(502 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 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):
- 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."
- Sample size used for the test set and the data provenance: Not mentioned.
- 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.
- Adjudication method: Not applicable.
- 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.
- 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.
- 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.
- 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.
- 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Baxter Healthcare Corporation Dhiraj Bizzul Sr. Manager, Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015
August 30, 2022
Re: K211125
Trade/Device Name: Novum IQ Syringe Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN, LZH Dated: May 18, 2022 Received: June 1, 2022
Dear Dhiraj Bizzul:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) TBD
Device Name Novum IQ Syringe Pump
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date: August 25, 2022
Owner:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015
Contact Person:
Dhiraj Bizzul Sr. Manager, Global Regulatory Affairs 35212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (847) 909-6828 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Novum IQ Syringe Pump Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, LZH
Table 1. Catalogue Code for Novum IO Syringe Pump
| Code Number | Name |
|---|---|
| 40800BAXUS | Novum IQ Syringe Pump |
PREDICATE DEVICE:
The Novum IQ Syringe Pump is substantially equivalent to the following predicate device:
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| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Medfusion Model 4000Syringe Pump | Smith's Medical, MDINC. | K111386 | August 29, 2011 |
Table 2. Predicate Device
DESCRIPTION OF THE DEVICE:
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 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 IO 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
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programming errors. The Novum IQ Syringe Pump is intended to be used by trained healthcare professionals.
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.
INDICATIONS FOR USE:
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.
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DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE:
| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| Indications for Use(see below for full list ofindications for use) | The Novum IQ Syringe Pump isintended to be used for thecontrolled administration of fluids.These include pharmaceutical drugs,parenteral nutrition, blood and bloodproducts, and enteral nutrition. | The Medfusion Model 4000 SyringeInfusion Pump is indicated for thefollow uses: In the administration offluids requiring precisely controlledinfusion rates including blood or bloodproducts, lipids, drugs, antibiotics,enteral solutions, and other therapeuticfluids. | Lipids are types of nutritional fluids andantibiotics are types of pharmaceuticaldrugs. These differences do not raisedifferent questions of safety andeffectiveness. |
| Routes ofAdministration | The Novum IQ Syringe Pump isintended to deliver an infusionthrough the following clinicallyaccepted routes of administration:intravenous, arterial, enteral andsubcutaneous. | By following delivery routes: arterial,epidural, intravenous, intrathecal,subcutaneous and enteral. | The intended use of the device is thesame as the predicate. The absence of oneroute of administration in the subjectdevice does not raise new questions ofsafety and effectiveness. |
| Syringe Usage | The Novum IQ Syringe Pump isintended to be used in conjunctionwith legally marketed andcompatible administration sets,syringes, and medications providedby the user. | Not specified as part of indication foruse | Although not specified, Medfusion Model4000 syringe infusion pump is to be usedwith legally marketed and compatibleadministration sets, syringes andmedications as defined in the predicateoperator's manual. |
Table 3. Comparison of Indications for Use
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| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| UseEnvironment/TreatmentPopulation | The Novum IQ Syringe Pump issuitable for patient care in hospitalsand outpatient health care facilities.The Novum IQ Syringe Pump isintended for use on adults, pediatricsand neonates. | In critical care, anesthesia, neonatal andpediatric applications or other healthcaresettings where the use of the syringeinfusion pump can be monitored orsupervised by a clinician. | The clinical care areas for the predicatedevice are all found within hospitals andoutpatient health care facilities. Thesedifferences do not raise differentquestions of safety and effectiveness. |
