(385 days)
Not Found
No
The summary describes software for creating and managing drug libraries with safety limits, but there is no mention of AI or ML algorithms for tasks like prediction, pattern recognition, or automated decision-making beyond predefined rules.
No.
The device is software that helps create drug libraries for infusion pumps; it does not directly administer fluids or diagnose/treat patients.
No
The device is intended to create and maintain drug libraries and configure pump settings for fluid administration, not to directly diagnose medical conditions. Its function is to support medication safety by reducing errors, not to perform diagnostic assessments.
Yes
The device is described as a "standalone (not embedded in pumps) browser-based software application" that is installed on a hospital-provided computing platform. Its function is to create and configure drug libraries for compatible infusion pumps, not to directly control or interface with the hardware. The summary explicitly states it "does not directly interface with or control the compatible infusion pump."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support the controlled administration of fluids using infusion pumps by allowing users to create and maintain drug libraries and configure pump settings. This is related to drug delivery and pump management, not the diagnosis of disease or other conditions.
- Device Description: The device is software that creates a drug library file for infusion pumps. It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any activities typically associated with IVDs, such as analyzing blood, urine, tissue, or other biological specimens, or providing information for the diagnosis, monitoring, or treatment of disease.
The device is clearly focused on the safe and accurate delivery of medications via infusion pumps, which falls under the category of drug delivery systems and associated software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids.
Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps.
Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump.
Dose IQ Safety Software is intended to be used by licensed pharmacists.
Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
PHC
Device Description
Dose IQ is a standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform. It provides the hospital's pharmacists the ability to create and configure a facility-specific drug library file for the either the Novum IQ Large Volume Pump or the Novum IQ Syringe Pump. Dose IQ stores the created drug library for future transfer to an infusion pump that is compatible with the drug library file through the IQ Enterprise Gateway, or via a USB. It is intended to be used by multiple users simultaneously. Authorized users access the software though a Google Chrome web browser (build 76.0.3809.100 and above).
Creating a facility-specific drug library in Dose IQ is one method to implement a Dose Error Reduction System (DERS) – a safety system intended to reduce medication errors. A hospital-defined drug library defines medications with individual concentrations, concentration limits, dosing units, dosing limits, alarm configuration settings, and administration requirements that are specific to each patient care area. Pump programming values are checked against these hospital-defined limits. The pump alerts clinicians if programmed values exceed these limits. Also included in the drug library are hospital-defined individual care area settings and general pump settings. DERS is not active when programming an infusion using Basic Mode, which requires the pump user to manually specify the parameters for the infusion on the pump, therefore only individual Care Area settings, general pump settings, and pump default settings apply.
Dose IQ does not directly interface with or control the compatible infusion pump. It solely provides the ability to create a drug library file that can then be loaded to the compatible infusion pump. Dose IQ does not deploy the file to the pump; this is done by USB media or the IQ Enterprise Gateway software. A copy of the drug library file is stored in each pump, so that the pump can operate, without real-time interaction, with other components of the Novum IQ Platform.
Baxter provides a list of syringe containers that are permissible with the Novum IQ Syringe pump based on specific syringe brands and sizes. The Approved Syringe List is available on Baxter's Technical Service Portal and must be uploaded into Dose IQ. The Approved Syringe List cannot be modified in Dose IQ. The pharmacist selects the required syringe brands and sizes from this Approved Syringe List to create the Facility Syringe List for use within the hospital. Dose IQ incorporates the Approved Syringe List and the Facility Syringe List as part of the drug library file for the Novum Syringe pump.
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
Not Found
Intended User / Care Setting
Dose IQ Safety Software is intended to be used by licensed pharmacists.
Dose IQ Safety Software is intended to be used 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 Dose IQ Safety Software has been performed against requirements for performance and safety, and to provide objective evidence that the device's intended use is met.
A Safety Assurance Case (SAC) was developed to demonstrate that hazardous situations resulting from the design, intended use and reasonably foreseeable misuse of the device have been adequately mitigated. The SAC 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,
- the device meets clinically valid essential performance.
Performance testing of the Dose IQ Safety Software was verified against requirements for performance and 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 requirements against pre-defined and approved protocols containing validated test methods and established acceptance criteria. System verification demonstrated that design outputs meet design and cyber security requirements. All the testing met acceptance criteria.
