(24 days)
Not Found
No
The document describes "guided programming" and "automation" for programming and documentation, but these features are presented as rule-based or pre-programmed functions, not as capabilities that learn or adapt from data, which is characteristic of AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
Yes.
The device delivers fluids, including drugs and nutrition, to patients, which directly contributes to therapy.
No
Explanation: The device is described as a syringe pump for the controlled administration of fluids, not for the purpose of diagnosing a medical condition.
No
The device description explicitly states it is a "software controlled, electromechanical syringe pump" and mentions "System requirements verification testing was performed as 'black box' testing with the Novum IQ Syringe Pump Software/hardware configuration," indicating it includes hardware components.
Based on the provided text, the Novum IQ Syringe Pump 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" into a patient's body through various routes (intravenous, arterial, enteral, subcutaneous). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces this by stating it's a "syringe-based, smart pump" for delivering fluids.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such function or interaction with patient specimens.
Therefore, the Novum IQ Syringe Pump is a medical device used for administering substances to a patient, not for testing specimens from a patient.
N/A
Intended Use / 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.
Product codes
FRN, LZH
Device Description
The Novum IQ Syringe Pump is a general purpose, syringe-based, smart pump within the Novum IQ syringe pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the Novum IQ Syringe Pump and its associated drug library are configured. The Novum IQ syringe pump is capable of delivering fluids in syringes ranging in size from 1 mL - 60 mL.
The Novum IQ Syringe Pump is a system that provides delivery of fluids into a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical syringe pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood products, and enteral nutrition through compatible syringes and administration sets at user selectable rates and volumes.
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, pediatrics and neonates
Intended User / Care Setting
trained healthcare professionals / 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)
The following testing was performed in support of the modified device, based on the change to updated the software of the Novum IQ Syringe Pump:
-
Unit testing was composed of software actor requirements verification and static analysis
-
Integration testing of software requirements, performed as "black box" testing
-
System requirements verification testing was performed as "black box" testing with the Novum IQ Syringe Pump Software/hardware configuration
Clinical testing is not applicable for this submission.
All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue text.
September 5, 2024
Baxter Healthcare Corporation Dhiraj Bizzul Regulatory Affairs Sr. Manager One Baxter Parkway Deerfield, Illinois 60015
Re: K242390
Trade/Device Name: Novum IQ Syringe Pump (40800BAXUS) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: August 7, 2024 Received: August 12, 2024
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" (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).
1
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
2
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D. Assistant 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) K242390
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 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.
| 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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4
| 510(k) #: | 510(k) Summary |
|---|---|
| ----------- | ---------------- |
| Prepared on: 2024-08-12 | |
|---|---|
| -- | ------------------------- |
Contact Details
| 21 CFR 807.92(a)(1) | |
|---|---|
| Applicant Name | Baxter Healthcare Corporation |
| Applicant Address | One Baxter Parkway Deerfield Deerfield IL 60015 United States |
| Applicant Contact Telephone | 847-909-6828 |
| Applicant Contact | Mr. Dhiraj Bizzul |
| Applicant Contact Email | dhiraj_bizzul@baxter.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | Novum IQ Syringe Pump (40800BAXUS) |
| Common Name | Infusion pump |
| Classification Name | Pump, Infusion |
| Regulation Number | 880.5725 |
| Product Code(s) | FRN, LZH |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | |
|---|---|
| -- | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K211125 | Novum IQ Syringe Pump | FRN |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The Novum IQ Syringe Pump is a general purpose, syringe-based, smart pump within the Novum IQ syringe pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the Novum IQ Syringe Pump and its associated drug library are configured. The Novum IQ syringe pump is capable of delivering fluids in syringes ranging in size from 1 mL - 60 mL.
The Novum IQ Syringe Pump is a system that provides delivery of fluids into a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical syringe pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood products, and enteral nutrition through compatible syringes and administration sets at user selectable rates and volumes.
21 CFR 807.92(a)(5)
Intended Use/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.
5
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 quided 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.
Indications for Use Comparison
The subject device has the same indications for use as the predicate device.
Technological Comparison
The subject device has the same technological characteristics as the scope of this notification is to update software and labeling related to the Post Occlusion feature on the pump. The intended use, indications for use, and functions of the proposed device remains the same as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing was performed in support of the modified device, based on the change to updated the software of the Novum IQ Syringe Pump:
-
Unit testing was composed of software actor requirements verification and static analysis
-
Integration testing of software requirements, performed as "black box" testing
-
System requirements verification testing was performed as "black box" testing with the Novum IQ Syringe Pump Software/hardware configuration
Clinical testing is not applicable for this submission.
All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)