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.

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 pump. For the specified meters, the download is accomplished by using the manufacturer specified connection cables.

AI/ML Overview

The provided text is related to a 510(k) submission for the "Animas ezManager Plus Diabetes Management Software". It describes the device, its intended use, and the FDA's decision regarding its substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices rather than providing detailed performance study results against predefined acceptance criteria for a new, groundbreaking technology. This type of submission often relies on a comparison of features, intended use, and historical safety/efficacy of predicate devices.

Therefore, I cannot populate the requested table and answer many of the questions from the provided text.

Here's what I can extract and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document

Explanation: The document does not define specific performance metrics (e.g., accuracy of insulin dose calculation, data transfer integrity rates) or corresponding acceptance thresholds for these metrics. It is a 510(k) summary, which generally focuses on demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. (The document does not describe a clinical or lab study that would generate this data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable, as no ground truth establishment for a test set is described.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: Not applicable. The device is a diabetes management software, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting cases.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance Study: Not described. The software's function is to manage data and calculate doses based on user-entered data and professional settings; it's inherently a human-in-the-loop system where the user interacts with the generated information.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no ground truth for a performance study is described. The "ground truth" in the context of this device would likely refer to the accuracy of data transfer from pumps/meters and the correctness of insulin/carbohydrate dose calculations based on specified algorithms and user inputs. However, no study demonstrating this is provided.

8. The sample size for the training set:

Not applicable, as the document does not describe a machine learning model that would require a training set. This is a software system for data management and calculation, not an AI/ML diagnostic or predictive model.

9. How the ground truth for the training set was established:

Not applicable.

Summary of what is available from the document:
The document primarily provides descriptive information about the device, its intended use, and the regulatory pathway. It identifies the device as an insulin infusion pump accessory (software) that allows for:

Downloading data from Animas insulin pumps and blood glucose meters.
Viewing data in various formats.
Uploading personal settings (basal programs, ratios, etc.) to Animas pumps.
Calculating insulin or carbohydrate doses based on prescribed settings and user input.

The document states that the predicate devices were:

Animas ezManager Plus, K022394
Deltec, CoZmanager, K062323

The FDA determined the device to be substantially equivalent to these predicate devices for its stated indications for use. This regulatory conclusion is the primary outcome of the 510(k) submission described.

Summary

{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

{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

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Indications for Use

510(k) Number (if known): K063674

Device Name: ezManager Plus Diabetes Management Software

Indications for Use:

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

Page 1 of 1 i

K063674 - Animas ezManager Plus Diabetes Management Software

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).