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 and increase accuracy of infusion documentation.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

Device Description

The proposed device, Spectrum IO Infusion System with Dose IO Safety Software is a large volume infusion system that provides safe and effective 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 infusion of 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.

AI/ML Overview

This document is a 510(k) summary for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230041). It references a previous 510(k) notification (K222048) for the Spectrum IQ Infusion System with Dose IQ Safety Software as the predicate device.

The provided text focuses on the K230041 submission, which specifically addresses an update to the algorithm and labeling related to the upstream occlusion alarm of the pump. It states that performance testing for the software was completed for this update.

However, the document does not provide detailed information about acceptance criteria or specific study results for this particular update. It primarily asserts substantial equivalence to the predicate device and mentions that the scope of the notification is limited to the occlusion alarm update.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for the occlusion alarm algorithm validation are not present in the provided text. The information below is limited to what can be inferred or directly stated from the provided document, acknowledging the significant gaps.

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance for the updated upstream occlusion alarm algorithm. It only mentions that "Performance testing for the software was completed" for this update. Without the actual test plan or report, these details cannot be provided.

Acceptance Criteria (Inferred from general device purpose)	Reported Device Performance (Not explicitly detailed for occlusion alarm update)
Ability to detect upstream occlusion events	Performance testing was completed. (Specific metrics not provided)
Alarm activation within acceptable timeframes	Not detailed.
Avoidance of false positive alarms	Not detailed.
Overall safe and effective delivery of fluids, as identified in 21 CFR 880.5725	The device is deemed substantially equivalent, implying it meets overall safety and effectiveness.
Reduction of pump programming errors and increased accuracy of infusion documentation (from Indications for Use)	Addressed by the Dose IQ Safety Software; not specifically evaluated for occlusion alarm update in this document.

Study Information (Specific to the upstream occlusion alarm algorithm update)

Sample size used for the test set and the data provenance:
- Not specified. The document states "Performance testing for the software was completed" but does not give details on the size or nature of the test set used for the occlusion alarm algorithm.
- Data provenance: Not specified. It's likely internal testing data, but the origin (e.g., country, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given it's a software/algorithm update for an occlusion alarm, ground truth would likely be established through controlled experimental setups (e.g., intentionally inducing occlusions) rather than expert review of clinical cases.
Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like "2+1" are typically for subjective assessments (e.g., image interpretation). For a technical alarm system like an occlusion detector, the "ground truth" is objectively verifiable (e.g., physical presence of an occlusion).
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. An MRMC study is not relevant here. This device is an infusion pump with a safety algorithm, not an AI diagnostic tool requiring human interpretation. The "AI" (algorithm) in this context is automating a safety function, not assisting human "readers" with diagnostic tasks.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Likely yes by implication, but not explicitly stated. The "performance testing for the software" would typically involve evaluating the algorithm's ability to detect occlusions in a controlled environment as a standalone component of the pump's safety system. The entire pump system, which includes the algorithm, operates primarily in a standalone manner to detect occlusions and trigger alarms, though a human operator would then respond to the alarm.
The type of ground truth used:
- Not specified, but likely objective, empirical truth. For an occlusion alarm, ground truth would be established by physically creating true occlusion events (and non-occlusion conditions) in a laboratory or simulated environment and measuring the algorithm's response. This is an objective "engineering" ground truth, not pathology, expert consensus, or outcomes data in the traditional sense.
The sample size for the training set:
- Not specified. There's no mention of a training set or machine learning model in the context of this specific occlusion alarm algorithm update. It might be a rule-based or signal-processing algorithm rather than a machine learning algorithm requiring a distinct training set. If it is a machine learning algorithm, the training set size is not provided.
How the ground truth for the training set was established:
- Not specified. Due to the lack of information on a training set or its nature.

Summary

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March 31, 2023

Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, Illinois 60073

Re: K230041

Trade/Device Name: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: December 21, 2022 Received: January 4, 2023

Dear Meaghan Bonn:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 -S

Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230041

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 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 be used by trained healthcare professionals.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5. 510(k) Summary

FEBRUARY 6, 2023

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Meaghan Bonn Principal Specialist, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224)270-6470 Fax: (224)270-4119

IDENTIFICATION OF THE DEVICE:

Common Name: Infusion Pump Trade/Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC

Table 1. Product Codes for Spectrum IQ Infusion System with Dose IQ Safety Software

Code Number	Name
3570009	Spectrum IQ Infusion System
35723v091	Dose IQ Safety Software

PREDICATE DEVICE:

The Spectrum IQ Infusion System with Dose IQ Safety Software is substantially equivalent to the following predicate device: See Table 2 for predicate device.

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Device	Company	Predicate 510(k)	Clearance Date
Spectrum IQ InfusionSystem with Dose IQSafety Software	Baxter HealthcareCorporation	K222048	2022-09-06

Table 2. Predicate Device(s)

DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

The Spectrum IO Infusion System with Dose IO 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 be used by trained healthcare professionals.

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The intended use and function of the proposed device remains the same as the predicate device. The 510(k) premarket notification, K222048, of the predicate device was cleared on September 6, 2022.

DISCUSSION OF NONCLINICAL TESTS:

The scope of this notification is to update the algorithm and labeling related to the upstream occlusion alarm of the pump. Performance testing for the software was completed. Biocompatibility is not affected by this notification. The intended use and function of the proposed device is the same as the predicate device.

CONCLUSION:

The scope of this notification is to update the algorithm and labeling related to the upstream occlusion alarm of the pump per the performance testing. The intended use and function of the proposed device is equivalent to the predicate 510(k), currently commercialized device.

Regulation Number and Section

§ 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).