- Software verification and validation was performed according to FDA Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." issued May 11, 2005. The software is considered a major level of concern. Software testing included Functional testing, Regression Testing, Smoke & Sanity testing, code review, static analysis, and unit testing.
A Human Factors evaluation was conducted in a simulated environment with the intended user population, use environment and use scenarios to simulate clinical conditions. Results showed the device 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
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 29, 2024
Baxter Healthcare Corporation Dhiraj Bizzul Sr. Manager, Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015
Re: K230665
Trade/Device Name: Dose IQ Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PHC Dated: March 27, 2024 Received: March 28, 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"
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) K230665
Device Name Dose IQ Safety Software
Indications for Use (Describe)
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids.
Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps.
Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump.
Dose IQ Safety Software is intended to be used by licensed pharmacists.
Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Dhiraj Bizzul Sr. Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (847) 909-6828 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Dose IQ Safety Software Common Name: Infusion Safety Management Software Classification Panel: General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PHC
Table 1. Catalogue Code for Dose IQ Safety Software
| Code Number | Name |
|---|---|
| DOSEIQW0001 | Dose IQ Safety Software |
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PREDICATE DEVICE:
The Dose IO Safety Software is substantially equivalent to the following predicate device:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Spectrum IQ Infusion System | |||
| with Dose IQ Safety Software1 | Baxter Healthcare | ||
| Corporation | K173084 | May 11, 2018 |
Table 2. Predicate Device
DESCRIPTION OF THE DEVICE:
Dose IQ is a standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform. It provides the hospital's pharmacists the ability to create and configure a facility-specific drug library file for the either the Novum IQ Large Volume Pump or the Novum IQ Syringe Pump. Dose IQ stores the created drug library for future transfer to an infusion pump that is compatible with the drug library file through the IQ Enterprise Gateway, or via a USB. It is intended to be used by multiple users simultaneously. Authorized users access the software though a Google Chrome web browser (build 76.0.3809.100 and above).
Creating a facility-specific drug library in Dose IO is one method to implement a Dose Error Reduction System (DERS) – a safety system intended to reduce medication errors. A hospital-defined drug library defines medications with individual concentrations, concentration limits, dosing units, dosing limits, alarm configuration settings, and administration requirements that are specific to each patient care area. Pump programming values are checked against these hospital-defined limits. The pump alerts clinicians if programmed values exceed these limits. Also included in the drug library are hospital-defined individual care area settings and general pump settings. DERS is not active when programming an infusion using Basic Mode, which requires the pump user to manually specify the parameters for the infusion on the pump, therefore only individual Care Area settings, general pump settings, and pump default settings apply.
Dose IQ does not directly interface with or control the compatible infusion pump. It solely provides the ability to create a drug library file that can then be loaded to the compatible infusion pump. Dose IO does not deploy the file to the pump; this is done by
4 Since this submission is limited to the Safety Software, equivalency is demonstrated only for the Safety Software referred to as "Spectrum IQ Infusion System with Dose IQ Safety Software" as predicate throughout this submission.
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Image /page/6/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.
USB media or the IQ Enterprise Gateway software. A copy of the drug library file is stored in each pump, so that the pump can operate, without real-time interaction, with other components of the Novum IQ Platform.
Baxter provides a list of syringe containers that are permissible with the Novum IQ Syringe pump based on specific syringe brands and sizes. The Approved Syringe List is available on Baxter's Technical Service Portal and must be uploaded into Dose IQ. The Approved Syringe List cannot be modified in Dose IQ. The pharmacist selects the required syringe brands and sizes from this Approved Syringe List to create the Facility Syringe List for use within the hospital. Dose IQ incorporates the Approved Syringe List and the Facility Syringe List as part of the drug library file for the Novum Syringe pump.
INDICATIONS FOR USE:
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IO Large Volume Pump to support the controlled administration of fluids. Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps. Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump. Dose IQ Safety Software is intended to be used by licensed pharmacists. Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.
DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE:
The Dose IO Safety Software is substantially equivalent to the predicate device with regards to intended use, indications for use, design attributes, features, functions, and performance specifications. The following table provides a comparison summary.
