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The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

The Hospira LifeCare PCA™ Infusion System is a microprocessor controlled, pole mounted, electromechanical infusion pump that allows a patient to self-administer analgesic using an attached patient pendant, within physician prescribed, programmed parameters. The Hospira LifeCare PCA™ Infusion System also includes a sterile empty vial that can be pharmacy-filled with appropriate medications, and dedicated administration sets to administer the medication.
The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient.
The infuser will accept either a pre-filled drug vial manufactured by Hospira or a sterile empty vial that can be filled by a hospital's pharmacy. Administration Sets compatible for use in the LifeCare PCA™ Infuser are provided sterile (fluid path) and intended for single-use application.
The infuser is equipped with wireless (802.11 a/b/g) and wired interfaces to Hospira MedNet™ Software. Drug Libraries and Auto-Programs are transferred using these interfaces. The subject device bi-directionally communicates to the hospital information system through the Hospira MedNet™ Server, which is optional software, and the device can also be programmed and used without the Hospira MedNet™ software.

The provided document is a 510(k) summary for the Hospira LifeCare PCA™ Infusion System. It describes the device, its intended use, and a summary of performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance against those criteria. Instead, it states that system verification and validation activities were conducted and that all testing met the acceptance criteria.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table with specific acceptance criteria and detailed reported device performance for each criterion. It broadly states: "System verification and validation activities for LifeCare PCA™ Infusion System confirmed that the system meets user needs and design inputs. All the testing met the acceptance criteria."

It lists several standards to which the device complies, implying that meeting the requirements of these standards constitutes the acceptance criteria. These standards include:

• Basic Safety and Essential Performance: ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
• Electromagnetic Compatibility: IEC Standard 60601-1-2:2007 3rd Ed.
• Alarm Systems: IEC 60601-1-8, Edition 2.1 2012-11
• Infusion Pump Basic Safety and Essential Performance: IEC 60601-2-24 Medical Electrical Equipment – Part- Edition 2.0 2012-10
• Biocompatibility: ISO 10993-1:2009 (Corrigendum 2010) and FDA Draft Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April 2013

Without specific performance values against each standard's criteria, a table cannot be fully constructed from this document. The document only confirms that the device met these criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes for any test sets used in performance testing. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The reported data relates to non-clinical performance and human factors evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided. The testing described is for an infusion pump, focusing on engineering performance, safety standards, and human factors, rather than a diagnostic device requiring expert interpretation for ground truth. "Human factors evaluations" were conducted, but details on the number or qualifications of participants/experts for establishing a "ground truth" are not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. The described testing refers to compliance with engineering and safety standards and human factors evaluations, not diagnostic image interpretation where adjudication methods like 2+1 or 3+1 would be used.

5. 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:

This information is not applicable and not provided. The device is an infusion pump, not an AI-powered diagnostic tool used by "human readers" to interpret cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device is an infusion pump with software, not a standalone algorithm in the context of AI performance. The document describes "System verification and validation activities" which imply testing of the integrated device. It also notes "Human factors evaluations," which specifically involve human-in-the-loop performance to validate the effectiveness of use error related mitigations. Therefore, testing was conducted on the complete system with human interaction being a component of the evaluation (for human factors).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing of the infusion pump, the "ground truth" is established by the requirements and specifications of the referenced international and national standards (e.g., IEC 60601 series, ISO 10993-1) and the device's own design inputs and user needs. The testing verifies if the device performs according to these engineering and safety specifications. For biocompatibility, the ground truth would be based on the biological evaluation criteria defined in ISO 10993. For human factors, the ground truth relates to the effectiveness of use-error mitigations and whether users can safely and effectively operate the device according to its design.

8. The sample size for the training set:

The concept of a "training set" is not applicable as this is a traditional medical device (infusion pump) and not an AI/machine learning model that undergoes training on data.

9. How the ground truth for the training set was established:

As the concept of a "training set" is not applicable, this question is not relevant to the provided document.

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The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

The Hospira LifeCare® PCA3 Infusion System is a microprocessor controlled, pole mounted, standalone, electromechanical infusion pump that allows a patient to self administer, analgeric usines, a patient pendant, within physician prescribed, programmed parameters. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. The infuser will accept a pre-filled drug vial manufactured by Haspire and includes one sterile empty vial that can be filled by a hospital's pharmacy.

The provided text is a 510(k) summary for the Hospira LifeCare® PCA3 Infusion System. It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for testing or training sets, ground truth establishment, expert involvement, or MRMC studies.

The document states that the device "meets the functional claims and intended use as described in the product labeling" and that "The proposed modifications do not raise new issues of safety and/or effectiveness." It also makes claims of substantial equivalence based on:

1. Same intended use
2. Same indication for use
3. Same fundamental technology and operating principle
4. Same physical, operational, environmental and performance attributes
5. Same materials of construction for infuser components and administration sets

It lists "Performance Features" such as "Delivery Rates, Dose Units, Delivery Accuracy, Delivery Modes, Occlusion Pressure Limits, Alarm Types and Conditions" as being "Same" as the predicate devices, implying these are the performance criteria that were considered. However, explicit numerical acceptance criteria and the results of a study demonstrating these are not present in this summary.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.

The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits.

The LifeCare PCA® Infusion System with MedNet™ Software consists of:

• an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements .
  • a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes
  • . a Nurse Call Port
  • networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems
  • hardware that is compatible with Hospira MedNet™ Software. .

This document is a 510(k) summary for the LifeCare PCA® Infusion System with Hospira MedNet™ Software. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. It does not contain the information requested in your prompt regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, or ground truth establishment.

Here's why the requested information is absent:

• 510(k) Summary Purpose: A 510(k) submission primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar technological characteristics and intended use, rather than conducting new, elaborate performance studies with predefined acceptance criteria for the new device as if it were a novel technology.
• Focus on Substantial Equivalence: The document explicitly states: "The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications do not raise new issues of safety and/or Frio proposou moome, the LifeCare PCA® Infusion System with Hospira™ MedNet Software is substantially equivalent to the predicate infusion pumps." This highlights the core of a 510(k) submission.
• Type of Device: This is an infusion pump, a well-established medical device type. Performance is typically assured through adherence to recognized standards (e.g., IEC 60601-1-2 mentioned for electrical safety) and comparison to existing, cleared devices, rather than new studies proving clinical efficacy or diagnostic accuracy with AI-like metrics.

Therefore, I cannot extract the information you requested from the provided text.

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