(60 days)
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 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.
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 IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.
Spectrum IQ is a large volume pump within the Spectrum IQ infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.
The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood and blood products through administration sets at clinician's selectable rates and volumes.
The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.
Dose IQ is a standalone software application installed on a hospital-provided computing platform and used to create a drug library file. Dose IQ facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file includes customers' dosing limits and additional pump configuration settings. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.
This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023.
The provided FDA 510(k) clearance letter for the Spectrum IQ Infusion System with Dose IQ Safety Software (K251636) does NOT describe a study involving an AI/Machine Learning algorithm for diagnostic or prognostic purposes, which would typically involve the criteria you've outlined.
Instead, this device is an infusion pump with safety software, intended to reduce operator interaction through guided programming to minimize "pump programming errors." The summary explicitly states: "This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023." This suggests that the changes are primarily bug fixes, usability improvements, and potentially enhanced safety features rather than the introduction of a novel AI-driven diagnostic tool.
Therefore, many of the requested details about acceptance criteria and study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. These criteria are typically relevant for AI/ML-enabled devices that perform interpretation of medical images, signals, or patient data for diagnostic or prognostic purposes where "ground truth" and human reader performance are central to validation.
The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (K230041) through a comparison of technological characteristics and non-clinical performance and safety testing.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Device Performance (Based on the provided document)
The document doesn't present specific quantitative acceptance criteria in a table format for a "study" as you might expect for an AI/ML diagnostic device. Instead, "acceptance criteria" for an infusion pump typically refer to meeting defined performance specifications (e.g., volumetric accuracy, alarm thresholds, power consumption, environmental limits) and safety standards (e.g., IEC 60601 series).
The document states that "Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use." However, it does not provide the specific quantitative criteria or the numerical reported device performance for each. It assumes these were adequately documented in the full submission to FDA.
The "performance" described relates to the functional aspects of the pump and software:
| Characteristic | Acceptance Criteria (Implicit from "Subject Device" values) | Reported Device Performance (Same as Subject Device values) |
|---|---|---|
| Spectrum IQ Infusion System | ||
| Pumping Mechanism | Linear peristaltic design | Linear peristaltic design |
| Modes of Delivery | Continuous, Intermittent | Continuous, Intermittent |
| Routes of Administration | IV, Arterial, Subcutaneous, Epidural | IV, Arterial, Subcutaneous, Epidural |
| User Interface Display | Color LCD | Color LCD |
| AC Power (Input) | 100-240 VAC, 50 / 60 Hz / 300 mA Max | 100-240 VAC, 50 / 60 Hz / 300 mA Max |
| AC Power (Output) | 9 VDC/1000 mA, short circuit protected | 9 VDC/1000 mA, short circuit protected |
| Operating Temperature | 15.6 to 32.2°C (60 to 90°F), 20 to 90% RH non-condensing | 15.6 to 32.2°C (60 to 90°F), 20 to 90% RH non-condensing |
| Atmospheric Pressure | 66kPa to 102kPa | 66kPa to 102kPa |
| Storage Temperature | -10 to +35°C (14 to 95°F), 10 to 90% RH non-condensing | -10 to +35°C (14 to 95°F), 10 to 90% RH non-condensing |
| Single Fault Condition Bolus | Max 0.56 mL | Max 0.56 mL |
| Air-In-Line Detection (> 2.5 cm) | Detects >2.5 cm (approx 140 μL) bubbles | Detects >2.5 cm (approx 140 μL) bubbles |
| Air-In-Line Accumulated Air (Room Temp) | Detects >1 mL over 15 min, excluding <10μL | Detects >1 mL over 15 min, excluding <10μL |
| Air-In-Line Accumulated Air (15.5°C) | Detects >1.5 mL over 15 min, excluding <10μL | Detects >1.5 mL over 15 min, excluding <10μL |
| Low Battery Alarm | ≤15 minutes of battery power remaining | ≤15 minutes of battery power remaining |
| Flow Rate Range | 0.5 to 999 mL/hr | 0.5 to 999 mL/hr |
| Low-Flow Continuity (No-Flow Period) | Max 90 seconds at 0.5 mL/hr | Max 90 seconds at 0.5 mL/hr |
| Low-Flow Continuity (Bolus Volume) | Not exceed 15 μL over 5 sec at 0.5-1.0 mL/hr | Not exceed 15 μL over 5 sec at 0.5-1.0 mL/hr |
| Volumetric Accuracy (Non-DEHP, 0.5-1.9 mL/hr) | ±0.1 mL/hr over ≤ 4 hrs | ±0.1 mL/hr over ≤ 4 hrs |
| Volumetric Accuracy (Non-DEHP, 2.0-999 mL/hr) | ±5% over ≤ 4 hrs | ±5% over ≤ 4 hrs |
| Dose IQ Safety Software | ||
| Drug Library Capacity (Drugs) | 5000 drugs | 5000 drugs |
| Drug Library Capacity (Care Areas) | 32 care areas | 32 care areas |
| Drug Library Capacity (Clinical Advisories) | 400 clinical advisories | 400 clinical advisories |
| Drug Library Capacity (Modifiers) | 500 modifiers | 500 modifiers |