7
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Indications for Use | Dose IQ Safety Software is intended | ||
| to be used with the Novum IQ | |||
| Syringe Pump and Novum IQ Large | |||
| Volume Pump to support the | |||
| controlled administration of fluids. | |||
| Dose IQ Safety Software is intended | |||
| to allow users to create and maintain | |||
| drug libraries, including the | |||
| configuration of pump settings for | |||
| the compatible pumps. | N/A | The indications for the Predicate Device were | |
| developed for the infusion pump and safety | |||
| software combined. As the subject device will be | |||
| standalone safety software, indications for it have | |||
| been specifically defined. The difference in | |||
| wording does not raise different questions of | |||
| safety or effectiveness. | |||
| Dose IQ Safety Software is intended | |||
| to allow users to establish the | |||
| facility-defined syringe list, which is | |||
| a subset of Baxter's approved | |||
| compatible syringes, for the Novum | |||
| IQ Syringe Pump | N/A | The subject device introduces a Syringe Library | |
| that is sent to the Novum IQ Syringe Pump as part | |||
| of the Drug Library file to provide users a limited | |||
| selection of only qualified disposables to be used | |||
| with compatible Syringe Pumps. The syringe | |||
| library file is a secure digitally signed file. The | |||
| syringe library and its contents cannot be modified | |||
| by the pharmacist in the Dose IQ Safety | |||
| Software. The pharmacist only selects the | |||
| required syringe brands and sizes from this | |||
| approved syringe library to be used for the specific | |||
| drug library being created. This change does not | |||
| raise different questions of safety or effectiveness | |||
| because the Syringe Library follows similar | |||
| concepts of the Master Drugs in how drugs are | |||
| assigned from preset Care Areas. | |||
| Use Environment | Dose IQ Safety Software is intended | ||
| to be used in hospitals and outpatient | |||
| health care facilities. | The Spectrum IQ Infusion System | ||
| with Dose IQ Safety Software is | |||
| suitable for a variety of patient care | Both subject and predicate devices are suitable for | ||
| hospitals and outpatient healthcare facilities; | |||
| difference in wording does not raise different | |||
| questions of safety or effectiveness. | |||
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| environments such as, but not limited | |||
| to hospitals and outpatient care areas. | |||
| Other Indications | |||
| for Use | Dose IQ Safety Software is intended | ||
| to be used by licensed pharmacists. | The Spectrum IQ Infusion System | ||
| with Dose IQ Safety Software is | |||
| intended to be used by trained | |||
| healthcare professionals. | The indications for the Predicate Device were | ||
| developed for the infusion pump and safety | |||
| software combined. Licensed pharmacists are also | |||
| trained healthcare professionals. The difference in | |||
| wording does not raise different questions of | |||
| safety or effectiveness. | |||
| Features, Functions and Performance Specifications | |||
| Infusion Delivery | |||
| Modes | Continuous | ||
| Amount/Time | |||
| Volume/Time | Same as subject device | N/A | |
| System Basis | A browser-based application | ||
| requiring Google Chrome on the | |||
| compatible hardware | Microsoft Windows® 7(32 or 64-bit) | ||
| and Microsoft Windows® 10(64-bit) | |||
| operating system compatibility. | The subject device uses web browser technology | ||
| that can be accessed from any computer and is no | |||
| longer a product directly installed on Microsoft | |||
| Windows. This change does not raise different | |||
| questions of safety or effectiveness as both | |||
| applications require access by authenticated users. | |||
| Drug Library | |||
| Capacity | Number of Care Areas: 32 | ||
| Number of Drugs: 5000 per pump | |||
| 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 that | |||
