(147 days)
- 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.
- Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
- Infusion of warmed fluid for irrigation in urology procedures.
The Belmont Fluid Management System (FMS2000) 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 FMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set 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. The study described in the provided text focuses on demonstrating the substantial equivalence of the FMS2000 to a predicate device, the Haemonetics Corporation Rapid Infusion System, R.I.S.®. The "acceptance criteria" discussed are essentially the specifications the device needs to meet to prove its performance and safety are comparable to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed with numerical targets as would be common in a modern clinical study. Instead, they are described in terms of functional capabilities and safety assessments. The reported performance indicates that the device met these functional specifications.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Pumping Accuracy | The system performed within specification for pumping fluids accurately over the full range of flow rates and operating conditions (including different input fluid temperatures, back pressure, ambient temperature, and fluid viscosity). |
| Fluid Warming Capability | The system performed within specification for warming cold fluids to physiological temperature over the full range of flow rates and operating conditions. |
| Safety and Alarm System | The system performed within specification for detecting and alarming at unsafe or ineffective operating conditions, including operator errors, sensor failures, software/computer failures, and other internal system malfunctions. |
| Biocompatibility | The system passed tests for cytotoxicity, sensitization, irritation, and systemic toxicity (per ANSI/AAMI 10993-1: 1994). |
| Hemocompatibility | The system was found to have a negligible effect on anticoagulated blood and was considered "nonhemolytic" (according to ASTM F756-93). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a dataset for AI or diagnostic performance evaluation. The "tests" described are likely engineering and laboratory bench tests performed on the device prototypes. Therefore, there is no mention of a sample size of patients or data, nor of data provenance (e.g., country of origin, retrospective/prospective). The tests were physical evaluations of the device's functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for these tests would be the established performance specifications for infusion pumps and warmers, and the results of the specific physical and chemical tests performed. There's no indication of human experts establishing ground truth for a diagnostic test set in this context.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation or adjudication of outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the premarket notification for a medical device (infusion pump with warmer), not an AI or diagnostic imaging product. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in a sense. The "tests" described in Section 12 ("Summary of Nonclinical Tests and Results") reflect the standalone performance of the device itself. These tests evaluated the device's ability to pump, warm, and alarm independently of human intervention during the measurement process. The device's "algorithm" (its internal microprocessor control logic) was tested within the physical system.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests was derived from:
- Established engineering specifications and design requirements: For pumping accuracy, flow rates, temperature control, and alarm thresholds.
- Recognized industry standards: Such as ANSI/AAMI 10993-1: 1994 for biocompatibility and ASTM F756-93 for hemocompatibility.
- Direct measurement and observation: During controlled laboratory testing to confirm the device's adherence to those specifications and standards.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI product that requires a training set of data. The device's internal control parameters and logic were likely developed through engineering design, prototyping, and iterative testing, not through a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no "training set" in the context of a machine learning algorithm. The design and performance targets for the device were established through engineering principles, regulatory requirements, and comparison to existing predicate devices.
§ 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).