(502 days)
Dose IQ Safety Software is intended to be used with the Novum IQ Syringe 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 Novum IQ Syringe Pump.
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 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 is a 510(k) summary for a medical device called "Dose IQ Safety Software." This document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing, but it does not describe a clinical study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study typically would.
Instead, the document emphasizes non-clinical testing, verification, and validation against design input requirements, user needs, and intended use, as well as demonstrating substantial equivalence to a predicate device. It explicitly states: "No clinical testing was performed in support of this premarket notification."
Therefore, I cannot provide a response that directly answers the request for "a table of acceptance criteria and the reported device performance" from a clinical study, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance" in the context of real-world clinical performance evaluation against health outcomes or diagnostic accuracy via expert read. The provided text deals with software verification and validation, and human factors.
However, I can extract the information related to the non-clinical acceptance criteria and validation efforts described in the document:
1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance
The document describes non-clinical testing against requirements for performance and safety. The acceptance criteria are broadly defined as meeting "design inputs and user needs" and "design and cyber security requirements."
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Safety Assurance Case (SAC) | "Dose IQ Safety Software is adequately safe and effective for its intended use." - Potential risks mitigated, residual risk acceptable. - Design verification and validation acceptable. - Device meets clinically valid essential performance. |
| Performance and Safety Requirements | "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." - "System verification demonstrated that design outputs meet design and cyber security requirements. All the testing met acceptance criteria." |
| Software Verification and Validation (FDA Guidance) | Per FDA guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (2005) (considered a major level of concern): - "Software testing included Functional testing. Regression Testing. Smoke & Sanity testing, code review, static analysis, and unit testing." - Outcome: All testing met acceptance criteria. |
| Human Factors Evaluation (Usability) | Per IEC 62366-1ed. 1.0 b:2015 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (2016): - Conducted in a simulated environment with intended user population, use environment, and scenarios. - Outcome: "Results of the human factors study show the device is suitable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "sample size" for a test set in the traditional sense of a clinical study (e.g., number of patients/cases). The testing described is software verification and validation, and human factors testing.
- Software Testing: These tests typically involve testing code against requirements, not patient data in the sense of a clinical study. The document mentions "Functional testing. Regression Testing. Smoke & Sanity testing, code review, static analysis, and unit testing." The "test set" would be the collection of test cases designed to cover software functionalities and requirements.
- Human Factors Evaluation: Conducted in a "simulated environment." The "sample size" for this would be the number of "intended user" participants. This number is not specified in the document.
- Data Provenance: Not applicable for clinical data. The tests are focused on software functionality, safety, and usability in simulated environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this submission. The "ground truth" for software functionality is defined by the design requirements and specifications themselves. For the human factors study, the "intended user population" was involved, but specific expert qualifications or adjudication for establishing a "ground truth" in terms of diagnostic reads or outcomes are not relevant to this type of testing.
4. Adjudication Method for the Test Set:
Not applicable, as there is no mention of a human-in-the-loop diagnostic study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document explicitly states: "No clinical testing was performed in support of this premarket notification." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The "Dose IQ Safety Software" is a standalone software application ("not embedded in pumps") that allows pharmacists to "create and maintain drug libraries." Its function is to configure pump settings. The "performance" assessment focuses on whether the software correctly generates these drug libraries according to specifications, and whether it is usable by pharmacists. Therefore, the non-clinical testing described effectively is a "standalone" performance assessment of the software's ability to meet its functional requirements and safety objectives. The document doesn't provide specific quantitative metrics of its "performance" (e.g., accuracy, precision) in the way one would for a diagnostic AI, but rather confirms its successful verification and validation.
7. The Type of Ground Truth Used:
- For software functionality: The "ground truth" is based on the defined "design input requirements" and "user needs."
- For human factors: The "ground truth" is based on the objectives of usability and safety in simulated clinical conditions, assessed by the "intended user population."
8. The Sample Size for the Training Set:
Not applicable. This is a software application for creating drug libraries, not a machine learning or AI model that is "trained" on a traditional dataset (e.g., medical images for diagnosis). The software's logic and rules are presumably programmed based on medical and engineering specifications relevant to infusion pump operation and drug administration safety.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's design and functionality is established through established medical device development processes, regulatory standards, clinical guidelines for drug administration, and engineering specifications for infusion pumps.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Baxter Healthcare Corporation Michelle Rixie Principal Specialist, Regulatory Affairs One Baxter Parkway Deerfield. Illinois 60015
August 30, 2022
Re: K211124
Trade/Device Name: Dose IO Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: PHC Dated: July 25, 2022 Received: July 29, 2022
Dear Michelle Rixie:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211124
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 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 Novum IQ Syringe Pump.