| aligns with the capacity requirements for the | |||
| compatible infusion pump. These differences do | |||
| not raise different questions of safety or | |||
| effectiveness. | |||
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Care Area Type | Standard | ||
| Anesthesia | |||
| Enteral Feeding (Only supported by | |||
| the Novum IQ Syringe) | |||
| (only one Enteral Feeding Care Area | |||
| allowed) | Standard | ||
| Anesthesia | The subject device supports the same settings for | ||
| large volume infusion pumps. Subject device | |||
| supports an additional Care Area Type to facilitate | |||
| use on the Syringe Pump as supported by the | |||
| Indications for Use. This difference does not raise | |||
| different questions of safety or effectiveness | |||
| because Baxter has already established different | |||
| care area types (Anesthesia and Standard), | |||
| available within the software to establish the | |||
| relevant limits. | |||
| Character Limits | Care Area Name & Drug Name | ||
| 20 characters | |||
| Name must be unique. | |||
| Clinical Advisory: | |||
| 200 characters | Care Area Name & Drug Name | ||
| 20 characters | |||
| Name must be unique. | |||
| Clinical Advisory: | |||
| 7 lines or 175 characters | Subject device accommodates increased character | ||
| limits for clinical advisory content compared to the | |||
| predicate. This difference does not raise different | |||
| questions of safety or effectiveness. | |||
| Downstream | |||
| Occlusion | |||
| Pressure Setting | Large Volume Pump | ||
| High | |||
| Medium | |||
| Low | |||
| Syringe Pump | |||
| High | |||
| Medium High | |||
| Medium | |||
| Low | |||
| Very Low | High | ||
| Medium | |||
| Low | The subject device supports the same settings for | ||
| large volume infusion pumps. Subject device | |||
| supports additional Downstream Occlusion | |||
| Pressure Settings to facilitate use on the Syringe | |||
| Pump. The additional settings align with the | |||
| requirements for the compatible infusion pumps. | |||
| This difference does not raise different questions | |||
| of safety or effectiveness. | |||
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| Downstream | |||
| Occlusion | |||
| Detection Speed | Normal | ||
| Rapid | N/A | Subject device supports Downstream Occlusion | |
| Detection Speed settings to facilitate use on the | |||
| Syringe Pump as supported by the subject | |||
| Indications for Use. The additional settings align | |||
| with the requirements for the compatible infusion | |||
| pump. This difference does not raise different | |||
| questions of safety or effectiveness. | |||
| Air in Line | |||
| bubble size | Large Volume Pump Only | ||
| 50 μL | |||
| 100 μL | |||
| 200 μL | |||
| 400 μL | N/A | Adjustable threshold feature allows user to | |
| consider the context of infusion therapy and | |||
| patient population when establishing the air-in-line | |||
| alarm sensitivity for a given care area. | |||
| This difference does not raise different questions | |||
| of safety or effectiveness. | |||
| EMR Integration | On | ||
| Off | Same as subject device | N/A | |
| Concentration | |||
| Type | Large Volume Pump: | ||
| Fixed | |||
| Standard | |||
| Variable | |||
| mL mode |
Syringe Pump:
Standard
Variable
mL mode | Fixed
Standard
Variable
mL mode | The subject device supports the same settings for
large volume infusion pumps. Fixed concentration
type is not applicable for Syringe Pump as this
device automatically detects the fill volume of the
syringe container. This difference does not raise
different questions of safety or effectiveness. |
| Dose Modes | Continuous
● mL/hr, mL/kg/min, mL/kg/hr | Continuous
● mL/hr, mL/kg/min, mL/kg/hr | Predefined dose modes reduce manual calculations
required by clinicians. Additional dose modes
align with the requirements for the compatible |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| | • g/hr | • g/hr | infusion pump. The subject device continues to
provide continuous and intermittent infusions.
