(1079 days)
Not Found
No
The summary describes "guided programming" and "automation of programming" to reduce errors, but this functionality appears to be based on pre-configured drug libraries and integration with EMR systems, not on learning or adaptive algorithms characteristic of AI/ML. There is no mention of AI, ML, or related concepts in the document.
Yes.
This device is an infusion pump intended for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, and blood products, which directly supports medical treatment and patient care.
No
The device is an infusion pump designed for the controlled administration of fluids and medications. It does not perform any diagnostic functions.
No
The device description clearly states it is an "electromechanical pump" with a "motorized pumping mechanism" and other physical components, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Novum IQ Large Volume Pump (LVP) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the controlled administration of fluids, drugs, nutrition, and blood products into a patient through various routes (intravenous, arterial, subcutaneous, epidural). This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a pump mechanism that delivers fluids to the patient. It focuses on controlled delivery, safety features related to infusion, and integration with EMR systems for documentation. There is no mention of analyzing samples from the patient.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Novum IQ LVP does not perform any such analysis.
The Novum IQ LVP is a medical device used for administering substances to a patient, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric subpopulations, except for neonates
neonates
Intended User / Care Setting
trained healthcare professionals
patients care in hospitals and outpatient health care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing of the Novum IQ LVP 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.
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 LVP is adequately safe for its intended use. The assurance case defined the device system, including the indications for use, patient population, 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 LVP was verified against requirements for performance, physical attributes, environmental conditions, safety, and to provide objective evidence that the device intended use is met.
- . Verification and validation demonstrated that design inputs and user needs were met. Verification involves testing of both system and subsystem level requirements against pre-defined and approved protocols containing validated test methods and established acceptance criteria.
- . 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.
- . 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 tested 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.
- . 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
Baxter conducted a Human Factors evaluation 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 demonstrated that the Novum IQ LVP is suitable for its intended use.
No clinical testing was performed in support of this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
March 29, 2024
Baxter Healthcare Corporation Dhiraj Bizzul Sr. Manager, Regulatory Affairs, Medication Delivery One Baxter Parkway Deerfield, Illinois 60015
Re: K211122
Trade/Device Name: Novum IQ Large Volume Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: March 10, 2023 Received: March 10, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K211122
Device Name Novum IQ Large Volume Pump
Indications for Use (Describe)
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.
| 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: March 18, 2024
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Dhiraj Bizzul Sr. Manager, Global Regulatory Affairs One Baxter Parkway Deerfield, IL 60015 Telephone: (847) 909-6828
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Novum IO Large Volume Pump Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN
PREDICATE DEVICE:
Spectrum IQ Infusion System with Dose IQ Safety Software (K173084)
DESCRIPTION OF THE DEVICE:
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
5
Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly slanted to the right, giving it a dynamic appearance. The word is the primary focus of the image, and the background is plain.
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.
INDICATIONS FOR USE:
The Novum IQ LVP is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and 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.
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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right.
The Novum IQ 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 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.
DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE:
| Characteristic | Subject Device - Novum IQ LVP | Predicate - Spectrum
IQ Infusion System
(K173084) | Discussion of
Differences |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use and Routes
of
Administration | The Novum IQ LVP is intended for
use on adults and pediatric
subpopulations, except for neonates,
for the controlled administration of
fluids, pharmaceutical drugs,
parenteral nutrition, blood and 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. | Intended to be used for
the controlled
administration of fluids.
These may include
pharmaceutical drugs,
blood, blood products.
The intended routes of
administration consist
of the following
clinically accepted
routes: intravenous,
arterial, subcutaneous
or epidural | Similar
Parenteral nutrition
was added to
provide additional
clarity on fluids
administered.
