ACCU-CHEK SMART PIX

K062395 · Roche Diagnostics Corp. · NBW · May 9, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062395
• Device Name: ACCU-CHEK SMART PIX
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream. The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.

Device Story

Interface device for diabetes management; transfers stored data from compatible blood glucose meters and insulin pumps to a PC. Input: IR signals from meters/pumps. Transformation: device acts as a data bridge; processes and formats data into reports (trend graphs, daily/weekly profiles, metabolic control graphs, logbooks) viewable via standard web browsers without additional installed software. Output: visual reports/data streams on PC. Used in home or clinical settings by patients or healthcare providers. Benefits: provides data integrity, speed, and flexibility for diabetes monitoring; facilitates clinical decision-making through standardized reporting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing of device features.

Technological Characteristics

USB-powered data transfer device; dimensions 104 x 74 x 38 mm; weight 90 g. Connects to ACCU-CHEK blood glucose monitors and Disetronic/ACCU-CHEK insulin infusion pumps. Provides LED-based state messaging. Performs basic statistical calculations on stored data for report generation.

Indications for Use

Indicated for persons with diabetes or healthcare professionals to facilitate monitoring and clinical management of diabetes by transferring stored data from compatible blood glucose monitors and insulin infusion pumps to a computer.

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.

Predicate Devices

• Roche Diagnostics, Acculink Modem (k000364)

Submission Summary (Full Text)

{0}------------------------------------------------

K062395

MAY - 9 2007

## 510(k) Summary: ACCU-CHEK® Smart Pix Device

| 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>Indianapolis, IN 46250<br>Contact Person: Scott Thiel<br>Data Prepared: March 27, 2007 |
| Device Name | We claim substantial equivalence to the current legally marketed ACCU-<br>CHEK® Acculink Modem. |
| Device<br>Description | Accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK<br>insulin infusion pump that enables the persons with diabetes or healthcare<br>professionals to send stored data to a compatible computer. |
| Indications for<br>Use Statement | The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare<br>professionals to send stored data from their compatible ACCU-CHEK blood<br>glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a<br>compatible computer as a set of reports or data stream.<br><br>The ACCU-CHEK Smart Pix is intended to help monitor and clinically<br>manage individuals with diabetes. |

Continued on next page

..............................................................................................................................................................................

:

{1}------------------------------------------------

## 510(k) Summary: ACCU-CHEK® Smart Pix Device, Continued

#### Similarities

The proposed modification is relatively modest in scope. The following is a list of some of the claims and features unaffected by the proposed modifications.

| Feature / Claim | Detail |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connect to blood glucose monitors | Both devices connect to and<br>download information stored on<br>ACCU-CHEK brand blood glucose<br>monitors. |
| Warnings and precautions | For in vitro diagnostic use only. |
| State Messaging | Both devices provide feedback to the<br>consumer through a combination of<br>LED flashes. |
| Reports | Both devices create reports and<br>graphs using basic statistical<br>calculations of the historic data<br>stored in the devices they can<br>connect to. |

Contimied on next page

... ... .. ..

{2}------------------------------------------------

# 510(k) Summary: ACCU-CHEK® Smart Pix Device, Continued

| Feature / Claim | ACCU-CHEK Smart<br>Pix | Predicate | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Power supply | USB port | AC adapter | |
| Weight | 90 g | 205 g | |
| Size | 104 x 74 x 38 mm | 137 x 113 x 41 mm | |
| Intended use | The ACCU-CHEK®<br>Smart Pix enables<br>persons with diabetes<br>or healthcare<br>professionals to send<br>stored data from their<br>compatible ACCU-<br>CHEK blood glucose<br>monitor and/or<br>Disetronic/ACCU-<br>CHEK Insulin infusion<br>pump to a compatible<br>computer as a set of<br>reports or data stream.<br><br>The ACCU-CHEK<br>Smart Pix is intended to<br>help monitor and<br>clinically manage<br>individuals with<br>diabetes. | The ACCU-CHEK®<br>Acculink modem is<br>designed to enable the<br>self-tester to send data<br>from a supported Accu-<br>Chek brand meter to<br>either a facsimile (fax)<br>machine or Roche<br>supported software<br>utilized by a physician,<br>pharmacist, or other<br>member of the self-<br>tester's health care<br>team. The data<br>transmission takes<br>place over standard<br>telephone service<br>(POTS) lines or<br>telephone line<br>emulator. | |
| | Ambient conditions | Service temperature:<br>5 - 40 C<br>Storage temperature:<br>-25 - 70 C<br>Humidity:<br>9.6 - 98% Rh | Operating temperature:<br>0-50 C<br>Storage temperature:<br>-25 - 65 C<br>Humidity:<br>0 – 95% Rh |

### Differences

The following is a listing of the key differences between the ACCU-CHEK Smart Pix and the predicate device.

:

. . . . . .

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 9 2007

Roche Diagnostics Corp. c/o Mr. Scott Thiel Global Regulatory Affairs Diabetes Care 9115 Hague Road Indianapolis, IN 46256

Re: k062395 Trade/Device Name: ACCU-CHEK® Smart Pix Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LZG, JQP Dated: March 28, 2007 Received: March 29, 2007

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 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).

{4}------------------------------------------------

Page 2 -

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.

Jean 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

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): ___K062395

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream.

The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.

Prescription Use XX (Part 21 CFR 801 Subpart D)

ANDJOR

Over-The-Counter Use XX (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)

Arin M. Cooper, M.S., D.V.M
Division Sign-Off

ce of In Vitro Di

Page 1 of 1