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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2016

Hospira, Inc Ms. Yuliya Matlin Associate Director, Global Regulatory Affairs 275 North Field Drive Lake Forest, Illinois 60045

Re: K143612

Trade/Device Name: Lifecare PCATM Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, FPA Dated: March 4, 2016 Received: March 10, 2016

Dear Ms. Matlin:

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. 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.

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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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143612

Device Name LifeCare™ PCA Infusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the logo for Hospira. The logo consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic features three curved lines that converge at the top, resembling a stylized flower or abstract design. The logo is presented in grayscale.

510(k) SUMMARY

A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92 is provided below for K143612.

Submitter Information
Name	Hospira, Inc.
Address	275 North Field Dr., Lake Forest, IL 60045
Phone number	858-391-1142
Fax number	224-212-5401
EstablishmentRegistration Number	3005579246
Name of contactperson	Yuliya Matlin
Date prepared	April 5, 2016
510(k) Number	K143612
Name of device
Trade or proprietaryname	LifeCare PCA™ Infusion System
Common or usualname	Patient Controlled Analgesia (PCA) Infusion Pump andAdministration Sets
Classification name	Infusion Pump
Classification panel	General Hospital
Regulation	21 CFR 880.5725 (Infusion Pump)
Product Code(s)	MEA - Patient Controlled Analgesia (PCA) Infusion PumpFPA - Administration Sets
Legally marketeddevice(s) to whichequivalence isclaimed	Hospira LifeCare™ PCA3 Infusion System, cleared under K043256Hospira LifeCare PCA™ Infusion Pump System with HospiraMedNet™ Software cleared under K042800No Reference Devices were used in this submission
Device description	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.
Indications for Use	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.
Summary of IntendedUse Compared toPredicate Device	The indication for use is nearly identical to the predicate. The difference in the intended use statements of the predicate and subject device clarifies that the subject device may deliver continuous or patient controlled administration of analgesic medications via intravenous or epidural routes of administration. This change in wording does not alter the function of the device in comparison to the predicate and is intended to provide clarity to the device's functionality.
Summary ofTechnologicalCharacteristicsCompared to PredicateDevice	The LifeCare PCA™ Infusion System with Hospira MedNet™ employs the same fundamental scientific technology, and principles of operation and intended/indications for use as are used by the predicate device(s). In addition, the LifeCare PCA™ Infusion System has the following technological characteristics comparable to predicate device(s) which previously received 510(k) clearance:• Utilize the same pumping technology; deliver fluids over the same flow rates with same accuracy.• Have similar drug library features and wired and wireless communication options using a facility's network infrastructure.• Incorporates the same basic Infusion System design with the exception of the design updates described in this 510(k).• Incorporate the same basic software driven electronic control system• Use comparable dedicated administration sets.
Summary ofTechnologicalCharacteristicsCompared to PredicateDevice (Continued)	Modifications to the software, hardware, labeling, and PCA consumables ascompared to the predicate device include:Software: Changes to the user interface to enhance auto-programmingworkflow. Alarm risk prioritization (low, medium, high) and alarm visualindicator updates to comply with IEC 60601-1 Edition 3. Addition of wirelessstrength and battery capacity indicators. Updates to the Biomed capabilitiesto include more diagnostic information and usage counters. Improvementsto the wireless connectivity to include global region support, enhancedroaming, and to update wireless system components. Implementcybersecurity enhancements.Hardware: Miscellaneous changes to hardware to comply with IEC60601-1Edition 3. Strengthened door and latch design. Material change to half nut/leadscrew. Added seal around barcode reader window to prevent fluid ingress.Labeling: Updates to the System Operating Manual, Technical ServiceManual and on pump label to align with IEC 60601-1 Edition 3 and toincorporate updated workflow for auto-programming. Updates to SterileEmpty vial providing guidelines for barcode label placement after filling withmedication.PCA Consumables: modified distal male luer adaptor design on alladministration sets. Increased activation pressure for the Pressure ActivatedValve (PAV). Changed slide clamp color to orange.
Performance Data - NonClinical Testing	An assurance case was provided for the LifeCare PCA™ Infusion System asrecommended in the FDA guidance document, Infusion Pumps Total ProductLife Cycle.The stated goal of the assurance case is:• The LifeCare PCA™ infusion system design is adequately safe for itsintended use.The assurance case defined the device system, including the indications foruse, system definition, operational description, patient populations, and useenvironments. The supporting assurance arguments covered the followingattributes:• Residual risks are analyzed and determined to be acceptably low• Design is verified and valid for its indications for use as it relates tosafety• Device design is reliable

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Image /page/4/Picture/1 description: The image shows the word "Hospira" in a serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the word, there is a logo consisting of three curved lines that resemble an abstract representation of a medical device or a stylized wave. A horizontal line is present below the word "Hospira".

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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name in a serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized arch or a stylized representation of motion.

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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font, with the letters in gray. Above the name is an abstract graphic consisting of three curved lines that converge at a point above the "i" in Hospira, creating a sense of movement or connectivity.

Performance Data – NonClinical Testing(Continued)	The following evidence was included in the assurance case:
	Performance Test SummarySystem verification and validation activities for LifeCare PCA™ InfusionSystem confirmed that the system meets user needs and designinputs. All the testing met the acceptance criteria.Human factors evaluations have been conducted to validate theeffectiveness of use error related mitigationsSoftware documentation as recommended in the following FDAguidance documents:Infusion Pumps Total Product Life Cycle Content of Premarket Submissions for Software Contained inMedical Devices Content of Premarket Submissions for Management ofCybersecurity in Medical Devices Biocompatibility evaluations of consumable products were conducted inaccordance with ISO 10993-1:2009 (Corrigendum 2010) FDA Draft Guidance for Industry and Food and Drug AdministrationStaff Use of International Standard ISO-10993, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing"issued April 2013 Electrical and Electromagnetic Compatibility testing were conducted. TheInfusion System complies with following standards:
	Basic Safety and EssentialPerformance	ANSI/AAMI ES60601-1:2005/(R) 2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012,
	ElectromagneticCompatibility	IEC Standard 60601-1-2:2007 3rd Ed.
	Alarm Systems	IEC 60601-1-8, Edition 2.1 2012-11
	Infusion Pump BasicSafety and EssentialPerformance	IEC 60601-2-24 Medical Electrical Equipment – Part-Edition 2.0 2012-10
Performance Data –Clinical Testing	Clinical evaluation is not required for this submission to support substantialequivalence. Human Factors studies have been conducted on subjectdevices, demonstrating passing results.

CONCLUSIONS DRAWN FROM CLINICAL AND NON-CLINICAL DATA

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).