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510(k) Data Aggregation
(28 days)
DEKA Infusion System, DEKA Administration Set
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.
The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.
The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.
The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged.
The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.
The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.
The provided text is a 510(k) summary for the DEKA Infusion System and DEKA Administration Set. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification, specifically an increased maximum programmable flow rate and an update to tilt angle detection.
However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria, the study proving the device meets the criteria, sample sizes, expert involvement, ground truth, or MRMC studies for an AI/ML-based device.
This document is for a mechanical/electrical infusion system that uses a camera for drop formation detection and flow rate measurement, not an AI/ML diagnostic or prognostic device that would involve a training set, test set, expert adjudication, or MRMC studies in the way your questions imply. The "Vision System Performance" mentioned is likely related to the camera's ability to accurately detect drops, not a complex AI model requiring extensive human-in-the-loop validation or ground truth established by multiple medical experts interpreting images.
Therefore, I cannot extract the requested information from this document. The questions you've asked are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving image interpretation or complex diagnostic algorithms. This 510(k) summary does not describe such a device or its corresponding validation studies.
The closest aspects discussed are:
- Acceptance Criteria for Flow Rate Accuracy: Mentioned as "± 10% nominally" and "± 25% under environmental limits of normal use." The document states "All tests met acceptance criteria."
- Study Proving Device Meets Criteria: "Formal performance testing was conducted on all areas of the subject device that are impacted by its changes with respect to the predicate device."
- Performance Data: "Flow Rate Accuracy," "Vision System Performance," "Stopping Flow," and "Device Handling Alarms" were tested.
But none of these provide the level of detail (sample size, expert ground truth, adjudication, MRMC) specific to AI/ML device validation that your questions are designed to elicit.
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(211 days)
DEKA Infusion System, DEKA Administration Set
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.
The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.
The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.
The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.
The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.
This document describes the regulatory submission for the DEKA Infusion System and DEKA Administration Set, emphasizing their substantial equivalence to previously cleared devices. It outlines performance data related to device testing but does not contain information on studies proving the device meets acceptance criteria related to AI/human reader performance or ground truth established by experts for such studies.
Therefore, I will extract relevant information that is present and note the absence of information specifically requested for AI/human reader performance studies.
Here's the analysis based on the provided text:
Acceptance Criteria and Device Performance (as far as described for the hardware components):
| Acceptance Criterion (Implicit/Derived from Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|
| DEKA Infusion System | |
| Device Classification Regulation and Product Code | 21 CFR 880.5725, Product Code: LDR |
| Class | II |
| Intended Use | Equivalent to predicate |
| Prescription or Over the Counter (OTC) | Prescription |
| Intended Patient Population | Adults |
| Environment of Use | Equivalent to predicate |
| Compatible Administration Set | DEKA Administration Set, 20 drop/mL (non-DEHP) (Equivalent to predicate) |
| Applicable Standards | ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304 (Identical) |
| Operating Environment Temperature | 15 °C to 40 °C (Wider, supported by testing) |
| Operating Environment Relative Humidity | 15 % to 90%, non-condensing (Wider, supported by testing) |
| Operating Environment Altitude | -300 m to 3000 m (Wider, supported by testing) |
| Specified Ingress Protection rating | IP42 (Higher, supported by testing) |
| Physical Weight |
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