MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE

K082595 · Roche Diagnostics · LZG · Oct 28, 2008 · General Hospital

Device Facts

• Record ID: K082595
• Device Name: MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
• Applicant: Roche Diagnostics
• Product Code: LZG · General Hospital
• Decision Date: Oct 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.

Device Story

Accessory software for PDAs; enables download, storage, and analysis of historical blood glucose and insulin pump data. Facilitates diabetes management for patients and clinicians. Features bolus calculator for insulin or carbohydrate dosing based on user-entered data. Requires communication with a supported insulin pump to activate bolus calculator functionality. Used by patients and healthcare professionals to review trends and evaluate therapy. Does not provide medical diagnoses. Supports effective diabetes management through data visualization and reporting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based diabetes management system; operates on personal digital assistants (PDAs). Connectivity via data download from compatible insulin pumps and blood glucose meters. Features include data storage, report generation, and bolus calculation. Security control requires pump communication to enable bolus calculator.

Indications for Use

Indicated for individuals with diabetes using compatible Disetronic insulin pumps and Accu-Chek blood glucose meters for data management and insulin/carbohydrate dose calculation. Available for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

• ACCU-CHEK Pocket Compass Diabetes Management Software (K082595)

Submission Summary (Full Text)

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# 510(k) Summary

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K082595

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] ext. 13362<br>Contact Person: Scott Thiel<br>Date Prepared: September 5, 2008 |
| 2) Device name | Proprietary name: ACCU-CHEK® Pocket Compass Diabetes Management Software<br>Common name: diabetes management software<br>Classification name: calculator/data processing module for clinical use<br>Classification Regulations: 880.5725, 862.1345, 862.2100<br>Product Codes: LZG, LFR, JQP |
| 3) Predicate device | We claim substantial equivalence to the current legally cleared product of the same name. |
| 4) Device Description | An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user entered data. The device is not intended to provide any diagnosis based upon patient results. |
| 5) Intended use | The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale. |

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### 510(k) Summary, Continued

## Comparison to Predicate Device

The Roche Diagnostics ACCU-CHEK Pocket Compass Similarities Diabetes Management Software is substantially equivalent to the current legally cleared version of ACCU-CHEK Pocket Compass Diabetes Management Software. The following is a list of some of the claims and features found to be similar to the predicate device.

| Feature/Claim | Detail |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Meter / pump<br>data download | Yes. Both products allow for the download of historical<br>data stored in the compatible devices |
| Pump data<br>upload | No. Neither product sends programming or parameter<br>information to the compatible pumps. |
| Support | Yes; through call center support, labeling and health care<br>professionals. |
| Data storage | On computer media. |
| Reports and<br>graphs | Similar graphs and reports can be generated for viewing<br>on a display screen, and hard copy printout. |
| Manual Data<br>Entry | Same |
| Delete Data | Same |
| Track non-<br>blood glucose<br>data | Same |
| Intended use | Same |
| Fundamental<br>scientific<br>technology | Same |
| Security of<br>Bolus<br>Calculator | Same; requires user to communicate to the software with<br>a supported insulin pump before the bolus calculator is<br>active |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 8 2008

Mr. Scott Thiel Regulatory Affairs Program Manager Roche Diagnostics Diabetes Care Division 9115 Hague Road Indianapolis, Indiana 46250

Re: K082595

Trade/Device Name: ACCU-CHEK® Pocket Compass Diabetes Management Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, LFR, JQP Dated: October 13, 2008 Received: October 15, 2008

Dear Mr. Thiel:

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 - Mr. Thiel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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):

#### Device Name: ACCU-CHEK® Pocket Compass Diabetes Management Software

Indications For Use:

The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabctcs by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use XX (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cim

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1-082595 510(k) Number: _