Dose IQ Safety Software

K230665 · Baxter Healthcare Corporation · PHC · Mar 29, 2024 · General Hospital

Device Facts

• Record ID: K230665
• Device Name: Dose IQ Safety Software
• Applicant: Baxter Healthcare Corporation
• Product Code: PHC · General Hospital
• Decision Date: Mar 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Dose IQ Safety Software is a standalone, browser-based application installed on hospital computing platforms. It enables pharmacists to create and configure facility-specific drug libraries (medication concentrations, dosing limits, alarm settings) for Novum IQ Large Volume and Syringe Pumps. The software does not directly interface with or control pumps; drug library files are transferred to pumps via USB or the IQ Enterprise Gateway. It incorporates a non-modifiable, Baxter-provided list of approved syringes for the Syringe Pump, from which pharmacists select a facility-specific subset. By implementing a Dose Error Reduction System (DERS), the software allows pumps to check programmed infusion values against hospital-defined limits, alerting clinicians if values exceed thresholds. This supports safer medication administration by reducing manual programming errors. The software is intended for use by licensed pharmacists in hospital and outpatient settings.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing, including functional, regression, smoke/sanity, code review, static analysis, and unit testing. A Safety Assurance Case (SAC) was developed to mitigate risks. Human factors evaluation was conducted in a simulated clinical environment to confirm suitability for the intended user population and use scenarios.

Technological Characteristics

Standalone browser-based software (Google Chrome). Operates on hospital-provided computing platforms. Features include drug library creation, facility-defined syringe list management, and secure digital file signing. Software is classified as a major level of concern. Connectivity via USB or IQ Enterprise Gateway for file transfer. Complies with IEC 62366-1 for usability engineering.

Indications for Use

Indicated for use by licensed pharmacists in hospitals and outpatient facilities to create/maintain drug libraries and facility-defined syringe lists for the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support controlled fluid administration.

Regulatory Classification

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.

Predicate Devices

• Spectrum IQ Infusion System with Dose IQ Safety Software (K173084)

Submission Summary (Full Text)

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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"

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(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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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### 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) | |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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: [phone] Fax: [phone]

### 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<br>with Dose IQ Safety Software1 | Baxter Healthcare<br>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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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.

