(366 days)
The ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.
Enthermics Medical Systems' ivNow Modular Fluid Warmer is designed to rapidly warm and maintain the temperature of injection / IV and irrigation fluid bags. Open on two sides with no cover or door, the device consists of a warming area module (alcove) in a "C" shape with a heating element that warms and maintains the temperature of the fluid. The basic device may be used as a single module or [pre]assembled in multiple configurations comprised of 1-6 modules with a common power switch and cord, fastened together by a unique rear mounting panel. The device is available in either 120v or 230v.
When an injection / IV or irrigation fluid bag is placed in the warming alcove, an optical sensor signals to the control that the alcove is occupied. The control then engages the heating element which warms the fluid in the bag. The temperature of the heating element and fluid is monitored by two sets of sensors contained within the device. When the desired temperature of the fluid is reached and confirmed, the real time temperature of the fluid is displayed on a panel at the front of the device (the control display). Internally, the heating element and fluid temperatures are monitored, and the heating element is regulated to raise the fluid to the desired temperature but never beyond that temperature. When the fluid reaches the desired temperature, the control displays the set temperature and a green indicator light next to the control display turns on. The control will continue to monitor the temperature of the heating element and fluid, and regulate the heating element to maintain the fluid at its set temperature indefinitely. The length of time that a particular bag has been warming in the alcove is also monitored and displayed (total residence time monitor display).
The provided document describes the ivNow Modular Fluid Warmer, a medical device designed to warm and maintain the temperature of injection/IV and irrigation fluid bags.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Warm injection/IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags. |
| Temperature Control & Display | Device warms and maintains fluid at a set temperature (factory preset: 40°C / 104°F). Real-time temperature of the fluid is displayed on a panel. A green indicator light turns on when the desired temperature is reached and confirmed. |
| Thermal Cutout Temperature | 1°C (or 1°F for "Factor") over set point temperature. |
| Residence Time Monitor | Total residence time duration of the fluid in the compartment is internally measured and displayed. |
| Safety | Confirmed to be safe through testing (implies meeting safety standards related to warming medical fluids). |
| Effectiveness | Confirmed to be effective for its intended use through testing (implies successful warming and temperature maintenance). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Device testing included a Thermal Performance Test, Life Cycle Test and Control Failure Test." However, it does not specify the sample size used for these tests (e.g., number of devices tested, number of fluid bags used).
The data provenance is internal testing conducted by Enthermics Medical Systems, Inc. The document does not indicate data from external sources, country of origin of data beyond the manufacturer's location, or if the testing was retrospective or prospective. It's implied to be prospective testing conducted during device development/validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on engineering tests (Thermal Performance, Life Cycle, Control Failure) rather than human interpretation or expert assessment.
4. Adjudication Method for the Test Set
As no experts were mentioned for establishing ground truth, and the tests were technical/engineering-based, there was no adjudication method described for a 'test set' in the context of expert review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on performance. The ivNow Modular Fluid Warmer is a therapeutic/supportive device, not a diagnostic one.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The studies mentioned ("Thermal Performance Test, Life Cycle Test and Control Failure Test") describe the standalone performance of the device itself. The device's primary function is automated temperature control, and these tests would evaluate the device's ability to perform this function independently, without human interaction during the warming process beyond initial setup. So, yes, the described tests are essentially standalone performance evaluations of the device's core functionalities.
7. Type of Ground Truth Used
The ground truth for the ivNow Modular Fluid Warmer's performance is based on objective, quantifiable physical parameters directly measured by the device and external instruments during testing. This includes:
- Fluid temperature (measured against a known set point).
- Heating element temperature.
- Time (for residence time monitoring).
- Operational integrity over time (for life cycle testing).
- Response to failure conditions (for control failure testing).
This is a form of empirical ground truth established through direct physical measurement and engineering validation.
8. Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning algorithms. The ivNow Modular Fluid Warmer is an electro-mechanical device with intelligent controls, but it is not described as utilizing machine learning or AI algorithms in a way that would require a distinct "training set" of data to learn from. Therefore, no sample size for a training set is mentioned or relevant in the context of this device description.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for a machine learning algorithm, this question is not applicable to the information provided in the document. The device's "programming" or operational parameters would have been set during its design and development, validated through the described testing.
§ 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).