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
August 25, 2022
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Michelle Rixie Principal Specialist, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-2861 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 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 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 Novum IQ Syringe Pump. 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 IQ 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 to allow users to create and maintain drug libraries including the configuration of pump settings for the Novum IQ Syringe Pump. | 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 environments such as, but not limited to hospitals and outpatient care areas. | 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 |
| Other Indicationsfor Use | Dose IQ Safety Software isintended to be used by licensedpharmacists. | 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 safety softwarecombined. Intended users are also trained healthcareprofessionals. The difference in wording does notraise different questions of safety or effectiveness. |
| 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 systemcompatibility. | The subject device uses web browser technology thatcan be accessed from any computer and is no longer aproduct directly installed on Microsoft Windows. Thischange does not raise different questions of safety oreffectiveness as both applications require access byauthenticated 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 that alignswith the capacity requirements for the compatibleinfusion pump. These differences do not raisedifferent questions of safety or effectiveness. |
| Care Area Type | StandardAnesthesiaEnteral Feeding(only one Enteral Feeding CareArea allowed) | StandardAnesthesia | Subject device supports an additional Care Area Typeto facilitate use on the Syringe Pump as supported bythe Indications for Use. This difference does not raisedifferent questions of safety or effectiveness becauseBaxter has already established different care areatypes (Anesthesia and Standard), available within thesoftware to establish the relevant limits. |
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| 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 | HighMedium HighMediumLowVery Low | HighMediumLow | Subject device supports additional DownstreamOcclusion Pressure Settings to facilitate use on theSyringe Pump. The additional settings align with therequirements for the compatible infusion pump. Thisdifference does not raise different questions of safetyor effectiveness. |
| DownstreamOcclusionDetection Speed | NormalRapid | N/A | Subject device supports Downstream OcclusionDetection Speed settings to facilitate use on theSyringe Pump as supported by the Indications for Use.The additional settings align with the requirements forthe compatible infusion pump. This difference doesnot raise different questions of safety oreffectiveness. |
| EMR Integration | OnOff | Same as subject device | N/A |
| ConcentrationType | StandardVariablemL mode | FixedStandardVariablemL mode | Fixed concentration type is not applicable for SyringePump as this device automatically detects the fillvolume of the syringe container. This difference doesnot raise different questions of safety or effectiveness. |
| Dose Modes | Continuous | Continuous• mL/hr, mL/kg/min, mL/kg/hr | Predefined dose modes reduce manual calculationsrequired by clinicians. Additional dose modes alignwith the requirements for the compatible infusion |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| mL/hr, mL/kg/min, mL/kg/hr g/hr 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 ng/min, ng/kg/min Units/hr, Units/kg/hr, Units/min, Units/kg/min MillionUnits/day mUnits/min, mUnits/kg/hr, mUnits/kg/min mEq/hr, mEq/kg/hr mmol/hr, mmol/kg/hr Amount / TimeNon-weight-based: mg, Units, g, mcg, mEq, mmol, MillionUnits Weight based: mL/kg, mg/kg, Units/kg, g/kg, mcg/kg, mEq/kg, mmol/kg | g/hr 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 ng/min, ng/kg/min Units/hr, Units/kg/hr, Units/min, Units/kg/min mUnits/min, mUnits/kg/hr, mUnits/kg/min mEq/hr, mEq/kg/hr mmol/hr, mmol/kg/hr Amount / TimeNon-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 BSA based: mg/m², Units/m², g/m², mcg/m² | pump. The subject device continues to providecontinuous and intermittent infusions. Thesedifferences do not raise different questions of safetyor effectiveness. | |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| MillionUnits/kg BSA based: mg/m2, Units/m2, g/m2, mcg/m2, MillionUnits/m2 Volume / Time Total Volume / Total Time | Volume / TimeTotal Volume / Total Time | ||
| Bolus / LoadingDose | EnableDisable (default) | Same as subject device | N/A |
| Bolus/LoadingDose Amountlimits and TimeLimits | Lower Hard, Lower Soft, Starting,Upper Soft, Upper Hard1 lower and 1 upper limit requiredfor Care Area Drug | Same as subject device | N/A |
| Characteristic | Subject Device | Predicate Device (K173084)¹ | Discussion of Differences |
