(305 days)
Not Found
No
The document does not mention AI, ML, or related concepts, and the description focuses on standard infusion pump functionalities and software communication.
Yes
The "Intended Use / Indications for Use" states the device is "indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products," which are all therapeutic interventions.
No
The device description clearly states it is a "volumetric Infusion System" intended for delivering therapies and blood products, not for diagnosing conditions.
No
The device description explicitly states it is a "volumetric Infusion System" and mentions hardware components like an LCD display, keypads, and network interface connectors, indicating it is a physical device with integrated software, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "parenteral, enteral and epidural therapies and the administration of whole blood and blood products." These are all related to delivering substances into the body, not analyzing samples from the body to diagnose conditions.
- Device Description: The description focuses on the mechanics of an infusion system (volumetric, administration sets, user interface for programming therapy). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The device is an infusion pump, which is a therapeutic device used to administer fluids and medications to a patient.
N/A
Intended Use / Indications for Use
Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Product codes
FRN, PHC, FPA
Device Description
The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a volumetric 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 alphanumeric 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 MedNet Software allows communication between the Infusion Pump, MedNet server and the facility's communication systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data - Non Clinical Testing: The following standards and associated methods were applied to demonstrate the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to the current device after the historical and subject changes are applied. IEC 60601-1Medical Electrical Equipment-Part 1: General Requirement for Basic Safety and Essential Performance, 2005/(R)2012/C1:2009/(R)2012, Including Amendment 1:2012; IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers, Edition 2.0 2012; 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; IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems, Edition 2.0 2006. A risk analysis was applied to assess the impact of modifications necessary to include a bolus feature with the system. The analysis demonstrates the changes do not introduce new risks to the patient. All risks which are identified have been mitigated as low as reasobaly possible. The device safety assurance case was updated to include the bolus feature that is being added to the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle. The assurance case defined the device system, including the indications for use, system specifications, use environments, and user population. The supporting assurance arguments covered the following attributes: All potential risks have been mitigated and residual risk is acceptable. Design verification and validation of device specifications are adequate. Device reliability is adequate. The following evidence was included in the assurance case: Performance Test Summary: System verification and validation activities for Plum 360 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 the bolus feature. Software verification and validation as recommended in the following FDA guidance documents: Infusion Pumps Total Product Life Cycle, Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices. Electrical and Electromagnetic Compatibility testing were conducted. Updates due to the bolus feature complies with following standard: IEC 60601-2-24 Medical Electrical Equipment - Part-24: Infusion Pump Basic Safety and Essential Edition 2.0 2012-10 Performance.
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 Non-Clinical Data: The conclusions drawn from the non-clinical tests demonstrate that the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2017
Hospira, Inc Keith Dunn Associate Director, Global Regulatory Affairs, Devices 275 North Field Drive Lake Forest, Illinois 60045
Re: K161469
Trade/Device Name: Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN. PHC. FPA Dated: February 22, 2017 Received: February 28, 2017
Dear Keith Dunn:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the name is the letter "s" preceded by a hyphen. The signature is a series of loops and curves.
