ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

K080227 · Roche Diagnostics Corp. · MRZ · May 15, 2008 · General Hospital

Device Facts

• Record ID: K080227
• Device Name: ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: MRZ · General Hospital
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ACCU-CHEK® 360° Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without diabetes related information, which can be shown in report and graphical format. This device is indicated for professional use and over-the-counter sale.

Device Story

ACCU-CHEK 360° Diabetes Management System is software for diabetes management; functions as accessory to ACCU-CHEK blood glucose meters and Disetronic/ACCU-CHEK insulin infusion pumps. Device downloads memory data from connected meters/pumps; allows manual entry of additional health parameters (e.g., carbohydrates, insulin, event codes). Software processes data to generate reports and graphical statistics for retrospective analysis. Used by patients (home) or healthcare professionals (clinics/facilities). Output viewed on-screen, printed, or emailed to assist clinical decision-making and diabetes management. Features include password protection, multi-patient database support, and activation keys to manage program functionality.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based diabetes management system. Compatible with Microsoft XP OS. Implements secure socket layer (SSL) protocol with 128-bit encryption for data security. Features include password protection, manual data entry, and multi-patient database management. Connectivity via device memory download from glucose meters and insulin pumps.

Indications for Use

Indicated for individuals with diabetes or healthcare professionals managing diabetes in home or clinical settings. Supports data entry of health parameters and diabetes-related information for report generation.

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

• Camit Diabetes Management Software (K001907)
• Smart Pix Device Reader (K062395)

Submission Summary (Full Text)

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K080227

MAY 1 5 2008

______________________________________________________________________________________________________________________________________________________________________________

# 510(k) Summary: ACCU-CHEK® 360° Diabetes Management System

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd.<br>PO Box 50457<br>Indianapolis, IN 46250<br>Contact Person: Scott Thiel |
| Device<br>Classification | Trade Name: ACCU-CHEK® 360° Diabetes Management System<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 |
| Predicate<br>Device(s) | We claim substantial equivalence of the ACCU-CHEK 360° Diabetes<br>Management System to the current legally marketed Camit Diabetes<br>Management Software (K001907) and Smart Pix Device Reader (K062395). |
| Device<br>Description | Software accessory to ACCU-CHEK® brand meters and/or<br>Disetronic/ACCU-CHEK insulin infusion pumps. |
| Indications for<br>Use Statement | The ACCU-CHEK® 360° Diabetes Management System is indicated for use<br>by individuals or healthcare professionals in the home or health care facilities<br>to support effective diabetes management. The software also allows for entry<br>of other healthcare parameters with or without diabetes related information,<br>which can be shown in report and graphical format. This device is indicated<br>for professional use and over-the-counter sale. |

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## 510(k) Summary: ACCU-CHEK® 360 Diabetes Management System, Continued

The following tables provide a listing of product similarities and differences Similarities and Differences between the ACCU-CHEK® 360° Diabetes Management System and the predicate devices: ACCU-CHEK® Camit Diabetes Management Software and ACCU-CHEK® Smart Pix.

| ACCU-CHEK® 360° | Camit | Smart Pix |
|---------------------------------------------------------------------------------------------------------------|-------|-----------|
| Downloads device memory from ACCU-<br>CHEK blood glucose monitors. | Yes | Yes |
| Downloads device memory from ACCU-<br>CHEK insulin infusion pumps. | No | Yes |
| Generates reports and basic statistics to<br>support retrospective data analysis. | Yes | Yes |
| Generates reports using retrospective data<br>from both blood glucose monitors and<br>insulin infusion pumps. | No | Yes |
| Uses activation key to establish which<br>program functionality is made available to<br>the end user. | No | No |
| Compatible with Microsoft XP Operating<br>System (OS). | Yes | Yes |
| Support through ACCU-CHEK Customer<br>Care | Yes | Yes |
| Data storage on computer media | Yes | Yes |
| Track non-blood glucose data (e.g.<br>carbohydrates, insulin, time blocks, event<br>codes) | Yes | Yes |
| On-line help | Yes | No |
| Ability to support multiple patients in the<br>same database | Yes | No |
| Password protection | Yes | No |
| Allows for manual entry of data | Yes | No |

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# 510(k) Summary: ACCU-CHEK® 360 Diabetes Management System, Continued

#### Similarities and Differences (continued)

| ACCU-CHEK® 360° | Camit | Smart Pix |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Security through secure socket layer<br>protocol with 128-bit encryption. Reliance<br>upon user to maintain security of user id<br>and password. | Yes | Yes |
| User has option of sending reports via<br>email, printing, or viewing on screen | User has option of<br>reviewing on screen or<br>printing. | User has option of<br>reviewing on screen or<br>printing. |
| On-line help, tour, getting started guide,<br>frequently asked questions (FAQ). | Yes | Yes |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 15 2008

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

Re: K080227

Trade/Device Name: ACCU-CHEK® 360° Diabctes Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: May 1, 2008 Received: May 2, 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 Office of Compliance 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 http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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): K080227

Device Name: ACCU-CHEK® 360° Diabetes Management System

Indications for Use:

The ACCU-CHEK® 360° Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without nianagement. The betwere and in report and graphical format. This device is indicated for professional use and over-the-counter sale.

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

XX 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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K080227