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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.

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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 IO 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 IO 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 infusion platform. 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 patient in 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 and blood products, and enteral nutrition through compatible syringes and administration sets at user selectable rates and volumes.

The feedback-controlled, motorized pumping mechanism of the Novum IQ Syringe Pump is a stepper motor acting with a lead screw to depress the plunger of a syringe. The syringe pump accepts a horizontally loaded syringe, held in place by a barrel clamp. The outer diameter of the loaded syringe is sensed, and compared against a stored look-up table to enable user assisted identification of the loaded syringe.

The Novum IO Syringe Pump is designed to detect and react to situations that could impact patient safety. When a situation that could impact patient safety is detected, the syringe infusion pump will notify the clinician with a visual alert and an audible alarm tone.

The Novum IQ Syringe Pump is designed to operate on AC power with an internally mounted rechargeable battery pack to facilitate the continuation of therapy during patient transport or AC power loss.

The provided text does not contain detailed acceptance criteria and a study meeting those criteria for a device. Instead, it is an FDA 510(k) clearance letter for the Novum IQ Syringe Pump, asserting its substantial equivalence to a predicate device (Medfusion Model 4000 Syringe Pump).

While the document discusses performance specifications and verification/validation activities, it does not present a specific study that proves the device meets explicit acceptance criteria in the format requested.

Here's a breakdown of what can be extracted and what information is missing:

Information from the document:

• Device Name: Novum IQ Syringe Pump
• Predicate Device: Medfusion Model 4000 Syringe Pump (K111386)
• Non-Clinical Testing: Performance, physical attributes, environmental conditions, safety, cleaning and disinfection, wireless functionality, software verification and validation (major level of concern), cybersecurity verification, interoperability, electrical safety, EMC, essential performance, and human factors evaluations. These were performed against various IEC and UL standards and FDA guidance documents.
• Conclusion: The Novum IQ Syringe Pump has been verified and validated against design input requirements, user needs, and intended uses. The subject device is substantially equivalent to the predicate device.

Missing Information (based on the request):

1. A table of acceptance criteria and the reported device performance: While there are comparisons to the predicate device regarding features, functions, and some performance specifications (e.g., flow rate range, flow rate accuracy in general terms, bolus accuracy as ±10% under most conditions), the document does not explicitly define acceptance criteria as a clear pass/fail threshold for each performance characteristic, nor does it present specific measured performance data for the Novum IQ Syringe Pump in a discrete table. It states that "functional and performance tests support the operational conditions for the subject device" and "Detailed bolus accuracy disclosed in the labeling."
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's not a clinical study requiring expert ground truth in the traditional sense. The "ground truth" here would be the technical specifications, standards, and safety assurance case.
4. Adjudication method: 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: Not applicable. This device is an infusion pump, 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: The document mentions "Human Factors evaluations in a simulated environment" and that "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." This suggests there are automated functions, but details on standalone performance or a study specifically evaluating algorithm-only performance are scarce. The human factors study involved "intended user population, use environment and use scenarios to simulate clinical conditions," implying human-in-the-loop testing.
7. The type of ground truth used: For non-clinical performance, the "ground truth" is defined by established engineering principles, international standards (IEC, UL), and FDA guidance for medical devices, particularly infusion pumps. Design input requirements, user needs, and the safety assurance case serve as the basis for verification and validation.
8. The sample size for the training set: Not applicable, as this is hardware/software medical device verification and validation, not a machine learning model with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information that minimally addresses some points:

• Clinical Testing: "No clinical testing was performed in support of this premarket notification." This explicitly states no clinical studies were conducted.
• Non-Clinical Testing: Extensive non-clinical testing was performed against various performance, physical attributes, environmental conditions, safety, and specific functional requirements (e.g., cleaning, wireless, software, cybersecurity, interoperability, electrical safety, EMC, alarms, human factors). These tests "provide objective evidence that the device's intended use is met."
• Human Factors Study: Conducted in a simulated environment with intended users, use environment, and use scenarios. "Results of human factors studies show the device is suitable for its intended use."
• Flow Rate Accuracy: "For most of the Compatible Syringes: ±5% under most conditions. Certain syringes: -10% to +5% under most conditions." This is a reported performance metric, but the corresponding "acceptance criteria" against which it's judged are not explicitly stated in this segment, only that "Differences do not raise different questions of safety and effectiveness."
• Bolus Volume Accuracy: "±10% under most conditions." Similar to flow rate, this is reported performance.

To provide a complete answer as requested, the specific acceptance criteria for each tested aspect and the detailed results of those tests would be needed, which are not provided in this public FDA 510(k) summary. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and adherence to recognized standards and FDA guidance.

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