(90 days)
No
The description focuses on data acquisition, storage, display, and reporting of historical glucose data. There is no mention of AI/ML terms, algorithms, or functions that would suggest predictive analysis, pattern recognition beyond simple statistics, or automated decision support based on learned models.
No.
The device is a software application designed for data management, review, analysis, and evaluation of historical glucose test results. It does not directly treat or diagnose a disease state.
No
The device is described as a "Health Management System" and "PC-based software application" that aids in the "review, analysis and evaluation of historical glucose test results." It's used for "data acquisition and storage" and allows the display of "graphs and statistics." This functionality points to a data management and analysis tool, not a device that directly performs a diagnosis. While it supports an "effective diabetes management program," it does so by providing information from previously collected data, not by diagnosing a condition itself.
Yes
The device is described as a "PC-based software application" and a "data acquisition and storage application" that operates on a "Microsoft Windows Operating System platform." It explicitly states it is software and does not mention any accompanying hardware components that are part of the device itself.
Based on the provided information, the CoPilot™ Health Management System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "aid in the review, analysis and evaluation of historical glucose test results." It does not perform the glucose test itself.
- Device Description: The device is described as 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." It's a data management tool, not a device that analyzes biological samples.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CoPilot system only processes data from devices that perform these tests.
In essence, the CoPilot system is a data management and analysis tool that works with the results generated by IVD devices (the blood glucose monitoring systems). It doesn't perform the diagnostic test itself.
N/A
Intended Use / 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.
Product codes
NBW
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.
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
Home and clinical settings by people with diabetes and healthcare professionals.
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)
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.
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.
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
§ 862.1345 Glucose test system.
(a)
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.(b)
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.
0
Abbott Diabetes Care 1380 South Loop Road. Alameda. CA 94502
Image /page/0/Picture/3 description: The image shows a logo of the letter 'a' in a stylized font. The logo is created using a pattern of small dots or pixels, giving it a textured appearance. The background is white, which makes the logo stand out.
GEC 1 4 2005
510(k) Summary
General Information
| Submitter Information | Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 |
|-----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Mary Rose
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
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.
1
Abbott Diabetes Care 1380 South Loop Road. Alameda, CA 94502
Image /page/1/Picture/2 description: The image shows a stylized letter 'a' in a sans-serif font. The letter is formed by a thick outline, creating a hollow space within. The outline is composed of a dense pattern of small, indistinct characters or symbols, giving it a textured appearance.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
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).
3
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 (240) 276-0490. 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 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
4
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
Page 1 of __