Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.

Vigilant Master Med is a drug library software that is used by pharmacists to create and identify limits according to policy and procedure of the institution. The infusion devices will notify and clearly indicate to a clinician if the dose for the medication is beyond the limits entered by the pharmacist and provided by Vigilant Master Med in the drug library.

Device Description

Vigilant Master Med is one component of Vigilant Software Suite (VSS) a multifunction device product. VSS Vigilant Master Med the subject of this submission, is also referred to as Drug Library Software. VSS Vigilant Master Med is drug library software that creates, customizes and manages drug lists, therapies, drug libraries, device configurations, profiles and data sets which are uploaded into compatible infusion pumps.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Vigilant Software Suite - Vigilant Master Med" and its comparison to a predicate device, "Vigilant Drug' Lib Agilia." However, the document primarily focuses on demonstrating substantial equivalence based on non-clinical testing and technological comparison. It explicitly states that "Clinical evaluation is not required for this submission to support substantial equivalence." and "no further clinical investigation or testing is needed."

Therefore, I cannot provide details on the acceptance criteria or a study that proves the device meets specific performance criteria in a clinical context, as such data is not included in the provided text. The submission relies on verification and validation of product requirements, human factors engineering testing, interoperability testing, performance testing at maximum capacity, and cybersecurity testing to demonstrate safety and effectiveness, and thus substantial equivalence.

Based on the information provided in the document, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document implicitly defines "acceptance criteria" through the comparison to the predicate device and the findings of non-clinical tests. The "reported device performance" is essentially the determination of "Similar," "Same," or "Different" with supporting statements that these differences do not affect safety or effectiveness, or that verification/testing found no new issues.

