(331 days)
The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in where the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS.
The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered.
The provided text describes a 510(k) premarket notification for the ISSYS Drug Flow Monitor®. It includes information on the device's intended use and performance specifications, which can be interpreted as acceptance criteria. However, it does not detail a specific study proving the device meets these criteria in the comprehensive manner requested (e.g., sample size, expert ground truth, MRMC study, training set details).
Here's a breakdown of the information that can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the "Indications For Use" section, the following can be constructed:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flow Rate Range | 5 to 200 mL/hr |
| Accuracy at 5 mL/hr | +/- 20% |
| Accuracy at 200 mL/hr | +/- 5% |
| Alarm Trigger | Visible and audible if flow rate or volume falls outside preset range |
Missing Information:
The document does not provide details of a specific study that proves these performance metrics. It merely states them as characteristics of the device and its intended use. There is no mention of study design, methodology, or results from an independent study to validate these claims.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information:
The document does not describe a test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). The provided text is a regulatory clearance letter, not a scientific study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Missing Information:
No information is provided regarding experts, ground truth establishment, or their qualifications. This is not a study involving human interpretation of medical images or data.
4. Adjudication Method
Missing Information:
No information is provided about an adjudication method. This is not relevant for a device that directly measures flow rates.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information:
An MRMC study is not relevant for this device. The ISSYS Drug Flow Monitor® is a "passive monitoring device" that "uses a flow sensor to measure the amount of liquid." It's an automated measurement device, not one that assists human readers in interpreting clinical data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates "standalone" in the sense that it automatically measures and alarms, the document does not describe a study to test its standalone performance against a gold standard or reference. It only states the device's claimed accuracy specifications.
7. Type of Ground Truth Used
Missing Information:
No information is provided regarding the type of ground truth used for performance validation. For a device measuring flow, the ground truth would typically be highly accurate reference flow meters, but the document does not describe how these specific accuracy figures were derived or verified in a formal study for regulatory submission.
8. Sample Size for the Training Set
Missing Information:
There is no mention of a "training set." This type of device is likely based on physical principles of fluid dynamics and sensor calibration, not on machine learning or algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Missing Information:
As there's no mention of a training set, there's no information on how its ground truth was established.
Summary of Document's Relevance to the Request:
The provided FDA letter serves as regulatory clearance based on the manufacturer's claims and submissions, not as a detailed scientific study report. It states the device's intended use and performance specifications (which can be interpreted as acceptance criteria), but it does not describe the specific studies that validated these claims according to the detailed scientific rigor outlined in your request. The format of the request (e.g., MRMC studies, expert ground truth) is more applicable to diagnostic imaging AI devices, whereas the ISSYS Drug Flow Monitor is a measurement and alarm device for gravity infusion systems.
§ 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).