(80 days)
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.
This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from Bayer's DIDGET® blood glucose meter to the DIDGET®World Reports web server through the use of a USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways:
Electronic logbook where all of the data can be seen
Glucose trend of the results by date
Daily blood glucose trend (standard day)
Weekly blood glucose trend (standard week)
Summary chart (histogram or pie chart)
The DIDGET® World Reports Diabetes Management Software is a diabetes data management software program. The performance assessment focused on its ease of use and understandability of results.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Program is easy to use | The study showed that the program is easy to use |
| Results are understandable by users | The study showed that the results are understandable by the users |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Fifty (50) subjects.
- 3 healthcare professionals (HCPs)
- 47 lay users (35 young adults with diabetes and 12 parents or legal guardians of children with diabetes).
- Data Provenance: The document does not specify the country of origin. The study was a "Performance Assessment," implying it was a prospective study designed specifically to evaluate this software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is software for viewing and printing blood sugar readings. The performance assessment was about usability and understandability rather than diagnostic accuracy against a "ground truth" established by experts in the typical clinical sense (e.g., radiologists interpreting images). The "ground truth" in this context was subjective user feedback on ease of use and understandability of the presented data. The study included 3 healthcare professionals, but their role was as participants providing feedback, not as independent adjudicators establishing a gold standard for the data.
4. Adjudication method for the test set:
Not applicable. The study assessed subjective user experience (ease of use and understandability) rather than objective clinical outcomes requiring adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a data management software, not an AI-powered diagnostic tool, and the study did not involve human readers interpreting cases or AI assistance for diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance assessment focused on the human-in-the-loop experience (users interacting with the software). A standalone performance of the algorithm itself (e.g., data transfer accuracy, report generation accuracy) is implied by the "verification and validation studies" mentioned, but specific details of such standalone tests are not provided in this summary. The stated performance assessment is user-centric.
7. The type of ground truth used:
The "ground truth" for this performance study was subjective user feedback and experience regarding the software's ease of use and the understandability of its presented data.
8. The sample size for the training set:
Not applicable. This regulatory submission concerns a diabetes data management software. There is no mention of a machine learning or AI model being trained, thus no "training set" in that context. The software's functionality is based on displaying and organizing existing data, not on learning from data to make predictions or classifications.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.
{0}------------------------------------------------
Bayer HealthCare Diabetes Care
MAR 1 2 2010
Image /page/0/Picture/2 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once vertically and once horizontally, forming a cross shape. The entire logo is enclosed within a double-lined circle.
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 RoadTarrytown, NY 10591Phone (914) 333-6736; FAX (914) 333-6160 |
| Contact: | Susan Brocchi, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: DIDGET® World Reports DiabetesManagement Software |
| Common/Usual Name: | Diabetes data management software program. |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 NBW, JQP |
| Predicate Device: | GLUCOFACTS® Express Diabetes Management Software, K082486 |
| Device Description: | This software application allows the transfer of blood glucoseresults, along with time, date, and certain data markers, fromBayer's DIDGET® blood glucose meter to the DIDGET®WorldReports web server through the use of a USB cable. Data analysisincludes allowing the home-user or healthcare professional toview the data in five different ways: |
| Electronic logbook where all of the data can be seenGlucose trend of the results by dateDaily blood glucose trend (standard day)Weekly blood glucose trend (standard week)Summary chart (histogram or pie chart) |
{1}------------------------------------------------
510(k) Summary, continued DIDGET® WORLD REPORTS Diabetes Management Software Page 2 of 2
| Intended Use: | DIDGET® World Reports Diabetes Management Software is anover-the-counter software program for use by healthcareprofessionals and patients with diabetes for viewing and printingreports that display blood sugar readings from Bayer's DIDGET®blood glucose meter. |
|---|---|
| TechnologicalCharacteristics: | There were no changes to the fundamental scientific technology. |
| Comparison toPredicate device: | DIDGET® World Reports Diabetes Management Software issimilar in function to the predicate device, GLUCOFACTS® ExpressDiabetes Management Software, K082486, but has been updated torun off of the Didget World web server. |
| Assessment ofPerformance: | Performance was assessed in a study that included fifty (50)subjects consisting of 3 healthcare professionals (HCPs) and 47 layusers (35 young adults with diabetes and 12 parents or legalguardians of children with diabetes). The study showed that theprogram is easy to use and the results are understandable by theusers. |
| Conclusion: | The results of the verification and validation studies of theDIDGET® World Reports Diabetes Management Softwaredemonstrated that the product is safe and effective in the hands oflay users and healthcare professionals. The product issubstantially equivalent to the predicate device. |
ूं में
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.
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).
{3}------------------------------------------------
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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
{4}------------------------------------------------
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
§ 862.1345 Glucose test system.
(a)
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.(b)
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.