Feature	Predicate (K121613)	Proposed (K210075)	Acceptance Criteria (Inferred from "Substantial Equivalence Analysis")	Reported Device Performance
Software Name	Vigilant Drug' Lib Agilia	Vigilant Software Suite - Vigilant Master Med	Consistency in core function (drug library software)	Similar – Both products are drug library software.
Regulation Number	21 CFR 880.5725 (Infusion Pump), Product Code: 80-FRN	21 CFR 880.5725 (Infusion Pump), Product Code: 80-PHC	Alignment with infusion pump regulation, acceptable product code change	Similar – Predicate was an accessory under 80-FRN. No new safety/effectiveness issues with PHC.
Indications for Use (Key Aspects)	Create drug libraries for patients (250g-250kg). Used by Pharmacists, IT Specialists, etc.	Create, customize, manage drug library data and device configurations for Adults, Pediatrics, and Neonates; reduce risk of drug administration errors via DERS. Pharmacists create limits. Infusion devices notify clinicians of limits.	Expanded patient populations (Neonates) and explicit mention of DERS; no adverse effect on safety/effectiveness.	Similar - Descriptive information in the indications for use provides more detailed information about use of the device with specific patient populations and how specific users interact with the device. The modified intended use does not affect the safety and effectiveness of the subject device.
Supported Pumps	Volumat MC Agilia	Agilia SP MC WiFi, Agilia VP MC WiFi	Compatibility with current pump designs without new safety issues.	Similar - Pump compatibility matches the proposed pump design. Verification, human factors, performance (stress/load) and interoperability testing found no new issues of safety or effectiveness.
Software Requirements (OS)	Windows XP SP2, Vista, 7	Microsoft Windows Server 2016	Updated OS compatibility without new safety issues.	Similar - Compatible operating systems with more recent version has been expanded to match those currently in use and available. Verification testing found no new issues of safety or effectiveness.
.NET Framework	4.0 or Higher	4.8 or Higher	Updated framework without new safety issues.	Similar - Software development framework with recent version. Verification testing found no new issues of safety or effectiveness.
SQL Server Platform	ITTIA DB SQLTM	Microsoft SQL Server 2016	Different database, but no new safety/effectiveness issues.	Similar. Verification testing found no new issues of safety or effectiveness.
Pump Data Transmission	USB cable (single pump)	Wireless (multiple pumps)	Wireless transmission without new safety/effectiveness issues, verified through testing.	Similar - The same drug library data is transmitted wirelessly instead of through a cable. Verification, performance, and interoperability testing found no new issues of safety or effectiveness.
Type of Application	Desktop	Web Based	Application type change without new safety/effectiveness issues.	Similar - The application type (web based versus desktop) is secondary to the function of the software. Verification, human factors, performance and interoperability testing found no new issues of safety or effectiveness.
Interfacing Software Applications	Single Stand Alone Software System	Multi-Function Software System (Vigilant Master Med, Centerium, Insight, Agilia Partner)	Broader system integration with no new safety/effectiveness issues.	Similar - Although the function of the drug library software is similar, the change to the architecture supports more functions (...) and has been broken into separate sub-systems. Verification, human factors, performance and interoperability testing found no new issues of safety or effectiveness.
User Rights and Privileges	Single User	Multiple User (approval for drug library release, multi-factor authentication)	Enhanced user control and security consistent with guidance.	Similar - Multiple user approval (...) and multi-factor authentication (...) permit the healthcare facility more control of user rights, access, privileges, and permissions. This is consistent with updated guidance on software in medical devices and cybersecurity. Verification and human factors testing found no new issues of safety or effectiveness.
Total Number of Drugs/Therapy in Drug Library System	Based on memory (approx. 600)	10,000	Increased capacity without new safety/effectiveness issues.	Similar - The increase gives users the ability to configure a larger number of drugs and therapies in the library. Safety and effectiveness concerns are the same. Verification and performance testing found no new issues of safety or effectiveness.
Total Number of Drug Entries per Pump	3800	3800	Identical.	Same.
Number of Drug Libraries	Limited by Available Memory	50	Increased number of libraries without new safety/effectiveness issues.	Similar - The increase gives users the ability to configure a larger number of drug libraries. Verification testing found no new issues of safety or effectiveness.
Max Number of Drug/Therapy Entries per Individual Drug Library	200	200	Identical.	Same.
Drug Name Length (max characters)	19	24	Extended length, no new safety/effectiveness issues.	Similar - The extended drug name field length is enabled by software differences in the newer operating systems. Safety and effectiveness concerns are the same. Verification and human factors testing found no new issues of safety or effectiveness.
Number of Therapies per Drug	0	30	New feature: ability to configure multiple therapies per drug, no new safety/effectiveness issues.	Different - This feature gives users the ability to configure multiple therapies per drug. Verification testing found no new issues of safety or effectiveness.
Number of Device Configurations	Limited by Available Memory	50	Increased number of configurations without new safety/effectiveness issues.	Similar - The increase gives users the ability to configure a larger number of device configurations. Verification testing found no new issues of safety or effectiveness.
Number of Profiles/Care Area	Limited by Available Memory	50	Increased number of profiles without new safety/effectiveness issues.	Similar - The increase gives users the ability to configure a larger number of profiles/care areas. Verification testing found no new issues of safety or effectiveness.
Number of Drug Categories	0	50	New feature: organizes drugs by category, no new safety/effectiveness issues.	Different - This feature gives users the ability to organize drugs within the drug library by drug category. Verification testing found no new issues of safety or effectiveness.
Drug Library Report	Yes	Yes	Identical.	Same.
Clinical Advisories/Remarks per Drug Entry	Yes	Yes	Identical.	Same.
Clinical Reminder / Allowed per Drug Entry	No	Yes	New feature: additional clinical info, no new safety/effectiveness issues.	Different - The clinical reminder is a new feature that provides users with additional clinical information. Verification and human factors testing found no new issues of safety or effectiveness.
Clinical Advisories Length (max characters)	149	149	Identical.	Same.
