(385 days)
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.
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 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.
The provided text describes the 510(k) premarket notification for the Baxter Dose IQ Safety Software. However, it explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, there is no information in the provided document about "acceptance criteria" based on clinical performance, a "study that proves the device meets the acceptance criteria" in a clinical context, or details like sample size, expert ground truth establishment, MRMC studies, or standalone performance.
The document primarily focuses on non-clinical testing, verification, and validation to demonstrate substantial equivalence to a predicate device. It details software testing and a human factors evaluation.
Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, primarily from a non-clinical testing and verification/validation perspective:
1. A table of acceptance criteria and the reported device performance:
Since the document does not present clinical acceptance criteria, the "acceptance criteria" implied here are related to software verification and validation, and meeting design inputs and user needs. The reported performance is a general statement of successful completion of these tests.
| Acceptance Criteria (Implied from Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Potential risks mitigated and residual risk acceptable | Confirmed: Potential hazards identified and adequately mitigated. |
| Design verification and validation acceptable | Confirmed: Design verification and validation acceptable. |
| Meets clinically valid essential performance | Confirmed: Device meets clinically valid essential performance. |
| Design inputs and user needs met | Confirmed: Validation demonstrated design inputs and user needs were met. |
| Design outputs meet design and cybersecurity requirements | Confirmed: System verification demonstrated design outputs meet design and cybersecurity requirements. |
| All testing met acceptance criteria | Confirmed: All the testing met acceptance criteria. |
| Software verification and validation (functional, regression, smoke & sanity, code review, static analysis, unit testing) performed according to FDA guidance | Confirmed: Performed according to FDA Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." issued May 11, 2005. |
| Human factors evaluation results suitable for intended use | Confirmed: Results show the device is suitable for its intended use. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data, as no clinical testing was performed. For non-clinical software testing, the "sample size" would refer to the number of test cases, which is not specified but implied to be comprehensive enough for "functional testing, regression testing, smoke & sanity testing, code review, static analysis, and unit testing."
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the test data (e.g., specific testing labs or environments), but it implies internal company testing or external contracted testing. The testing is non-clinical verification and validation, not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical ground truth was established from expert readings or similar methods for a clinical test set. The "truth" for software testing is defined by the functional and non-functional requirements and design specifications.
- For the human factors study, it was conducted "with the intended user population." The number and specific qualifications of these users (e.g., licensed pharmacists, as per the indications for use) are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication of expert opinions was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states, "No clinical testing was performed."
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Again, no clinical performance studies were conducted. The device itself is "standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform." Its primary function is to create drug libraries for infusion pumps, not to directly perform real-time patient-facing actions or diagnoses that typically warrant standalone algorithm performance metrics. It's a tool for pharmacists to configure other medical devices.
7. The type of ground truth used:
- For non-clinical software testing: The ground truth is effectively the design requirements, specifications, and established functional behavior of the software as defined by the developers and verified against those specifications.