| Other indications forUse | The Novum IQ Syringe Pump isintended to aid in the reduction ofoperator interaction through guidedprogramming, including a way toautomate the programming ofinfusion parameters anddocumentation of infusion therapieswhen integrated with an ElectronicMedical Record (EMR) system. Thisautomation is intended to aid in thereduction of programming errors.The Novum IQ Syringe Pump isintended to be used by trainedhealthcare professionals. | By following delivery modes:continuous, volume/time, mass, bodyweight, custom dilution, intermittent andbolus. | Both devices provide guidedprogramming workflows and transferinfusion information and configured druglibraries using established bidirectionalcommunication protocols. The subjectdevice also utilizes auto-programmingand auto-documentation features totransfer information to/from an EMRusing wireless technology. Although thesubject device's indications do not listspecific delivery modes, the subjectdevice supports the same delivery modesas the predicate. The differences do notraise different issues of safety andeffectiveness. |
Table 3. Comparison of Indications for Use
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| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| Design Attributes | |||
| Pumping Mechanism | Stepper Motor Driving Leadscrew | Same as subject device | N/A |
| Modes of Delivery | Continuous, Intermittent | Same as subject device | N/A |
| Microprocessors | Multiple processors | Dual Processor | The difference in allocated functions for thesubject device is based on a Hardware safetyfeature to initiate corrective action and/or safestates. |
| Fluid Ingress Protection | IPX2 | IPX3 | Difference in IPX2 and IPX3 does not have asignificant impact based on the use environmentindicated for the devices and do not raise differentquestions of safety and effectiveness. |
| User Interface Display | LCD display with adjustable backlitcapability. | Same | Displays provide pump operating and statusinformation. Differences do not raise differentquestions of safety and effectiveness. |
| External Interfaces | USB 2.0, Type-A receptacle | Ethernet | Both provide a means of transferring data,differences do not raise different questions ofsafety and effectiveness. |
Table 4. Comparison of Design Attributes
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| Table 5. Comparison of Features/Functions and Performance Specifications | |
|---|---|
| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Features/Functions and Performance Specifications | |||||||||
| AC Power | Input: 100-240 V~, 50-60 Hz, 0.5A (0.5A-0.35 A)Output: 16 VDC/1.25 A, short circuitprotected | Input: 100-240 VAC 50/60HzOutput: Not Known | The differences in power ratings donot raise different questions of safetyand effectiveness. | ||||||
| Battery | Smart Battery Pack- Lithium Ion (internal battery unit), 10.8VDC nominal-Maximum 16 hour recharge time at 23 ±2° C(73.4 ±3.6° F)*-Battery capacity for a new fully chargedSmart Battery Pack, at the medium backlightsetting and wireless enabled use is as follows:Flow Rate (mL/hr) Capacity (hrs) 10 ≥8 1200 ≥6 | Rechargeable Lithium ion10 hrs at 5 mL/hr with 60 mL syringeCharge time: 10 hrs | The pump is able to operateindependent from AC power duringthe voltage supply. Differences do notraise different questions of safety and effectiveness. | ||||||
| Alarms | Per IEC 60601-1-8 | Not known | The subject device is designedaccording to current FDA recognizedstandards. Both the subject andpredicate devices have similar alarmsand alarm priorities, as such, anydifference in alarm setting to thepredicate do not raise differentquestions of the safety and effectiveness. |
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| Table 5. Comparison of Features/Functions and Performance Specifications | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| LoggingCapability | Yes | Same as subject device | N/A |
| BolusCapability | Yes | Same as subject device | N/A |
| Bolus VolumeAccuracy | ±10% under most conditions | Information not publicly available | Differences do not raise differentquestions of safety and effectiveness.Detailed bolus accuracy disclosed inthe labeling. |
| Syringe size | 1 - 60 mL | Same as subject device | N/A |
| Flow Raterange(mL/hr) | 0.01- 1200 mL/hr | 0.01 - 1130 mL/hr | Equivalent resolution over the flowrate range. Both the subject andpredicate devices have implementedMinimum programable and minimumrecommended flowrates.The subject device has implementedequivalent minimum programmableflow rate as the predicate andestablished higher minimumrecommended flow rate as comparedto the predicate.These differences do not raisedifferent questions of safety andeffectiveness. |
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| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| Flow Rateaccuracy | For most of the Compatible Syringes:$\pm$ 5% under most conditionsCertain syringes:-10% to +5% under most conditions | Information not publicly available | Differences do not raise differentquestions of safety and effectiveness.Detailed flow rate accuracy disclosedin the labeling. |
