(317 days)
K000965, K001479, K993685, K001648, K003058, K990264, K960010, K990715, K000717, K983792, K954848, K990731, K000713, K993510, K993674, K011116, K012971, K020822, K040207, K041300, K003099, K002347, K010892, K012971, K020822, K040207, K041300, K993685, K001648, K003058, K960010, K990715, K003099, K000717, K983792, K954848, K990731
Not Found
No
The description focuses on data download, display, printing, saving, and calculation based on user-entered data and physician settings, with no mention of AI or ML terms or functionalities.
No.
The primary functions of the device are downloading, displaying, printing, and saving data from other medical devices, and calculating dosage based on physician settings, which are management and informational tasks rather than direct therapeutic actions.
No
The device is described as diabetes management software that downloads data from other devices and calculates insulin/carbohydrate dosages. It does not perform diagnostic functions.
Yes
The device description explicitly states it is "diabetes management software" intended for a personal computer or handheld organizer, and its functions are described as software-based operations (downloading, viewing, printing, saving data, and calculating dosages). While it interacts with hardware (insulin pump and glucose meters), the device itself is the software.
Based on the provided information, the Animas ezManager Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Animas ezManager Plus Function: The primary functions of the Animas ezManager Plus are:
- Data Management: Downloading, viewing, printing, and saving data from blood glucose meters and insulin pumps. This is data that has already been generated by other devices.
- Dose Calculation: Calculating insulin or carbohydrate doses based on user-entered data and physician settings. This is a calculation based on existing information, not an analysis of a biological specimen.
While the software uses data from blood glucose meters (which are IVDs), the software itself does not perform the diagnostic test on a biological specimen. It's a tool for managing and utilizing data generated by other devices and for performing calculations.
Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Animas ezManager Plus is intended to serve as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. It is also intended for use in the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user data input.
The Animas ezManager Plus is indicated for use as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.
Product codes
LZG
Device Description
The Animas ezManager Plus diabetes management software is intended for a Microsoft Windows based personal computer or a Palm handheld organizer. The ezManager Plus allows the user to download, view, print, and save data from a number of commercially available glucose meters and the Animas IR1000 Insulin Infusion Pump. It also calculates an insulin or carbohydrate dosage based physician prescribed settings and data entered by the user. This software was developed using a Borland Delphi integrated development environment using an MS Access database structure and ActiveX Data Objects database connections. The synchronization dynamic library is totally compliant with the Palm Operating System (OS) Conduit requirement and was developed using Microsoft Visual C++ and the Palm OS Software Development Kit.
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
patient's or a physician's personal computer
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Minimed Solutions Software, Model 7311, and Therasense FreeStyle Tracker Diabetes Management System
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).
0
K07-2394
Section 5 510(k) Summary
- Submitter: Animas Corporation, 590 E. Lancaster Avenue, Frazer, PA 19355
- Michael J. Andrews, Ph.D., Director, Regulatory Affairs, Contact: Telephone: (610)-644 8990, extension 257, Fax: (610)-644-8717, Email: michaeland@animascorp.com
- Name of Device: Animas ezManager Plus
- Predicate Devices: Minimed Solutions Software, Model 7311, and Therasense FreeStyle Tracker Diabetes Management System
Description of the New Device: The Animas ezManager Plus diabetes management software is intended for a Microsoft Windows based personal computer or a Palm handheld organizer. The ezManager Plus allows the user to download, view, print, and save data from a number of commercially available glucose meters and the Animas IR1000 Insulin Infusion Pump. It also calculates an insulin or carbohydrate dosage based physician prescribed settings and data entered by the user. This software was developed using a Borland Delphi integrated development environment using an MS Access database structure and ActiveX Data Objects database connections. The synchronization dynamic library is totally compliant with the Palm Operating System (OS) Conduit requirement and was developed using Microsoft Visual C++ and the Palm OS Software Development Kit.
Intended Use of the New Device: The Animas ezManager Plus is intended to serve as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. It is also intended for use in the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user data input.
Comparision of the Technological Features of the Modified Device and the Predicate Device: The Animas ezManager Plus and the predicate devices are very similar in their technological features. Both the ezManager and the Solutions Software facilitate the transmission of pump data to a computer. The ezManager Plus can calculate an insulin or carbohydrate dosage based on the user's input. The FreeStyle Tracker
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uses data input by the user to calculate an insulin dosage necessary to correct an out of range blood glucose level.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 5 2003
Michael J. Andrews Ph.D. Director, Regulatory Affairs Animas Corporation 590 E. Lancaster Avenue Frazer, Pennsylvania 19355
Re: K022394
Trade/Device Name: Animas ezManager Plus Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 19, 2003 Received: March 20, 2003
Dear Dr. Andrews:
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 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 - Dr. Andrews
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. 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 Division 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,
Susan Runner, DDS, MA
Interim 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 Section 7
510(k) Number:
Device Name: Animas ezManager Plus
Indications for Use: The Animas ezManager Plus is indicated for use as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paturo Ciconte
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022394