Search Results
Found 1 results
510(k) Data Aggregation
(224 days)
Spectrum IQ Infusion System, Dose IQ Safety Software
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Spectrum IO Infusion System with Dose IO Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors.
The Spectrum IO Infusion System with Dose IO Safety Software is intended to be used by trained healthcare professionals.
The proposed device, which is the subject of this Traditional 510(k) premarket notification, is the Spectrum IQ Infusion System with Dose IQ Safety Software. The Spectrum IQ Infusion System with Dose IQ Safety Software is a large volume infusion pump system that provides delivery of fluids into a patient in a controlled manner. The system includes a software controlled, electromechanical pump used for the infusion of fluids such as pharmaceutical drugs, blood, and blood products through intravenous administration sets at user selectable rates and volumes, and a software application that allows the generation, configuration and management of a downloadable drug library into the pump. The feedback-controlled, motorized pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The pump utilizes a primary and secondary processor to maintain operation while providing infusion pump capabilities for a wide range of applications.
The pump is specifically manufactured and calibrated for use with Baxter's standard administration sets, as indicated in the device labeling. For use, the administration set is loaded into the infusion pump. After acceptance of program parameters, the pump is started and fluid is propelled by the peristaltic action of the pumping mechanism. The pump is designed to create smooth fluid dynamics, precise volumetric accuracy, and a uniform flow rate. None of the pump materials contact the fluid path of the administration set.
The Dose IQ Safety Software is a software application that allows for the generation, configuration, and management of a downloadable drug library into a selected Spectrum pump. The drug library can be loaded directly into the pump through a wireless network host or through an Infrared Data Association (IrDA) device. The Dose IQ Safety Software operates on a standard software, Microsoft Windows®, platform.
Using the Dose IQ Safety Software application, a facility can develop preprogrammed delivery profiles, advisories, and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus aiding in the reduction of medication errors. The Dose IO Safety Software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The Dose IQ Safety Software application also provides a feature to restrict/limit the access of data to only appropriate personnel, providing additional security and rights to specific users.
The Spectrum IQ Infusion System with Dose IQ Safety Software is also capable of automatically populating infusion parameters based on an infusion order that is wirelessly received from a facility's electronic medical record (EMR) system. Although the pump can accept remote orders and populate the infusion parameters, it requires a clinician to verify the information before the start of an infusion.
This FDA 510(k) summary for the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software details the device's characteristics and its comparison to a predicate device, focusing on non-clinical testing.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance:
The document states that "Non-Clinical testing of the Spectrum IQ Infusion system with Dose IQ Safety Software met all acceptance criteria". However, it does not explicitly list the quantitative acceptance criteria for each test and its specific performance result in the format of a table you requested. Instead, it broadly states "Per Baxter Test Methods" for several categories of testing. We can infer some performance characteristics from the "Technological Characteristics and Substantial Equivalence" section, which compares the proposed device to the predicate.
Here's an attempt to construct a table based on the provided information, understanding that concrete acceptance criteria and specific numerical performance against those criteria are not explicitly detailed for most points, but rather implied by meeting "Baxter Test Methods" and showing "substantial equivalence":
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (as described or compared) |
|---|---|---|
| Central Management Subsystem | Per Baxter Test Methods | Met |
| Case Works Subsystem | Per Baxter Test Methods | Met |
| Pumping Subsystem | Per Baxter Test Methods | Met (Linear peristaltic design, smooth fluid dynamics, precise volumetric accuracy, uniform flow rate) |
| Power Subsystem | Per Baxter Test Methods | Met |
| System Level Testing | Per Baxter Test Methods | Met |
| Software Testing | Per Baxter Test Methods | Met |
| Reliability Testing | Per Baxter Test Methods | Met |
| Consensus Standards Testing | Specific IEC/ANSI/AAMI standards (e.g., ANSI/AAMI ES60601-1:2005) | Met (Compliance indicated) |
| Human Factors Evaluation | Use errors not greater than minimal risk for critical tasks | Met (Evaluated in simulated environment) |
| Specific Device Performance Characteristics for Substantial Equivalence Comparison: | ||
| Bolus Volume Accuracy (0.5 ml) | Not explicitly stated, predicate is "Identical to proposed" | 0.5 ml ± 20% |
