(28 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® Rapid Infuser, RI2, (same as the existing Rapid Infuser) 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 Rapid Infuser infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 1000 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.
This document describes the premarket notification (510(k)) for the Belmont® Rapid Infuser, RI2. It is a submission for substantial equivalence to an existing device, not a new device. Therefore, the information provided focuses on demonstrating that the modified device performs as well as the predicate device.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner as might be expected for an AI/software-as-a-medical-device (SaMD) submission. Instead, it details a series of non-clinical tests performed to verify that the modified device (RI2) meets the specifications of the predicate device. The performance is described qualitatively as "performed within specifications."
| Acceptance Criteria (Inferred from Test Descriptions) | Reported Device Performance |
|---|---|
| a. Pumping Accuracy: Ability to pump fluids accurately over the full range of flow rate and operating conditions (different input fluid temperatures, back pressure, ambient temperature, fluid viscosity for crystalloid and packed red blood cells). | "The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests." |
| b. Fluid Warming Performance: Ability to warm cold fluids to physiological temperature over the full range of flow rate and operating conditions. | "The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests." |
| c. Safety Detection and Alarm: Ability to detect and alarm at unsafe or ineffective operating conditions (over-temperature, unsafe high line pressure, out of fluid, air in the line, internal fault conditions). | "The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests." |
| d. Risk Assessment & Mitigation (Keypad): Verification and validation to ensure risks related to the keypad (key stick, bounce/failure, operator error, unintentional activation, fluid spillage) are mitigated and controls implemented correctly. | "We performed the verification and validation tests to ensure that these risks were mitigated and method of controls were implemented correctly." (Implied performance is successful mitigation). |
| e. Software Validation: Software life cycle in accordance with IEC 62304; validation of each algorithm for each function element; extensive system testing with software to ensure hardware and software functions meet all system requirements. | "We validated each algorithm for each function element in the software specification using an approved procedure. We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met." (Implied performance is successful validation and meeting requirements). |
| f. Medical Electrical Equipment Standard (Basic Safety & Essential Performance): Compliance with IEC 60601-1. | "The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests." |
| g. Electromagnetic Compatibility Standard: Compliance with relevant collateral standard. | "The Belmont® Rapid Infuser, R12, performed within specifications in all of the above tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of how many devices were tested or how many data points were collected during each test. It refers to testing the system "over the full range of flow rate and operating conditions."
- Data Provenance: Not applicable in the context of device performance testing. The tests are for device functional performance, not clinical data analysis. The testing appears to have been conducted by the manufacturer, Belmont Instrument Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a hardware and software performance verification, not a diagnostic or AI-driven medical imaging device that requires expert ground truth for interpretation. The "ground truth" here is the defined functional specifications of the device.
4. Adjudication Method for the Test Set
Not applicable. There is no ambiguous data requiring adjudication for this type of device performance testing. The tests are objective and based on whether the device operates according to its 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 therapeutic rather than a diagnostic device, and it does not involve human "readers" or AI assistance in the interpretation of medical data. The submission is for hardware and software updates to an existing infusion pump, not a new AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A form of standalone testing was done for the device's systems, particularly its software. The document states:
- "We generated a software life cycle in according to the IEC 62304."
- "We validated each algorithm for each function element in the software specification using an approved procedure."
- "We also performed extensive testing for the entire system with software in place to test both the hardware and software functions to ensure that all system requirements are met."
This indicates that the software was thoroughly tested in isolation (algorithms) and within the full system, without human intervention in the primary operational functions it controls.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is its predefined engineering and performance specifications. For example, the criteria for "pumping fluids accurately" means the output flow rate must fall within a specified tolerance of the targeted flow rate under given conditions. "Warming cold fluids to physiological temperature" means achieving a specific temperature range. These are objective, measurable performance targets.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model that requires a "training set" in the conventional sense. The "software life cycle" and "algorithm validation" mentioned refer to traditional software development and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI training set. The ground truth for the software and hardware validation is based on the documented design specifications and engineering requirements of the device.
§ 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).