Added clarification
to exclude the
neonate population
from the adult and
pediatric clinically
accepted routes of
administration by
limiting the
indicated routes to
intravenous and
arterial. |
| Characteristic | Subject Device – Novum IQ LVP | Predicate - Spectrum
IQ Infusion System
(K173084) | Discussion of
Differences |
| Set Usage | The Novum IQ LVP is intended to
be used in conjunction with legally
marketed and compatible
administration sets, and medications
provided by the user. | Intended to be used in
conjunction with
legally marketed and
compatible intravenous
administration sets and
medications provided
by the user. | Similar; removed
"intravenous" |
| Use
Environment | The Novum IQ LVP is suitable for
patient care in hospitals and
outpatient health care facilities. | Suitable for a variety of
patient care
environments such as,
but not limited to
hospitals and outpatient
care areas. | Same |
| Other
Indications for
Use | 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
when integrated with an Electronic
Medical Record (EMR) system. This
automation is intended to aid in the
reduction of programming errors. | Intended to reduce
operator interaction
through guided
programming,
including a way to
automate the
programming of
infusion parameters and
documentation of
infusion therapies. This
automation is intended
to reduce pump
programming errors. | Similar |
| Pumping
Mechanism | The Novum IQ LVP is intended to
be used by trained healthcare
professionals. | Same as subject device. | N/A |
| | Peristaltic design with active
restoration of administration set
tubing. | Peristaltic design. | Similar.
Performance tests
confirm the active
restoration does
not raise different
questions of safety
and effectiveness. |
| Microprocessor | Multiple processors | Same as subject device. | N/A |
| User Interface
Display | LCD display with adjustable backlit
capability. | Same as subject device. | N/A |
| Fluid Ingress
Protection | IPX2 | Same as subject device. | N/A |
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a dynamic and modern look.
| Characteristic | Subject Device – Novum IQ LVP | Predicate - Spectrum
IQ Infusion System
(K173084) | Discussion of
Differences | | | | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AC Power | Input: 100-240VAC, 50/60 Hz / 500 mA
Output: 16 VDC/1.25 A, short
circuit protected | Input: 100-240VAC,
50/60 Hz / 300 mA
Output: 9VDC/1000
mA, short circuit
protected | The differences in
power ratings do
not raise different
questions of safety
and effectiveness. | | | | | | |
| Battery | Smart Battery Pack
-Lithium Ion (internal battery unit),
10.8 VDC nominal
-Maximum 16 hour recharge time at
$23 \pm 2°$ C ( $73.4 \pm 3.6°$ F)*
-Battery capacity for a new fully
charged Smart Battery Pack, at the
medium backlight setting and
wireless enabled use is as follows:
Flow Rate (mL/hr) Capacity (hrs) 25-125 ≥8 1200 ≥6
- Charging occurs if the AC power
adapter is plugged in, whether the
pump is on or off. | | | | | | | Lithium Ion (external
Wireless Battery
Module)
- 7.4 VDC nominal
Capacity 5 hours (at
intermediate rate (25
ml/hr) at highest
backlight settings).
Capacity 4 hours (at
125 mL/hr at the default
backlight setting and
wireless ON)
Capacity 3.1 hours (at
999 ml/hr with highest
backlight setting with
wireless ON).
16 hour recharge time
$22.2 \pm 1.1°$ C ( $72 \pm 2 °$
F)
Charging occurs if AC
Power Adaptor is
plugged in, whether
pump is ON or OFF. | 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. |
| Alarms | Per IEC 60601-1-8 | Same as subject device. | N/A | | | | | | |
| Logging
Capability | Yes | Same as subject device. | N/A | | | | | | |
| Infusion
Delivery Modes | Continuous (Primary and
Secondary), Multi-Step, Bolus,
Amount/Time (Primary and
Secondary) and Volume/Time
(Primary and Secondary) | Continuous (Primary
and Secondary), Multi-
Step, Cyclic TPN,
Bolus, Amount/Time
(Primary/Secondary)
and Volume/Time | Similar
Cyclic TPN mode
not needed as it
can be
administered using
Multi-Step
programming. | | | | | | |
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| Characteristic | Subject Device – Novum IQ LVP | Predicate - Spectrum
IQ Infusion System
(K173084) | Discussion of
Differences |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate | 0.5 to 1200 mL/hr with 0.1 mL/hr
increments from 0.1 to 99.9 mL/hr
and 1.0 mL/hr increments from 100
to 1200 mL/hr | 0.5 to 999 mL/hr with
0.1 mL/hr increments
from 0.5 to 99.9 mL/hr
and 1.0 mL/hr
increments from 100 to
999 mL/hr | Similar
Performance tests
confirm that the
flow rate range for
the subject device
does not raise
different questions
of safety and
effectiveness. |
| Volumetric /
Flow Rate
Accuracy under
standard
conditions | Accuracy depends on set material
under standard conditions:
For primary set material:
0.5 - 0.9 ml/hr: +/-10%
1 - 1200 ml/hr: +/-5% | Accuracy depends on
set material.