| Bolus Volume Accuracy (999 ml) | Not explicitly stated, predicate is "Identical to proposed" | 999 ml ± 10% |
| Flow Rates | Not explicitly stated, predicate is "Identical to proposed" | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr and 1.0 mL/hr increments from 100 to 999 mL/hr |
| KVO Rate | Not explicitly stated, predicate is "Identical to proposed" | Default 1 mL/hr, configurable 0.5 - 50 mL/hr (primary), Fixed 1 mL/hr (secondary callback) |
| Logging Memory | Minimum 4,500 event capacity | Minimum 4,500 event capacity |
| Low-Flow Continuity | No-flow max 90 seconds @ 0.5 mL/hr, bolus ≤ 15 µL over 5 sec | Maximum period of no-flow is 90 seconds at 0.5 mL/hr with a bolus volume that does not exceed 15 µL over a 5 second sample volume interval. |
| Occlusion Pressure | Adjustable (High, Medium, Low) | High (19 ±9 PSI), Medium (13 ±6 PSI), Low (6 ±4 PSI) |
| Max Allowable Pressure (Downstream Occlusion) | 30 PSI | 30 PSI |
| Single Fault Condition (max bolus) | A maximum bolus of 0.56 mL | A maximum bolus of 0.56 mL |
| Total Drug Delivered | Not explicitly stated, predicate is "Identical to proposed" | 0.1 to 9999 mL with 0.1 mL increments from 0.1 to 99.9 mL and 1.0 mL increments from 100 to 9999 mL |
| Volumetric Accuracy (DEHP Sets 2.0-999 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ± 5% |
| Volumetric Accuracy (DEHP Sets 0.5-1.9 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ± 0.1 mL/hr |
| Volumetric Accuracy (Non-DEHP Sets 10-125 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ±10% ≤ 36 hrs |
| Volumetric Accuracy (Non-DEHP Sets 126-250 mL/hr) | Not explicitly stated, predicate is "Identical to proposed" | ±10% ≤ 4 hrs |
| Drug Capacity | Up to 5,000 drugs and 32 care areas | Up to 5,000 drugs and 32 care areas |
2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., number of devices tested, number of simulated scenarios).
The data provenance is from non-clinical testing performed by Baxter Healthcare Corporation, including bench testing and human factors evaluation in a simulated environment. There is no mention of country of origin of data beyond Baxter's internal testing as the manufacturer. The tests are prospective in nature, assessing the device's performance against defined requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions a "Human Factors evaluation in a simulated environment" and states it's intended to ensure use errors are not greater than minimal risk. It also mentions "trained healthcare professionals" for intended users.
However, the document does not specify the number of experts, nor their specific qualifications, who established a "ground truth" or evaluated the human factors test set. It implies user testing with qualified personnel but no detail is provided.
4. Adjudication method for the test set:
The document does not describe any adjudication method for establishing ground truth or resolving discrepancies in any of the testing. The testing is primarily "verification against requirements," implying a pass/fail outcome against predefined specifications rather than a consensus-driven ground truth process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was mentioned or performed. This device is an infusion pump with safety software, not an AI-assisted diagnostic imaging or decision-support tool where "human readers improve with AI" would be a relevant metric. The "Dose IQ Safety Software" automates programming and provides advisories, which is a form of decision support/error reduction, but not in the context of interpreting medical cases like radiologists.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The core device is an infusion pump, which operates independently in its functional delivery of fluids. The "Dose IQ Safety Software" provides automation but "requires a clinician to verify the information before the start of an infusion," indicating a human-in-the-loop system for critical operations. Standalone performance for the pump itself (e.g., flow rate accuracy) was implicitly tested through the "Pumping Subsystem Testing" and "System Level Testing" (which met acceptance criteria), but this is not an "algorithm-only" standalone performance in the typical sense of AI/ML.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is predominantly based on pre-defined engineering and performance requirements and compliance with consensus standards. For the human factors evaluation, the ground truth would be the identification of critical tasks and the assessment of use errors against pre-established risk thresholds, likely based on expert judgment and safety analyses. It's not "pathology" or "outcomes data" in a diagnostic sense.
8. The sample size for the training set:
No training set is mentioned. The document describes a "Dose IQ Safety Software" which allows for the creation and management of a drug library and automated programming. This is a rule-based or reference data-based system, not an AI/ML system that would require a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
As no training set (in the AI/ML sense) is mentioned, this question is not applicable. The "ground truth" for the drug library data would be established by the facility's clinical policies, pharmaceutical guidelines, and expert medical input during the configuration of the drug library itself.
Ask a specific question about this device
Page 1 of 1