| Rate/Dose Limits Fall within Pump Range | 0.5 to 999 mL/hr | 0.5 to 999 mL/hr |
Regarding the other specific questions:
-
Sample sizes used for the test set and data provenance:
This information is not provided in a way that aligns with AI/ML model validation. The "non-clinical testing" would refer to engineering tests (e.g., bench testing for flow accuracy, alarm functionality, battery life) rather than a dataset for an AI model. Therefore, specific "test set" sample sizes or data provenance (e.g., country, retrospective/prospective) are not detailed because it's not a data-driven AI/ML diagnostic product. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device does not use human experts to establish "ground truth" for a diagnostic "test set" in the way an AI/ML imaging device would. Ground truth for an infusion pump's performance is typically established by engineering measurement standards and physical verification methods, not expert consensus on medical data. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device. -
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:
Not applicable. This device is an infusion pump with safety software, not an AI-assisted diagnostic or interpretation tool that augments human readers. Its purpose is to "reduce operator interaction through guided programming... to reduce pump programming errors," which implies improved safety and efficiency, but not through a "reader" study. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "Dose IQ Safety Software" is part of the "Spectrum IQ Infusion System," which is a physical medical device (an infusion pump). It's inherently a human-in-the-loop device where clinicians interact with it for programming and administration. Its software functionality is integral to the pump's operation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Ground truth for an infusion pump's performance is based on engineering specifications, physical measurements (e.g., volume delivered over time, pressure readings, temperature, electrical parameters), and adherence to recognized industry standards (e.g., IEC 60601-1-8 for alarms). It's not based on expert consensus on clinical findings, pathology, or patient outcomes for diagnostic purposes. -
The sample size for the training set:
Not applicable. This is not an AI/ML device trained on a "dataset." The software is designed and validated against functional requirements and safety standards, not "trained" on a dataset in the machine learning sense. The "training set" for software development would typically be the iterative development and testing cycles against specifications. -
How the ground truth for the training set was established:
Not applicable, as there isn't a "training set" in the AI/ML context. Ground truth in this engineering context is established by design specifications derived from medical necessity, regulatory requirements, and established physical principles.
In conclusion, the provided FDA clearance letter details the regulatory approval of an infusion pump. While it includes "Dose IQ Safety Software," this software is focused on guided programming and error reduction (likely via a drug library and limits), not on AI/ML-driven diagnostics where the detailed validation criteria you've asked for would apply. The "study" referenced is non-clinical testing against performance and safety requirements, not a clinical trial or AI model validation study.
FDA 510(k) Clearance Letter - Spectrum IQ Infusion System with Dose IQ Safety Software
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 28, 2025
Baxter Healthcare Corporation
Jessica Andreshak
Senior Manager, Regulatory Affairs
One Baxter Parkway
Deerfield, Illinois 60015
Re: K251636
Trade/Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: FRN, PHC
Dated: May 29, 2025
Received: May 29, 2025
Dear Jessica Andreshak:
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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K251636 - Jessica Andreshak Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K251636 - Jessica Andreshak Page 3
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D.
Assistant Director, Infusion Devices
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251636
Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software
Indications for Use (Describe)
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 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.
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 IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 5
510(k) Summary
Date: July 14, 2025
Owner: Baxter Healthcare Corporation
711 Park Avenue
Medina, New York 14103
Registration No: 1314492
Contact: Jessica Andreshak
Sr. Manager, Regulatory Affairs
25212 W. Illinois Route 120
Round Lake, IL 60073
Telephone: (262) 716-3028
Jessica_Andreshak@Baxter.com
Trade / Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software
Classification Panel: 80 General Hospital
Regulation Name: Pump, Infusion
Regulation Number: 21 CFR 880.5725
Regulatory Class: Class II
Product Code: FRN
Assoc. Product Code: PHC
Predicate Device: The subject device is substantially equivalent to the following predicate device:
- Spectrum IQ Infusion System with Dose IQ Safety Software; cleared March 31, 2023 (K230041).
Device Description: Spectrum IQ is a large volume pump within the Spectrum IQ infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address
Page 6
specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.
