(80 days)
Not Found
No
The description focuses on data visualization and reporting, with no mention of AI/ML terms or functionalities like prediction, classification, or learning from data.
No
The device is a software program that allows viewing and printing reports of blood sugar readings. It does not directly treat or prevent a disease and is intended for management and viewing of data by healthcare professionals and patients.
No
The software is for viewing and reporting blood glucose readings; it does not perform diagnosis or aid in diagnosis directly.
Yes
The device is described as a "software program" and its function is to transfer, view, and analyze data from a separate hardware device (Bayer's DIDGET® blood glucose meter). The 510(k) summary focuses on the software's functionality and user interface, not on any hardware components included with the submission.
Based on the provided information, the DIDGET® World Reports Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The primary function of this software is to view and report blood glucose readings that have already been obtained by a separate device (the DIDGET® blood glucose meter). It does not perform any tests or analyses on biological samples itself.
- The software processes data, not biological specimens. It takes data from the blood glucose meter and presents it in different formats for analysis and understanding.
- The intended use is for managing diabetes based on existing data. The software helps users and healthcare professionals track and understand blood sugar trends, but it doesn't diagnose, monitor, or treat a disease by examining a specimen.
While the software is used in the context of managing a medical condition (diabetes) and is used by healthcare professionals, its function is data management and reporting, not in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
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)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals and patients with diabetes
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance was assessed in a study that included fifty (50) subjects consisting of 3 healthcare professionals (HCPs) and 47 lay users (35 young adults with diabetes and 12 parents or legal guardians of children with diabetes). The study showed that the program is easy to use and the results are understandable by the users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GLUCOFACTS® Express Diabetes Management Software, K082486
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Road |
| Tarrytown, NY 10591 | |
| Phone (914) 333-6736; FAX (914) 333-6160 | |
| Contact: | Susan Brocchi, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: DIDGET® World Reports Diabetes |
| Management Software | |
| Common/Usual Name: | Diabetes data management software program. |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 NBW, JQP | |
| Predicate Device: | GLUCOFACTS® Express Diabetes Management Software, K082486 |
| Device Description: | 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)
|
1
510(k) Summary, continued DIDGET® WORLD REPORTS Diabetes Management Software Page 2 of 2
| Intended 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. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | There were no changes to the fundamental scientific technology. |
| Comparison to
Predicate device: | DIDGET® World Reports Diabetes Management Software is
similar in function to the predicate device, GLUCOFACTS® Express
Diabetes Management Software, K082486, but has been updated to
run off of the Didget World web server. |
| Assessment of
Performance: | Performance was assessed in a study that included fifty (50)
subjects consisting of 3 healthcare professionals (HCPs) and 47 lay
users (35 young adults with diabetes and 12 parents or legal
guardians of children with diabetes). The study showed that the
program is easy to use and the results are understandable by the
users. |
| Conclusion: | The results of the verification and validation studies of the
DIDGET® World Reports Diabetes Management Software
demonstrated that the product is safe and effective in the hands of
lay users and healthcare professionals. The product is
substantially equivalent to the 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 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).
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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 (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
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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