growingprofessional healthcareenvironment for facilitiesthat utilize infusion and/ormonitoring devices. Thespecific intended use foreach Alaris® Systemmodule is specified in itsrespective submission.The Alaris System withGuardrails Suite MX isintended for use in today'sgrowing professionalhealthcare environment forfacilities that utilize syringepumps for the delivery offluids, medications, bloodand blood products. It isindicated for use on adults,pediatrics and neonates forcontinuous or intermittentdelivery through clinicallyacceptable routes ofadministration such asintravenous (IV), intra-arterial (IA), subcutaneous,epidural, enteral, orirrigation of fluid spaces.	The Agilia SP InfusionSystem is intended for adultand pediatric care for theintermittent or continuousdelivery of parenteral fluids,medication, blood, andblood derivatives throughclinically acceptedparenteral routes ofadministration. These routesof administration includeintravenous, intra-arterial,subcutaneous, andintraosseous using dedicatedadministration sets.The Agilia SP InfusionSystem is also intended forneonatal care for theintermittent or continuousdelivery of parenteral fluidsfor hydration and nutrition,medication, blood, andblood derivatives throughclinically acceptedparenteral routes ofadministration and criticaldrugs under specificconditions. These routes ofadministration includeintravenous, intra-arterial,and subcutaneous usingdedicated administrationsets.	SimilarOverall intendeduse except theproposed devicedoes not includeindications forepidural or enteralinfusion.
Type of Pump	Syringe Infusion Pump	Syringe Infusion Pump	Same
PatientPopulation	Adults, pediatrics, neonates	Adults, pediatrics, neonates	Same
Delivery Modes	Continuous, Intermittent,KVO, Bolus (Manual andProgrammable), LoadingDose, Basic infusion	Continuous, Intermittent,KVO, Bolus (Manual andProgrammable), LoadingDose, Basic infusion (alsocalled Basic Profile)	Same
Characteristic	Predicate Device	Subject Device	Comment
	K133532	K210074
Flow RateAccuracy	±5% for flow rates between1 and 999 mL/h±5.5% for flow rates lessthan 1 mL/h	±3% under most conditions	SimilarDetailed flow rateaccuracy disclosedin the labeling
WIFI	Yes	Yes	Same
Pump Control	Microcontroller controlled	Microcontroller controlled	Same
Number ofChannels	1	1	Same
MechanicalSensors	occlusion, temperature,pressure, syringeinstallation, force sensor	occlusion, temperature,pressure, syringeinstallation, force sensor	Same
ManualProgramming	Yes	Yes	Same
Alarms	High pressure / occlusion,temperature, systemmalfunction, empty syringe,plunger disengages, syringeunlocked, infusion near end,infusion complete, lowbattery, depleted battery,technical	High pressure / occlusion,temperature, systemmalfunction, empty syringe,plunger disengages, syringeunlocked, infusion near end,infusion complete, lowbattery, depleted battery,technical	Same
ClinicalAdvisories	Yes	Yes	Same
Infusion Modes	Basic infusion,continuous/intermittent,Volume to be infused, Doseto be infused, KVO, Bolus(direct and programmed),Loading Dose	Basic infusion,continuous/intermittent,Volume to be infused, Doseto 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 ErrorReductionSoftware / DrugLibrary	Basic Profile (within pump)	Basic Profile (within pump)	Same
Wireless ServerSoftware	Yes	Yes	Same
Characteristic	Predicate Device	Subject Device	Comment
	K133532	K210074
Number ofCompatibleSyringes	20	5	SimilarCompatibility ofsyringes isdependent on thepump.
Racking /Organization /Power	Maximum of 4	Agilia Link (for 4, 6 or 8pumps)Agilia Duo (for 2 pumps)	SimilarAccessoriesprovide equivalentfunctionality.
Electrical Safety	IEC 60601-1IEC 60601-1-2	IEC 60601-1: 2005+A1:2012 (3rd edition)IEC 60601-1-8: 2012IEC 60601-1-2: 2014	SimilarState-of-the-artcompliance
Mechanical /PowerSpecifications	Pump Size: 8.8 x 6.9 x 9(PC Unit) 15 x 4.5 x 7.5(syringe module) inchesPump Weight: 7.2 lbs. (PCunit) 4.5 lbs. syringe moduleLine Power: 100-240 VAC	Pump Size:5.3 x 13.6 x 6.7 inchesPump Weight: App. 4.6 lbs.Line Power: 100-240 VAC	SimilarSystem size andweight consideredmoderately small.
OperatingEnvironment	Temperature 41 °F to 104°FRelative Humidity: 20-90%w/o condensation	Temperature 41 °F to 104°FRelative Humidity: 20-90%w/o condensation	Same
StorageEnvironment	Temperature: 4 °F to 140°FRelative Humidity: 5-90%w/o condensation -	Temperature: 14°F to 140°FRelative Humidity: 10-90%w/o condensation	SimilarFunctional andexpected lifetesting have foundno new issues ofsafety oreffectiveness withthis 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).

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).