Max Number of Drug Libraries per Dataset	19	19	Identical.	Same.
Data Set Naming	Yes	Yes	Identical.	Same.
Dose/Concentration Settings (Key Aspects)	Standard parameters (dilution, conc., hi/lo limits, rates, units); Fixed conc./dil. up to 5; Dose 0.01-9999; Volume 1-2000mL; Flow Rate 0.1-1000mL/h. Lower hard limit: No.	Standard parameters; Fixed conc./dil. up to 5 per Therapy, 20 per Drug; Dose 0.01-70000; Agilia VP Vol. 1-9999mL, SP Vol. 1-60mL; Agilia VP Flow 0.1-1500mL/h, SP Flow 0.1-1200mL/h. Lower hard limit: Yes.	Enhanced flexibility for fixed concentrations, expanded range for dose, volume, and flow, and added lower hard limit. All changes verified to cause no new safety/effectiveness issues.	Similar - Concentration/dilutions can now be configured at both the Therapy and Drug level. Verification testing found no new issues of safety or effectiveness. Similar - Greater range of dose (concentrations/dilutions) for patient care. Verification testing found no new issues of safety or effectiveness. Similar - Greater range for volumetric pump provides more flexibility in patient care. Addition of syringe pump range. Verification testing found no new issues of safety or effectiveness. Different - Addition of lower hard limit risk control. Verification testing found no new issues of safety or effectiveness. Similar - Greater range for volumetric pump provides more flexibility in patient care. Addition of syringe pump range. Verification testing demonstrated found no new issues of safety or effectiveness.
Dose or Volume over Time Upper/Lower Limits (Agilia SP Specific Feature)	No	Yes	New syringe pump feature for setting limits based on protocol, no new safety/effectiveness issues.	Different - Feature for syringe pump that allows users to set dose or volume limits based on a facilities protocol. Verification and human factors testing found no new issues of safety or effectiveness.
Direct Bolus (Key Aspects)	Enable/disable, Volume Upper hard limit, Max Volume 1-60mL; Flow Rate 200-600 mL/h.	Enable/disable, Volume Upper hard limit, Max Volume 1-60mL; Agilia VP Flow 50-1500 mL/h, Agilia SP Flow 50-1200 mL/h.	Wider flow rate range for pumps, no new safety/effectiveness issues.	Same (for Bolus Enable, Volume, Max Volume). Similar - Greater range for volumetric pump provides more flexibility in patient care. Addition of syringe pump range. Verification and human factors testing found no new issues of safety or effectiveness.
Programmed Bolus (Key Aspects)	Enable/disable, Default volume/dose, Upper Volume/Dose Hard Limit; Volume 0.1-1000mL; Dose 0.01-9999. Upper/Lower Hard Duration Limit, Dose/Volume Upper/Lower soft limit, Dose/Volume Lower hard limit: No.	Enable/disable, Default volume/dose, Upper Volume/Dose Hard Limit; Agilia VP Vol. 0.1-1000mL, SP Vol. 0.1-99.9mL; Dose 0.01-9999. Upper/Lower Hard Duration Limit, Dose/Volume Upper/Lower soft limit, Dose/Volume Lower hard limit: Yes.	Added limits for duration, volume, and dose for programmed bolus, and expanded volume range for SP, no new safety/effectiveness issues.	Same (for Bolus Enable, Default/Upper Volume/Dose, Dose Unit). Similar - Addition of syringe pump range. Human factors testing found no new issues of safety or effectiveness. Different - Addition of duration, volume, and dose limits for programmed bolus feature. Verification and human factors testing found no new issues of safety or effectiveness.
Loading Dose (Key Aspects)	Enable/disable, Duration Lower hard limit, Default duration, Dose Upper/Lower soft limit, Default Dose, Dose Upper hard limit, Dose Range: 0.01-9999. Duration Upper hard limit and Dose Lower hard limit: No.	Enable/disable, Duration Lower hard limit, Default duration, Dose Upper/Lower soft limit, Default Dose, Dose Upper hard limit, Dose Range: 0.01-9999. Duration Upper hard limit and Dose Lower hard limit: Yes.	Added duration and dose limits, no new safety/effectiveness issues.	Same (for Bolus Enable, Lower Hard Limit, Default Duration, Upper/Lower soft, Default Dose, Upper Hard Limit, Dose Range). Different - Addition of duration and dose limits for loading dose feature. Verification and human factors testing found no new issues of safety or effectiveness.
Profile/Category/Profile Management (Key Aspects)	Max profiles per Dataset: 20; Drug Libraries per Profile: 1; Device Config Capabilities: Yes; Device Configs per profile: 1; Profile Name max: 19 characters.	Max profiles per Dataset: 20; Drug Libraries per Profile: 1; Device Config Capabilities: Yes; Device Configs per profile: 1; Profile Name max: 24 characters.	Extended profile name length, no new safety/effectiveness issues.	Same (for Max Profiles, Drug Libraries, Device Config Capabilities/per profile). Similar - Additional profiles provide users with more options. Verification and Human Factors testing were performed which found no new issues of safety or effectiveness.
General Configuration Options (Key Aspects)	Pressure Alarm Threshold, Type (3 levels), Near end of infusion alarm, KVO Enable/Disable; Pressure Limits (Low, Medium, High); Near end of infusion alarm Volume: 0-50mL, Duration: 2-30min; KVO Rate: 0-20mL/h.	Pressure Alarm Threshold, Type (3 levels), Near end of infusion alarm, KVO Enable/Disable; Agilia VP High Pres: 250-750mmHg/Range, SP High Pres: 250-900mmHg/Range; Near end of infusion alarm Volume: 1-50mL, Duration: 1-30min; Agilia SP KVO: 0.1-5mL/h, VP KVO: 1.0-20 mL/h.	Extended pressure limits and alarm ranges for SP/VP pumps, no new safety/effectiveness issues.	Same (for Alarm Threshold, Type, Near End Alarm, KVO Enable/Disable, Low/Medium Pressure Limits). Similar - Addition of pressure limit range for syringe pump. Verification and human factors testing found no new issues of safety or effectiveness. Similar - Change to minimum near end of infusion alarm volume range. Verification and human factors testing found no new issues of safety or effectiveness. Similar - Change to minimum near end of infusion alarm duration range. Verification and human factors testing demonstrated found no issues of safety or effectiveness. Similar - Change to minimum range for KVO rate and addition of range for syringe pump. Verification and human factors testing demonstrated found no issues of safety or effectiveness.
Pressure Management (per drug)	No	Yes	New feature: pressure management for specific clinical needs, no new safety/effectiveness issues.	Different - Pressure management for specific clinical needs. Verification and human factors testing found no issues of safety or effectiveness.
Air in Line Management (per drug)	No	Yes	New feature: air in line management for specific clinical needs, no new safety/effectiveness issues.	Different - Air in line management for specific clinical needs. Verification and human factors testing found no issues of safety or effectiveness.
Near end of infusion alarm Volume Default/Range	5mL/Default, 0-50mL/Range	N/A/Default, 1-50mL/Range	Changed default, no new safety/effectiveness issues.	Similar - Change to near end of infusion alarm volume range. Verification and human factors testing found no issues of safety or effectiveness.

