(224 days)
Not Found
No
The summary describes software for managing drug libraries and automating parameter population based on EMR data, but it does not mention any AI or ML techniques being used for these functions. The focus is on guided programming and preprogrammed profiles.
Yes.
Explanation: The device is intended for the controlled administration of fluids, including pharmaceutical drugs, blood, and blood products, which indicates its use in medical treatment and therapy.
No
This device is an infusion system that administers fluids and medications to patients. It does not perform any diagnostic functions.
No
The device description explicitly states that the system includes a "software controlled, electromechanical pump" and a "feedback-controlled, motorized pumping mechanism." While it also includes software (Dose IQ Safety Software), the core functionality relies on physical hardware for fluid delivery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled administration of fluids," including pharmaceutical drugs, blood, and blood products, through various routes (intravenous, arterial, subcutaneous, or epidural). This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose or monitor conditions.
- Device Description: The description details a "large volume infusion pump system" that uses a "software controlled, electromechanical pump" with a "linear peristaltic design" to propel fluids. It also describes software for managing a drug library and automating programming. None of these functions involve analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any components or processes typically associated with IVDs, such as:
- Reagents
- Assays
- Sample collection or preparation
- Analysis of biological samples (blood, urine, tissue, etc.)
- Measurement of analytes or biomarkers
The device is clearly designed for therapeutic delivery, not diagnostic testing.
N/A
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 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 IO Infusion System with Dose IO 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.
Intended Use
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids.
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, blood products. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, or epidural.
Other Indications for Use
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 is intended to aid in the reduction of pump programming errors.
Product codes (comma separated list FDA assigned to the subject device)
FRN, PHC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, Pediatric, and Neonates
Intended User / Care Setting
Intended User: trained healthcare professionals.
Care Setting: a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing of the Spectrum IQ Infusion System with Dose IQ Safety Software has been verified against requirements for performance, physical attributes, and environmental conditions, and to provide objective evidence that the device intended use is met. Verification was performed through bench testing in the following areas: Central Management Subsystem Testing, Case Works Subsystem Testing, Pumping Subsystem Testing, Power Subsystem Testing, System Level Testing, Software Testing, Reliability Testing, Consensus Standards Testing.
In addition, Baxter conducted a Human Factors evaluation in a simulated environment to ensure that use of the Spectrum IQ Infusion System with Dose IQ Safety Software would not exhibit use errors associated with critical tasks that are greater than the minimal risk. User needs and intended uses were evaluated through simulated testing of use, labeling evaluation, and blood and blood product testing.
Non-Clinical testing of the Spectrum IQ Infusion system with Dose IQ Safety Software met all acceptance criteria, demonstrating that the device is substantially equivalent to the predicate.
No clinical testing was performed in support of this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 11, 2018
Baxter Healthcare Corporation Dhiraj Bizzul Manager, Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073
Re: K173084
Trade/Device Name: Spectrum IQ Infusion System with Dose IQ Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, PHC Dated: April 11, 2018 Received: April 12, 2018
Dear Dhiraj Bizzul:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173084
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 IO Infusion System with Dose IO 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ̄ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the blue text stand out.
Section 5. 510(k) Summary
May 9, 2018
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Dhiraj Bizzul Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-2177 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
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. Baxter Catalog Numbers for Spectrum IQ Infusion System with Dose IQ Safety Software
| Baxter Catalog Number | Name |
|---|---|
| 3570009 | Spectrum IQ Infusion System |
| 35723v090 | Dose IQ Safety Software |
PREDICATE DEVICE:
The Spectrum IQ Infusion System with Dose IQ Safety Software is substantially equivalent to the following predicate device:
4
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Baxter SIGMA | |||
| Spectrum Infusion | |||
| Pump with Master Drug | |||
| Library | Baxter Healthcare | ||
| Corporation | K133801 | May 7, 2014 |
Table 2. Predicate Device
DESCRIPTION OF THE DEVICE:
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
5
Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly italicized, giving the word a sense of movement. The background is plain white, which makes the blue color stand out.
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.
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 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 is intended to aid in the reduction of pump programming errors.
