(145 days)
Not Found
No
The summary describes a standard infusion pump with a Master Drug Library for guided programming and error reduction, but there is no mention of AI or ML algorithms being used for decision-making, pattern recognition, or adaptive control. The "guided programming" appears to be based on pre-programmed drug libraries and limits.
Yes
The device is described as administering "pharmaceutical drugs, blood, blood products and mixtures of required patient therapy," directly supporting patient treatment.
No
The device is an infusion pump designed for controlled administration of fluids and drugs, 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 significant hardware components beyond just software. While it includes a software application (MDL Editor), the core medical device is a physical infusion pump.
Based on the provided information, 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, and blood products, directly into a patient. This is an in vivo (within a living organism) application, not an in vitro (in glass or outside the body) diagnostic test.
- Device Description: The description details a mechanical pump that propels fluid through administration sets into a patient. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Reagents or test kits
The device is a medical device used for delivering therapy, not for performing diagnostic tests on 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.
Indications for Use (Describe)
The Baxter SIGMA Spectrum Infusion Purn with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, 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 administrations 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 (comma separated list FDA assigned to the subject device)
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
Intended User: trained healthcare professionals
Care Setting: 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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library has been performed against requirements for performance, physical attributes, environmental conditions and safety, and to provide objective evidence that the device intended use is met. Verification was performed through bench testing and assured the following requirement attributes were met:
• Functional and Performance
• System Hardware
• Administration Set Compatibility
• Power
• Environmental and Physical
• Reliability
• System Software
o User Interface
o Processing
o Sensors and Alarms
• Network Interface
o Wireless Battery Module
o Serial Communication
• Labeling
• Consensus Standards
o IEC 60601-1 (1988), "Medical Electrical Equipment, Part 1: General Requirements for Safety" with Amendment 1 (1991) and Amendment 2 (1995)
o IEC 60601-1-2:2001, "Medical Electrical Equipment-Part 1-2 Edition 2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests with Amendment 1 (2004), Section 36, Deviation per IEC 60601-2-24:1998
o UL 60601-1 (2003), 1st Edition "Medical Electrical Equipment, Part 1: General Requirements for Safety"
o CAN/CSA C22.2 No 601.1-M90 (1990), "Medical Electrical Equipment, Part 1: General Requirements for Safety"
- IEC 60601-2-24 (1998), "Medical Electrical Equipment Part 2-24: Particular Requirements for the Safety of Infusion Pumps and Controllers"
- . Master Drug Library
In addition to the above, and in consideration of IEC 62366:2007. Medical devices -- Application of usability engineering to medical devices", Baxter conducted a Human Factors evaluation in a simulated environment to ensure that use of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library would not exhibit use errors that are greater than minimal risk. User needs and intended uses were evaluated through clinical assessment of use, industry literature, labeling evaluation and blood and blood component testing.
Lastly, in complying with the requirements in FDA draft guidance, "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] April 23, 2010", Baxter has developed a Safety Assurance Case to demonstrate that hazardous situations resulting from the design, intended use and reasonably foreseeable misuse of the device have been appropriately mitigated.
Non-clinical testing of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library met all acceptance criteria, demonstrating that the device is safe and effective for its intended use.
No clinical testing was performed in support of this premarket Assessment of Clinical Testing 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
Traditional 5 I0(k) Premarket Notification
Baxter SIGMA Spectrum Infusion Pump with MDL
、
Page 1 of 12 Section 5-510(k) Summary
| 510(K) SUMMARY | K133801 |
|---|---|
| Date: | May 6, 2014 |
| Contact: | Baxter Healthcare Corporation |
| 711 Park Avenue | |
| Medina, New York 14103 | |
| Registration No: 1314492 | |
| Thomas Sampogna | |
| Sr. Director, Regulatory Affairs | |
| Phone: 224-270-4307 | |
| Fax: 847-786-5116 | |
| Email: thomas_sampogna@baxter.com | |
| Trade Name: | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library |
| Model 35700 | |
| Common Name: | Infusion Pump |
| Classification Name: | Pump, Infusion |
| Classification: | Infusion Pump as defined in 21 CFR 880.5725, Class II |
| Product Code: | FRN, PHC |
| Predicate Device: | The Baxter SIGMA Spectrum Infusion Pump with Master Drug |
| Library is substantially equivalent to the following predicate | |
| device: | |
| SIGMA Spectrum and Spectrum with Master Drug Library, | |
| cleared Aug. 26, 2004 (K042121). | |
| 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. |
1
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.
2
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..
| Intended Use/
Indication 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. |
| Technological
Characteristics: | The Baxter SIGMA Spectrum Infusion Pump with Master Drug
Library is substantially equivalent to the predicate device with
regards to design, performance and intended use. The following
provides a comparison summary of the technical characteristics of |
| Characteristic | Proposed Device | Predicate Device (K042121 |
|---|---|---|
| Baxter SIGMA Spectrum Infusion Pump | ||
| Pump Type | Linear peristaltic pump | Linear peristaltic pump |
| Routes of | ||
| Administration | • Intravenous | |
| • Arterial | ||
| • Subcutaneous | ||
| • Epidural | ||
| • Irrigation of fluid space | • Intravenous | |
| • Arterial | ||
| • Subcutaneous | ||
| • Epidural | ||
| • Irrigation of fluid space | ||
| • Intrathecal | ||
| Characteristic | Proposed Device | Predicate Device (K042121) |
| AC Power | Input: 120VAC, 60 Hz / 300 mA | |
| Output (Power Adapter P/N | ||
| 35727): 9VDC/1200 mA, | Input: 100VAC - 240VAC, 50- | |
| 60 Hz / 200 mA | ||
| Output (Power Adapter P/N | ||
| 35714): 9VDC/800 mA | ||
| Alarm Volume | Variable at three levels: high, | |
| medium and low | Variable at three levels: high, | |
| medium and low | ||
| 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 5/8", alarm if >1 ml over 15 | ||
| minutes, Prescription Use (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. Chapman |
| Date: 2014.05.06 17:00:22 -04'00' |
FORM FDA 3881 (1/14)
shing Services (301) 443-6740
15
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