These differences do not raise different questions
of safety or effectiveness. |
| | • mg/hr, mg/kg/hr, mg/min,
mg/kg/min, mg/kg/day | • 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 | • mcg/hr, mcg/kg/hr, mcg/min,
mcg/kg/min, mcg/kg/day | |
| | • ng/min, ng/kg/min | • ng/min, ng/kg/min | |
| | • Units/hr, Units/kg/hr,
Units/min, Units/kg/min | • Units/hr, Units/kg/hr,
Units/min, Units/kg/min | |
| | • MillionUnits/day | • mUnits/min, mUnits/kg/hr,
mUnits/kg/min | |
| | • mUnits/min, mUnits/kg/hr,
mUnits/kg/min | | |
| | • mEq/hr, mEq/kg/hr | • mEq/hr, mEq/kg/hr | |
| | • mmol/hr, mmol/kg/hr | • mmol/hr, mmol/kg/hr | |
| | Amount / Time | Amount / Time | |
| | Non-weight-based: | Non-weight-based: | |
| | • mg, Units, g, mcg, mEq,
mmol, MillionUnits
Weight based: | • mL, mg, Units, g, mcg, mEq,
mmol
Weight based: | |
| | • mL/kg, mg/kg, Units/kg, g/kg,
mcg/kg, mEq/kg, mmol/kg | • mL/kg, mg/kg, Units/kg, g/kg,
mcg/kg, mEq/kg, mmol/kg
BSA based: | |
| | • MillionUnits/kg
BSA based: | • mg/m2, Units/m2, g/m2,
mcg/m2 | |
| | | Volume / Time | |
8
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| Table 3. Device Comparison | |||||
|---|---|---|---|---|---|
| -- | -- | -- | ---------------------------- | -- | -- |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| mg/m², Units/m², g/m², mcg/m², MillionUnits/m² | Total Volume / Total Time | ||
| Volume / Time Total Volume / Total Time | |||
| Bolus / Loading Dose | Enable | ||
| Disable (default) | Same as subject device | N/A | |
| Bolus/Loading Dose Amount limits and Time Limits | Lower Hard, Lower Soft, Starting, Upper Soft, Upper Hard |
1 lower and 1 upper limit required for Care Area Drug | Same as subject device | N/A |
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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Max Line Flush | Large Volume Pump | ||
| 1 to 100 mL | |||
| Applicable to Amount / | |||
| Time Infusions |
Syringe Pump
0.1 to 10 mL
Applicable to Amount / Time and
Volume/ Time Infusions | 1 to 100 mL
Applicable to Amount/Time drugs | Max Line Flush aligns with the requirements for
compatible infusion pumps. Subject device
supports expanded Max Line Flush to facilitate use
on the Syringe Pump as supported by the
Indications for Use. This difference does not raise
different questions of safety or effectiveness. |
| Clinical Advisory
Assignment | per concentration per modifier for all concentrations per drug for all concentrations | per modifier for all concentrations per drug for all concentrations | Both devices provide clinical advisories, which are
optional and facility defined. Differences do not
raise different questions of safety or effectiveness. |
| Modifiers
assignment | 2 to 5 per drug | Same as subject device | N/A |
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Image /page/14/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, giving it a dynamic appearance.
| Table 3. Device Comparison | |
|---|---|
| ---------------------------- | -- |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Single Step Rate | |||
| Change | 20% to 500% (standard Care Area) | ||
| 500% (Anesthesia Care Area) | |||
| Configurable increase limit between | |||
| 20% to | |||
| 500% with an auto-calculated | |||
| decrease limit of 50% | |||
| of the increase limit, up to 99% | |||
| decrease (Standard Care Area) | |||
| Fixed increase limit of 500% and | |||
| decrease limit of 99% | |||
| (Anesthesia Care Area) | Same as subject device | N/A | |
| Audio Level | |||
| Alarm | High | ||
| Medium | |||
| Low | |||
| Use Pump Settings | Same as subject device | N/A | |
| Near Empty | |||
| Alarm | Bag Near Empty: | ||
| On, [15,30,60,90,120 mins] | |||
| Off | |||
| Syringe Near Empty: | |||
| On, [1,5,10,30,60,90,120 mins] | |||
| Off | Bag Near Empty: | ||
| On, 30 minutes | |||
| Off | |||
| Use Pump Settings | Both the subject and predicate device issue an | ||
| alarm when a bag is near complete. Both the | |||
| subject and predicate device require the user to | |||
| correct the condition to proceed. Both the subject | |||
| and predicate have the same default time setting. | |||
| Syringe Near Empty Alarm was added to facilitate | |||
| use with the Syringe Pump. The additional settings | |||
| align with the requirements for the compatible | |||
| infusion pumps. These differences in the available | |||
| setting options do not raise different issues of | |||
| safety and effectiveness. | |||
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Maximum Keep | |||
| Vein Open (KVO) | |||
| Rate | Large Volume Pump | ||
| 0.5 to 50 mL/hr | |||
| Syringe Pump | |||
| 0.01 to 5 mL/hr | 0.5 to 50 mL/hr | The KVO feature is intended for use when | |
| delivering a series of infusions to a patient, and the | |||
| delivery site must remain patent between the end | |||
| of one infusion and the beginning of the | |||
| next. Lower end of KVO rate configuration aligns | |||
| with flow rate range of the respective pump. | |||
| Syringe KVO Rate was added to facilitate use with | |||
| the Syringe Pump. | |||
| The different range does not raise different | |||