- For the Human Factors evaluation: The "ground truth" would be the successful completion of tasks by intended users in a simulated environment, demonstrating the usability and safety in typical use scenarios.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that learns from a "training set" of data in the typical sense (e.g., image datasets). It's a configuration and management software.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI/ML model described.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| 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 Systemwith Dose IQ Safety Software1 | Baxter HealthcareCorporation | 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 intendedto be used with the Novum IQSyringe Pump and Novum IQ LargeVolume Pump to support thecontrolled administration of fluids.Dose IQ Safety Software is intendedto allow users to create and maintaindrug libraries, including theconfiguration of pump settings forthe compatible pumps. | N/A | The indications for the Predicate Device weredeveloped for the infusion pump and safetysoftware combined. As the subject device will bestandalone safety software, indications for it havebeen specifically defined. The difference inwording does not raise different questions ofsafety or effectiveness. |
| Dose IQ Safety Software is intendedto allow users to establish thefacility-defined syringe list, which isa subset of Baxter's approvedcompatible syringes, for the NovumIQ Syringe Pump | N/A | The subject device introduces a Syringe Librarythat is sent to the Novum IQ Syringe Pump as partof the Drug Library file to provide users a limitedselection of only qualified disposables to be usedwith compatible Syringe Pumps. The syringelibrary file is a secure digitally signed file. Thesyringe library and its contents cannot be modifiedby the pharmacist in the Dose IQ SafetySoftware. The pharmacist only selects therequired syringe brands and sizes from thisapproved syringe library to be used for the specificdrug library being created. This change does notraise different questions of safety or effectivenessbecause the Syringe Library follows similarconcepts of the Master Drugs in how drugs areassigned from preset Care Areas. | |
| Use Environment | Dose IQ Safety Software is intendedto be used in hospitals and outpatienthealth care facilities. | The Spectrum IQ Infusion Systemwith Dose IQ Safety Software issuitable for a variety of patient care | Both subject and predicate devices are suitable forhospitals and outpatient healthcare facilities;difference in wording does not raise differentquestions of safety or effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| environments such as, but not limitedto hospitals and outpatient care areas. | |||
| Other Indicationsfor Use | Dose IQ Safety Software is intendedto be used by licensed pharmacists. | The Spectrum IQ Infusion Systemwith Dose IQ Safety Software isintended to be used by trainedhealthcare professionals. | The indications for the Predicate Device weredeveloped for the infusion pump and safetysoftware combined. Licensed pharmacists are alsotrained healthcare professionals. The difference inwording does not raise different questions ofsafety or effectiveness. |
| Features, Functions and Performance Specifications | |||
| Infusion DeliveryModes | ContinuousAmount/TimeVolume/Time | Same as subject device | N/A |
| System Basis | A browser-based applicationrequiring Google Chrome on thecompatible hardware | Microsoft Windows® 7(32 or 64-bit)and Microsoft Windows® 10(64-bit)operating system compatibility. | The subject device uses web browser technologythat can be accessed from any computer and is nolonger a product directly installed on MicrosoftWindows. This change does not raise differentquestions of safety or effectiveness as bothapplications require access by authenticated users. |
| Drug LibraryCapacity | Number of Care Areas: 32Number of Drugs: 5000 per pumpNumber of Clinical Advisories: 800Number of Modifiers: 1000 | Number of Care Areas: 32Number of Drugs: 5000Number of Clinical Advisories: 400Number of Modifiers: 500 | Subject device supports increased capacity in theareas of Clinical Advisories and Modifiers thataligns with the capacity requirements for thecompatible infusion pump. These differences donot raise different questions of safety oreffectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Care Area Type | StandardAnesthesiaEnteral Feeding (Only supported bythe Novum IQ Syringe)(only one Enteral Feeding Care Areaallowed) | StandardAnesthesia | The subject device supports the same settings forlarge volume infusion pumps. Subject devicesupports an additional Care Area Type to facilitateuse on the Syringe Pump as supported by theIndications for Use. This difference does not raisedifferent questions of safety or effectivenessbecause Baxter has already established differentcare area types (Anesthesia and Standard),available within the software to establish therelevant limits. |