The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood and blood products through administration sets at clinician's selectable rates and volumes.
The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.
Dose IQ is a standalone software application installed on a hospital-provided computing platform and used to create a drug library file. Dose IQ facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file includes customers' dosing limits and additional pump configuration settings. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.
This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023.
Intended Use / Indications for Use:
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
Page 7
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 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.
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 IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.
Technological Characteristics:
The subject device is substantially equivalent to the primary predicate device (K230041) with regards to design, performance and intended use. The following table provides a comparison summary of the technical characteristics of each device.
| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| Spectrum IQ Infusion System | ||
| Pumping Mechanism | Linear peristaltic design | Linear peristaltic design |
| Modes of Delivery | Continuous, Intermittent | Continuous, Intermittent |
| Routes of Administration | • Intravenous• Arterial• Subcutaneous• Epidural | • Intravenous• Arterial• Subcutaneous• Epidural |
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| User Interface Display | Color LCD | Color LCD |
| AC Power | • Input: 100-240 VAC, 50 / 60 Hz / 300 mA Max• Output: 9 VDC/1000 mA, short circuit protected | • Input: 100-240 VAC, 50 / 60 Hz / 300 mA Max• Output: 9 VDC/1000 mA, short circuit protected |
| Operational Conditions | With 802.11a/b/g/n WBM• Operating temperature: 15.6 to 32.2°C (60 to 90°F), 20 to 90% relative humidity non-condensing.• Atmospheric Pressure: 66kPa to 102kPa | With 802.11a/b/g/n WBM• Operating temperature: 15.6 to 32.2°C (60 to 90°F), 20 to 90% relative humidity non-condensing.• Atmospheric Pressure: 66kPa to 102kPa |
| Storage and Packing Conditions | With Wireless Battery Module• Storage temperature: -10 to +35°C (14 to 95°F), 10 to 90% relative humidity non-condensing | With Wireless Battery Module• Storage temperature: -10 to +35°C (14 to 95°F), 10 to 90% relative humidity non-condensing |
| Overall Size (Pump) | With Wireless Battery Module:• Without IV pole clamp - 8.0"h x 5.7"w x 3.6"d• With standard IV pole clamp - 8.0"h x 8.2"w x 5.9"d | With Wireless Battery Module:• Without IV pole clamp - 8.0"h x 5.7"w x 3.6"d• With standard IV pole clamp - 8.0"h x 8.2"w x 5.9"d |
| Weight (Pump) | Pump alone (no WBM or pole clamp) = 861.97gPump with Wireless Battery Module• Without IV pole clamp: 1.235 kg (45.6 oz ± 1.0 oz)• With IV pole clamp: 1.462 kg (51.6 oz ±1.0 oz) | Pump alone (no WBM or pole clamp) = 861.97gPump with Wireless Battery Module• Without IV pole clamp: 1.235 kg (45.6 oz ± 1.0 oz)• With IV pole clamp: 1.462 kg (51.6 oz ±1.0 oz) |
| Timekeeping | Real Time Clock, battery backed, 7-year life | Real Time Clock, battery backed, 7-year life |
| Logging Memory | Yes | Yes |
| Single Fault Condition | A maximum bolus of 0.56 mL may be generated as a result of a Single Fault Condition (a failure of the Spectrum IQ Infusion System, which stops the pump motor and results in an alarm) | A maximum bolus of 0.56 mL may be generated as a result of a Single Fault Condition (a failure of the Spectrum IQ Infusion System, which stops the pump motor and results in an alarm) |
| Anti-Free Flow System | Set-based, utilizing IV set slide clamp | Set-based, utilizing IV set slide clamp |
| Auto-programming | Yes | Yes |
| Battery Weight | Wireless Battery Module = 155.19g | Wireless Battery Module = 155.19g |
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| Battery Power | 802.11 a/b/g/n Wireless Battery Module• Lithium Ion, minimum 1700 mA/h, 7.4 VDC nominal• 16 hour recharge time• Charging occurs if AC Power Adaptor is plugged in, whether pump is ON or OFF | 802.11 a/b/g/n Wireless Battery Module• Lithium Ion, minimum 1700 mA/h, 7.4 VDC nominal• 16 hour recharge time• Charging occurs if AC Power Adaptor is plugged in, whether pump is ON or OFF |
| Battery Capacity | • Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hours (at 125 mL/hr at the highest backlight settings)• Capacity 3.1 hrs (at 999 mL/hr at highest backlight setting on and WiFi on) | • Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hours (at 125 mL/hr at the highest backlight settings)• Capacity 3.1 hrs (at 999 mL/hr at highest backlight setting on and WiFi on) |
