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510(k) Data Aggregation
(103 days)
The Medfusion® Model 4000 Syringe Infusion Pump is indicated for the following uses:
- . In the administration of fluids requiring precisely controlled infusion rates including blood or blood products. lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- . By the following delivery routes: arterial, epidural, intrathecal, subcutaneous, and enteral.
- . By the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- . In critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- . Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
The PharmGuard® Toolbox 2 Medication Safety Software is indicated to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medfusion® Model 4000 Syringe Infusion Pump with software version 1.X. The PharmGuard® Toolbox 2 Medication Safety Software collects and downloads operational, infusion and alarm history events, library usage counts, and PharmGuard® safety events from the Medfusion® Model 4000 Syringe Infusion Pump. It is intended to provide a dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medfusion® Model 4000 Syringe Infusion Pump.
The PharmGuard® Supported Syringes is an accessory to the PharmGuard® Toolbox 2 Medication Safety Software that expands the available supported syringes that can be selected when creating user defined configuration parameters using the PharmGuard® Toolbox 2 Medication Safety Software.
The Medfusion® Model 4000 Syringe Infusion Pump software version 1.1 is a wireless capable electro-mechanical syringe infusion pump.
The PharmGuard® Toolbox 2 Medication Safety Software is designed to accommodate the features and capabilities of the 4000 pump with software version 1.X.
The provided 510(k) summary for K111386 describes the Medfusion® Model 4000 Syringe Infusion Pump and its associated software and accessories. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain the kind of detailed acceptance criteria, study design, or performance metrics typically seen in studies for AI/CADe devices.
In the context of the provided document, the "acceptance criteria" are implied by the performance of the predicate devices and general safety/effectiveness standards for infusion pumps. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical bench tests that ensure the device functions as intended and safely.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a traditional medical device like an infusion pump.
Here's an attempt to answer the questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the device and submission:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are broadly aligned with ensuring its safety, effectiveness, and functional performance, demonstrating substantial equivalence to its predicate devices. The "reported device performance" refers to the successful completion of various bench tests and validation studies.
| Acceptance Criteria Category | Specific Criterion (Implied) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Functional Performance | Accurate and controlled infusion rates; correct operation of programming functions (e.g., continuous, volume/time, mass mode). | Accuracy Testing with All Supported Syringes conducted; Programming Functions (Continuous, Volume/Time, Dose/Time, Mass, Body Weight, Body Surface Area, Intermittent, Dose/Kg/Time, Bolus) confirmed to be present and functional (Table 2.1). |
| Safety - Mechanical/Electrical | Compliance with relevant electrical and mechanical safety standards. | Mechanical and Electrical Safety Testing in Accordance with EN IEC 60601-1 and EN IEC 60601-2-24 performed. |
| Safety - Environmental Durability | Resistance to impact, environmental conditions (altitude), moisture ingress, and chemical exposure. | Impact Testing, Environmental Testing, Accuracy Testing at Simulated Altitude, Moisture Ingress Testing, Chemical Compatibility Testing performed. |
| Safety - Electromagnetic | Compatibility with electromagnetic environments (EMC) and resistance to radio frequency interference (RFI). | EMC Testing in Accordance with EN IEC 60601-2 and Radio Frequency Interference Testing performed. |
| Safety - MRI Compatibility | Safe operation within specified MRI environments. | Magnetic Resonance Testing in Accordance with ASTM-F2052 performed. Device compatible up to ≤ 150 Gauss/1.5 Tesla. |
| Safety - Occlusion Detection | Timely and accurate detection of occlusions to prevent patient harm. | Fast Occlusion Detection present and functional. Force Occlusion Alarm present and functional. Pressure Increasing Alarm present and functional. |
| Safety - Alarms | Proper functioning of various safety alarms (e.g., KVO, Infusion Complete, Empty, Syringe Not in Place, Low Battery). | All listed alarms (KVO, Infusion Complete, Near Empty, Empty, Invalid Syringe Size, Syringe Not in Place, Pressure Increasing, Force Occlusion, Battery Failed, Low Battery) confirmed to be present and functional. |
| Software Functionality | Software operates as designed, allows for parameter upload/download, collects data, and supports medication safety features. | Software Validation Testing performed. PharmGuard® Toolbox 2 designed to accommodate pump features, allows creation and upload of parameters, collects operational/infusion/alarm history, and facilitates data analysis to lessen operator error. |
| Human Factors | Ease of use, intuitiveness of pump programming and operation, preventing user error. | Human Factors Engineering validation studies conducted in a simulated use environment demonstrated product understanding, pump programming, and operation. Concluded the device performed as designed and is safe and effective. |
| Biocompatibility | Materials in contact with patient or fluids are biocompatible. | Biocompatibility assessment performed, concluding the device is biocompatible based on similarity of materials to other marketed devices from Smiths Medical ASD, Inc. |
| Product Reliability | Device maintains performance over its expected lifespan. | Product Reliability Testing performed. |
| Fault Conditions | Device responds appropriately to error or fault states. | Fault Condition Testing performed. |
| Sensor Functionality | All sensors (e.g., plunger force, other system sensors) function correctly. | Sensor Testing performed. Plunger Force Sensing confirmed. |
| Power Management | Efficient and safe power usage (battery, AC). | Power Management testing performed. |
| Drug Compatibility | Materials contacting drugs/fluids do not adversely interact. | Drug Compatibility Testing performed. |
| Wireless Communications | Wireless capabilities function as intended and securely. | Device has Wireless Communications Capabilities. (No specific test details provided beyond enablement). |
Study Details (Based on Provided Text):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for individual bench tests. The testing involved various units of the Medfusion® 4000 Syringe Infusion Pump and associated software.
- Data Provenance: Not specified, but generally, bench testing is conducted in-house by the manufacturer. Retrospective/Prospective is not applicable as this describes non-human, laboratory-based testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. The "ground truth" for an infusion pump's performance is objective measurement against engineering specifications and industry standards, not expert consensus in the medical imaging sense. Human Factors Engineering studies involved "clinicians" but their specific number or qualifications beyond being "clinicians" is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically for subjective assessments (e.g., reading medical images). Bench testing involves objective pass/fail criteria against predefined specifications.
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
- Not applicable. This device is an infusion pump, which is a hardware device with software, not an AI/CADe system designed to assist human readers in image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. While the software operates within the pump, "standalone performance" in the context of AI/CADe is not relevant here. The device's performance is inherently its function (algorithm and hardware combined) in delivering fluids.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Performance Standards: The "ground truth" for the tests mentioned are the specific acceptable ranges for flow rates, alarm thresholds, resistance levels, and compliance with national/international safety and performance standards (e.g., EN IEC 60601-1, ASTM-F2052).
8. The sample size for the training set
- Not applicable. The device is not an AI/ML model that is "trained" on a dataset in the conventional sense. Its software is programmed and validated.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device. The software is developed based on engineering requirements and validated through testing.
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