For primary set
material:
0.5 - 1.9 ml/hr: +/-0.1
ml/hr
2- 999 ml/hr: +/-5%
For other compatible set
materials:
5 - 999 ml/hr: +/-10% | Similar
Detailed flow rate
accuracy for all
sets disclosed in
labeling |
| Drug Library
Capacity | Number of Care Areas: 32
Number of Drugs: 5000
Number of Clinical Advisories: 800
Number of Modifiers: 1000 | Number of Care Areas:
32
Number of Drugs: 5000
Number of Clinical
Advisories: 400
Number of Modifiers:
500 | Subject device
supports increased
capacity in the
areas of Clinical
Advisories and
Modifiers. |
| Operational
Conditions | Operating temperature: 59 to 104°F
(15 to 40° C), 10 to 80% relative
humidity non-condensing. | Operating temperature:
60 to 90°F (15.6 to
32.2° C), 20 to 90%
relative humidity non-
condensing. | Functional and
performance tests
support the
operational
conditions for the
subject device. |
| Storage
Conditions | Storage temperature: 14 to 120°F (-
10 to 49°C), 10 to 80% relative
humidity non-condensing. | Storage temperature: 14
to 120°F (-10 to 49°C),
10 to 90% relative
humidity non-
condensing. | Functional and
performance tests
support the storage
conditions for the
subject device. |
| Characteristic | Subject Device – Novum IQ LVP | Predicate - Spectrum
IQ Infusion System
(K173084) | Discussion of
Differences |
| Approximate Size (Pump) | 4.1"h x 9.8"w x 6.7"d | 7.4"h x 5.2"w x 3.3"d | Human Factors
studies support the
Physical
Dimensions and
Form Factor for
the subject device. |
| Approximate Weight (Pump) | 2.8 kg (5.5 lbs) | 1.4 kg (3 lbs) | Human Factors
studies support the
Weight of the
subject device. |
| Auto-programming | Yes | Same as subject device. | N/A |
| Wireless | Yes | Same as subject device. | N/A |
| Administration Set Loading | Guided administration set loading
using visual and audible prompts
with automatic ejection of the slide
clamp upon door closure. | Guided administration
set loading using visual
and audible prompts,
requiring removal of
slide clamp by user
upon door closure. | The proposed
device is
automating a
process which was
manual in the
predicate device by
the use of a
hardware design
change.
Functional tests
and Human Factors
studies support that
this difference does
not raise different
questions of safety
and effectiveness. |
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Image /page/10/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and has a modern look.
DISCUSSION OF NONCLINICAL TESTS:
Non-Clinical testing of the Novum IQ LVP 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.
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Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly slanted to the right. The word is likely a logo or brand name.
The stated goal of the safety assurance case is to document that the design of the Novum IQ LVP is adequately safe for its intended use. The assurance case defined the device system, including the indications for use, patient population, 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 LVP was verified against requirements for performance, physical attributes, environmental conditions, safety, and to provide objective evidence that the device intended use is met.
- . Verification and validation demonstrated that design inputs and user needs were met. Verification involves testing of both system and subsystem level requirements against pre-defined and approved protocols containing validated test methods and established acceptance criteria.
- . 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.
- . 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.
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Image /page/12/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and has a slightly italicized appearance. The word is the logo for the healthcare company Baxter International.
-
. Interoperability was assessed and tested 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.
-
. 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 62366-1 ed. 1.0 b:2007, 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 a Human Factors evaluation 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 demonstrated that the Novum IQ LVP is suitable for its intended use.
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DISCUSSION OF CLINICAL TESTS:
No clinical testing was performed in support of this premarket notification.
CONCLUSION:
The Novum IQ LVP has been verified and validated against design input requirements, user needs and intended uses. The subject device is substantially equivalent to the predicate device.