| Drug LibraryCapacity | Number of Care Areas: 32Number of Drugs: 5000Number of Clinical Advisories: 800Number of Modifiers: 1000 | Number of Care Areas: 16Number of Drugs: 4608Number of Clinical Advisories (Drug Alerts):Information Not KnownNumber of Modifiers: N/A | While the devices have differentcapacity, both allow for user defineddifferentiation. This difference doesnot raise different questions of safetyand effectiveness. |
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| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| Keep VeinOpen (KVO)Rate | Range 0.01-5 mL/hr based on the drug in thedrug library | Range 0 - 9.9 mL/hr | KVO can be enabled in the druglibrary or configured at the pump andwill deliver at the KVO rate at the endof an infusion for both the predicateand subject device. The rate range forKVO is intended to-differentiate theKVO rate from the infusion rate tomaintain site patency. The differentrange does not raise differentquestions of safety and effectiveness.Restrictions regarding maximumKVO flow rate per syringe size isprovided as an additional safetymitigation. |
| OcclusionPressureSetting | User selectable downstream occlusionpressure settings. | Same as subject device | N/A |
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| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| Dose Modes | Continuous Delivery Modes:mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr,mg/kg/hr, mg/min, mg/kg/min, mg/kg/day,mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min,mcg/kg/day, ng/min, ng/kg/min, Units/hr,Units/kg/hr, Units/min, Units/kg/min,mUnits/min, mUnits/kg/hr, mUnits/kg/min,mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr,MillionUnits/day | ContinuousmL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr,mg/kg/hr, mg/min, mg/kg/min, mg/kg/daymcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min,mcg/kg/day, ng/min, ng/kg/min, Units/hr,Units/kg/hr, Units/min, Units/kg/min,MillionUnits/day, mUnits/min, mUnits/kg/hr,mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr,mmol/kg/hr | The subject device also providescontinuous and intermittent infusions.Differences do not raise differentquestions of safety and effectiveness. |
| Amount / Time | |||
| Intermittent Delivery Modes:mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2,mcg, mcg/kg, mcg/m2, Units, Units/kg,Units/m2, mEq, mEq/kg, mmol, mmol/kg,MillionUnits, MillionUnits/kg,MillionUnits/m2 | Non-weight-based:mg, Units, g, mcg, mEq, mmol, MillionUnits | ||
| Weight based:mL/kg, mg/kg, Units/kg, g/kg, mcg/kg,mEq/kg, mmol/kg, MillionUnits/kg | |||
| BSA based:mg/m², Units/m², g/m², mcg/m²,MillionUnits/m2 | |||
| Volume / TimeTotal Volume / Total Time | |||
| Rate or DoseLimits | 0.01 - 1200 mL/hr (depending on syringe sizeand rate). | 0.01 mL/hr to 1130 mL/hr in increments of0.01 or 0.1 mL/hr (depending on syringe sizeand rate). | Equivalent resolution over the flowrange. Differences do not raisedifferent issues of safety andeffectiveness. |
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| Table 5. Comparison of Features/Functions and Performance Specifications | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
|---|---|---|---|
| OperationalConditions | Operating temperature:50 to 104°F (10 to 40° C), 10 to 95% relativehumidity non-condensing.Atmospheric Pressure: 70 kPa to 102 kPa | Temperature: 5° to 40° C (40° to 104° F)Relative Humidity: 20 to 95% non-condensingAmbient Pressure: 70 kPa to 106 kPa (10.2 psiato 15.4 psia) | Functional and performance testssupport the operational conditions forthe subject device. These differencesdo not raise different questions ofsafety and effectiveness. |
| StorageTemperature | Storage temperature:14 to 120°F (-10 to 49°C), 10 to 95% relativehumidity non-condensing | Store at controlled room temperature 15° to30°C (59° to 86°F). | Functional and performance testssupport the storage conditions for thesubject device. These differences donot raise different questions of safetyand effectiveness. |
| ApproximateSize | 102mm H x 240mm W x 161mm D | 160x270x145 mm | Human Factors studies support thephysical dimensions and Form Factorfor the subject device. Thesedifferences do not raise differentquestions of safety and effectiveness. |
| ApproximateWeight | 2.8 kg (6.2lb) | 4.5 lb | Human Factors studies support theweight of the subject device. Thisdifference does not raise differentquestions of safety and effectiveness. |
| Auto-programming | Yes | No | The subject device allows automatedpopulation of infusion deliveryinformation from an EMR in additionto manually programming infusionsthrough the pump interface.Automated data transfer usingestablish protocols does not raisedifferent questions of safety andeffectiveness as infusion programmingis confirmed by the clinician prior tostarting an infusion. |
| Characteristic | Subject Device | Predicate Device (K111386) | Discussion of Differences |
| Wireless | Yes | Same as subject device | N/A |
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DISCUSSION OF NON-CLINICAL TESTS
Non-Clinical testing of the Novum IO Syringe Pump has been performed against requirements for performance, physical attributes, environmental conditions and safety, and to provide objective evidence that the device's intended use is met.
