(476 days)
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.
§ 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).