(198 days)
Plum 360™ Infusion System with Hospira Mednet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood products.
The Plum 360TM Infusion System with Hospira MedNet™ remains a volumentric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient.
The device has a user interface consisting of LCD display, front panel numeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library, and software that provides pre-defined display screens for therapy programming.
The continued use of the Hospira MedNet™ Software allows communication between the Infusion Pump, Hospira MedNet™ server and the facility's communication systems.
The provided text is a 510(k) Summary for the Plum 360™ Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical characteristics, rather than a clinical study measuring diagnostic accuracy or human reader performance with AI. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth in the context of device performance metrics (like sensitivity, specificity, accuracy) is not directly available or applicable from this document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported numerical device performance beyond stating "PASS" for various tests. The acceptance criteria for each test were meeting the requirements of the specified standard/guidance.
| Characteristics | Standard/Test/FDA Guidance | Reported Device Performance |
|---|---|---|
| Electrical and Mechanical Safety | ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, 2005 / (R)2012 / C1:2009 / (R)2012, including Amendment 1:2012 | PASS |
| Electromagnetic Compatibility | IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Edition 3:2007-03 | PASS |
| Alarms System | IEC 60601-1-8 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Edition 2.0 2006-10 | PASS |
| Infusion Pump Basic Safety and Essential Performance | IEC 60601-2-24 Medical Electrical Equipment - Part-24: Particular Requirements for the Basic Safety and Essential Performance of Infusion Pump and Controllers, Edition 2.0 2012-10 | PASS |
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, Fourth edition 2009-10-15 | PASS |
The document also states: "System verification and validation activities for subject devices confirmed that the system meets and design inputs. All the testing met the acceptance criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are engineering and analytical tests (e.g., electrical, mechanical, EMC, biocompatibility) rather than tests on a "test set" of patient data as might be relevant for AI/diagnostic devices.
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 ground truth for these types of tests would be established by validated test equipment and established scientific principles, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation of data.
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
No MRMC comparative effectiveness study was conducted or reported. This document pertains to a medical device's safety and effectiveness (infusion system) through performance testing, not a diagnostic AI system requiring reader studies. The document notes "Human Factors studies have been conducted to validate the effectiveness of use related error mitigations" but does not provide details on their design or results beyond "demonstrating passing results."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an infusion system's performance testing described here. The "algorithm" here refers to the software controlling the infusion pump, and its performance is evaluated as part of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described consists of established engineering standards, regulatory requirements, and validated test methods (e.g., for electrical safety, EMC, alarm systems, pump performance, biocompatibility). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable and not provided. The device is not an AI/ML model that is "trained" on a dataset in the typical sense.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" in the context of this device's submission.
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Hospira, Incorporated Yuliva Matlin. M.S., M.B.A. Associate Director of Global Regulatory Affairs 275 North Field Drive Lake Forest, Illinois 60045
Re: K141789
Trade/Device Name: Plum 360™ Infusion System with Hospira Mednet™, Smart Card Plug 'N Play CE 3.0 Upgrade Module for Plum A+TM Infusion System, and Plum Administration Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II
Product Code: FRN, PHC, FPA Dated: December 15, 2014 Received: December 17, 2014
Dear Ms. Malin:
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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Tina Kiang -S
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) K141789
Device Name
Plum 360 Infusion System with Hospira Mednet Smart Card Plug 'N Play CE 3.0 Upgrade Module for Plum A+ Infusion System Plum Administration Sets
Indications for Use (Describe)
Plum 360™ Infusion System with Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood products.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-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 a point, creating a sense of movement or flow.