Tina Kiang, Ph.D. Acting 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) K161469
Device Name
Plum 360™ Infusion System with Hospira MedNet™/ Smart Card Plug 'n' Play Module
Indications for Use (Describe)
Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and 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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Section 5: 510(k) Summary
A summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | ICU Medical |
| Address | D-393 |
| 600 North Field Drive | |
| Lake Forest, IL. 60045 | |
| Phone number | 224-212-4898 |
| Fax number | 224-212-5402 |
| Establishment | |
| Registration | |
| Number | 3005579246 |
| Name of contact | |
| person | Yuliya Matlin |
| Date prepared | March 28, 2017 |
| Name of device | |
| Trade or | |
| proprietary | |
| name | Plum 360TM Infusion System with MedNet/ Smart Card Plug 'n' Play Module |
| Common or | |
| usual name | Infusion Pump |
| Classification | |
| name | Infusion Pump |
| Classification panel | 80 |
| Regulation | 21 CFR 880.5725 |
| Product Code(s) | FRN, PHC, FPA |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | Infusion System: |
| Plum 360TM Infusion System with MedNet / Smart Card Plug 'n' Play (K141789) | |
| Device description | The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a |
| volumetric 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 alphanumeric 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 MedNet Software allows communication between the Infusion Pump, | |
| MedNet server and the facility's communication systems. | |
| Indication for Use | The Plum 360TM Infusion System with Hospira MedNet TM is indicated for use in parenteral, |
| enteral, and epidural therapies and the administration of whole blood and blood products. |
4
| Summary of
Indications for Use
Compared to
Predicate Device
Summary of the | | | With exception to the system name, the Indications for Use is identical to the predicate device.
Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play employs the same |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics
Compared to
Predicate Device | fundamental scientific technology, and principles of operation and intended use as the predicate
device. In addition, Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play
Module has the following technological characteristic enhancements compared to predicate
device with the following changes related to the bolus feature: | | |
| | | Feature | Subject Plum 360 Infusion System with
Bolus Feature Compared to Predicate Plum
360 Infusion System |
| | | CPU Software | Updated to 15.10
Software differences included introduction of
bolus functionality and associated user
interface modifications, addition of the dosing
units and modifications to programmable dose
ranges, infusion log updates and cybersecurity
enhancements |
| | | Communication Engine (CE) | Updated to 3.03
Software differences included Cybersecurity
enhancements and changes to support
additional bolus functionality |
| | | | |
5
| Performance Data -
Non Clinical Testing | The following standards and associated methods were applied to demonstrate the Plum 360™
Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the current device after the historical and subject changes are applied
· IEC 60601-1Medical Electrical Equipment-Part 1: General Requirement for Basic
Safety and Essential Performance, 2005/(R)2012/C1:2009/(R)2012, Including |
| | Amendment 1:2012 |
| | · IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for
the basic safety and essential performance of infusion pumps and controllers, Edition
2.0 2012 |
| | · 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 |
| | · IEC 60601-1-8 Collateral Standard: General Requirements, test and guidance for alarm
systems in medical electrical equipment and medical electrical systems, Edition 2.0
2006 |
| | A risk analysis was applied to assess the impact of modifications necessary to include a bolus
feature with the system. The analysis demonstrates the changes do not introduce new risks to
the patient. All risks which are identified have been mitigated as low as reasobaly possible. |
| | The device safety assurance case was updated to include the bolus feature that is being added to
the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module, as
recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle |
| | |
| | The assurance case defined the device system, including the indications for use, system
specifications, use environments, and user population. The supporting assurance arguments
covered the following attributes: |
| | · All potential risks have been mitigated and residual risk is acceptable. |
| | · Design verification and validation of device specifications are adequate. |
| | · Device reliability is adequate. |
| | The following evidence was included in the assurance case: |
| | · Performance Test Summary: System verification and validation activities for Plum 360
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 the bolus
feature. |
| | · Software verification and validation as recommended in the following FDA guidance
documents: |
| | Infusion Pumps Total Product Life Cycle
O |
| | Content of Premarket Submissions for Software Contained in Medical Devices
O
Applying Human Factors and Usability Engineering to Medical Devices
O |
| | |
| | Electrical and Electromagnetic Compatibility testing were conducted. Updates due to the bolus
feature complies with following standard: |
| | IEC 60601-2-24 Medical Electrical Equipment - Part-24:
Infusion Pump Basic
Safety and Essential
Edition 2.0 2012-10
Performance |
| | |
| 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. |
6
CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
The conclusions drawn from the non-clinical tests demonstrate that the Plum 360™ Infusion System with MedNet / Smart Card Plug 'n' Play Module is substantially equivalent to the predicate device.