(70 days)
The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira Infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters.
The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.
The Hospira MedNet™ Medication Management Suite (MMS) is an optional software product intended for use in healthcare facilities by trained healthcare professionals to facilitate networked communications (wired or wireless) between MMS compatible hospital information systems and compatible infusion pumps.
The MMS provides healthcare professionals with the capability to send, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pump default configurations, pump location, history, events, trending, alarms and status. The MMS cannot remotely start, modify, or terminate ongoing infusions.
Below is a summary of the acceptance criteria and study information for the Hospira MedNet™ Medication Management Suite:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on software changes to an existing device and primarily relies on non-clinical performance testing for validation. Therefore, the acceptance criteria are related to meeting design requirements and ensuring safety and effectiveness after software modifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software meets user needs and design inputs | Confirmed through verification and validation activities. |
| New feature design requirements are met | Confirmed through verification and validation testing. |
| Pre-existing design requirements continue to be met | Re-tested and reconfirmed through verification and validation testing. |
| Risk management activities are incorporated and safety demonstrated | Safety Assurance Case generated to demonstrate safety. |
| Effectiveness of use-related error mitigations | Validated through Human Factors studies. |
| Device remains safe and effective after modifications | Demonstrated by results of verification/validation, risk analysis, and Human Factors studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data for a machine learning model. Instead, the validation involved software verification and validation activities and Human Factors studies.
- Sample Size: Not applicable in the traditional sense of a clinical test set. The validation refers to software testing and human factors studies, but specific numbers of test cases or participants are not provided.
- Data Provenance: Not applicable for clinical data. The studies performed were non-clinical (software verification/validation) and human factors studies. The geographical origin of these studies is not specified, but they were conducted by Hospira, Inc.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
This information is not provided. Given that the validation involves software testing and human factors studies for a medical device accessory software, "ground truth" would likely be established by internal engineering and human factors experts, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for establishing ground truth from multiple expert interpretations, especially in image analysis. Since no clinical trials or image interpretation tasks were involved, no adjudication method is described or applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical trials have been performed." The device is an infusion pump accessory software for medication management, not a diagnostic imaging device that typically requires MRMC studies.
6. Standalone Performance Study
No standalone performance study in the typical sense of algorithm-only performance without human interaction was conducted. The device is software designed to be used by trained healthcare professionals to facilitate communication and automate programming, meaning human-in-the-loop interaction is inherent to its intended use. The validation focused on the software meeting design requirements and human factors.
7. Type of Ground Truth Used
The "ground truth" for this device's validation was based on:
- Design Specifications and Requirements: The software's performance was evaluated against its pre-defined design inputs and user needs.
- Risk Analysis Outcomes: Demonstrating that identified risks were acceptably mitigated.
- User Performance in Human Factors Studies: Validating the effectiveness of use-related error mitigations during interaction with the software.
8. Sample Size for the Training Set
Not applicable. The document describes a software update to an existing medical device, not a machine learning or AI model that requires a "training set" in the traditional sense. The development likely involved standard software engineering practices and testing, rather than an AI training paradigm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set for a machine learning model was described, there is no information on how its "ground truth" would be established.