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document does not specify exact "sample sizes" in terms of number of cases or data points for the non-clinical tests (verification, human factors, interoperability, performance, cybersecurity testing). It refers to the sufficiency of these tests to conclude safety and effectiveness.
Data Provenance: Not specified in terms of country of origin. The data is generated from non-clinical (laboratory/engineering) testing rather than patient data. The studies are prospective in the sense that they are specifically conducted for the regulatory submission to verify and validate the new device.

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

Number of Experts: Not explicitly stated. The "ground truth" for this device (software for managing infusion pump drug libraries) would primarily be established by:
- Engineers/Developers: Defining correct software functionality and performance.
- Quality Assurance personnel: Verifying adherence to requirements.
- Human Factors Specialists: Assessing usability and safety in simulated clinical tasks.
- Pharmacists and Clinicians (as users): Participating in human factors evaluations to ensure the software's design supports their workflow and safety goals. The document states "Human Factors studies have been conducted on the subject device demonstrating passing results," implying clinical domain experts were involved in a user capacity.
Qualifications of Experts: Not explicitly stated for specific roles. However, given the context of medical device regulation, these would be qualified professionals in their respective fields (e.g., software engineers, human factors engineers, clinical experts - likely pharmacists and nurses for an infusion pump system).

4. Adjudication method for the test set:

Since no multi-reader or multi-expert assessment of clinical "cases" is described (as it's a software substantial equivalence submission based on non-clinical tests), there is no mention of an adjudication method like 2+1 or 3+1. The "adjudication" is implicitly the outcome of the comprehensive verification and validation processes and the safety assurance case.

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 study was done. This is not an AI-assisted diagnostic device where human reader improvement would be measured. The device is a software for drug library management for infusion pumps, not a medical image analysis or similar AI tool.

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

The software's core function is to create and manage drug libraries, which is "algorithm only" in its processing of data and rules. However, its purpose is to be used with human-in-the-loop (pharmacists inputting data, clinicians interacting with the infusion pump).
Standalone algorithmic verification: Yes, this is implied by "Verification testing of product requirements," "Performance testing at maximum capacity," and "Cybersecurity penetration testing." These tests assess the software's inherent functionality and robustness independent of user interaction, but within the context of its overall intended use.

7. The type of ground truth used:

The primary "ground truth" used for this submission is:
- Pre-defined product requirements and specifications: The software must perform according to these.
- Safety standards and regulatory guidance: Adherence to these is the "truth" for demonstrating safety and effectiveness.
- Usability goals derived from human factors analysis: The software's design must support safe and effective use by intended users.
- Functionality of the predicate device: The new device's functions are compared to the legally marketed predicate.
It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data, as this is not a diagnostic device.

8. The sample size for the training set:

Not applicable/Not provided. This is a traditional software engineering development and a 510(k) submission based on substantial equivalence, not a machine learning/AI model that requires a "training set" for its development. The "learning" here is human engineering and design, not algorithmic learning from data.

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

Not applicable. As stated above, there is no "training set" in the machine learning sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2022

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

Re: K210075

Trade/Device Name: Vigilant Software Suite - Vigilant Master Med Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PHC Dated: January 31, 2022 Received: February 3, 2022

Dear Keith Dunn:

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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) K210075

Device Name Vigilant Software Suite - Vigilant Master Med

Indications for Use (Describe)

X 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/0 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".

