(476 days)
No Reference Devices were used in this submission
No
The description focuses on electromechanical components, microprocessor control for programmed parameters, and standard communication interfaces. There is no mention of AI/ML terms, image processing, or data training/testing.
Yes
This device is an infusion pump designed to administer analgesic medications, which directly contributes to the treatment and management of pain, thus acting as a therapeutic device.
No
Explanation: The device is an infusion system designed for administering analgesic medications, not for diagnosing medical conditions.
No
The device description clearly states it is a "microprocessor controlled, pole mounted, electromechanical infusion pump" and details hardware components like a stepper motor, power source, battery, and interfaces. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravenous or epidural administration of analgesic medications." This describes a therapeutic function, delivering medication directly into the body.
- Device Description: The description details a pump that physically delivers medication from a vial into a patient. It focuses on the mechanical and electronic aspects of infusion.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is an infusion pump, which is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
MEA, FPA
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.
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
Not Found
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
Performance Test Summary
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.
Human factors evaluations have been conducted to validate the effectiveness of use error related mitigations
Software documentation as recommended in the following FDA guidance documents:
Infusion Pumps Total Product Life Cycle Content of Premarket Submissions for Software Contained in Medical Devices Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Biocompatibility evaluations of consumable products were conducted in accordance with ISO 10993-1:2009 (Corrigendum 2010) 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 Electrical and Electromagnetic Compatibility testing were conducted. The Infusion System complies with following standards: 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
Clinical evaluation is not required for this submission to support substantial equivalence. Human Factors studies have been conducted on subject devices, demonstrating passing results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No Reference Devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with a wing-like shape extending above them.
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.
1
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
2
Indications for Use
510(k) Number (if known) K143612
Device Name LifeCare™ PCA Infusion System
Indications for Use (Describe)
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.
| 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 |
| Establishment | |
| Registration Number | 3005579246 |
| Name of contact | |
| person | Yuliya Matlin |
| Date prepared | April 5, 2016 |
| 510(k) Number | K143612 |
| Name of device | |
| Trade or proprietary | |
| name | LifeCare PCA™ Infusion System |
| Common or usual | |
| name | Patient Controlled Analgesia (PCA) Infusion Pump and |
| Administration 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 Pump |
| FPA - Administration Sets | |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | Hospira LifeCare™ PCA3 Infusion System, cleared under K043256 |
| Hospira LifeCare PCA™ Infusion Pump System with Hospira | |
| MedNet™ Software cleared under K042800 | |
| No 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 Intended | |
| Use Compared to | |
| Predicate 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 of | |
| Technological | |
| Characteristics | |
| Compared to Predicate | |
| Device | 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 of | |
| Technological | |
| Characteristics | |
| Compared to Predicate | |
| Device (Continued) | Modifications to the software, hardware, labeling, and PCA consumables as |
| compared to the predicate device include: |
Software: Changes to the user interface to enhance auto-programming
workflow. Alarm risk prioritization (low, medium, high) and alarm visual
indicator updates to comply with IEC 60601-1 Edition 3. Addition of wireless
strength and battery capacity indicators. Updates to the Biomed capabilities
to include more diagnostic information and usage counters. Improvements
to the wireless connectivity to include global region support, enhanced
roaming, and to update wireless system components. Implement
cybersecurity enhancements.
Hardware: Miscellaneous changes to hardware to comply with IEC60601-1
Edition 3. Strengthened door and latch design. Material change to half nut/lead
screw. Added seal around barcode reader window to prevent fluid ingress.
Labeling: Updates to the System Operating Manual, Technical Service
Manual and on pump label to align with IEC 60601-1 Edition 3 and to
incorporate updated workflow for auto-programming. Updates to Sterile
Empty vial providing guidelines for barcode label placement after filling with
medication.
PCA Consumables: modified distal male luer adaptor design on all
administration sets. Increased activation pressure for the Pressure Activated
Valve (PAV). Changed slide clamp color to orange. |
| Performance Data - Non
Clinical Testing | An assurance case was provided for the LifeCare PCA™ Infusion System as
recommended in the FDA guidance document, Infusion Pumps Total Product
Life Cycle.
The stated goal of the assurance case is:
• The LifeCare PCA™ infusion system design is adequately safe for its
intended use.
The assurance case defined the device system, including the indications for
use, system definition, operational description, patient populations, and use
environments. The supporting assurance arguments covered the following
attributes:
• Residual risks are analyzed and determined to be acceptably low
• Design is verified and valid for its indications for use as it relates to
safety
• 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 – Non
Clinical Testing
| (Continued) | The following evidence was included in the assurance case: | |
|---|---|---|
| Performance Test Summary | ||
| 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. |
Human factors evaluations have been conducted to validate the
effectiveness of use error related mitigations
Software documentation as recommended in the following FDA
guidance documents:
Infusion Pumps Total Product Life Cycle Content of Premarket Submissions for Software Contained in
Medical Devices Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices Biocompatibility evaluations of consumable products were conducted in
accordance with ISO 10993-1:2009 (Corrigendum 2010) 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 Electrical and Electromagnetic Compatibility testing were conducted. The
Infusion System complies with following standards: | |
| | 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 |
| Performance Data –
Clinical Testing | Clinical evaluation is not required for this submission to support substantial
equivalence. Human Factors studies have been conducted on subject
devices, 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.