(198 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard software and communication features for an infusion system.
Yes
The device is used for parenteral, enteral, and epidural therapies and the administration of whole blood products, which are all forms of medical treatment aimed at improving health, therefore it is a therapeutic device.
No
The device is an infusion system used 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, audible/visual indicators, and network interface connectors. 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 "parenteral, enteral and epidural therapies and the administration of whole blood products." These are all related to delivering substances into the body, not for testing samples outside the body to diagnose conditions.
- Device Description: The description focuses on the mechanics of an infusion system, including pumps, administration sets, user interfaces, and software for programming and communication. This aligns with a device used for administering fluids and medications, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Plum 360™ Infusion System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRN, PHC, FPA
Device Description
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.
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)
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)" 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.
Electrical and Mechanical Safety (ANSI/AAMI ES60601-1): PASS
Electromagnetic Compatibility (IEC 60601-1-2): PASS
Alarms System (IEC 60601-1-8): PASS
Infusion Pump Basic Safety and Essential Performance (IEC 60601-2-24): PASS
Biocompatibility (ISO 10993-1): PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042081, K982159, K052722, K061432, K101677, K103224, K103344, K113683
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
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 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Which | |
| Equivalence 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 and | |
| Others (K052722) | |
| Hospira Enteral Feeding Set, Model 20640 (K061432) | |
| Hospira Infusion Blood Sets (K101677) | |
| Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe | |
| Tubing (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-Plum |
| 360™ Infusion System with Hospira MedNet™ with enhanced | |
| software, hardware and connectivity features. |
Introduction of an optional Smart Card Plug 'n' Play module with
CE 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 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. |
| Intended Use/Indication For Use | Plum 360™ Infusion System with Hospira Mednet™ and Plum
A+TM (360 EnabledTM) Infusion System are indicated for use in
parenteral, enteral and epidural therapies and the administration of
whole 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 of
operation 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 management
enhancments.
• Enhanced connectivity engine CE 3.0 with imporved Wi-Fi Performance, network connectivity and throughput to
Hospira 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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Image /page/4/Picture/0 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font. Above the name is an abstract graphic consisting of three curved lines that converge at the bottom, creating a stylized, arch-like shape.
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)"
5
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 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 | |
| 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 been | ||
| conducted on subject devcies demonstrating passing results. | ||
| Conclusion | ||
| Hospira, Inc. considers Plum 360™ Infusion System Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System | ||
| with Hospira MedNet™ to be as safe and effective as its predicate devices. Therefore, Plum 360™ Infusion System | ||
| compatible with Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System with Hospira MedNet™ are | ||
| substantially equivalent to predicate devices. |