PHARMGUARD TOOLBOX, MODEL G6000782

K042432 · Medex, Inc. · FRN · Jan 4, 2005 · General Hospital

Device Facts

• Record ID: K042432
• Device Name: PHARMGUARD TOOLBOX, MODEL G6000782
• Applicant: Medex, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jan 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

PharmGuard™ Toolbox is a software-based configuration and data management tool for Medex Infusion Pumps. It functions as a vehicle to create, store, and securely upload user-defined drug libraries and infusion parameters to pumps. The device collects operational, infusion, and alarm history, as well as safety event logs from the pumps. Clinicians or hospital staff use the tool to analyze this data to optimize infusion processes and minimize manual entry errors. By standardizing infusion parameters via uploaded libraries, the device aims to improve patient safety and reduce the likelihood of medication administration errors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based configuration and data management tool. Facilitates data transfer between a host computer and Medex Infusion Pumps. Enables creation of drug libraries and parameter sets; collects pump event logs and usage data. Operates as a support utility for infusion pump systems.

Indications for Use

Indicated for use by healthcare facilities to configure Medex Infusion Pumps and manage infusion data. Intended to reduce operator error during parameter entry by facilitating the creation and upload of drug libraries and configuration parameters, and the collection of infusion/alarm history.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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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