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The COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components.
The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes.
The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback infusion modes.

The COLLEAGUE pump can be used in the following care areas:

• General Floor of the Hospital
• Critical / Intensive Care
• Neonatal Intensive Care
• Pediatric Care
• Labor / Delivery / Postpartum
• Operating Room / Anesthesia
• Post Anesthesia / Recovery
• Cardiac Catheterization Lab
• Emergency Room
• Ground Ambulance
• Hospice Facility
• Outpatient / Subacute Facilities
• Nursing Facilities
• Long Term Care / Rehabilitation Facilities
• Diagnostic Nuclear Medicine
• Oncology Floor
• Burn Unit / Trauma

The COLLEAGUE Volumetric Infusion Pump product is a software controlled, electromechanical, large volumetric infusion pump that includes either one or three infusion channels. The COLLEAGUE Volumetric Infusion Pump product provides the necessary infusion therapy modes to deliver medications and solutions through a Baxter standard administration set. The pump uses a shuttle pumping mechanism to achieve flow. None of the pump device materials come in contact with the solution path.

The COLLEAGUE Volumetric Infusion Pump is designed to accept Baxter standard administration sets equipped with keyed slide clamps that are labeled as being COLLEAGUE pump compatible. The unidirectional slide clamp helps ensure proper set loading. The pump will accept a variety of currently marketed solution containers including flexible containers, glass bottles, and syringes (with an accessory adapter).

The pump is intended to operate primarily on AC power and is equipped with a rechargeable battery to facilitate use during transport.

The COLLEAGUE GUARDIAN feature is a configurable option that helps to reduce the potential for medication programming errors by allowing program limits to be predefined for labels in the pump's label library, including custom labels, based on hospital or care area protocols.

The COLLEAGUE GUARDIAN feature (Monochrome and CX devices) is available for dose mode programming only. The COLLEAGUE GUARDIAN feature allows the facility to set up labels for programming standard concentrations of a dose mode infusion.

The COLLEAGUE Enhanced GUARDIAN feature (CXE devices) is a configurable option that is available for both rate/volume and dose mode programming. The COLLEAGUE Enhanced GUARDIAN feature allows the facility to set up labels set up for programming nonstandard concentrations of a dose mode infusion (modifying the Drug Amount, Diluent Volume and/or Concentration from the default.

The COLLEAGUE Volumetric Infusion Pump supports the use of a proprietary software accessory; COLLEAGUE GUARDIAN Configuration Tool. The configuration tool supports the creation and maintenance of Personalities (custom feature set for individual care area or for specific therapies), as well as the clinical labels and parameters established by the hospital using the COLLEAGUE GUARDIAN dose error reduction software. This software accessory is not required to operate the pump.

The COLLEAGUE Volumetric Infusion Pump also supports the use of proprietary software accessory: COLLEAGUE DL2 Event History Download Software Application. The COLLEAGUE DL2 Event History Download Software Application is a service application that downloads the event history log. This software accessory is not required to operate the pump.

The COLLEAGUE Volumetric Infusion Pump has the ability to communicate externally via a data communications interface.

Here's an analysis of the provided text regarding the COLLEAGUE Volumetric Infusion Pump, focusing on acceptance criteria and supporting studies:

A. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing numerical acceptance criteria for performance metrics (e.g., flow rate accuracy, pressure limits, alarm response times) alongside reported device performance. Instead, it offers a more general statement:

B. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for any "test set" in the context of typical clinical or AI model validation studies. The testing described is "Non-clinical testing associated with compliance and safety software, and intended use claims."

• Sample Size: Not explicitly stated in terms of a numerical count of patients, cases, or specific test scenarios.
• Data Provenance: The document states that "Human Factors evaluation and use scenario testing was performed under simulated use and environmental conditions utilizing clinical care personnel from hospital environments." This implies a prospective, simulated environment with real clinical users, but it doesn't specify countries of origin for hospitals or personnel.

C. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The concept of "ground truth" as typically defined in AI/ML studies (e.g., expert labels on images) is not directly applicable here. The "ground truth" for the performance of an infusion pump would be its adherence to engineering specifications, safety standards, and intended functional behavior.

• Number of Experts: Not specified. The testing involved "clinical care personnel from hospital environments" during Human Factors evaluation and use scenario testing. These personnel would serve as experts in the operational context of the device, validating its usability and functional aspects, rather than establishing diagnostic ground truth in an AI sense.
• Qualifications of Experts: Described as "clinical care personnel from hospital environments." Specific qualifications (e.g., years of experience, specialty) are not detailed.