As recommended by FDA guidance, "Infusion Pumps Total Product Life Cycle" issued December 2, 2014, Baxter has developed a Safety Assurance Case (SAC) to demonstrate that hazardous situations resulting from the design, intended use, and reasonably foreseeable misuse of the device have been appropriately mitigated.
The stated goal of the safety assurance case is to document that the design of the Novum IQ Syringe Pump is adequately safe for its intended use. The assurance case defined the device system, including the indications for use, patient populations, use environments, and system specifications. The supporting assurance arguments confirmed that:
- potential risks have been mitigated and the residual risk is acceptable, ●
- design verification and validation of the device is acceptable, .
- device reliability is acceptable, ●
- the device meets clinically valid essential performance.
Performance testing of the Novum IQ Syringe Pump was verified against requirements for performance, physical attributes, environmental conditions, safety, and to provide objective evidence that the device intended use is met.
- . Validation demonstrated that design inputs and user needs were met. Verification involves testing of both subsystem and system level requirements against predefined and approved protocols containing validated test methods and established acceptance criteria. System verification including software verification demonstrated that design outputs meet design input requirements, connectivity requirements, interface requirements and cyber security requirements. System verification also includes testing of interfaces with other devices or accessories that are intended to be used with the system.
- . Cleaning and Disinfection validation was performed according to FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2015.
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- . Wireless functionality was implemented according to FDA Guidance Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013.
- . Software verification and validation was performed according to Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, issued May 11, 2005 and Infusion Pumps Total Life Cycle, issued December 2, 2014. The software is considered a major level of concern. Software testing included code review, static analysis, unit testing, integration testing, and regression testing.
- Cybersecurity verification and information was performed and provided . according to FDA's Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 18, 2018, and FDA's draft Guidance Postmarket Management of Cybersecurity in Medical Devices, issued December 28th 2016.
- Interoperability was assessed and testing in accordance with FDA's Guidance on . Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Device, issued September 6, 2017.
Electrical safety, EMC and essential performance testing was successfully completed according to the following standards and associated methods:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirement for . Basic Safety and Essential Performance
- IEC 60601-2-24 Medical equipment Part 2-24: Particular requirements for the . basic safety and essential performance of infusion pumps and controllers
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- . IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- AIM 7351731 rev 2: 2017, Medical Electrical Equipment and System . Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
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- IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline . or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- . UL 2054 2nd Edition Household and Commercial Batteries
- UL 1642 5th Edition Lithium Batteries ●
In addition to the above, and in consideration of IEC 62366-1ed. 1.0 b:2015, Medical devices - Part 1: Application of usability engineering to medical devices as well as FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016, Baxter conducted Human Factors evaluations in a simulated environment. The human factors study was conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of human factors studies show the device is suitable for its intended use.
DISCUSSION OF CLINICAL TESTS:
No clinical testing was performed in support of this premarket notification.
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.
§ 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).