(109 days)
No
The description focuses on data review, analysis, evaluation, and dose calculation based on pre-set parameters, not on learning or adaptive algorithms. There is no mention of AI, ML, or related concepts.
No.
This device is software that helps manage diabetes by analyzing data and calculating insulin/carbohydrate doses, but it does not directly apply therapy or alter the structure/function of the body.
No
The device is described as diabetes management software that allows for the review, analysis, and evaluation of insulin delivery and blood glucose history information, and for calculating insulin or carbohydrate doses. While it helps manage diabetes, it does not independently diagnose a condition.
No
While the core functionality is software, the description explicitly mentions the use of an "IR dongle" and "manufacturer specified connection cables" for data transfer, indicating reliance on specific hardware components beyond a general-purpose computer.
Based on the provided information, the Animas ezManager Plus diabetes management software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Animas ezManager Plus software primarily works with data downloaded from insulin pumps and blood glucose meters. While blood glucose meters themselves are IVDs (as they analyze a blood sample), the software is processing and analyzing the results of those tests, not performing the diagnostic test itself on a biological specimen.
- The intended use is for managing diabetes based on existing data and calculating doses. The software helps patients and healthcare professionals review, analyze, and evaluate historical data and calculate insulin or carbohydrate doses. This is a management and decision-support function, not a diagnostic function performed on a biological sample.
The software acts as an accessory to IVDs (the blood glucose meters) and a medical device (the insulin pump) to facilitate the management of a diagnosed condition. It does not perform a diagnostic test on a biological specimen to determine the presence or state of a disease.
N/A
Intended Use / Indications for Use
The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information.
The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.
Product codes
LZG
Device Description
The Animas ezManager Plus diabetes management system is software that is loaded onto a patient's or health care professional's personal computer to allow for downloading information from Animas insulin pumps and specified commercially available blood glucose meters. The system allows for users to view data stored in the pump and meter history such as basal deliveries, bolus deliveries and blood glucose measurements. The data can be displayed in numerous formats and configurations to facilitate trending and better diabetes management.
The Animas ezManager Plus diabetes management system also allows for Animas pump users to upload personal setting information to their pump. Personal setting information includes basal programs and rates, insulin to carbohydrate ratios, insulin sensitivity factors, target blood glucose ranges, and when available pump food database information (food, serving size and carbohydrate information). This feature allows users the convenience of programming and saving all of this information on their personal computers. Once the information is uploaded to the pump, the user is prompted to verify the active basal program before initiating therapy.
For Animas pumps the download and upload is completed using an IR dongle and the IR window on the back of the For the specified meters, the download is pump. accomplished by using the manufacturer specified connection cables.
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 and/or health care professional
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)
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
MAR 3 0 2007
510(k) Summary
SUBMITTER:
Animas Corporation 200 Lawrence Drive West Chester, PA 19380
Contact: Amy Smith; Manager, Regulatory & Clinical Affairs
Animas ezManager Plus Diabetes Management Software
COMMON OR USUAL NAME:
PREDICATE DEVICE:
DEVICE CLASSIFICATION:
DESCRIPTION:
DEVICE NAME:
Class II per CFR 21 §880.5725, Infusion Pump, product code LZG
Animas ezManager Plus, K022394 Deltec, CoZmanager, K062323
Insulin infusion pump accessory
The Animas ezManager Plus diabetes management system is software that is loaded onto a patient's or health care professional's personal computer to allow for downloading information from Animas insulin pumps and specified commercially available blood glucose meters. The system allows for users to view data stored in the pump and meter history such as basal deliveries, bolus deliveries and blood glucose measurements. The data can be displayed in numerous formats and configurations to facilitate trending and better diabetes management.
The Animas ezManager Plus diabetes management system also allows for Animas pump users to upload personal setting information to their pump. Personal setting information includes basal programs and rates, insulin to carbohydrate ratios, insulin sensitivity factors, target blood glucose ranges, and when available pump food database information (food, serving size and carbohydrate information). This feature allows users the convenience of programming and saving all of this information on their personal computers. Once the information is uploaded to the pump, the user is prompted to verify the active basal program before initiating therapy.
1
Kc63674 1 of 2
For Animas pumps the download and upload is completed using an IR dongle and the IR window on the back of the For the specified meters, the download is pump. accomplished by using the manufacturer specified connection cables.
INTENDED USE:
The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. I m The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information.
The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles in a row, with a flowing design element above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Smith Manager, Regulatory & Clinical Affairs Animas Corporation 200 Lawrence Drive West Chester, Pennsylvania 19380
MAR 3 0 2007
Re: K063674
Trade/Device Name: ezManager Plus Diabetes Management Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 8, 2007 Received: March 9, 2007
Dear Ms. Smith:
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.
3
Page 2 - Ms. Smith
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 your 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 (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snette y. Michael Oms.
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
4
Indications for Use
510(k) Number (if known): K063674
Device Name: ezManager Plus Diabetes Management Software
Indications for Use:
The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information.
The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anten Vm
f Anesthesiology, Regional Hospital Memorial Hospital
Suction Control, Control Devices
- Number: K463674
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K063674 - Animas ezManager Plus Diabetes Management Software