D. Adjudication Method for the Test Set

Again, the concept of adjudication in the context of expert consensus for ground truth (common in AI/ML) does not directly apply here. The document states that "All tests successfully passed the acceptance criteria," suggesting a pass/fail outcome based on pre-defined engineering and safety standards, rather than an adjudication process between conflicting expert opinions on data labels.

• Adjudication Method: Not applicable in the traditional sense of expert adjudication for data labeling. The acceptance of test results would be based on exceeding or meeting pre-defined performance thresholds.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No, a traditional MRMC comparative effectiveness study, common for evaluating human reader performance with and without AI assistance, was not performed or mentioned.
• Effect Size: Not applicable, as no MRMC study was conducted.

F. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done?: Yes, the primary testing described is "Non-clinical testing associated with compliance and safety software, and intended use claims." This refers to the standalone performance of the device's hardware and software against specifications. The "Human Factors evaluation and use scenario testing" also implicitly assesses the device's standalone functionality in a simulated user environment. The "COLLEAGUE GUARDIAN" and "COLLEAGUE Enhanced GUARDIAN" features are software functionalities whose performance would be tested in a standalone manner against their design requirements to reduce programming errors.

G. The Type of Ground Truth Used

The "ground truth" for this medical device (an infusion pump) is rooted in:

• Engineering Specifications: Adherence to defined parameters for flow rate accuracy, pressure monitoring, alarm functionality, battery life, etc.
• Safety Standards: Compliance with relevant national and international safety standards for medical devices.
• User Needs and Intended Uses: Validation that the device fulfills its defined clinical functions and usability requirements in the specified care environments for various patient populations and types of infusions.
• Predicate Device Equivalence: The ultimate ground truth being established is that the modified device performs "as well as or better than the predicate COLLEAGUE Volumetric Infusion Pump."

H. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning models. While the COLLEAGUE Volumetric Infusion Pump does contain software, the description does not indicate that it employs a machine learning algorithm that requires a distinct "training set" in the modern AI sense. The software functions (like GUARDIAN) are rule-based or pre-programmed to enforce limits and protocols.

• Sample Size for Training Set: Not applicable/not mentioned, as the device doesn't appear to use machine learning requiring a training phase for its core functionality.

I. How the Ground Truth for the Training Set Was Established

Since there is no mention of a machine learning training set, the establishment of "ground truth" for it is not applicable. The integrity of the pump's software (including the Guardian features) would be established through a rigorous Software Development Life Cycle (SDLC), including requirements definition, design verification, unit testing, integration testing, and validation, rather than typical AI model training with labeled data.

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Baxter Colleague Infusion Pumps are designed to meet the fluid delivery requirements of clinically acceptable routes of administration in a variety of clinical environments. These pumps can be utilized for continuous or intermittent delivery of solutions and or irrigation of fluid spaces applications.

Fluid delivery applications include:

• parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, analgesics, or chemotherapy);
• solutions for irrigation procedures, etc.; and
• whole blood and blood products.

Colleague Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to:

• A Hospital:
  • General Floor
  • · Medical/Surgical
  • · Critical/Intensive Care Areas
  • · Pediatrics/Neonatal
  • · Labor/Delivery/Post Partum
  • · OR/Anesthesia
• · Post Anesthesia/Recovery · P
• Cardiac Cath Lab
• · Emergency Room
• · Burn/Trauma Units
• Mobile Intensive Care A Nursing Homes A
  • Homecare* A

· Oncology

• *Colleague and Colleague CX pumps only.
• Blood Centers
• Nuclear Medicine A
• Hospice A
• Subacute Facilities A
• Outpatient/Surgical Centers A
• Long Term Care A

Colleague pumps use a shuttle and valve control system mechanism to provide accurate, continuous infusions. Colleague provides continuous infusion and combined modes of operation. The pumps have configurable input parameters, which allow institutions to pre-select which modes of operation will be available to users and which units of measure will be used for data entry. Baxter Healthcare proposes to modify the Colleague family of infusion pumps with the addition of new software features to expand the Colleague Guardian feature and to further enhance the safety of the device.

The provided text is a 510(k) summary for an infusion pump, which discusses its intended use, device description, and comparison to predicate devices, along with an FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving device effectiveness.

The document specifically states under the "Performance Data" section: "The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices." However, it does not provide the actual performance data or the specific requirements (acceptance criteria) that were met.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The requested information regarding a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth information is not present in the provided 510(k) summary.

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Ask a specific question about this device