| Alarms | Per IEC 60601-1-8 | Per IEC 60601-1-8 |
| Alarm Volume | Variable (three levels: high, medium and low) | Variable (three levels: high, medium and low) |
| Air-In-Line Alarm | Dual-beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass.• Detects air bubbles >2.5 cm (>1 in) (approximately 140 μL in Baxter sets)• Detects >1 mL of accumulated air over 15 min., excluding <10 μL bubbles, at room temperature• Detects >1.5 mL of accumulated air over 15 min., excluding <10 μL bubbles, at 15.5°C (60°F)NOTE: Air bubbles >= 50 μL are counted towards accumulated air. Air bubbles < 10 μL are excluded towards accumulated air. When detected, air bubbles < 50 μL and > 10 μL are counted as 50 μL towards accumulated air. This algorithm was tested using 35 μL air bubbles. | Dual-beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass.• Detects air bubbles >2.5 cm (>1 in) (approximately 140 μL in Baxter sets)• Detects >1 mL of accumulated air over 15 min., excluding <10 μL bubbles, at room temperature• Detects >1.5 mL of accumulated air over 15 min., excluding <10 μL bubbles, at 15.5°C (60°F)NOTE: Air bubbles >= 50 μL are counted towards accumulated air. Air bubbles < 10 μL are excluded towards accumulated air. When detected, air bubbles < 50 μL and > 10 μL are counted as 50 μL towards accumulated air. This algorithm was tested using 35 μL air bubbles. |
| Downstream Occlusion Alarms | When the Downstream Occlusion Automatic Restart is enabled, automatic restart occurs after the downstream occlusion is cleared. Actuation can be set to:• Low, 41 kPa ±27 kPa (6 ±4 psi) | When the Downstream Occlusion Automatic Restart is enabled, automatic restart occurs after the downstream occlusion is cleared. Actuation can be set to:• Low, 41 kPa ±27 kPa (6 ±4 psi) |
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| • Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi) | • Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi) | |
| Upstream Occlusion Time to Alarm | Time to detect USO is dependent on occlusion distance and flow rate. Time to detection for an USO 50.8 cm (20 in.) from the top of the pump at nominal temperature of 22.2°C±1.1°C (72°F±2°F) is as follows: | Time to detect USO is dependent on occlusion distance and flow rate. Time to detection for an USO 50.8 cm (20 in.) from the top of the pump at nominal temperature of 22.2°C±1.1°C (72°F±2°F) is as follows: |
| Low Battery Alarm | Very Low Battery: ≤15 minutes of battery power remaining | Very Low Battery: ≤15 minutes of battery power remaining |
| Due for Inspection Alarm | Due for inspection: Preventive Maintenance and/or Network Certification | Due for inspection: Preventive Maintenance and/or Network Certification |
| Infusion Modes | Continuous (Primary and Secondary), Multi-Step, Cyclic TPN, Amount/Time (Primary/Secondary) and Volume/Time | Continuous (Primary and Secondary), Multi-Step, Cyclic TPN, Amount/Time (Primary/Secondary) and Volume/Time |
| Dose Modes - Continuous Infusion | 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, mUnits/min, mUnits/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr | 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, mUnits/min, mUnits/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr |
| Dose Modes – Loading Dose and Bolus | mL, mL/kg, g, g/kg, mg, mg/kg, mcg, mcg/kg, ng, ng/kg, Units, Units/kg, mUnits, mUnits/kg, mEq, mEq/kg, mmol, mmol/kg | mL, mL/kg, g, g/kg, mg, mg/kg, mcg, mcg/kg, ng, ng/kg, Units, Units/kg, mUnits, mUnits/kg, mEq, mEq/kg, mmol, mmol/kg |
| Dose Modes – Amount/Time Infusions | mL, mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2, mcg, mcg/kg, mcg/m2, Units, Units/kg, Units/m2, mEq, mEq/kg, mmol, mmol/kg | mL, mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2, mcg, mcg/kg, mcg/m2, Units, Units/kg, Units/m2, mEq, mEq/kg, mmol, mmol/kg |
| Flow Rate | 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 | 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 |
| Low-Flow Continuity | • The maximum period of no-flow is 90 seconds at a flow rate of 0.5 mL/hr. | • The maximum period of no-flow is 90 seconds at a flow rate of 0.5 mL/hr. |
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| • The maximum period of no-flow is 90 seconds with a bolus volume that does not exceed 15 μL over a 5 second sample volume interval at a flow rate of 0.5-1.0 mL/hr inclusive. | • The maximum period of no-flow is 90 seconds with a bolus volume that does not exceed 15 μL over a 5 second sample volume interval at a flow rate of 0.5-1.0 mL/hr inclusive. | |
