(21 days)
A. Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
C. Infusion of warmed fluid for irrigation in urology procedures.
The Belmont Fluid Management System (7MS2000) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont 7MS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at userset rates from 10 to 500 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating.
The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.
A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.
The Belmont Fluid Management System (FMS2000) is an infusion pump with a warmer designed for rapid infusion of warmed fluids in high blood loss surgical procedures, trauma, and situations requiring rapid replacement of warmed blood or replacement fluid. The reported information focuses on the nonclinical tests conducted to verify the device's performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Pumping Accuracy | Performed "within specification" across full range of flow rates and operating conditions (different input fluid temperatures, back pressure, ambient temperature, fluid viscosity). |
| Fluid Warming to Physiological Temperature | Performed "within specification" across full range of flow rates and operating conditions. |
| Detection and Alarm for Unsafe/Ineffective Conditions | Performed "within specification" for detecting and alarming on operator errors, sensor failures, system software/computer failures, and other internal system malfunctions. |
| Hemocompatibility (Red Cell Hemolysis & Fragility) | Found to have "negligible effect on anticoagulated blood" and considered "non-hemolytic" according to ASTM F756-93. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set in terms of number of devices or number of test conditions run. It mentions "full range of flow rate and operating conditions" for the pumping and warming tests. The tests were non-clinical, implying they were laboratory-based tests. The country of origin for the data is implicitly the United States, as the submitting company is based in Billerica, MA, USA, and the submission is to the FDA. The testing was prospective, conducted to verify the performance of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. For non-clinical performance and safety tests of this nature (pumping accuracy, warming, alarm functions, hemocompatibility), ground truth is typically established by established engineering specifications, industry standards (like ASTM F756-93 for hemocompatibility), and established medical parameters (e.g., "physiological temperature"). Human experts would be involved in designing the test protocols and evaluating the results against these objective criteria, but the document does not specify their number or qualifications as "ground truth experts" in the typical AI/diagnostic sense.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective performance tests against predefined specifications and standards, not evaluations requiring human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is an infusion pump/warmer, not an AI diagnostic tool that assists human readers in interpreting medical images or data. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The tests described are standalone performance tests of the device itself (hardware and embedded software) without human intervention in the continuous operation for which the performance is being measured. The device's safety features autonomously detect and alarm at unsafe conditions.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was established by:
- Engineering Specifications: For pumping accuracy, fluid warming to target temperatures, and pressure/air detection.
- Industry Standards: Specifically, ASTM F756-93 for the assessment of hemolytic properties.
- Predefined Operating Conditions: The "full range of flow rate and operating conditions" serve as the defined parameters against which performance is measured.
- Safety Requirements: The ability to detect and alarm at unsafe conditions against predefined failure modes and operational limits.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" in the context of data-driven model development. Its functionality is based on direct engineering design and control logic.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, this device does not utilize a training set in the AI sense.
§ 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).