(125 days)
The Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid is low. The device provides both visual and audible alarms when preset condition is met.
The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infirsed. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of the low-fluid-level status.
LM771: 1-channel, DC battery power LM781: 1-channel, DC plug-in power LM785: 5-channel DC plug-in power
Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid level is low. Fluid Level Monitor provides both visual and audible alarms when preset condition is met. Fluid Level Monitor operates on DC power source.
Fluid Level Monitor includes both main control unit and external sensor. There are status LEDs on the main control unit to display run, alarm and battery-low status. There is a buzzer on the main control unit to provide audible alarm.
The external sensor is connected to the main control unit via shielded signal cable. The sensor can be clipped on the tubing to monitor fluid level.
The provided text describes the Coleman Laboratories' Fluid Level Monitor and its 510(k) submission. However, it does not contain specific details about acceptance criteria and a study that proves the device meets those criteria in the format explicitly requested. The document does mention "Summary Performance Data" and states: "Based on the risk analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 18. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." Unfortunately, "Section 18" is not included in the provided text.
Therefore, I cannot populate most of the requested fields. I can, however, extract the limited performance information provided.
Here's a summary based on the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific functional acceptance criteria are not provided in this document. | - Confirmed compliance to design specifications. |
| - All functions verified to operate as designed. | |
| - System power consumption remains the same when using DC battery or DC plug-in power. | |
| - System power consumption remains the same when using 1-channel or 5-channel sensing. | |
| Conclusion based on provided information: | The design difference on the number of monitoring points does not raise safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance:
Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as the device is a passive sensor and the testing described is functional, not a diagnostic or AI-assisted interpretation requiring expert ground truth.
4. Adjudication method for the test set:
Not applicable.
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:
No, a MRMC comparative effectiveness study was not done. This device is a passive sensor for low-fluid alarms, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance testing described appears to be a standalone functional validation of the device's alarm system, without human interaction as part of the primary performance measurement.
7. The type of ground truth used:
Functional verification against design specifications. For example, verifying the alarm triggers when the fluid level is low, and that power consumption is consistent across power sources and channels.
8. The sample size for the training set:
Not applicable as this is a hardware device with embedded logic, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable.
Additional Note: The document emphasizes substantial equivalence to predicate devices (K030136 - Drip Alert, K903193 - Levelert) based on design principles, material, indications for use, and intended use. This suggests the performance expectations might be benchmarked against these existing devices.
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).