| Max Line Flush | 0.1 to 10 mLApplicable to Amount / Time andVolume/Time Infusions | 1 to 100 mLApplicable to Amount/Time drugs | Max Line Flush aligns with the requirements for thecompatible infusion pump. Subject device supportsexpanded Max Line Flush to facilitate use on theSyringe Pump as supported by the Indications for Use.This difference does not raise different questions ofsafety or effectiveness. |
| Clinical AdvisoryAssignment | ●per concentration●per modifier for allconcentrations●per drug for allconcentrations | ●per modifier for allconcentrations●per drug for allconcentrations | Both devices provide clinical advisories, which areoptional and facility defined. Differences do not raisedifferent questions of safety or effectiveness. |
| Modifiersassignment | 2 to 5 per drug | Same as subject device | N/A |
| Single Step RateChange | 20% to 500% (standard Care Area)500% (Anesthesia Care Area)Configurable increase limitbetween 20% 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 |
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
| Audio LevelAlarm | HighMediumLowUse Pump Settings | Same as subject device | N/A |
| Near EmptyAlarm | Syringe Near Empty:On, [1,5,10,30,60,90,120 mins]Off | Bag Near Empty:On, 30 minutesOffUse Pump Settings | Syringe Near Empty Alarm was added to facilitate usewith the Syringe Pump. Both the subject and predicatedevice require the user to correct the condition toproceed. Both the subject and predicate have the samedefault time setting. The additional settings align withthe requirements for the compatible infusion pump.These differences in the available setting options donot raise different issues of safety and effectiveness. |
| Maximum KeepVein Open (KVO)Rate | 0.01 to 5 mL/hr | 0.5 to 50 mL/hr | Syringe KVO Rate was added to facilitate use withthe Syringe Pump. The KVO feature is intended foruse when delivering a series of infusions to a patient,and the delivery site must remain patent between theend of one infusion and the beginning of thenext. Lower end of KVO rate configuration alignswith flow rate range of the compatible pump.The different range does not raise different questionsand safety or effectiveness. |
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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| 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 whenenabled by hospital administrator | Keypad in predicate and subject devices can only belocked while the infusion is running. Subject deviceintroduces customizable lock code for Anesthesia carearea restricting access to authorized personnel.Subject device provides Hospital administrators theability to establish a single hospital wide passcode.This customizable passcode provides an added levelof security by restricting access to only authorizedpersonnel when accessing Anesthesia careareas. Regarding Biomed Passcode, both predicateand subject devices prevent unauthorized access tonon-clinical functions.These differences do not raise different questions ofsafety or effectiveness. |
| Certificates | Required | Optional | Both devices use certificates to prevent tampering.Differences do not raise different questions of safetyand effectiveness. |
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| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Available RateLimits | 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 pump. | All Rates and Drug Library Limits must fall within Spectrum Pump operational range of 0.5 to 999 mL/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 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 |
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| 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 digitallysigned file. The syringe libraryand its contents cannot be modifiedby the pharmacist in the Dose IQSafety Software. The pharmacistonly selects the required syringebrands and sizes from thisapproved syringe library to be usedfor the specific drug library beingcreated. | N/A | The subject device introduces a Syringe Library thatis sent to the Novum IQ Syringe Pump as part of theDrug Library file to provide users a limited selectionof only qualified disposables to be used withcompatible Syringe Pumps. This change does notraise different questions of safety or effectivenessbecause the Syringe Library follows similar conceptsof the Master Drugs in how drugs are assigned frompreset Care Areas. |
| Infusion PumpCompatibility | Compatible with Novum IQSyringe Pump | Compatible with Spectrum IQ pump | The subject device will be compatible with theNovum IQ Syringe Pump and meets the requirementsfor the compatible infusion pump. This change doesnot raise different questions of safety or effectivenessand the function was verified to meet the intended useof the device. |
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Table 3. Device Comparison
| Characteristic | Subject Device | Predicate Device (K173084)1 | Discussion of Differences |
|---|---|---|---|
| Interface withdifferent 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 | Through a Binary Drug Library file 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. |
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 the intended use. 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).