Fresenius Kabi Three Corporate Drive ake Zurich, Illinois 60047 847-550-2300 T 888-391-6300 www.fresenius-kabi.us

K210075

510(K) SUMMARY

Date Prepared

February 25, 2022

Owner/Operator

Fresenius Kabi AG 61346 Bad Homburg Germany

Owner/Operator #: 9027285

Contact Person

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

224-817-2430 847-550-2960

keith.dunn@fresenius-kabi.com

Device Trade Name

Vigilant Software Suite - Vigilant Master Med

Common Name/Usual Name

Infusion Safety Management Software

Regulation Name/Number

Infusion Pump / 21 CFR 880.5725

Product Code and Classification Panel

80 - PHC

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Kabi. On the left side of the logo are three blue wavy lines stacked vertically. To the right of the wavy lines is the text "FRESENIUS" stacked on top of the text "KABI". The text is also in blue.

vw.fresenius-kabi.us

Legally Marketed Predicate Device

Vigilant Drug' Lib Agilia that was cleared as an accessory to K121613 Agilia Infusion Svstem

Device Description

Statement of Intended Use / Indications for Use

Technological Comparison as Compared to the Predicate Device

Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Name	Vigilant Drug' Lib Agilia	VSS Vigilant Master Med	Similar – Both productsare drug library software
Regulation Number	Regulation Number:21 CFR 880.5725Product Code:80-FRN	Regulation Number:21 CFR 880.5725Product Code:80-PHC	Similar – The Predicatewas submitted as ainfusion pump accessoryunder product code 80-FRN
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Indications for Use	Vigilant Drug'Lib softwaremust only be used tocreate drug libraries forpatients whose weight isfrom 250 g to 250 kg.Vigilant Drug'Lib isintended to be used byPharmacists (Primaryusers). Physicians,Biomedicals, ITSpecialists, Fresenius KabiProduct Specialists andCustomer ProjectManagers.	Vigilant Master Med ispart of a Dose ErrorReduction System (DERS)for use with Adults,Pediatrics, and Neonates.It is intended to create,customize, and managedrug library data anddevice configurations to beuploaded to compatibleFresenius Kabi infusiondevices which may reducethe risk of drugadministration errors. Itenhances safety bypreventing infusion errorswith the use of Dose ErrorReduction System (DERS)in combination with theinfusion device.Vigilant Master Med is adrug library software thatis used by pharmacists tocreate and identify limitsaccording to policy andprocedure of theinstitution. The infusiondevices will notify andclearly indicate to aclinician if the dose for themedication is beyond thelimits entered by thepharmacist and providedby Vigilant Master Med inthe drug library.	Similar -Descriptive information inthe indications for useprovides more detailedinformation about use ofthe device with specificpatient populations andhow specific users interactwith the device. Themodified intended usedoes not affect the safetyand effectiveness of thesubject device.
Supported pumps	Volumat MC Agilia	Agilia SP MC WiFiAgilia VP MC WiFi	SimilarPump compatibilitymatches the proposedpump design includedwith this submission.Verification, humanfactors, performance(stress/load) andinteroperability testingfound no new issues ofsafety or effectiveness.
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Software requirement(PC Operating System)	Microsoft Windows XPSP2Windows Vista andWindows 7	Microsoft WindowsServer 2016	SimilarCompatible operatingsystems with more recentversion has beenexpanded to match thosecurrently in use andavailable. Verificationtesting found no newissues of safety oreffectiveness.
.NET framework	Microsoft .NETFramework 4.0 or Higher	Microsoft .NETFramework 4.8 or Higher	SimilarSoftware developmentframework with recentversion. Verificationtesting found no newissues of safety oreffectiveness.
SQL server platform	ITTIA DB SQLTM	Microsoft SQL Server2016	Similar. Verificationtesting found no newissues of safety oreffectiveness.
Pump Data Transmission	USB cable transmission toindividual pump	Wireless transmission tomultiple pumps	SimilarThe same drug librarydata is transmittedwirelessly instead ofthrough a cable.Verification, performance,and interoperabilitytesting found no newissues of safety oreffectiveness.
Type of application	Desktop	Web Based	SimilarThe application type (webbased versus desktop) issecondary to the functionof the software.Verification, humanfactors, performance andinteroperability testingfound no new issues ofsafety or effectiveness,
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Interfacing SoftwareApplications	Single Stand AloneSoftware System	Multi-Function SoftwareSystem including VigilantMaster Med, VigilantCenterium, and VigilantInsight, and Agilia Partner	SimilarAlthough the function ofthe drug library softwareis similar, the change tothe architecture supportsmore functions (dataanalytics/concurrent pumpmanagement) and hasbeen broken into separatesub-systems based onspecific function.Verification, humanfactors, performance andinteroperability testingfound no new issues ofsafety or effectiveness,
