(94 days)
The Infutest 2000 Infusion Device Analyzer (Infutest) is intended to verify the correct operation of infusion pumps. Infutest is designed to be used by biomedical electronics technicians, third party service personnel, and others who may be charged with the responsibility of determining the functionality of an infusion pump.
The Infutest 2000 Infusion Pump Analyzer is an instrument for measuring the volume of fluid delivered by an infusion pump. The instrument is based on an optically instrumented burette. Flow rates from 0.1 to 999.9 millilitres per hour can be derived from the incremental volume measurements in relation to the time of delivery. Infutest 2000 is a two channel system, which can be expanded to four channels by the addition of an accessory two channel sensor assembly called the Remote Sensor Module.
The Infutest 2000 is designed to accurately measure volumes and rates on a wide variety of infusion pump types, including syringe, linear and rotary peristaltic, cassette based, enteral and patient controlled analgesia.
In addition to volume and flow rate, Infutest can measure the pressure developed by an infusion pump that is pumping into an occluded line. This feature is designed to measure the occlusion pressure alarm limits of the infusion pump.
Results of all tests performed can be printed to paper and/or sent to an external device using the serial communications port.
Here's an analysis of the provided text regarding the Infutest 2000 Infusion Pump Analyzer, outlining its acceptance criteria and the study information.
It's important to note that the provided document is a 510(k) summary from 1998 for an infusion pump analyzer, not a medical device designed for direct patient care with AI components. As such, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like those involving expert labels, MRMC studies, or training/test sets for AI models) will not be present or directly applicable. This device is a measurement tool, and its "performance" is about accuracy and precision in measuring infusion pumps.
Acceptance Criteria and Device Performance for Infutest 2000 Infusion Pump Analyzer
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of "acceptance criteria" with specific numerical targets for accuracy, precision, or other performance metrics. Instead, it describes the device's capabilities and implies that performance is achieved if these capabilities are met and the device is substantially equivalent to predicates. The "Verification and Validation" section confirms that the device was tested to work "per the input design and marketing specifications."
Based on the description of capabilities, here's a reconstructed table reflecting what the device claims to measure and how well it measures based on the context of its intended use as an analyzer, rather than specific acceptance criteria thresholds. The performance is implied by its design for accurate measurement of these parameters.
| Feature/Acceptance Criterion (Implied) | Reported Device Performance (as described) |
|---|---|
| Flow Rate Measurement Range | 0.1 to 999.9 milliliters per hour |
| Volume Measurement Increment | As low as 15 microliters |
| Occlusion Pressure Range | 0-50 psi (measured by internal transducers) |
| Channel Capacity | Two independently operating channels (expandable to four with Remote Sensor Module) |
| Test Types | Single Rate, Dual Rate, PCA, Occlusion Pressure |
| Data Output | Print to paper (Centronics parallel), serial communications port to external device |
| Alarm Monitoring | Checks nurse call alarm output during occlusion tests |
| PCA Triggering | Activates trigger input of PCA pump during PCA test |
| Programmability | Up to 9 user-defined test protocols (timed rate, timed occlusion, formatted output) |
Notes on Acceptance Criteria: The document emphasizes "accurate measurement" in its description of the technological characteristics but does not quantify "accuracy" or "precision" with specific tolerances (e.g., ±X% of reading). The primary "acceptance" for this 510(k) is substantial equivalence to predicate devices (Bio-Tek IDA-2 Plus, DNI Nevada 404A). This implies that if the Infutest 2000 performs comparably to these legally marketed devices, it meets the regulatory acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "extensively tested, verified and validated" but does not provide details on the number of devices or types of infusion pumps used in the testing.
- Data Provenance: Not specified. It's internal validation by the manufacturer (Datrend Systems, Inc.). Given the nature of a 510(k) for a test device, this would likely involve new data generated by the manufacturer to demonstrate performance of their device against known reference standards or predicate devices. There's no mention of external data or specific countries of origin beyond the manufacturer's location in Burnaby, BC, Canada. The testing would be prospective in the sense that it was performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided for this type of device. The Infutest 2000 is an analyzer that measures physical parameters (volume, flow rate, pressure) of infusion pumps. Ground truth for its measurements would be established through calibrated reference standards for flow, volume, and pressure, not expert human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1 consensus) are typically used for establishing ground truth in subjective assessments, such as medical image interpretation by human experts. For a device measuring physical quantities, comparison would be against known, calibrated standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable and not provided. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. The Infutest 2000 is a standalone measurement device with no human-in-the-loop AI assistance component in its intended function.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "Verification and Validation" section describes testing of the "Infutest 2000, the remote sensor module, the serial data transfer program and the graphics display program." This implies standalone testing of the device's functionality and its associated software components to ensure they meet design specifications. However, it's not "algorithm only" in the context of an AI/ML algorithm, but rather the integrated system's performance.
7. The Type of Ground Truth Used
The ground truth used for validating this device would be calibrated reference standards. This would involve:
- Known Volume Standards: Highly accurate measures of fluid volume (e.g., precise pipettes, gravimetric methods, or certified volumetric containers) to verify the Infutest's volume measurement accuracy.
- Known Flow Rate Standards: Systems capable of delivering fluid at precisely controlled and measured flow rates to verify the Infutest's flow rate accuracy.
- Calibrated Pressure Transducers/Gauges: To verify the accuracy of the Infutest's internal pressure transducers against known pressure inputs.
The document does not explicitly state how these ground truths were implemented, but this is the standard practice for calibrating and validating such an analyzer.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Infutest 2000 is not described as utilizing AI/ML algorithms that would require a "training set" in the conventional sense. Its operation is based on optical measurement and embedded logic, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8. There is no mention of a training set for an AI/ML model for this 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).