(24 days)
The Novum IQ Syringe Pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition.
The Novum IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous.
The Novum IQ Syringe Pump is intended to be used in conjunction with legally marketed and compatible administration sets, syringes, and medications provided by the user.
The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities.
The Novum IQ Syringe Pump is intended for use on adults, pediatrics and neonates.
The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.
The Novum IQ Syringe Pump is intended to be used by trained healthcare professionals.
The Novum IQ Syringe Pump is a general purpose, syringe-based, smart pump within the Novum IQ syringe pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the Novum IQ Syringe Pump and its associated drug library are configured. The Novum IQ syringe pump is capable of delivering fluids in syringes ranging in size from 1 mL - 60 mL.
The Novum IQ Syringe Pump is a system that provides delivery of fluids into a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical syringe pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood products, and enteral nutrition through compatible syringes and administration sets at user selectable rates and volumes.
The provided text is a 510(k) summary for the Novum IQ Syringe Pump. It details the device's indications for use, technological characteristics, and non-clinical testing performed to support its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or information about studies that prove the device meets said acceptance criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, or AUC).
This document describes a medical device (an infusion pump) and its regulatory clearance, focusing on software updates and labeling. It is not an AI/ML device in the context of diagnostic or predictive capabilities that would involve traditional "performance" metrics for acceptance criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance in a table, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for the training set was established. These items are typically relevant for AI/ML-driven diagnostic or prognostic devices, which the Novum IQ Syringe Pump is not.
The document states:
- "Clinical testing is not applicable for this submission."
- The testing performed was "Unit testing was composed of software actor requirements verification and static analysis," "Integration testing of software requirements, performed as "black box" testing," and "System requirements verification testing was performed as "black box" testing with the Novum IQ Syringe Pump Software/hardware configuration."
- "All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process."
This indicates that the "acceptance criteria" were related to software and system functionality and safety, rather than diagnostic accuracy or clinical outcomes that would be assessed using the requested metrics.
§ 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).