(211 days)
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 |
§ 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).