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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Dose IQ Safety Software is intended<br>to be used with the Novum IQ<br>Syringe Pump and Novum IQ Large<br>Volume Pump to support the<br>controlled administration of fluids.<br>Dose IQ Safety Software is intended<br>to allow users to create and maintain<br>drug libraries, including the<br>configuration of pump settings for<br>the compatible pumps. | N/A | The indications for the Predicate Device were<br>developed for the infusion pump and safety<br>software combined. As the subject device will be<br>standalone safety software, indications for it have<br>been specifically defined. The difference in<br>wording does not raise different questions of<br>safety or effectiveness. |
| | Dose IQ Safety Software is intended<br>to allow users to establish the<br>facility-defined syringe list, which is<br>a subset of Baxter's approved<br>compatible syringes, for the Novum<br>IQ Syringe Pump | N/A | The subject device introduces a Syringe Library<br>that is sent to the Novum IQ Syringe Pump as part<br>of the Drug Library file to provide users a limited<br>selection of only qualified disposables to be used<br>with compatible Syringe Pumps. The syringe<br>library file is a secure digitally signed file. The<br>syringe library and its contents cannot be modified<br>by the pharmacist in the Dose IQ Safety<br>Software. The pharmacist only selects the<br>required syringe brands and sizes from this<br>approved syringe library to be used for the specific<br>drug library being created. This change does not<br>raise different questions of safety or effectiveness<br>because the Syringe Library follows similar<br>concepts of the Master Drugs in how drugs are<br>assigned from preset Care Areas. |
| Use Environment | Dose IQ Safety Software is intended<br>to be used in hospitals and outpatient<br>health care facilities. | The Spectrum IQ Infusion System<br>with Dose IQ Safety Software is<br>suitable for a variety of patient care | Both subject and predicate devices are suitable for<br>hospitals and outpatient healthcare facilities;<br>difference in wording does not raise different<br>questions of safety or effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| | | environments such as, but not limited<br>to hospitals and outpatient care areas. | |
| Other Indications<br>for Use | Dose IQ Safety Software is intended<br>to be used by licensed pharmacists. | The Spectrum IQ Infusion System<br>with Dose IQ Safety Software is<br>intended to be used by trained<br>healthcare professionals. | The indications for the Predicate Device were<br>developed for the infusion pump and safety<br>software combined. Licensed pharmacists are also<br>trained healthcare professionals. The difference in<br>wording does not raise different questions of<br>safety or effectiveness. |
| Features, Functions and Performance Specifications | | | |
| Infusion Delivery<br>Modes | Continuous<br>Amount/Time<br>Volume/Time | Same as subject device | N/A |
| System Basis | A browser-based application<br>requiring Google Chrome on the<br>compatible hardware | Microsoft Windows® 7(32 or 64-bit)<br>and Microsoft Windows® 10(64-bit)<br>operating system compatibility. | The subject device uses web browser technology<br>that can be accessed from any computer and is no<br>longer a product directly installed on Microsoft<br>Windows. This change does not raise different<br>questions of safety or effectiveness as both<br>applications require access by authenticated users. |
| Drug Library<br>Capacity | Number of Care Areas: 32<br>Number of Drugs: 5000 per pump<br>Number of Clinical Advisories: 800<br>Number of Modifiers: 1000 | Number of Care Areas: 32<br>Number of Drugs: 5000<br>Number of Clinical Advisories: 400<br>Number of Modifiers: 500 | Subject device supports increased capacity in the<br>areas of Clinical Advisories and Modifiers that<br>aligns with the capacity requirements for the<br>compatible infusion pump. These differences do<br>not raise different questions of safety or<br>effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Care Area Type | Standard<br>Anesthesia<br>Enteral Feeding (Only supported by<br>the Novum IQ Syringe)<br>(only one Enteral Feeding Care Area<br>allowed) | Standard<br>Anesthesia | The subject device supports the same settings for<br>large volume infusion pumps. Subject device<br>supports an additional Care Area Type to facilitate<br>use on the Syringe Pump as supported by the<br>Indications for Use. This difference does not raise<br>different questions of safety or effectiveness<br>because Baxter has already established different<br>care area types (Anesthesia and Standard),<br>available within the software to establish the<br>relevant limits. |
| Character Limits | Care Area Name & Drug Name<br>20 characters<br>Name must be unique.<br>Clinical Advisory:<br>200 characters | Care Area Name & Drug Name<br>20 characters<br>Name must be unique.<br>Clinical Advisory:<br>7 lines or 175 characters | Subject device accommodates increased character<br>limits for clinical advisory content compared to the<br>predicate. This difference does not raise different<br>questions of safety or effectiveness. |
| Downstream<br>Occlusion<br>Pressure Setting | Large Volume Pump<br>High<br>Medium<br>Low<br>Syringe Pump<br>High<br>Medium High<br>Medium<br>Low<br>Very Low | High<br>Medium<br>Low | The subject device supports the same settings for<br>large volume infusion pumps. Subject device<br>supports additional Downstream Occlusion<br>Pressure Settings to facilitate use on the Syringe<br>Pump. The additional settings align with the<br>requirements for the compatible infusion pumps.<br>This difference does not raise different questions<br>of safety or effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| Downstream<br>Occlusion<br>Detection Speed | Normal<br>Rapid | N/A | Subject device supports Downstream Occlusion<br>Detection Speed settings to facilitate use on the<br>Syringe Pump as supported by the subject<br>Indications for Use. The additional settings align<br>with the requirements for the compatible infusion<br>pump. This difference does not raise different<br>questions of safety or effectiveness. |
| Air in Line<br>bubble size | Large Volume Pump Only<br>50 μL<br>100 μL<br>200 μL<br>400 μL | N/A | Adjustable threshold feature allows user to<br>consider the context of infusion therapy and<br>patient population when establishing the air-in-line<br>alarm sensitivity for a given care area.<br>This difference does not raise different questions<br>of safety or effectiveness. |
| EMR Integration | On<br>Off | Same as subject device | N/A |
| Concentration<br>Type | Large Volume Pump:<br>Fixed<br>Standard<br>Variable<br>mL mode<br><br>Syringe Pump:<br>Standard<br>Variable<br>mL mode | Fixed<br>Standard<br>Variable<br>mL mode | The subject device supports the same settings for<br>large volume infusion pumps. Fixed concentration<br>type is not applicable for Syringe Pump as this<br>device automatically detects the fill volume of the<br>syringe container. This difference does not raise<br>different questions of safety or effectiveness. |
| Dose Modes | Continuous<br>● mL/hr, mL/kg/min, mL/kg/hr | Continuous<br>● mL/hr, mL/kg/min, mL/kg/hr | Predefined dose modes reduce manual calculations<br>required by clinicians. Additional dose modes<br>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<br>provide continuous and intermittent infusions.<br>These differences do not raise different questions<br>of safety or effectiveness. |
| | • mg/hr, mg/kg/hr, mg/min,<br>mg/kg/min, mg/kg/day | • mg/hr, mg/kg/hr, mg/min,<br>mg/kg/min, mg/kg/day | |
| | • mcg/hr, mcg/kg/hr, mcg/min,<br>mcg/kg/min, mcg/kg/day | • mcg/hr, mcg/kg/hr, mcg/min,<br>mcg/kg/min, mcg/kg/day | |
| | • ng/min, ng/kg/min | • ng/min, ng/kg/min | |
| | • Units/hr, Units/kg/hr,<br>Units/min, Units/kg/min | • Units/hr, Units/kg/hr,<br>Units/min, Units/kg/min | |
| | • MillionUnits/day | • mUnits/min, mUnits/kg/hr,<br>mUnits/kg/min | |
| | • mUnits/min, mUnits/kg/hr,<br>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,<br>mmol, MillionUnits<br>Weight based: | • mL, mg, Units, g, mcg, mEq,<br>mmol<br>Weight based: | |
| | • mL/kg, mg/kg, Units/kg, g/kg,<br>mcg/kg, mEq/kg, mmol/kg | • mL/kg, mg/kg, Units/kg, g/kg,<br>mcg/kg, mEq/kg, mmol/kg<br>BSA based: | |
| | • MillionUnits/kg<br>BSA based: | • mg/m2, Units/m2, g/m2,<br>mcg/m2 | |
| | | Volume / Time | |