The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Spectrum IQ Infusion System with Dose IO Safety Software is substantially equivalent to the predicate device with regards to design, performance, and intended use. The following provides a comparison summary of technical characteristics.
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| Characteristic | Proposed Device | Predicate Device (K133801) |
|---|---|---|
| Indications for Use | ||
| Intended Use | The Spectrum IQ Infusion | |
| System with Dose IQ Safety | ||
| Software is intended to be used | ||
| for the controlled administration | ||
| of fluids. | Identical to proposed. | |
| 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, | ||
| blood products. | The Baxter SIGMA Spectrum | |
| Infusion Pump with Master Drug | ||
| Library is intended to be used | ||
| for the controlled administration | ||
| of fluids. These may include | ||
| pharmaceutical drugs, blood, | ||
| blood products and mixtures of | ||
| required patient therapy. | ||
| Routes of Administration | The intended routes of | |
| administration consist of the | ||
| following clinically accepted | ||
| routes; intravenous, arterial, | ||
| subcutaneous, or epidural. | The intended routes of | |
| administration consist of the | ||
| following clinically accepted | ||
| routes; intravenous, arterial, | ||
| subcutaneous, epidural or | ||
| irrigation of fluid space. | ||
| Set Usage | 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. | Identical to proposed. | |
| Use Environment | 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. | Identical to proposed. | |
| Other Indications for Use | 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 is | ||
| intended to aid in the reduction | ||
| of pump programming errors. | The Baxter SIGMA Spectrum | |
| infusion pump with Master Drug | ||
| Library is intended to reduce | ||
| operator interaction through | ||
| guided programming, thereby | ||
| helping to reduce errors. |
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| ( | ||
|---|---|---|
| 1 | ||
| r | able | . . |
| Characteristic | Proposed Device | Predicate Device (K133801) |
|---|---|---|
| The Spectrum IQ Infusion | ||
| System with Dose IQ Safety | ||
| Software is intended to be used | ||
| by trained healthcare | ||
| professionals. | Identical to proposed. | |
| Intended Treatment Population | Adults, Pediatric, and Neonates | Identical to proposed |
| Design Attributes | ||
| Pump Software Version | V9.00.01 | V8.00.00 |
| MDL Software Version | V9.0.1 | V8.0.0 |
| Wireless Battery Module | ||
| Software Version | V9 | V8 |
| Pumping Mechanism | Linear peristaltic design | Identical to proposed. |
| Number of Available Models | One (1) | Identical to proposed. |
| Drug Library Transfer | • Wireless transfer from | |
| Personal Computer (PC) | ||
| through network host to | ||
| selected pump(s) using | ||
| wireless battery module | ||
| (802.11 set of standards) | ||
| Wireless infrared signal transfer | ||
| from Personal Computer (PC) to | ||
| the pump through an IrDA | • Wireless transfer from | |
| Personal Computer (PC) | ||
| through network host to | ||
| selected pump(s) using | ||
| wireless battery module | ||
| (802.11 set of standards) | ||
| Wireless infrared signal transfer | ||
| from Personal Computer (PC) to | ||
| a mobile Personal Digital | ||
| Assistant (PDA) and by infrared | ||
| from the PDA to a selected | ||
| pump | ||
| Communication protocols | Proprietary communication | |
| protocol INTCOM and | ||
| EXTCOM version 2.0 | Proprietary communication | |
| protocol INTCOM and | ||
| EXTCOM version 1.0 | ||
| Modes of Delivery | Continuous and Intermittent | Identical to proposed. |
| Features/Functions/Performance Specification | ||
| Spectrum IQ Infusion System | ||
| AC Power | • Input: 100-240VAC, 50- | |
| 60 Hz / 300 mA |
• Output (P/N 30205):
9VDC/1000 mA, short
circuit protected
Cord length 3.0 m ( 9.75 feet) | • Input: 120VAC, 60 Hz /
300 mA
• Output (P/N 35727):
9VDC/1200 mA, short
circuit protected
Cord length - Identical to
proposed |
| Alarm Volume | Variable (three levels: high,
medium and low) | Identical to proposed. |
| Characteristic | Proposed Device | Predicate Device (K133801) |
| Air-In-Line | Air In Line: 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 1.5 mL of accumulated
air over 15 min., excluding