User Rights and Privileges	Single User	Multiple User	Similar -Multiple user approval fordrug library release andmulti-factorauthentication for thesubject device permit thehealthcare facility morecontrol of user rights,access, privileges, andpermissions.This is consistent withupdated guidance onsoftware in medicaldevices and cybersecurity.Verification and humanfactors testing found nonew issues of safety oreffectiveness.
Total number of drugs andtherapy allowed in theDrug Library System	Based on memory(approx. 600)	10,000	SimilarThe increase gives usersthe ability to configure alarger number of drugsand therapies in thelibrary. Safety andeffectiveness concerns arethe same. Verificationand performance testingfound no new issues ofsafety or effectiveness.
Total number of drugentries created by theDrug Library software perpump	3800	3800	Same
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
# of Drug Libraries	Limited by AvailableMemory	50	SimilarThe increase gives usersthe ability to configure alarger number of druglibraries. Verificationtesting found no newissues of safety oreffectiveness.
Max number of differentdrug and therapy entriesper individual drug library	200	200	Same
Drug name length (maxnumber of characters)	19	24	SimilarThe extended drug namefield length is enabled bysoftware differences in thenewer operating systems.Safety and effectivenessconcerns are the same.Verification and humanfactors testing found nonew issues of safety oreffectiveness.
# of Therapies per Drug	0	30	DifferentThis feature gives usersthe ability to configuremultiple therapies perdrug. Verification testingfound no new issues ofsafety or effectiveness.
# of DeviceConfigurations	Limited by AvailableMemory	50	SimilarThe increase gives usersthe ability to configure alarger number of deviceconfigurations.Verification testing foundno new issues of safety oreffectiveness.
# of Profiles/Care Area	Limited by AvailableMemory	50	SimilarThe increase gives usersthe ability to configure alarger number ofprofiles/care areas.Verification testing foundno new issues of safety oreffectiveness.
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
# Drug Categories	0	50	DifferentThis feature gives usersthe ability to organizedrugs within the druglibrary by drug category.Verification testing foundno new issues of safety oreffectiveness.
Drug Library report	Yes	Yes	Same
Clinicaladvisories/Remarksallowed per drug entry	Yes	Yes	Same
Clinical Reminder/Allowed per drug entry	No	Yes	DifferentThe clinical reminder is anew feature that providesusers with additionalclinical information.Verification and humanfactors testing found nonew issues of safety oreffectiveness.
Clinical advisories length(max number ofcharacters)	149	149	Same
Max number of druglibraries per dataset	19	19	Same
Data Set Naming	Yes	Yes	Same
Dose/ConcentrationSettings	Dilution/concentration(optional), Drugconcentrations in dose/mL,Drug dilution indose/volume,Concentration rangeupper/lower hard limit,Drug configuration in flowrate and dose rate, Defaultrate, Dose/Flow RateUpper/Lower soft limit,Dose/Flow Rate UpperHard Limit, andContinuous Dose RateUnit: 0.01 - 9999 DoseUnit.	Dilution/concentration(optional), Drugconcentrations in dose/mL,Drug dilution indose/volume.Concentration rangeupper/lower hard limit,Drug configuration in flowrate and dose rate, Defaultrate, and Dose/Flow RateUpper/Lower soft limit,Dose/Flow Rate UpperHard Limit, andContinuous Dose RateUnit: 0.01 - 9999 DoseUnit.	Same
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
	Max number of fixed drugconcentrations / dilutions:5	Max number of fixed drugconcentrations / dilutions:5 per Therapy20 per Drug	SimilarConcentration/dilutionscan now be configured atboth the Therapy andDrug level. Verificationtesting found no newissues of safety oreffectiveness
	Dose ofConcentration/Dilution:0.01 - 9999	Dose ofConcentration/Dilution:0.01 - 70000	SimilarGreater range of dose(concentrations/dilutions)for patient care.Verification testing foundno new issues of safety oreffectiveness.
	Volume ofConcentration/Dilution:1 – 2000 mLVolume ofConcentration/Dilution:	Agilia VP: 1 – 9999 mLAgilia SP: 1 - 60mL	SimilarGreater range forvolumetric pump providesmore flexibility in patientcare. Addition of syringepump range. Verificationtesting found no newissues of safety oreffectiveness.
	Dose/Flow Rate Lowerhard limit: No	Dose/Flow Rate Lowerhard limit: Yes	DifferentAddition of lower hardlimit risk control.Verification testing foundno new issues of safety oreffectiveness.
	Continuous Flow RateUnit: 0.1 - 1000mL/h	Continuous Flow RateUnit:Agilia VP: 0.1–1500mL/hAgilia SP: 0.1–1200mL/h	SimilarGreater range forvolumetric pump providesmore flexibility in patientcare. Addition of syringepump range. Verificationtesting demonstratedfound no new issues ofsafety or effectiveness.