| questions and safety or effectiveness. | |||
| Passcodes | Keypad Lock Passcode: | ||
| On | |||
| Off | |||
| Custom (3 to 4 digits) | |||
| Anesthesia Passcode: | |||
| For Anesthesia Care Area Type | |||
| On | |||
| Off | |||
| Custom (2- 6 digits) required | |||
| Biomed Passcode: | |||
| N/A - Established via User Lists | Keypad Lock Passcode: | ||
| On | |||
| Off | |||
| Custom (3 to 4 digits) | |||
| Anesthesia Passcode: | |||
| N/A | |||
| Biomed Passcode: | |||
| Level 1, 4 - 8 digits | |||
| Level 2, 4- 8 digits. | |||
| Level 2 only available when enabled | |||
| by hospital administrator | Keypad in predicate and subject devices can only | ||
| be locked while the infusion is running. Subject | |||
| device introduces customizable lock code for | |||
| Anesthesia care area restricting access to | |||
| authorized personnel. | |||
| Subject device provides Hospital administrators | |||
| the ability to establish a single hospital wide | |||
| passcode. This customizable passcode provides an | |||
| added level of security by restricting access to only | |||
| authorized personnel when accessing Anesthesia | |||
| care areas. Regarding Biomed Passcode, both | |||
| predicate and subject devices prevent unauthorized | |||
| access to non-clinical functions. | |||
| These differences do not raise different questions | |||
| of safety or effectiveness. | |||
| Certificates | Required | Optional | Both devices use certificates to prevent tampering. |
| Differences do not raise different questions of | |||
| safety and effectiveness. | |||
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| Available Rate | |||
| Limits | • Upper Hard Limit must be | ||
| greater than or equal to Upper | |||
| Soft Limit. | • Upper Hard Limit must be | ||
| greater than or equal to Upper | |||
| Soft Limit. | Operational ranges are controlled by the respective | ||
| compatible infusion pump. This change does not | |||
| raise different questions of safety or effectiveness. | |||
| • Upper Soft Limit must be | |||
| greater than or equal to a | |||
| Starting Rate. | • Upper Soft Limit must be | ||
| greater than or equal to a | |||
| Starting Rate. | |||
| • Starting Rate must be greater | |||
| than or equal to a Lower Soft | |||
| Limit. | • Starting Rate must be greater | ||
| than or equal to a Lower Soft | |||
| Limit. | |||
| • Lower Soft Limit must be | |||
| greater than or equal to a | |||
| Lower Hard Limit. | • Lower Soft Limit must be | ||
| greater than or equal to a | |||
| Lower Hard Limit. | |||
| • Lower Hard Limit must be | |||
| less than or equal to a Lower | |||
| Soft Limit | • Lower Hard Limit must be | ||
| less than or equal to a Lower | |||
| Soft Limit | |||
| All Rates and Drug Library Limits | |||
| must fall within the operational range | |||
| of the compatible pumps. | All Rates and Drug Library Limits | ||
| must fall within Spectrum Pump | |||
| operational range of 0.5 to 999 | |||
| mL/hr. |
15
T
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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Security Roles | Drug Library Roles (customer) Read only User Full Access User Administrative roles (customer) User Management Certificate Management User Audit Administrative Roles (Baxter) Baxter Administrator | Read-Only Access Limited Access Full Access | The subject device introduces a number of new |
| roles as a consequence of the architecture of the | |||
| subject device – in particular the administrative | |||
| functions which were not applicable in the | |||
| predicate device. The subject device maintains the | |||
| 'Full Access' and 'Read-only' roles as per the | |||
| predicate. The 'Limited Access' role is not | |||
| included in the subject device as the functionality | |||
| of this role is incorporated in the 'Read-only' role. | |||
| These differences do not raise different questions | |||
| of safety or effectiveness. |
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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Reports | Clinical Validation Report Master Drug List Report Bolus and Loading Dose Report Clinical Advisory Report Drug Change Report Facility Syringe List Report Audit reports for changes made to the Drug Library with the date the change was performed | Clinical Validation Report Master Drug List Report Bolus and Loading Dose Report Clinical Advisory Report Drug Change Report Audit reports for changes made to the Drug Library with the date the change was performed | Subject device supports an additional Report to facilitate use on the Syringe Pump as supported by the subject Indications for Use. This difference does not raise different questions of safety or effectiveness. |
| Clinical Advisory | Optional facility-defined clinical notes that appear in a pop-up window on the pump when a drug is selected. | Same as subject device | N/A |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Syringe Library | Baxter provides the syringe library | ||
| that is approved for use with the | |||
| Novum IQ Syringe Pump based on | |||
| specific syringe brands and sizes. | |||
| Each syringe brand and size have | |||
