(413 days)
Not Found
No
The summary describes software for managing drug libraries and device configurations for infusion pumps. There is no mention of AI or ML capabilities, and the description of the software's function aligns with standard database and configuration management tools. The performance studies focus on verification, human factors, interoperability, and cybersecurity, not on the performance metrics typically associated with AI/ML models.
No.
Vigilant Master Med is a drug library software that manages drug library data and device configurations for infusion devices to help reduce drug administration errors. It does not directly provide therapy to patients.
No
This device is software used to create and manage drug libraries for infusion devices to reduce medication errors. It does not diagnose medical conditions.
Yes
The device is described as "drug library software" and its function is to create, customize, and manage data for infusion devices. There is no mention of hardware components included with the device itself, only its interaction with compatible infusion pumps.
Based on the provided information, Vigilant Master Med is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with infusion devices. Its purpose is to manage drug library data and device configurations to reduce the risk of drug administration errors. It does not mention analyzing biological samples or providing diagnostic information about a patient's health.
- Device Description: The description reinforces that it is drug library software used to create and manage data for infusion pumps.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Vigilant Master Med is a software tool designed to enhance the safety of drug administration through infusion devices by managing drug library data and configurations. This falls under the category of medical device software, but not specifically an In Vitro Diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
PHC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, Pediatrics, and Neonates
Intended User / Care Setting
Pharmacists (Primary users). Physicians, Biomedicals, IT Specialists, Fresenius Kabi Product Specialists and Customer Project Managers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- 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 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.
Supporting assurance arguments covered:
- Residual risks are analyzed and determined to be acceptably low using industry-standard 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.
Evidence included:
- 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, 2014
- Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016
Clinical Testing:
Clinical evaluation is not required for this submission to support substantial equivalence. Human Factors studies have been conducted on the subject device demonstrating passing results.
Key results:
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. The conclusion drawn from the non-clinical tests demonstrate that VSS Vigilant Master Med is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image 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)
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Fresenius Kabi Three Corporate Drive ake Zurich, Illinois 60047 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
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
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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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: | Agilia VP: 1 – 9999 mL
Agilia SP: 1 - 60mL | 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. |
| | Dose/Flow Rate Lower
hard limit: No | Dose/Flow Rate Lower
hard limit: Yes | Different
Addition of lower hard
limit risk control.
Verification testing found
no new issues of safety or
effectiveness. |
| | Continuous Flow Rate
Unit: 0.1 - 1000mL/h | Continuous Flow Rate
Unit:
Agilia VP: 0.1–1500mL/h
Agilia SP: 0.1–1200mL/h | 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 | 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. |
| Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence
Analysis |
| Direct Bolus | Direct Bolus enable /
disable, Volume Upper
hard limit, Max Volume
Range: 1-60mL | Direct Bolus enable /
disable, Volume Upper
hard limit, Max Volume
Range: 1-60mL | Same |
| | Flow Rate Range:
200 – 600 mL/h | Flow Rate Range:
Agilia VP:50 - 1500 mL/h
Agilia SP:50 - 1200 mL/h | 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 | 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:
0.1-1000mL
0.01 -9999 (Dose Unit) | Volume Unit:
Agilia VP: 0.1-1000mL
Agilia SP: 0.1-99.9mL
0.01 -9999 (Dose Unit) | Similar
Addition of syringe pump
range. Human factors
testing found no new
issues of safety or
effectiveness. |
| Programmed Bolus
Upper/Lower Hard
Duration Limit, Dose /
Volume Upper/Lower soft
limit, Dose / Volume
Lower hard limit | No | Yes | 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 | Loading dose enable /
disable, Duration Lower
hard limit, Default
duration, Dose Upper /
Lower soft limit, Default
Dose, Dose Upper hard
limit, Dose Range: 0.01 -
9999 | Loading dose enable /
disable, Duration Lower
hard limit, Default
duration, Dose Upper /
Lower soft limit, Default
Dose, Dose Upper hard
limit, Dose Range: 0.01 -
9999 | Same |
| Loading Dose
Duration Upper hard limit
and Dose Lower hard
limit | No | Yes | Different
Addition of duration and
dose limits for loading
dose feature. Verification
and human factors testing
found no new issues of
safety or effectiveness. |
| Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence
Analysis |
| Profile/Category/Profile
management | Max number of profiles
per Dataset:
20 (1 factory default plus
up to 19 custom)
Number of Drug Libraries
per Profile: 1
Device Configuration
Capabilities: Yes
Number of device
configurations per profile:
1 | Max number of profiles
per Dataset:
20 (1 factory default plus
up to 19 custom)
Number of Drug Libraries
per Profile: 1
Device Configuration
Capabilities: Yes
Number of device
configurations per profile:
1 | Same |
| | Profile Name (max
characters): 19 | Profile Name (max
characters): 24 | 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 | Pressure Alarm Threshold
per Profile, Pressure
Alarm Type Default mode:
3 levels, Near end of
infusion alarm, KVO
Enable/Disable | Pressure Alarm Threshold
per Profile, Pressure
Alarm Type Default mode:
3 levels, Near end of
infusion alarm, KVO
Enable/Disable | Same |
| Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence
Analysis |
| | Low pressure Limit
Default/Range:
50-300mmHg/Range
Medium pressure Limit
Default/Range:
150-600mmHg/Range
High pressure Limit
Default/Range:
250-750mmHg/Range | Low pressure Limit
Default/Range:
50-300mmHg/Range
Medium pressure Limit
Default/Range:
150-600mmHg/Range
High pressure Limit
Default/Range:
Agilia VP: 250-
750mmHg/Range
Agilia SP: 250-
900mmHg/Range | Similar
Addition of pressure limit
range for syringe pump.
Verification and human
factors testing found no
new issues of safety or
effectiveness. |
| | Near end of infusion alarm
Volume Default/Range:
0-50mL/Range | Near end of infusion alarm
Volume Default/Range
1-50mL/Range | Similar
Change to minimum near
end of infusion alarm
volume range.
Verification and human
factors testing found no
new issues of safety or
effectiveness. |
| | Near end of infusion alarm
Duration Default/Range:
5min/Default)
2-30min/Range | Near end of infusion alarm
Duration Default/Range:
5min/Default
1-30min/Range | Similar
Change to minimum near
end of infusion alarm
duration range.
Verification and human
factors testing
demonstrated found no
issues of safety or
effectiveness. |
| | KVO Rate (per drug):
0 to 20mL/h | KVO Rate (per drug):
Agilia SP: 0.1 to 5mL/h
Agilia VP: 1.0 to 20 mL/h | 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 | Different
Pressure management for
specific clinical needs.
Verification and human
factors testing found no
issues of safety or
effectiveness. |
| Feature | Predicate (K121613) | Proposed (K210075) | Substantial Equivalence
Analysis |
| Air in Line Management
(per drug) | No | Yes | 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 | Similar
Change to near end of
infusion alarm volume
range. Verification and
human factors testing
found no issues of safety
or 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.
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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:
15
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
16
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.