(86 days)
Not Found
No
The summary describes a standard infusion pump with a Master Drug Library for guided programming and error reduction. There is no mention of AI or ML algorithms for decision-making, data analysis, or predictive capabilities. The "guided programming" appears to be based on pre-programmed drug libraries and limits, not adaptive learning.
Yes
The device is intended for the controlled administration of fluids, including pharmaceutical drugs, blood, and blood products, which are used for patient therapy. This direct delivery of substances for treatment aligns with the definition of a therapeutic device.
No
The device is an infusion pump designed for the controlled administration of fluids and medications, not for diagnosing medical conditions.
No
The device description explicitly states it is a "software controlled, electromechanical device" and describes a "feedback-controlled, motorized pumping mechanism," indicating it includes significant hardware components beyond just software.
Based on the provided text, the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "controlled administration of fluids," including pharmaceutical drugs, blood, blood products, and mixtures, through various routes (intravenous, arterial, subcutaneous, epidural, or irrigation). This describes a device used for delivering substances into the patient's body.
- Device Description: The description details a "large volume infusion pump system" that "provides for safe and effective delivery of fluids into a patient." It describes a mechanical pump that propels fluid through administration sets.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any interaction with patient specimens or analysis of biological samples.
The device is a medical device used for administering therapy to a patient, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
Product codes
FRN, PHC
Device Description
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a large volume infusion pump system that provides for safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR, 880.5725. The pump is a software controlled, electromechanical device used for the infusion of pharmaceutical drugs, blood, blood products and mixtures of required patient therapy through administration sets at user selectable rates and volumes. 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 assure safe operation while providing infusion pump capabilities for a wide range of applications.
The pump is specifically manufactured and calibrated for the application of a manufacturer's brand of standard gravity 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 against the outside surface of the administration set tubing. The pump is controlled to create smooth fluid dynamics, precision volumetric accuracy and uniformity of flow rate. None of the pump materials contact the administration set's fluid path.
The infusion pump is small in comparison to the traditional Large Volume Parenteral (LVP) infusion pumps currently on the market. It is designed to be used in a variety of patient care environments such as, but not limited to hospitals and outpatient care areas using an IV pole mounted configuration.
The Master Drug Library (MDL) Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump.
The drug library can be loaded directly into the SIGMA Spectrum infusion pump through a wireless network host or through an Infrared Data Association (IrDA) device. The MDL Editor software operates on a Microsoft Windows® platform.
Using the MDL Editor software application, a facility can provide preprogrammed delivery profiles, advisories and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus reducing the risk of medication errors.
The MDL Editor software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The MDL Editor 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.
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
Not Found
Intended User / Care Setting
trained healthcare professionals / 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
Nonclinical testing for the software was completed, specifically related to updating the algorithm for the upstream occlusion alarm of the pump.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
March 31, 2023
Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake. Illinois 60073
Re: K230022
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Indications for Use (Describe)
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. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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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 and slightly italicized. The word is horizontally oriented and takes up most of the frame.
Section 5. 510(k) Summary
January 4, 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: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library 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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
| Code Number | Name |
|---|---|
| 35700BAX2 | SIGMA Spectrum Infusion System |
| 35723v080 | Master Drug Library |
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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue, sans-serif font. The letters are slightly slanted to the right, giving the word a sense of movement. The word is the logo for Baxter International, a global healthcare company.
PREDICATE DEVICE:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is substantially equivalent to the following predicate device: See Table 2 for predicate device.
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Baxter SIGMA | |||
| Spectrum Infusion | |||
| Pump with Master Drug | |||
| Library | Baxter Healthcare | ||
| Corporation | K133801 | 04/07/2014 |
Table 2. Predicate Device(s)
DESCRIPTION OF THE DEVICE:
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a large volume infusion pump system that provides for safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR, 880.5725. The pump is a software controlled, electromechanical device used for the infusion of pharmaceutical drugs, blood, blood products and mixtures of required patient therapy through administration sets at user selectable rates and volumes. 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 assure safe operation while providing infusion pump capabilities for a wide range of applications.
The pump is specifically manufactured and calibrated for the application of a manufacturer's brand of standard gravity 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 against the outside surface of the administration set tubing. The pump is controlled to create smooth fluid dynamics, precision volumetric accuracy and uniformity of flow rate. None of the pump materials contact the administration set's fluid path.
The infusion pump is small in comparison to the traditional Large Volume Parenteral (LVP) infusion pumps currently on the market. It is designed to be used in a variety of patient care environments such as, but not limited to hospitals and outpatient care areas using an IV pole mounted configuration.
5
Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, slanting slightly to the right. The background is plain white, which makes the blue text stand out.
The Master Drug Library (MDL) Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump.
The drug library can be loaded directly into the SIGMA Spectrum infusion pump through a wireless network host or through an Infrared Data Association (IrDA) device. The MDL Editor software operates on a Microsoft Windows® platform.
Using the MDL Editor software application, a facility can provide preprogrammed delivery profiles, advisories and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus reducing the risk of medication errors.
The MDL Editor software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The MDL Editor 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.
INDICATIONS FOR USE:
The 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, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
6
Image /page/6/Picture/0 description: The image contains the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the primary focus of the image and is positioned horizontally.
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, K133801, of the predicate device was cleared on May 7, 2014.
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.