FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).