| Keep Vein Open (KVO) Rate | Yes | Yes |
| Occlusion Pressure | User adjustable downstream occlusion pressure settings:• High (19 ±9 PSI)• Medium (13 ±6 PSI)• Low (6 ±4 PSI)Maximum allowable pressure while in downstream occlusion:• 207 kPa (30 psi) | User adjustable downstream occlusion pressure settings:• High (19 ±9 PSI)• Medium (13 ±6 PSI)• Low (6 ±4 PSI)Maximum allowable pressure while in downstream occlusion:• 207 kPa (30 psi) |
| Bolus Capability | Yes | Yes |
| Bolus Volume Accuracy | Bolus Volume with DEHP Administration SetsBolus Volume with N-DEHP Administration Sets | Bolus Volume with DEHP Administration SetsBolus Volume with N-DEHP Administration Sets |
| Volumetric Accuracy (DEHP) | Accuracy is based on volume collected over one hour using compatible Baxter (DEHP) Standard IV Sets.Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F. | Accuracy is based on volume collected over one hour using compatible Baxter (DEHP) Standard IV Sets.Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F. |
| Volumetric Accuracy (Non-DEHP) | Accuracy is based on volume collected over one hour using compatible Baxter non-DEHP Standard IV Sets. | Accuracy is based on volume collected over one hour using compatible Baxter non-DEHP Standard IV Sets. |
| Rate | Accuracy | Tubing use |
|---|---|---|
| 0.5 – 1.9 mL/hr | ±0.1 mL/hr | ≤ 4 hrs |
| 2.0 – 999 mL/hr | ±5% | ≤ 4 hrs |
Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F.
Accuracy is based on volume collected over one hour using compatible Baxter non-DEHP Standard IV Sets.
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| Rate or Dose Limits | 0.5 – 999 mL/hr | 0.5 – 999 mL/hr |
| Wireless Capability | Yes | Yes |
| Wireless Security | WPA/WPA2/802.11i• Encryption: TKIP, CCMP (AES), Mixed-Mode (AES+TKIP)• Wireless Security: WPA-PSK, WPA2-PSK• 802.1X authentication: PEAP/MSCHAPv2; EAP-FAST; EAP-TLS; EAP-TTLS/PAP; EAP-TTLS/MSCHAPv2 | WPA/WPA2/802.11i• Encryption: TKIP, CCMP (AES), Mixed-Mode (AES+TKIP)• Wireless Security: WPA-PSK, WPA2-PSK• 802.1X authentication: PEAP/MSCHAPv2; EAP-FAST; EAP-TLS; EAP-TTLS/PAP; EAP-TTLS/MSCHAPv2 |
| Dose IQ Safety Software | ||
| Drug Library Capacity | • Number of Care Areas: 32• Number of Drugs: 5000• Number of Clinical Advisories: 400• Number of Modifiers: 500 | • Number of Care Areas: 32• Number of Drugs: 5000• Number of Clinical Advisories: 400• Number of Modifiers: 500 |
| Available Limits | • Upper Hard Limit must be greater than or equal to Upper Soft Limit.• 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.• 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• All Rates and Drug Library Limits must fall within Spectrum Pump operational range of 0.5 to 999 mL/hr. | • Upper Hard Limit must be greater than or equal to Upper Soft Limit.• 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.• 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• All Rates and Drug Library Limits must fall within Spectrum Pump operational range of 0.5 to 999 mL/hr. |
| Security Roles | • Read-Only Access• Limited Access• Full Access | • Read-Only Access• Limited Access• Full Access |
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| Characteristic | Subject Device | Predicate Device (K230041) |
|---|---|---|
| Reports | • Standard and custom Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc.• Audit reports for a list of changes made to the Drug Library along with the date the change was performed | • Standard and custom Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc.• Audit reports for a list of changes made to the Drug Library along with the date the change was performed |
| Gateway | • CareEverywhere Gateway Version 16 and higher.• IQ Enterprise Infusion Gateway V3.0.1 and higher. | • CareEverywhere Gateway Version 16 and higher. |
Summary of Testing: Non-clinical testing has been executed against requirements for performance and safety, and to provide objective evidence that the subject device's intended use is met. Testing compared the subject device to a previous version of the subject device (K173084). Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use.
Conclusion: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Spectrum IQ Infusion System with Dose IQ Safety Software is substantially equivalent to the Spectrum IQ Infusion System with Dose IQ Safety Software cleared under K230041 with respect to the indications for use, target populations, treatment method, and technological characteristics.
§ 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).