| Character Limits | Care Area Name & Drug Name20 charactersName must be unique.Clinical Advisory:200 characters | Care Area Name & Drug Name20 charactersName must be unique.Clinical Advisory:7 lines or 175 characters | Subject device accommodates increased characterlimits for clinical advisory content compared to thepredicate. This difference does not raise differentquestions of safety or effectiveness. |
| DownstreamOcclusionPressure Setting | Large Volume PumpHighMediumLowSyringe PumpHighMedium HighMediumLowVery Low | HighMediumLow | The subject device supports the same settings forlarge volume infusion pumps. Subject devicesupports additional Downstream OcclusionPressure Settings to facilitate use on the SyringePump. The additional settings align with therequirements for the compatible infusion pumps.This difference does not raise different questionsof safety or effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| DownstreamOcclusionDetection Speed | NormalRapid | N/A | Subject device supports Downstream OcclusionDetection Speed settings to facilitate use on theSyringe Pump as supported by the subjectIndications for Use. The additional settings alignwith the requirements for the compatible infusionpump. This difference does not raise differentquestions of safety or effectiveness. |
| Air in Linebubble size | Large Volume Pump Only50 μL100 μL200 μL400 μL | N/A | Adjustable threshold feature allows user toconsider the context of infusion therapy andpatient population when establishing the air-in-linealarm sensitivity for a given care area.This difference does not raise different questionsof safety or effectiveness. |
| EMR Integration | OnOff | Same as subject device | N/A |
| ConcentrationType | Large Volume Pump:FixedStandardVariablemL modeSyringe Pump:StandardVariablemL mode | FixedStandardVariablemL mode | The subject device supports the same settings forlarge volume infusion pumps. Fixed concentrationtype is not applicable for Syringe Pump as thisdevice automatically detects the fill volume of thesyringe container. This difference does not raisedifferent 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 calculationsrequired by clinicians. Additional dose modesalign 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 toprovide continuous and intermittent infusions.These differences do not raise different questionsof 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, MillionUnitsWeight based: | • mL, mg, Units, g, mcg, mEq,mmolWeight 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/kgBSA based: | ||
| • MillionUnits/kgBSA based: | • mg/m2, Units/m2, g/m2,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 | EnableDisable (default) | Same as subject device | N/A |
| Bolus/Loading Dose Amount limits and Time Limits | Lower Hard, Lower Soft, Starting, Upper Soft, Upper Hard1 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 Pump1 to 100 mLApplicable to Amount /Time InfusionsSyringe Pump0.1 to 10 mLApplicable to Amount / Time andVolume/ Time Infusions | 1 to 100 mLApplicable to Amount/Time drugs | Max Line Flush aligns with the requirements forcompatible infusion pumps. Subject devicesupports expanded Max Line Flush to facilitate useon the Syringe Pump as supported by theIndications for Use. This difference does not raisedifferent questions of safety or effectiveness. |
| Clinical AdvisoryAssignment | 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 areoptional and facility defined. Differences do notraise different questions of safety or effectiveness. |
| Modifiersassignment | 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 RateChange | 20% to 500% (standard Care Area)500% (Anesthesia Care Area)Configurable increase limit between20% to500% with an auto-calculateddecrease limit of 50%of the increase limit, up to 99%decrease (Standard Care Area)Fixed increase limit of 500% anddecrease limit of 99%(Anesthesia Care Area) | Same as subject device | N/A |
| Audio LevelAlarm | HighMediumLowUse Pump Settings | Same as subject device | N/A |
| Near EmptyAlarm | Bag Near Empty:On, [15,30,60,90,120 mins]OffSyringe Near Empty:On, [1,5,10,30,60,90,120 mins]Off | Bag Near Empty:On, 30 minutesOffUse Pump Settings | Both the subject and predicate device issue analarm when a bag is near complete. Both thesubject and predicate device require the user tocorrect the condition to proceed. Both the subjectand predicate have the same default time setting.Syringe Near Empty Alarm was added to facilitateuse with the Syringe Pump. The additional settingsalign with the requirements for the compatibleinfusion pumps. These differences in the availablesetting options do not raise different issues ofsafety and effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Maximum KeepVein Open (KVO)Rate | Large Volume Pump0.5 to 50 mL/hrSyringe Pump0.01 to 5 mL/hr | 0.5 to 50 mL/hr | The KVO feature is intended for use whendelivering a series of infusions to a patient, and thedelivery site must remain patent between the endof one infusion and the beginning of thenext. Lower end of KVO rate configuration alignswith flow rate range of the respective pump.Syringe KVO Rate was added to facilitate use withthe Syringe Pump.The different range does not raise differentquestions and safety or effectiveness. |
