DIDGET WORLD REPORTS

K093930 · Bayer Healthcare, LLC · NBW · Mar 12, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093930
• Device Name: DIDGET WORLD REPORTS
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The DIDGET World Reports Diabetes Management Software is intended for use by patients with diabetes to track and manage their blood glucose data. The software is designed to be used in conjunction with the DIDGET blood glucose meter to download, store, and display blood glucose results.

Device Story

Software application; transfers blood glucose results, time, date, and data markers from Bayer DIDGET® blood glucose meter to DIDGET® World Reports web server via USB cable. Used by patients with diabetes and healthcare professionals in home or clinical settings. Transforms raw meter data into five report formats: electronic logbook, glucose trend by date, daily blood glucose trend (standard day), weekly blood glucose trend (standard week), and summary charts (histogram/pie chart). Enables visualization of glucose data to assist in diabetes management and clinical decision-making.

Clinical Evidence

Performance assessed in a study of 50 subjects: 3 healthcare professionals and 47 lay users (35 young adults with diabetes, 12 parents/guardians of children with diabetes). Study demonstrated ease of use and understandability of results for the target user population.

Technological Characteristics

Web-based software application; connectivity via USB cable for data transfer from blood glucose meter. No changes to fundamental scientific technology compared to predicate. Software-based data management and reporting system.

Indications for Use

Indicated for patients with diabetes to track and manage blood glucose data using the DIDGET blood glucose meter.

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

• GLUCOFACTS® Express Diabetes Management Software (k082486)

Submission Summary (Full Text)

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# Bayer HealthCare Diabetes Care

MAR 1 2 2010

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### 510(k) SUMMARY

## DIDGET® World Reports Data Management Software

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is ﮮ۔ 39.393

| Prepared: | December 18, 2009 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer HealthCare Diabetes Care |
| Address: | 777 Old Saw Mill River Road<br>Tarrytown, NY 10591<br>Phone [phone]; FAX [phone] |
| Contact: | Susan Brocchi, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: DIDGET® World Reports Diabetes<br>Management Software |
| Common/Usual Name: | Diabetes data management software program. |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code - 75 NBW, JQP |
| Predicate Device: | GLUCOFACTS® Express Diabetes Management Software, k082486 |
| Device Description: | This software application allows the transfer of blood glucose<br>results, along with time, date, and certain data markers, from<br>Bayer's DIDGET® blood glucose meter to the DIDGET®World<br>Reports web server through the use of a USB cable. Data analysis<br>includes allowing the home-user or healthcare professional to<br>view the data in five different ways: |
| | Electronic logbook where all of the data can be seen<br><br>Glucose trend of the results by date<br><br>Daily blood glucose trend (standard day)<br><br>Weekly blood glucose trend (standard week)<br>Summary chart (histogram or pie chart)<br> |

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### 510(k) Summary, continued DIDGET® WORLD REPORTS Diabetes Management Software Page 2 of 2

| Intended Use: | DIDGET® World Reports Diabetes Management Software is an<br>over-the-counter software program for use by healthcare<br>professionals and patients with diabetes for viewing and printing<br>reports that display blood sugar readings from Bayer's DIDGET®<br>blood glucose meter. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | There were no changes to the fundamental scientific technology. |
| Comparison to<br>Predicate device: | DIDGET® World Reports Diabetes Management Software is<br>similar in function to the predicate device, GLUCOFACTS® Express<br>Diabetes Management Software, k082486, but has been updated to<br>run off of the Didget World web server. |
| Assessment of<br>Performance: | Performance was assessed in a study that included fifty (50)<br>subjects consisting of 3 healthcare professionals (HCPs) and 47 lay<br>users (35 young adults with diabetes and 12 parents or legal<br>guardians of children with diabetes). The study showed that the<br>program is easy to use and the results are understandable by the<br>users. |
| Conclusion: | The results of the verification and validation studies of the<br>DIDGET® World Reports Diabetes Management Software<br>demonstrated that the product is safe and effective in the hands of<br>lay users and healthcare professionals. The product is<br>substantially equivalent to the predicate device. |

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

Bayer Healthcare LLC c/o Susan Brocchi 777 Old Saw Mill River Road, Tarrytown, NY 10591

HAR : 2 2010

Re: k093930

Trade/Device Name: DIDGET World Reports Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: February 17, 2010 Received: February 18, 2010

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 (QS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cfa

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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## Indications for Use

Ko93930 510(k) Number (if known):

Device Name: DIDGET® World Reports Diabetes Management Software

Indications for Use:

DIDGET® World Reports Diabetes Management Software is an over-the -counter software program for use by healthcare professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Bayer's DIDGET® blood glucose meter.

Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use __X (21 CFR Part 801 Subpart C)

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

And/Or

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) K093930