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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<br>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<br><br>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<br>1 to 100 mL<br>Applicable to Amount /<br>Time Infusions<br><br>Syringe Pump<br>0.1 to 10 mL<br>Applicable to Amount / Time and<br>Volume/ Time Infusions | 1 to 100 mL<br>Applicable to Amount/Time drugs | Max Line Flush aligns with the requirements for<br>compatible infusion pumps. Subject device<br>supports expanded Max Line Flush to facilitate use<br>on the Syringe Pump as supported by the<br>Indications for Use. This difference does not raise<br>different questions of safety or effectiveness. |
| Clinical Advisory<br>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<br>optional and facility defined. Differences do not<br>raise different questions of safety or effectiveness. |
| Modifiers<br>assignment | 2 to 5 per drug | Same as subject device | N/A |

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| Table 3. Device Comparison | |
|----------------------------|--|
|----------------------------|--|

| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Step Rate<br>Change | 20% to 500% (standard Care Area)<br>500% (Anesthesia Care Area)<br>Configurable increase limit between<br>20% to<br>500% with an auto-calculated<br>decrease limit of 50%<br>of the increase limit, up to 99%<br>decrease (Standard Care Area)<br>Fixed increase limit of 500% and<br>decrease limit of 99%<br>(Anesthesia Care Area) | Same as subject device | N/A |
| Audio Level<br>Alarm | High<br>Medium<br>Low<br>Use Pump Settings | Same as subject device | N/A |
| Near Empty<br>Alarm | Bag Near Empty:<br>On, [15,30,60,90,120 mins]<br>Off<br>Syringe Near Empty:<br>On, [1,5,10,30,60,90,120 mins]<br>Off | Bag Near Empty:<br>On, 30 minutes<br>Off<br>Use Pump Settings | Both the subject and predicate device issue an<br>alarm when a bag is near complete. Both the<br>subject and predicate device require the user to<br>correct the condition to proceed. Both the subject<br>and predicate have the same default time setting.<br>Syringe Near Empty Alarm was added to facilitate<br>use with the Syringe Pump. The additional settings<br>align with the requirements for the compatible<br>infusion pumps. These differences in the available<br>setting options do not raise different issues of<br>safety and effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Maximum Keep<br>Vein Open (KVO)<br>Rate | Large Volume Pump<br>0.5 to 50 mL/hr<br>Syringe Pump<br>0.01 to 5 mL/hr | 0.5 to 50 mL/hr | The KVO feature is intended for use when<br>delivering a series of infusions to a patient, and the<br>delivery site must remain patent between the end<br>of one infusion and the beginning of the<br>next. Lower end of KVO rate configuration aligns<br>with flow rate range of the respective pump.<br>Syringe KVO Rate was added to facilitate use with<br>the Syringe Pump.<br>The different range does not raise different<br>questions and safety or effectiveness.…