510(k) Summary of Safety and Effectiveness
K141789
| Submitter Information | |
|---|---|
| Name | Hospira, Inc. |
| Address | 275 N Field Drive, Lake Forest, IL 60045 USA |
| Phone Number | 224-212-4857 |
| Fax Number | 224-212-5402 |
| Establishment Registration Number | 3005579246 |
| Name of Contact Person | Yuliya Matlin, M.S., M.BA |
| Date Prepared | June 30, 2014 |
| Name of Device | |
| Trade or Proprietary Name | Plum 360TM Infusion System with Hospira MedNetTM |
| Smart Card Plug'n' Play Module with CE 3.0 for Plum A+TM Infusion System | |
| PlumTM Administration Sets | |
| Common or Usual Name | Infusion Pumps, Infusion safety management software &Intravascular Administration Sets |
| Classification Name | Infusion Pumps, Infusion safety management software &Intravascular Administration Sets |
| Classification Panel | 80 |
| Regulation(s) | 21 CFR 880.5725 & 21 CFR 880.5440 |
| Product Code(s) | FRN, PHC, FPA |
| Legally Marketed Device(s) To WhichEquivalence is Claimed | Infusion System:Plum A+TM Infusion System with Hospira MednetTM (K042081)Administration Sets:Abbott Plum A+ Pump and Sets (K982159)Lifeshield Latex-Free Microbore Extentsion Set, Model 14949 andOthers (K052722)Hospira Enteral Feeding Set, Model 20640 (K061432)Hospira Infusion Blood Sets (K101677)Hospira Plum Infusion Set; Hospira Infusion Set with Yellow StripeTubing (K103224) |
| Infusion Sets (K103344) | |
| Lifeshield Vision Infusion Set with Pre-pierced Reseal (K113683) | |
| Reason for 510(k) Submission | Introduction of the next generation of Plum™ Infusion System-Plum360™ Infusion System with Hospira MedNet™ with enhancedsoftware, hardware and connectivity features.Introduction of an optional Smart Card Plug 'n' Play module withCE 3.0 for Plum A+TM Infusion System upgrade. |
| Changes to secure lock component of Plum™ Administration Sets. | |
| Device Description | The Plum 360TM Infusion System with Hospira MedNet™ remains avolumentric Infusion System intended for use in parenteral, enteraland epidural therapies and the administration of whole blood andblood products. Dedicated administration sets are used for delivery ofinfusion therapy to the patient.The device has a user interface consisting of LCD display, frontpanel numeric keypads and keys, audible and visual indicators,audible indicator volume control, nurse call interface, networkinterface connectors, the drug library, and software that provides pre-defined display screens for therapy programming.The continued use of the Hospira MedNet™ Software allowscommunication between the Infusion Pump, Hospira MedNet™server and the facility's communication systems. |
| Intended Use/Indication For Use | Plum 360™ Infusion System with Hospira Mednet™ and PlumA+TM (360 EnabledTM) Infusion System are indicated for use inparenteral, enteral and epidural therapies and the administration ofwhole blood and blood products. |
| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | |
| Plum 360TM Infusion System with Hospira MedNet™ employs the same fundamental scientific technology, principles ofoperation and intended/indications for use. In addition, the subject device includes the following notable characteristics:• Latest CPU software version 15.0 featuring drug library enhancements, autoprogramming and alarm managementenhancments.• Enhanced connectivity engine CE 3.0 with imporved Wi-Fi Performance, network connectivity and throughput toHospira MedNet™• Enhanced hardware including egronomic enclosure, proximal tubing guides, ratcheting pole clamp and keypad.• Enhancements to dedicated administration sets to include a modified secure lock.• An optional Smart Card Plug 'n' Play with CE 3.0 Module allows Plum A+TM Infusion System upgrades to the |
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Performance Data
Summary of Non-Clinical Tests Conducted For Determination of Substantial Equivalence
Performance Test Summary - Subject Device
configuration.
System verification and validation activities for subject devices confirmed that the system meets and design inputs. All the testing met the acceptance criteria.
Risk management activities are incorporated in to the design and development process and safety assurance cases has been generated to demonstrate the safety of the subject devcies.
Risk management as well as verification activities incorporate the principles of applicable FDA guidance such as "Total Product Life Cycle: infusion Pump –Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE)"
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Image /page/5/Picture/0 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic is composed of three curved lines that converge at the top, resembling a stylized arch or a simplified representation of a medical device. The logo is in black and white.
Plum 360™ Infusion system with Hospira MedNet™/ Smart Card Plug 'n' Play CE 3.0 Module Traditional 510(k) Section 5: 510(k) Summary
issued in April 23, 2010 and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," issued January 11, 2002.
Human Factors studies have been conducted to validate the effectiveness of use related error mitigations.
| Characteristics | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Electrical and MechanicalSafety | ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part1: General Requirements for Basic Safety and EssentialPerformance, 2005 / (R)2012 / C1:2009 / (R)2012, includingAmendment 1:2012 | PASS |
| ElectromagneticCompatibility | IEC 60601-1-2 Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests, Edition 3:2007-03 | PASS |
| Alarms System | IEC 60601-1-8 Collateral Standard: General requirements,tests and guidance for alarm systems in medical electricalequipment and medical electrical systems, Edition 2.0 2006-10 | PASS |
| Infusion Pump Basic Safetyand Essential Performance | IEC 60601-2-24 Medical Electrical Equipment - Part-24:Particular Requirements for the Basic Safety and EssentialPerformance of Infusion Pump and Controllers, Edition 2.02012-10 | PASS |
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process,Fourth edition 2009-10-15 | PASS |
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information | ||
| Clinical evaluation is not required for this submission to support substantial equivalence. Human factors studies have beenconducted on subject devcies demonstrating passing results. | ||
| Conclusion | ||
| Hospira, Inc. considers Plum 360™ Infusion System Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion Systemwith Hospira MedNet™ to be as safe and effective as its predicate devices. Therefore, Plum 360™ Infusion Systemcompatible with Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System with Hospira MedNet™ aresubstantially equivalent to predicate devices. |
§ 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).