Dose or Volume overTime Upper/Lower Limits(Agilia SP SpecificFeature)	No	Yes	DifferentFeature for syringe pumpthat allows users to setdose or volume limitsbased on a facilitiesprotocol. Verification andhuman factors testingfound no new issues ofsafety or effectiveness.
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Direct Bolus	Direct Bolus enable /disable, Volume Upperhard limit, Max VolumeRange: 1-60mL	Direct Bolus enable /disable, Volume Upperhard limit, Max VolumeRange: 1-60mL	Same
	Flow Rate Range:200 – 600 mL/h	Flow Rate Range:Agilia VP:50 - 1500 mL/hAgilia SP:50 - 1200 mL/h	SimilarGreater range forvolumetric pump providesmore flexibility in patientcare. Addition of syringepump range. Verificationand human factors testingfound no new issues ofsafety or effectiveness.
Programmed Bolus	Programmed bolus enable/ disable, Default volume /Dose and Upper Volume /Dose Hard Limit	Programmed bolus enable/ disable, Default volume /Dose and Upper Volume /Dose Hard Limit	Same
	Volume Unit:0.1-1000mL0.01 -9999 (Dose Unit)	Volume Unit:Agilia VP: 0.1-1000mLAgilia SP: 0.1-99.9mL0.01 -9999 (Dose Unit)	SimilarAddition of syringe pumprange. Human factorstesting found no newissues of safety oreffectiveness.
Programmed BolusUpper/Lower HardDuration Limit, Dose /Volume Upper/Lower softlimit, Dose / VolumeLower hard limit	No	Yes	DifferentAddition of duration,volume, and dose limitsfor programmed bolusfeature. Verification andhuman factors testingfound no new issues ofsafety or effectiveness.
Loading Dose	Loading dose enable /disable, Duration Lowerhard limit, Defaultduration, Dose Upper /Lower soft limit, DefaultDose, Dose Upper hardlimit, Dose Range: 0.01 -9999	Loading dose enable /disable, Duration Lowerhard limit, Defaultduration, Dose Upper /Lower soft limit, DefaultDose, Dose Upper hardlimit, Dose Range: 0.01 -9999	Same
Loading DoseDuration Upper hard limitand Dose Lower hardlimit	No	Yes	DifferentAddition of duration anddose limits for loadingdose feature. Verificationand human factors testingfound no new issues ofsafety or effectiveness.
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Profile/Category/Profilemanagement	Max number of profilesper Dataset:20 (1 factory default plusup to 19 custom)Number of Drug Librariesper Profile: 1Device ConfigurationCapabilities: YesNumber of deviceconfigurations per profile:1	Max number of profilesper Dataset:20 (1 factory default plusup to 19 custom)Number of Drug Librariesper Profile: 1Device ConfigurationCapabilities: YesNumber of deviceconfigurations per profile:1	Same
	Profile Name (maxcharacters): 19	Profile Name (maxcharacters): 24	Similar --Additional profilesprovide users with moreoptions. Verification andHuman Factors testingwere performed whichfound no new issues ofsafety or effectiveness.
General ConfigurationOptions	Pressure Alarm Thresholdper Profile, PressureAlarm Type Default mode:3 levels, Near end ofinfusion alarm, KVOEnable/Disable	Pressure Alarm Thresholdper Profile, PressureAlarm Type Default mode:3 levels, Near end ofinfusion alarm, KVOEnable/Disable	Same
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
	Low pressure LimitDefault/Range:50-300mmHg/RangeMedium pressure LimitDefault/Range:150-600mmHg/RangeHigh pressure LimitDefault/Range:250-750mmHg/Range	Low pressure LimitDefault/Range:50-300mmHg/RangeMedium pressure LimitDefault/Range:150-600mmHg/RangeHigh pressure LimitDefault/Range:Agilia VP: 250-750mmHg/RangeAgilia SP: 250-900mmHg/Range	SimilarAddition of pressure limitrange for syringe pump.Verification and humanfactors testing found nonew issues of safety oreffectiveness.
	Near end of infusion alarmVolume Default/Range:0-50mL/Range	Near end of infusion alarmVolume Default/Range1-50mL/Range	SimilarChange to minimum nearend of infusion alarmvolume range.Verification and humanfactors testing found nonew issues of safety oreffectiveness.
	Near end of infusion alarmDuration Default/Range:5min/Default)2-30min/Range	Near end of infusion alarmDuration Default/Range:5min/Default1-30min/Range	SimilarChange to minimum nearend of infusion alarmduration range.Verification and humanfactors testingdemonstrated found noissues of safety oreffectiveness.
	KVO Rate (per drug):0 to 20mL/h	KVO Rate (per drug):Agilia SP: 0.1 to 5mL/hAgilia VP: 1.0 to 20 mL/h	SimilarChange to minimumrange for KVO rate andaddition of range forsyringe pump.Verification and humanfactors testingdemonstrated found noissues of safety oreffectiveness.
Pressure Management (perdrug)	No	Yes	DifferentPressure management forspecific clinical needs.Verification and humanfactors testing found noissues of safety oreffectiveness.
Feature	Predicate (K121613)	Proposed (K210075)	Substantial EquivalenceAnalysis
Air in Line Management(per drug)	No	Yes	DifferentAir in line managementfor specific clinical needs.Verification and humanfactors testing found noissues of safety oreffectiveness..
Near end of infusionalarm VolumeDefault/Range	5mL/Default0-50mL/Range	N/A/Default1-50mL/Range	SimilarChange to near end ofinfusion alarm volumerange. Verification andhuman factors testingfound no issues of safetyor effectiveness.

