(118 days)
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Not Found
No
The summary describes a software tool for managing infusion pump configurations and collecting data, but there is no mention of AI or ML being used for analysis or decision-making.
No
The device is a software tool used to configure, upload, and download data from infusion pumps; it does not directly treat or diagnose patients.
No
The device is described as a tool for configuring and uploading parameters to infusion pumps, and for collecting operational data for analysis to improve processes and reduce errors. It does not provide information about a patient's health status or disease.
Unknown
The provided text describes software functionality for configuring and collecting data from infusion pumps. However, without a "Device Description" section, it's impossible to definitively determine if the submission covers only the software or includes associated hardware components or modifications to the pumps themselves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for managing configuration parameters, drug libraries, and collecting data from infusion pumps. This relates to the operation and management of medical devices used for administering fluids and medications, not for testing samples taken from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
The device's function is focused on the management and configuration of infusion pumps, which are medical devices used for patient treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.
Product codes
FRN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 2005
Ms. Barbara Law Regulatory Affairs Manager Medex, Incorporated 6250 Shier-Rings Road Dublin, Ohio 43016
Re: K042432
Trade/Device Name: PharmGuard™ Toolbox Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 15, 2004 Received: December 16, 2004
Dear Ms. Law
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it nay of of 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
Page 2 -- Ms. Law
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements modifine and Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal barrequirements, including, but not limited to: registration 1 od intist comply with a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 OF reveality systems (QS) regulation (21 CFR Part 820); and if requirements as set form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon yoursely of substantial equivalence of your device to a premaired notification.
Iegally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific arration at (301) 594-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chris Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known):
PharmGuard™ Toolbox Device Name:
Indications for Use:
PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quinn
(Division Sign-Off) (Division Sign Oigh Oigh General Hospital, Infection Control, Dental Devices
510(k) Number:_**_
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