DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

K090628 · Bayer Healthcare, LLC · NBW · Dec 4, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090628
• Device Name: DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Device Story

Didget Blood Glucose Monitoring System; consists of meter, test strips, and control solution. Input: fresh capillary whole blood from fingertip. Operation: electrochemical measurement of glucose concentration. Output: blood glucose level displayed on meter. Designed for home use by patients (ages 4+) with adult supervision. Includes interface for Nintendo gaming system to encourage monitoring compliance. Healthcare providers use output to assess glycemic control and adjust diabetes management plans. Benefits: facilitates routine glucose monitoring in pediatric/young adult populations through gamification.

Clinical Evidence

Laboratory and clinical studies conducted with diabetic subjects aged 5-24. Performance compared against the predicate Contour system and a laboratory reference method. Results demonstrated equivalent performance to the predicate device.

Technological Characteristics

Electrochemical glucose dehydrogenase-based sensing. Meter includes interface for Nintendo gaming system. No changes to fundamental scientific technology compared to predicate.

Indications for Use

Indicated for self-testing of blood glucose concentrations in patients with diabetes, ages 4 and older, using fresh capillary whole blood from the fingertip. Not for neonates, nor for diagnosis or screening of diabetes mellitus.

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

• Contour Blood Glucose Monitoring System (k062058)
• Contour Blood Glucose Monitoring System (k060470)

Submission Summary (Full Text)

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KC090628

DEC - 4 2009

Image /page/0/Picture/2 description: The image shows the Bayer HealthCare logo. The logo consists of the Bayer company symbol on the left and the text "Bayer HealthCare" and "Diabetes Care Division" on the right. The Bayer company symbol is a circle with the word "BAYER" written vertically inside.

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

The assigned 510(k) number is: K090628

| Prepared: | November 30, 2009 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer Healthcare Diabetes Care |
| Address: | Bayer Healthcare, Diabetes Care<br>777 Old Saw Mill River Road<br>Tarrytown, NY 10591<br>Phone [phone] FAX [phone] |
| Contact: | Susan Brocchi<br>Regulatory Affairs Specialist |
| Device: | Trade/ Proprietary Name: Didget<br>Common/Usual Name: Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Regulation - 21CFR 862.1345<br>Product Code - 75 LFR (Glucose Dehydrogenase, Glucose) |
| Predicate Devices: | Contour Blood Glucose Meter (K062058, K060470) |
| Device Description: | The Didget Blood Glucose Monitoring System consists of:<br>1. Didget Blood Glucose Monitor<br>2. Contour Blood Glucose Test Strips<br>3. Contour Control Solution |

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## Bayer Healthcare Didget Blood Glucose Monitoring System

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| Intended Use: | The Didget blood glucose monitoring system (meter, strips, and controls)<br>is intended for self-testing by people with diabetes to monitor glucose<br>concentrations in fresh capillary whole blood samples drawn from the<br>fingertip only. It is intended for those ages four and older, with adult<br>supervision as needed. The Didget blood glucose monitoring system is<br>not intended for the diagnosis of or screening for diabetes mellitus and is<br>not intended for use on neonates. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | There were no changes to the fundamental scientific technology |
| Comparison to<br>Predicate Device: | The modifications to the device encompass meter size/shape design<br>changes. There has been no change to the operating principle. An<br>interface for a Nintendo gaming system was added. The indication was<br>modified. |
| Assessment of<br>Performance: | An evaluation of the Didget Blood Glucose Monitoring System<br>was studied in the laboratory and in a clinical setting using persons with<br>diabetes, ages 5 through 24. The results were compared to results from<br>the currently marketed Contour system and to a laboratory method. The<br>studies showed equivalent performance with the current Contour system. |
| Conclusion: | The results of clinical evaluations of the Didget Blood Glucose<br>Monitoring System demonstrated that the device can produce blood<br>glucose results that are substantially equivalent to results obtained on the<br>predicate device. |

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wave-like lines beneath it.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DEC 4 2009

Bayer HealthCare Diabetes Care c/o Ms. Susan Brocchi Regulatory Affairs Specialist 777 Old Saw Mill River Road Tarrytown, NY 10591

k090628 Re:

Trade Name: Didget Blood Glucose Monitoring System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: November 03, 2009 Received: November 04, 2009

Dear Ms. Brocchi:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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## Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR 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 [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

Courtney C. Harper, Ph.D. 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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## Indication for Use

510(k) Number (if known): 090628

Device Name: Didget

Indication for Use:

The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K0910628

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