A comparison of the key features between VSS Vigilant Master Med and the predicate device Vigilant Drug' Lib Agilia is provided in the table below.

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Image /page/5/Picture/0 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".

Fresenius Kabi

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Image /page/6/Picture/0 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 above the word "KABI".

Fresenius Kabi

Fresenius Kabi
Three Corporate Ithois 60047
Lake Zuriach Illenois 60047
Three Zurion 22000
T 888-3391-233000
www.fressenius-kabi.us

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Image /page/7/Picture/0 description: The image shows the Fresenius Kabi logo. On the left side of the logo are three blue wavy lines stacked vertically. To the right of the wavy lines is the text "FRESENIUS KABI" in blue. The word "FRESENIUS" is on top of the word "KABI".

Fresenius Kabi

Fresenius Kabi
Three Corporate Ithois 60047
Lake Zuriach Illenois 60047
Three Zurion 22000
T 888-3391-233000
www.fressenius-kabi.us

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Image /page/8/Picture/0 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 above the word "KABI".

Fresenius Kabi

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Image /page/9/Picture/0 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 words are stacked, with "FRESENIUS" on top and "KABI" on the bottom.

Fresenius Kabi

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Image /page/10/Picture/0 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".

Fresenius Kabi

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Image /page/11/Picture/0 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".

Fresenius Kabi

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Image /page/12/Picture/0 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 above the word "KABI".

Fresenius Kabi

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Image /page/13/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are stacked on top of each other in blue, sans-serif font. The overall design is clean and corporate.

Fresenius Kabi

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Image /page/14/Picture/0 description: The image shows the Fresenius Kabi logo. On the left side of the logo, there are three blue wavy lines. To the right of the wavy lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI".

Fresenius Kabi

hree Cornorate Drive ake Zurich, Illinois 60047 847-550-2300 T 888-391-6300 www.fresenius-kabi.us

Non-Clinical Testing

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

Verification testing of product requirements.
Human factors engineering testing of critical tasks. ●
Interoperability testing of sub-system interfaces including Vigilant Master Med, ● Vigilant Centerium, Vigilant Insight, Agilia Partner, and connected infusion pumps.
Performance testing at maximum capacity using worst case data flow and worst case ● network conditions.
Cybersecurity penetration testing to identify potential vulnerabilities of the system.

A safety assurance case was provided for VSS Vigilant Master Med 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:

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Image /page/15/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue.

ree Cornorate Drive e Zurich. Illinois 60047 888-391-6300 ww.fresenius-kabi.us

Residual risks are analyzed and determined to be acceptably low using industrystandard risk analysis practices and regulatory guidance
The design is verified and validated for its indications for use as it relates to safety
The system is reliable over the system's expected lifetime.

The following evidence was included in the safety assurance case:

Risk Management File
Device reliability activities and testing confirmed the Vigilant Master Med met its reliability goal at the system, product 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 evaluations have been conducted to validate the effectiveness of userelated 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.
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
- Postmarket Management of Cybersecurity in Medical Devices, December 28, O 2016
Standards followed include: ●
- o 14971 Second Edition 2007 - Medical Devices - Application of Risk Management to Medical Devices
- IEC 62304 Edition 1.1 2015 Medical Device Software Software Life Cycle o Processes
- IEC 62366-1 Edition 1.0 2015 Medical Devices Part 1: Application of usability о engineering to medical devices

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Image /page/16/Picture/0 description: The image shows the logo for Fresenius Kabi. The logo consists of three blue wavy lines on the left, followed by the words "FRESENIUS" and "KABI" stacked on top of each other in blue. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability. The wavy lines may represent the flow of fluids or the company's commitment to innovation.

resenius Kabi nree Cornorate Drive ke Zurich, Illinois 60047 847-550-2300 888-391-6300 /ww.fresenius-kabi.us

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 verification and validation testing conclude that the VSS Vigilant Master Med is safe and effective for the intended users, uses and use environments, and that no further clinical investigation or testing is needed. Fresenius Kabi believes that the methods and results described in the verification testing and human factors evaluation (HFE/UE) reports support this conclusion. The conclusion drawn from the non-clinical tests demonstrate that VSS Vigilant Master Med is substantially equivalent to the predicate device.

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).