| Passcodes | Keypad Lock Passcode:OnOffCustom (3 to 4 digits)Anesthesia Passcode:For Anesthesia Care Area TypeOnOffCustom (2- 6 digits) requiredBiomed Passcode:N/A - Established via User Lists | Keypad Lock Passcode:OnOffCustom (3 to 4 digits)Anesthesia Passcode:N/ABiomed Passcode:Level 1, 4 - 8 digitsLevel 2, 4- 8 digits.Level 2 only available when enabledby hospital administrator | Keypad in predicate and subject devices can onlybe locked while the infusion is running. Subjectdevice introduces customizable lock code forAnesthesia care area restricting access toauthorized personnel.Subject device provides Hospital administratorsthe ability to establish a single hospital widepasscode. This customizable passcode provides anadded level of security by restricting access to onlyauthorized personnel when accessing Anesthesiacare areas. Regarding Biomed Passcode, bothpredicate and subject devices prevent unauthorizedaccess to non-clinical functions.These differences do not raise different questionsof safety or effectiveness. |
| Certificates | Required | Optional | Both devices use certificates to prevent tampering.Differences do not raise different questions ofsafety and effectiveness. |
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| Available RateLimits | • Upper Hard Limit must begreater than or equal to UpperSoft Limit. | • Upper Hard Limit must begreater than or equal to UpperSoft Limit. | Operational ranges are controlled by the respectivecompatible infusion pump. This change does notraise different questions of safety or effectiveness. |
| • Upper Soft Limit must begreater than or equal to aStarting Rate. | • Upper Soft Limit must begreater than or equal to aStarting Rate. | ||
| • Starting Rate must be greaterthan or equal to a Lower SoftLimit. | • Starting Rate must be greaterthan or equal to a Lower SoftLimit. | ||
| • Lower Soft Limit must begreater than or equal to aLower Hard Limit. | • Lower Soft Limit must begreater than or equal to aLower Hard Limit. | ||
| • Lower Hard Limit must beless than or equal to a LowerSoft Limit | • Lower Hard Limit must beless than or equal to a LowerSoft Limit | ||
| All Rates and Drug Library Limitsmust fall within the operational rangeof the compatible pumps. | All Rates and Drug Library Limitsmust fall within Spectrum Pumpoperational range of 0.5 to 999mL/hr. |
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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 newroles as a consequence of the architecture of thesubject device – in particular the administrativefunctions which were not applicable in thepredicate device. The subject device maintains the'Full Access' and 'Read-only' roles as per thepredicate. The 'Limited Access' role is notincluded in the subject device as the functionalityof this role is incorporated in the 'Read-only' role.These differences do not raise different questionsof 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 librarythat is approved for use with theNovum IQ Syringe Pump based onspecific syringe brands and sizes.Each syringe brand and size haveunique characteristics that areverified by Baxter with the NovumIQ Syringe Pump. The syringelibrary file is a secure digitally signedfile. The syringe library and itscontents cannot be modified by thepharmacist in the Dose IQ SafetySoftware. The pharmacist onlyselects the required syringe brandsand sizes from this approved syringelibrary to be used for the specificdrug library being created. | N/A | The subject device introduces a Syringe Librarythat is sent to the Novum IQ Syringe Pump as partof the Drug Library file to provide users a limitedselection of only qualified disposables to be usedwith compatible Syringe Pumps. This change doesnot raise different questions of safety oreffectiveness because the Syringe Library followssimilar concepts of the Master Drugs in how drugsare assigned from preset Care Areas. |
| Infusion PumpCompatibility | Compatible with Novum IQ LargeVolume Pump and Novum IQSyringe Pump | Compatible with Spectrum IQ pump | The subject device will be compatible with theNovum IQ platform and meets the requirementsfor compatible infusion pumps. This change doesnot raise different questions of safety oreffectiveness and the function was verified to meetthe intended use of the device. |
| Interface withdifferent pump | Dose IQ Safety Software does nothave a direct interface to the infusionpump. The Binary Drug Library fileis transferred via:• USB• Wireless communication viathe Gateway | Dose IQ Safety Software does nothave a direct interface to the infusionpump. The Binary Drug Library fileis transferred via:• IrDA• Wireless communication viathe Gateway | Both provide a means of transferring data via afile. Change in interface does not raise differentquestions of safety or effectiveness and thefunction was verified on the pump to meet theintended use of the device. |
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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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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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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.
§ 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).