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.

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.

AI/ML Overview

The provided text describes the Animas ezManager® MAX Diabetes Management Software, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what is and is not available in the provided text, in relation to your request:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: The document states the device "met software verification and validation test parameters, and label comprehension study requirements" but does not specify what those parameters or requirements were, nor the numerical performance results against them.
Sample size used for the test set and the data provenance: No details are provided about the size of the test set for verification/validation, nor the origin of any data used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for testing.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "software verification and validation test parameters" would likely involve standalone testing, but no details are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
The sample size for the training set: As this is software that processes existing data, there isn't a "training set" in the machine learning sense. The software processes data from insulin pumps and blood glucose meters.
How the ground truth for the training set was established: Not applicable in the machine learning sense for this device. The "ground truth" for this device is the accurate representation and calculation of the data it receives from the connected medical devices.

Information that is available (or can be inferred from) the provided text:

1. Acceptance Criteria (Indirectly discussed via testing):
- Acceptance Criteria (Implied): The Animas ezManager MAX must meet "software verification and validation test parameters" and "label comprehension study requirements."
- Reported Device Performance: "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." (No specific metrics or quantitative results are provided).
6. If a standalone was done: Yes, non-clinical testing including "software verification and validation test parameters" was performed, which implies standalone performance evaluation of the software itself. The letter states, "The Animas ezManager MAX met software verification and validation test parameters, and label comprehension study requirements to assure the device performs as intended."
7. The type of ground truth used: For a device like this, which processes and displays data from other medical devices, the "ground truth" implicitly refers to the accuracy and integrity of the data received from the Animas insulin pumps and specified commercially available blood glucose meters, and the correctness of the software's processing, analysis, and display of that data. The software's function is to accurately reflect external data.

Summary based on the provided text:

The document states that the Animas ezManager MAX Diabetes Management Software underwent "software verification and validation test parameters, and label comprehension study requirements" and that "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." However, it does not provide detailed acceptance criteria, specific performance metrics, sample sizes, or specifics on how ground truth was established beyond the general statement of validation. It is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the way one might expect for a novel therapeutic or diagnostic device requiring extensive efficacy studies.

Summary

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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 Corporation200 Lawrence DriveWest Chester, PA 19380
Contact Person:	Jennifer Bosley, Regulatory Affairs ManagerPh: (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 Pump21 CFR § 880.5725 Class II, 80 MRZ—General Hospital

Device Description:

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

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Indications for Use Statement

510(k) Number (if known):

Device Name: ezManager® MAX Diabetes Management Software

Indications For Use:

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

Page 1 of 1

Regulation Number and Section

§ 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).