(1079 days)
The Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural.
The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial.
The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user.
The Novum IO LVP is suitable for patient care in hospitals and outpatient health care facilities.
The Novum IQ LVP 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 with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.
The Novum IQ LVP is intended to be used by trained healthcare professionals.
The Novum IQ Large Volume Pump (LVP) is a large volumetric smart pump within the Novum IQ infusion platform. The 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 pump and its associated drug library are configured.
Novum IQ LVP 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 pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood and blood products through administration sets at clinician's selectable rates and volumes.
The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user. The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities. The Novum IO LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate 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 LVP is intended to be used by trained healthcare professionals.
The Novum IQ LVP employs a feedback controlled, motorized pumping mechanism that works based on peristaltic action and uses inlet and outlet valves for flow control. To deliver medication correctly, the Novum IQ LVP peristaltically compresses the administration set. The pump channel is designed to interface to a Baxter standard administration set. The pumping mechanism interfaces with the keyed slide clamp and tubing to prevent free flow of drug.
The Novum IQ LVP is designed to detect and react to situations that could impact patient safety. When a situation that could impact patient safety is detected. the Novum IO LVP will notify the clinician with a visual alert and an audible alarm tone.
The Novum IQ LVP is designed to operate on Alternating Current (AC) power with an internally mounted rechargeable battery pack to facilitate the continuation of therapy during patient transport or AC power loss.
The provided document is a 510(k) Premarket Notification for the Novum IQ Large Volume Pump. It primarily discusses the device's substantial equivalence to a predicate device based on non-clinical testing and engineering evaluations. It explicitly states that "No clinical testing was performed in support of this premarket notification."
Therefore, I cannot provide information regarding acceptance criteria based on clinical studies, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these would typically be derived from clinical trials, which were not conducted for this submission.
However, based on the non-clinical tests and the device comparison provided, I can infer the acceptance criteria relate to meeting the performance, physical attributes, environmental conditions, and safety requirements of relevant international standards and FDA guidance documents. The "reported device performance" would be that the device successfully met these requirements.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Based on the "DISCUSSION OF NONCLINICAL TESTS" and "DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE" sections, the acceptance criteria are primarily derived from regulatory standards and the performance of the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from documentation) | Reported Device Performance (as stated or implied) |
|---|---|---|
| General Safety & Performance | Device design is adequately safe for its intended use; potential risks mitigated; residual risk acceptable; design verification and validation acceptable; device reliability acceptable; device meets clinically valid essential performance. (from Safety Assurance Case) | "The Novum IQ LVP has been verified and validated against design input requirements, user needs and intended uses." |
| Cleaning & Disinfection | Validation according to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). | "Cleaning and Disinfection validation was performed according to FDA Guidance..." |
| Wireless Functionality | Implementation according to FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013). | "Wireless functionality was implemented according to FDA Guidance..." |
| Software V&V | According to "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (May 11, 2005) and "Infusion Pumps Total Life Cycle" (December 2, 2014); software considered major level of concern; includes code review, static analysis, unit testing, integration testing, and regression testing. | "Software verification and validation was performed according to Guidance for the Content of Premarket Submission..." |
| Cybersecurity | Verification and information provided according to FDA's Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 18, 2018) and draft Guidance Postmarket Management of Cybersecurity in Medical Devices (Dec 28, 2016). | "Cybersecurity verification and information was performed and provided according to FDA's Guidance..." |
| Interoperability | Assessed and tested in accordance with FDA's Guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Device (Sept 6, 2017). | "Interoperability was assessed and tested in accordance with FDA's Guidance..." |
| Electrical Safety, EMC, Essential Performance | Compliance with IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2, IEC 60601-1-8, AIM 7351731 rev 2: 2017, IEC 62133-2 Ed.1.0 2017-02, UL 2054 2nd Edition, UL 1642 5th Edition. | "Electrical safety, EMC and essential performance testing was successfully completed according to the following standards..." |
| Human Factors/Usability | Evaluation in a simulated environment with intended user population, use environment, and scenarios, according to IEC 62366-1 ed. 1.0 b:2007 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016). | "Baxter conducted a Human Factors evaluation in a simulated environment. Results demonstrated that the Novum IQ LVP is suitable for its intended use." |
| Flow Rate Accuracy | Accuracy under standard conditions: For primary set material: 0.5 - 0.9 mL/hr: +/-10%; 1 - 1200 mL/hr: +/-5%. (Compared to Predicate: 0.5 - 1.9 mL/hr: +/-0.1 mL/hr; 2- 999 mL/hr: +/-5%) | "Similar. Detailed flow rate accuracy for all sets disclosed in labeling." (Implies meeting or exceeding predicate performance for ranges). |
| Battery Performance | Smart Battery Pack - Lithium Ion (internal), 10.8 VDC nominal; Max 16 hr recharge time at 23 +/- 2°C; Capacity (medium backlight, wireless enabled): 25-125 mL/hr >=8 hrs; 1200 mL/hr >=6 hrs. (Compared to a predicate with external battery module and different capacity specs). | "The pumps are able to operate independent from AC power during transport situations or interruptions of the voltage supply. Differences do not raise different questions of safety and effectiveness." |
| Operational Conditions | Operating temperature: 15 to 40°C, 10 to 80% relative humidity non-condensing. (Compared to predicate: 15.6 to 32.2°C, 20 to 90% RH). | "Functional and performance tests support the operational conditions for the subject device." |
| Storage Conditions | Storage temperature: -10 to 49°C, 10 to 80% relative humidity non-condensing. (Compared to predicate: -10 to 49°C, 10 to 90% RH). | "Functional and performance tests support the storage conditions for the subject device." |
| Administration Set Loading | Guided administration set loading using visual and audible prompts with automatic ejection of the slide clamp upon door closure. (Compared to predicate: manual removal of slide clamp). | "Functional tests and Human Factors studies support that this difference does not raise different questions of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific component or system-level test. The document refers to "testing" and "verification and validation" efforts, but not the number of units or test cases used.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical tests, the data provenance would be internal laboratory testing and controlled simulated environments conducted by Baxter Healthcare Corporation. The document does not specify country of origin for the non-clinical data, but the submission is to the US FDA by Baxter Healthcare Corporation in Deerfield, Illinois.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is typically relevant for studies involving human interpretation (e.g., radiology for AI algorithms). Since no clinical testing was performed and the ground truth for engineering and V&V tests is based on design specifications and standard requirements, this question is not applicable to the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical study involving human readers or interpretation requiring adjudication was performed.
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, as no clinical testing or studies involving human-in-the-loop performance were conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an infusion pump, not an AI algorithm intended for diagnostic or interpretive tasks. Its performance is measured by its mechanical and electronic functionality, safety features, and accuracy in fluid delivery, not by an independent algorithm's diagnostic output.
7. The type of ground truth used:
- For performance, physical attributes, environmental conditions, safety (non-clinical testing): The ground truth was established by adherence to recognized international standards (e.g., IEC 60601 series, UL standards) and FDA guidance documents, as well as internal design specifications and requirements.
- For human factors/usability: The ground truth was the ability of intended users to safely and effectively operate the device in simulated clinical scenarios, as evaluated against predefined criteria.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., image datasets for deep learning). The device undergoes design, development, and engineering verification.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
§ 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).