Who is the manufacturer of Vigilant Software Suite Vigilant Master Med?

Fresenius Kabi AG filed the 510(k) submission for Vigilant Software Suite Vigilant Master Med (K210075).

What is the FDA product code for Vigilant Software Suite Vigilant Master Med?

PHC. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Vigilant Software Suite Vigilant Master Med?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Vigilant Software Suite Vigilant Master Med?

Vigilant Drug' Lib Agilia (K121613).

Who can help prepare an FDA 510(k) submission like Vigilant Software Suite Vigilant Master Med?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Vigilant Software Suite Vigilant Master Med

K210075 · Fresenius Kabi AG · PHC · Mar 1, 2022 · General Hospital

Device Facts

Record ID	K210075
Device Name	Vigilant Software Suite Vigilant Master Med
Applicant	Fresenius Kabi AG
Product Code	PHC · General Hospital
Decision Date	Mar 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Software as a Medical Device, Pediatric

Intended Use

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 Story

Vigilant Master Med is a web-based drug library software used by pharmacists to create, customize, and manage drug lists, therapies, and device configurations. It functions as part of a Dose Error Reduction System (DERS). Pharmacists define medication limits based on institutional policy; these libraries are uploaded to compatible Fresenius Kabi infusion pumps (Agilia SP MC WiFi, Agilia VP MC WiFi). During operation, the infusion pump compares programmed doses against the library limits; if a dose exceeds these limits, the pump notifies the clinician. This system supports multi-user access, multi-factor authentication, and wireless data transmission. By providing standardized drug parameters and hard/soft limits, the device assists clinicians in preventing infusion errors, thereby enhancing patient safety.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical testing, including software verification and validation, human factors engineering (HFE/UE) studies, interoperability testing, performance testing at maximum capacity, and cybersecurity penetration testing.

Technological Characteristics

Web-based software; Microsoft Windows Server 2016; Microsoft SQL Server 2016; .NET Framework 4.8. Supports wireless transmission to Agilia SP/VP MC WiFi pumps. Standards followed: ISO 14971 (Risk Management), IEC 62304 (Software Life Cycle), IEC 62366-1 (Usability). Features multi-factor authentication and multi-user access control.

Indications for Use

Indicated for use with adults, pediatrics, and neonates as part of a Dose Error Reduction System (DERS) to manage drug library data and infusion device configurations to reduce medication administration errors.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

Vigilant Drug' Lib Agilia (K121613)

Related Devices

K230665 — Dose IQ Safety Software · Baxter Healthcare Corporation · Mar 29, 2024
K211124 — Dose IQ Safety Software · Baxter Healthcare Corporation · Aug 30, 2022
K042432 — PHARMGUARD TOOLBOX, MODEL G6000782 · Medex, Inc. · Jan 4, 2005
K121613 — AGILIA INFUSION SYSTEM · Fresenius Kabi AG · May 1, 2013
K042121 — SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY · Sigma Intl. · Aug 26, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210075 Device Name Vigilant Software Suite - Vigilant Master Med #### Indications for Use (Describe) 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. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 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. #### Statement of Intended Use / Indications for Use 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. # Technological Comparison as Compared to the Predicate Device | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | |---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Vigilant Drug' Lib Agilia | VSS Vigilant Master Med | Similar – Both products are drug library software | | Regulation Number | Regulation Number: 21 CFR 880.5725 Product Code: 80-FRN | Regulation Number: 21 CFR 880.5725 Product Code: 80-PHC | Similar – The Predicate was submitted as a infusion pump accessory under product code 80- FRN | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | Indications for Use | Vigilant Drug'Lib software must only be used to create drug libraries for patients whose weight is from 250 g to 250 kg. Vigilant Drug'Lib is intended to be used by Pharmacists (Primary users). Physicians, Biomedicals, IT Specialists, Fresenius Kabi Product Specialists and Customer Project Managers. | 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 device. 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. | 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 | Similar Pump compatibility matches the proposed pump design included with this submission. Verification, human factors, performance (stress/load) and interoperability testing found no new issues of safety or effectiveness. | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | Software requirement (PC Operating System) | Microsoft Windows XP SP2 Windows Vista and Windows 7 | Microsoft Windows Server 2016 | 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 | Microsoft .NET Framework 4.0 or Higher | Microsoft .NET Framework 4.8 or Higher | 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 | Similar. Verification testing found no new issues of safety or effectiveness. | | Pump Data Transmission | USB cable transmission to individual pump | Wireless transmission to multiple pumps | 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 | 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, | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | Interfacing Software Applications | Single Stand Alone Software System | Multi-Function Software System including Vigilant Master Med, Vigilant Centerium, and Vigilant Insight, and Agilia Partner | Similar Although the function of the drug library software is similar, the change to the architecture supports more functions (data analytics/concurrent pump management) and has been broken into separate sub-systems based on specific function. Verification, human factors, performance and interoperability testing found no new issues of safety or effectiveness, | | User Rights and Privileges | Single User | Multiple User | Similar - Multiple user approval for drug library release and multi-factor authentication for the subject device 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 and therapy allowed in the Drug Library System | Based on memory (approx. 600) | 10,000 | 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 created by the Drug Library software per pump | 3800 | 3800 | Same | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | # of Drug Libraries | Limited by Available Memory | 50 | 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 different drug and therapy entries per individual drug library | 200 | 200 | Same | | Drug name length (max number of characters) | 19 | 24 | 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. | | # of Therapies per Drug | 0 | 30 | Different This feature gives users the ability to configure multiple therapies per drug. Verification testing found no new issues of safety or effectiveness. | | # of Device Configurations | Limited by Available Memory | 50 | 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. | | # of Profiles/Care Area | Limited by Available Memory | 50 | 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. | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | # Drug Categories | 0 | 50 | 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 | Same | | Clinical advisories/Remarks allowed per drug entry | Yes | Yes | Same | | Clinical Reminder/ Allowed per drug entry | No | Yes | 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 number of characters) | 149 | 149 | Same | | Max number of drug libraries per dataset | 19 | 19 | Same | | Data Set Naming | Yes | Yes | Same | | Dose/Concentration Settings | Dilution/concentration (optional), Drug concentrations in dose/mL, Drug dilution in dose/volume, Concentration range upper/lower hard limit, Drug configuration in flow rate and dose rate, Default rate, Dose/Flow Rate Upper/Lower soft limit, Dose/Flow Rate Upper Hard Limit, and Continuous Dose Rate Unit: 0.01 - 9999 Dose Unit. | Dilution/concentration (optional), Drug concentrations in dose/mL, Drug dilution in dose/volume. Concentration range upper/lower hard limit, Drug configuration in flow rate and dose rate, Default rate, and Dose/Flow Rate Upper/Lower soft limit, Dose/Flow Rate Upper Hard Limit, and Continuous Dose Rate Unit: 0.01 - 9999 Dose Unit. | Same | | Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence Analysis | | | Max number of fixed drug concentrations / dilutions: 5 | Max number of fixed drug concentrations / dilutions: 5 per Therapy 20 per Drug | Similar Concentration/dilutions can now be configured at both the Therapy and Drug level. Verification testing found no new issues of safety or effectiveness | | | Dose of Concentration/Dilution: 0.01 - 9999 | Dose of Concentration/Dilution: 0.01 - 70000 | Similar Greater range of dose (concentrations/dilutions) for patient care. Verification testing found no new issues of safety or effectiveness. | | | Volume of Concentration/Dilution: 1 – 2000 mL Volume of Concentration/Dilution:…

Vigilant Software Suite Vigilant Master Med

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Intended Use

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Vigilant Software Suite Vigilant Master Med