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JUL 0882014
1
K141102 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements ` of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Hospira, Inc |
| Address | 275 North Field Dr, Lake Forest, IL 60045 |
| Phone number | 858-391-1142 |
| Fax number | 224-212-5401 |
| EstablishmentRegistrationNumber | 3005579246 |
| Name of contactperson | Tom Gutierrez |
| Date prepared | April 28, 2014 |
| Name of device | |
| Trade orproprietary name | Hospira MedNet™ Medication Management Suite |
| Common orusual name | Infusion Pump Accessory Software |
| Classificationname | Infusion Pump |
| Classification panel | General Hospital |
| Regulation | 880.5725 |
| Product Code(s) | FRN |
| Legally marketeddevice(s) to whichequivalence is claimed | Hospira MedNet™ Medication Management Suite (MMS), clearedunder K042609. |
| Reason for 510(k)submission | Software Changes |
| Device description | The Hospira MedNet™ Medication Management Suite (MMS) isan optional software product intended for use in healthcarefacilities by trained healthcare professionals to facilitatenetworked communications (wired or wireless) between MMScompatible hospital information systems and compatible infusionpumps.The MMS provides healthcare professionals with the capability tosend, receive, and store information from infusion pumps. The bi-directional communication includes infusion parameters, pumpdefault configurations, pump location, history, events, trending,alarms and status. The MMS cannot remotely start, modify, or |
| terminate ongoing infusions. | |
| Intended use/Indications for use ofthe device | The Hospira MedNet™ Medication Management Suite (MMS) isintended to facilitate networked communication between MMScompatible computer systems and Hospira Infusion pumps. TheMMS provides trained healthcare professionals with thecapability to send, receive, report, and store information frominterfaced external systems, and to configure and edit infusionprogramming parameters. |
| The MMS is intended to provide a way to automate theprogramming of infusion parameters, thereby decreasing theamount of manual steps necessary to enter infusion data. Alldata entry and validation of infusion parameters is performed bya trained healthcare professional according to physician'sorders. |
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Summary of the technological characteristics of the device compared to the predicate device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Characteristic | Subject DeviceHospira MedNet™Medication ManagementSuite | Predicate Hospira MedNet™Medication Management SuiteK042609 |
|---|---|---|
| Drug Library Editor (DLE) | Yes | Yes |
| DLE on PC | ||
| Manage Download andUploading via server | Yes | Yes |
| Configure Pumps | Yes | Yes |
| Manage Pump Logs | Yes | Yes |
| Multiple Drug entries perCCA | Yes | Yes |
| Multiple CCAs | Yes | Yes |
| Pre-populating pump | Yes | Yes |
| Wireless Communications | Yes | Yes |
| Bi-directionalCommunications | Yes | Yes |
i
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CN A THE SERVER A SPERFORMANCE DATA - CATAL - CATAL CARA - C
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*
Non-Clinical Performance Test Summary
Verfication and validation activities for Hospira MedNet™ software confirmed that the software meets user needs and design inputs.
Verification and validation testing was conducted and confirmed that the new feature design requirements were met. Additionally, pre-existing design requirements were re-tested. It was reconfirmed that Hospira MedNet™ continued to meet all pre-existing design requirements.
Risk management activities are incorporated in to the design and development process and a Safety Assurance Case has been generated to demonstrate the safety of the Hospira MedNet™ Medication Management Suite.
Human Factors studies have been conducted to validate the effectiveness of use related error mitigations.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information
No clinical trials have been performed. The modifications described in the submission do not meet the clinical testing criteria outlined in the FDA guidance "Total Product Life Cycle: infusion Pump –Premarket Notification {510(k)} Submissions (DRAFT GUIDANCE) issued in April 23, 2010, given:
- Hospira MedNet is not a new device
- there were no changed or modification in the intended use of the device
- the modifications were not intended to correct problems with the design of the user interface or usability of the product
A CONCLUSIONS DRAWNIFROM NON-CLINICAL AND CLINICAL DATA
The results of the verification and validation testing as well as the risk analysis applied, supported by the Human Factors studies, demonstrate that the modifications described in the submission met design specifications and the device as a whole continues to be safe and effective.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
Hospira, Incorporated Mr. Tom Gutierrez Associate Director Global Regulatory Affairs 275 North Field Drive Lake Forest, IL 60045
Re: K141102
Trade/Device Name: Hospira MedNet™ Medication Management Suite Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 6, 2014 Received: June 9, 2014
Dear Mr. Gutierrez:
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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Page 2 - Mr. Gutierrez
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 (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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.
510(k) Number (if known)
241102
Device Name
Hospira MedNet™ Medication Management Suite
Indications for Use (Describe)
The Hospira MedNet™ Medication Management Suite (MMS) is intended to facilitate networked communication between MMS computer systems and Hospira Infusion pumps. The MMS provides trained healtheare professionals with the capability to send, receive, report, and store interfaced external systems, and to configure and edit infusion programming parameters.
The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the arnount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.
Type of Use (Select one or both, as applicable)
2 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) | |
| Digitally signed byRichard C. Chapman -SDate: 2014.07.0810:04:40 -04'00' |
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§ 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).