| unique characteristics that are | |||
| verified by Baxter with the Novum | |||
| IQ Syringe Pump. The syringe | |||
| library file is a secure digitally signed | |||
| file. The syringe library and its | |||
| contents cannot be modified by the | |||
| pharmacist in the Dose IQ Safety | |||
| Software. The pharmacist only | |||
| selects the required syringe brands | |||
| and sizes from this approved syringe | |||
| library to be used for the specific | |||
| drug library being created. | N/A | The subject device introduces a Syringe Library | |
| that is sent to the Novum IQ Syringe Pump as part | |||
| of the Drug Library file to provide users a limited | |||
| selection of only qualified disposables to be used | |||
| with compatible Syringe Pumps. This change does | |||
| not raise different questions of safety or | |||
| effectiveness because the Syringe Library follows | |||
| similar concepts of the Master Drugs in how drugs | |||
| are assigned from preset Care Areas. | |||
| Infusion Pump | |||
| Compatibility | Compatible with Novum IQ Large | ||
| Volume Pump and Novum IQ | |||
| Syringe Pump | Compatible with Spectrum IQ pump | The subject device will be compatible with the | |
| Novum IQ platform and meets the requirements | |||
| for compatible infusion pumps. This change does | |||
| not raise different questions of safety or | |||
| effectiveness and the function was verified to meet | |||
| the intended use of the device. | |||
| Interface with | |||
| different pump | Dose IQ Safety Software does not | ||
| have a direct interface to the infusion | |||
| pump. The Binary Drug Library file | |||
| is transferred via: | |||
| • USB | |||
| • Wireless communication via | |||
| the Gateway | Dose IQ Safety Software does not | ||
| have a direct interface to the infusion | |||
| pump. The Binary Drug Library file | |||
| is transferred via: | |||
| • IrDA | |||
| • Wireless communication via | |||
| the Gateway | Both provide a means of transferring data via a | ||
| file. Change in interface does not raise different | |||
| questions of safety or effectiveness and the | |||
| function was verified on the pump to meet the | |||
| intended use of the device. |
19
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Table 3. Device Comparison
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| ---------------- | ---------------- | ----------------------------- | --------------------------- |
1 Since this submission is limited to the Safety Software, equivalency is demonstrated only for the Safety Software referred to as "Spectrum IQ Infusion System with Dose IQ Safety Software" as predicate throughout this submission.
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Image /page/21/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.
DISCUSSION OF NONCLINICAL TESTS:
Non-Clinical testing of Dose IO Safety Software has been performed against requirements for performance and safety, and to provide objective evidence that the device's intended use is met. A summary of testing performed is identified below.
As recommended by FDA guidance, "Infusion Pumps Total Product Life Cycle" issued December 2, 2014, Baxter 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 adequately mitigated.
The Dose IQ SAC takes the form of a top-level claim that Dose IQ Safety Software is adequately safe and effective for its intended use, divided into constituent claims, each supported by evidence-based arguments. These arguments demonstrate that potential hazards arising from risks present in using the software only device to build libraries for infusion systems have been identified and adequately mitigated. The SAC 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,
- the device meets clinically valid essential performance.
Performance testing of the Dose IQ Safety Software was verified against requirements for performance and 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 requirements against pre-defined and approved protocols containing validated test methods and established acceptance criteria. System verification demonstrated that design outputs meet design and cyber security requirements. All the testing met acceptance criteria.
- . Software verification and validation was performed according to FDA Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." issued May 11, 2005. The software is considered a major level of concern. Software testing included Functional testing. Regression Testing. Smoke & Sanity testing, code review, static analysis, and unit testing.
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Image /page/22/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, giving it a dynamic appearance. The background is plain white.
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 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 of the human factors study 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 Dose IQ Safety Software has been verified and validated against design input requirements, user needs and intended uses. The subject device is substantially equivalent to the predicate device.