COPILOT HEALTH MANAGEMENT SYSTEM

K062770 · Abbott Diabetes Care, Inc. · NBW · Dec 14, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062770
• Device Name: COPILOT HEALTH MANAGEMENT SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CoPilot™ Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.

Device Story

CoPilot Health Management System is PC-based software for diabetes data management. It ingests glucose data uploaded from FreeStyle and Precision Blood Glucose Monitoring Systems. Software functions include data entry, report generation, and synchronization. Used in home and clinical settings by patients, caregivers, and healthcare professionals. Users view glucose data via various graphs and statistics based on selectable date intervals, time segments, and target ranges. Output facilitates review and analysis of historical glucose results to support diabetes management decisions.

Clinical Evidence

No clinical data. Performance established through software, software QA, and system verification testing in accordance with FDA guidance for medical device software.

Technological Characteristics

PC-based software application operating on Microsoft Windows. Functions include data acquisition, storage, and reporting. Features data entry, report generation, and synchronization. Connectivity via data upload from blood glucose monitoring systems.

Indications for Use

Indicated for people with diabetes and healthcare professionals in home and clinical settings to aid in the review, analysis, and evaluation of historical glucose test results to support diabetes management programs.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Abbott Diabetes Care 1380 South Loop Road. Alameda. CA 94502

K062770

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GEC 1 4 2005

# 510(k) Summary

#### General Information

| Submitter Information | Abbott Diabetes Care Inc.<br>1360 South Loop Road<br>Alameda, CA 94502 |
|-----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Mary Rose<br>Regulatory Affairs Supervisor |
| Telephone No.: | 510.239.2634 |
| Fax No. | 510.864.4770 |
| Date Prepared | October 26, 2006 |
| Device Information: | |
| Proprietary Name: | CoPilot™ Health Management System |
| Common Name: | Data Management Software |
| Predicate Device: | Precision Link™ Diabetes Data Management<br>System (cleared 3/25/2004, under K040628) |

## Device Description

The CoPilot™ Health Management System is a PC-based software application that permits people with diabetes, their healthcare team, and caregivers to upload data from FreeStyle and Precision Blood Glucose Monitoring Systems into the CoPilot System. The CoPilot™ Health Management System is intended for use in home and clinical settings to upload data from these devices to a patient's or healthcare professional's computer where the data may be saved, displayed in a number of formats, printed, or exported to an authorized user.

#### Intended Use

The CoPilot™ Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.

Image /page/0/Picture/12 description: The image shows the Abbott logo. The logo consists of a stylized letter 'A' on the left, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller font size.

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Abbott Diabetes Care 1380 South Loop Road. Alameda, CA 94502

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### Technological Characteristics

The CoPilot Health Management System software is a data acquisition and storage application used for diabetes data management. The CoPilot software features three main data functions of data entry, reports, and synchronization.

CoPilot Health Management System software operates in a Microsoft Windows Operating System platform. The software allows the user to display a variety of graphs and statistics based on userselectable date intervals, time of day segments, and blood glucose target ranges.

#### Performance Data

The CoPilot™ Health Management System software has been developed in accordance with the FDA's Guidance for the Content of Premarket Submission for Medical Devices Containing Software (May 11, 2005) and General Principles of Software Validation 1/11/2002: Final Guidance for Industry and FDA Staff, where applicable and appropriate.

Software, Software QA, and System verification testing demonstrates that the CoPilot™ Health Management System meets the performance requirements for the intended use of the system.

#### Non-clinical/Clinical Conclusions

Results of non-clinical and clinical testing demonstrate that the performance of the CoPilot™ Health Management System is acceptable and comparable to the performance and safety characteristics of the predicate device when used according to its intended use.

Image /page/1/Picture/11 description: The image shows the logo for Abbott. The logo consists of a stylized letter "a" on the left, followed by the word "Abbott" in bold, sans-serif font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, serif font.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 6 2007

Ms. Mary Rose Regulatory Affairs Supervisor Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502

Re: k062770

Trade/Device Name: CoPilot Health Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: September 14, 2006 Received: September 18, 2006

#### Dear Ms. Rose:

This letter corrects our substantially equivalent letter of December 14, 2006.

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k062770

Device Name: CoPilot™ Health Management System

Indications For Use:

The CoPilot™ Health Management System is intended for use in the home and clinical settings by people with diabetes and healthcare professionals as an aid in the review, analysis and evaluation of historical glucose test results in support of an effective diabetes management program.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Sz
Division Sign-Off

Division Sign-Off

Office of In Vitro Dlag Device Evaluation a

510/k

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