(73 days)
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No
The description focuses on data display and reporting, with no mention of AI/ML terms or functionalities like prediction, classification, or learning.
No.
The device is a diabetes management software that helps review, analyze, and evaluate insulin delivery and blood glucose history information. It is an accessory to insulin pumps and blood glucose meters, and its purpose is to facilitate trending and diabetes management, not to directly treat or diagnose a disease.
No
The software facilitates the review, analysis, and evaluation of existing data (insulin delivery and blood glucose history) to support diabetes management. It does not generate new diagnostic information or directly diagnose a disease.
Yes
The device is described as "Software" and is installed on a personal computer. Its function is to download, display, and analyze data from external medical devices (insulin pumps and blood glucose meters), not to directly interact with the patient's body or perform a physical function. The description focuses solely on software functionalities and data management.
Based on the provided information, the Animas ezManager® MAX Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software's intended use is to support diabetes management by allowing for the review, analysis, and evaluation of existing insulin delivery and blood glucose history information. It does not perform any tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The software downloads and displays historical data from insulin pumps and blood glucose meters. It facilitates trending and management based on this data, but it doesn't perform any diagnostic testing itself.
- Lack of IVD Characteristics: IVDs typically involve reagents, calibrators, controls, and procedures for analyzing biological samples (like blood, urine, etc.) to provide diagnostic information. This software does not have any of these characteristics.
The software is described as an accessory to Animas insulin pumps and blood glucose meters, which are themselves medical devices, but the software's function is data management and analysis, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Animas ezManager® MAX 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 healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
Product codes
MRZ
Device Description
The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.
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 healthcare 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
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Summary of Performance Studies
Non-Clinical Testing: The Animas ezManager MAX met software verification and validation test parameters, and label comprehension study requirements to assure the device performs as intended. Results of all testing provide reasonable assurance of safety and effectiveness for its intended use.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image shows the logo for Animas Corporation, a Johnson & Johnson company. The logo features a stylized figure integrated into the letter 'A' of 'Animas'. Below 'Animas' is the word 'Corporation' in smaller, block letters, and below that is the text 'a Johnson+Johnson company' in a cursive font.
MAY 1 5 2008
510(k) Summary
| Submitted by: | Animas Corporation
200 Lawrence Drive
West Chester, PA 19380 |
|--------------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, Regulatory Affairs Manager
Ph: (610) 644-8990 Fax: (484) 885-2381 |
| Date Prepared: | May 9, 2008 |
| 510(k) Number: | K080587 |
| Device Trade Name: | Animas ezManager® MAX Diabetes Management Software |
| Common/Usual Name: | Insulin Infusion Pump Accessory |
| Proposed Classification: | Infusion Pump
21 CFR § 880.5725 Class II, 80 MRZ—General Hospital |
Device Description:
The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.
Indications for Use:
The Animas ezManager MAX 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 healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
Predicate Device:
K063674 - Animas ezManager® Plus Diabetes Management Software (Animas Corporation)
Substantial Equivalence: .
The Animas ezManager MAX is substantially equivalent to the legally marketed predicate. Animas ezManager Plus. Both devices have the same intended use and fundamental scientific technology.
Non-Clinical Testing:
The Animas ezManager MAX met software verification and validation test parameters, and label comprehension study requirements to assure the device performs as intended. Results of all testing provide reasonable assurance of safety and effectiveness for its intended use.
200 LAWRENCE DRIVE * WEST CHESTER PA 19380 * PHONE 610- 644-8990 * FAX 610-644-87 13
Image /page/0/Picture/16 description: The image shows a circular seal or emblem. The seal has a dark background with a lighter-colored design in the center. The central design appears to be an abstract or stylized image, possibly representing a bird or a stylized letter. The design is surrounded by a circular border with text or patterns along the edge of the seal.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
Ms. Jennifer J. Bosley Manager, Regulatory Affairs Animas Corporation 200 Lawrence Drive West Chester, Pensylvania 19380
Re: K080587
Trade/Device Name: ezManager MAX Diabetes Management Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: February 29, 2008 Received: March 3, 2008
Dear Ms. Bosley:
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 - Ms. Bosley
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
3
Indications for Use Statement
510(k) Number (if known):
Device Name: ezManager® MAX Diabetes Management Software
Indications For Use:
The Animas ezManager® MAX 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 healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(P.R. 21-01-001 Backpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles Broth fr. A. Du
(Division Sign Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K080587
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