(41 days)
GLUCOFACTS® Express Diabetes Management Software is an over-the-counter software program for use by health care professionals and patients with diabetes for transferring blood glucose data from a blood glucose meter to a personal computer for the purpose of viewing and printing reports that display blood glucose readings from Bayer's CONTOUR®, CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucose meters.
GLUCOFACTS® Express Diabetes Management Software is an overthe-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.
This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from a Bayer blood glucose meter to a personal computer through the use of a serial or USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways: 1. Electronic logbook where all of the data can be seen 2. Glucose trend of the results by date 3. Daily blood glucose trend (standard day) 4. Weekly blood glucose trend (standard week) 5. Summary chart (histogram or pie chart)
The provided text describes the 510(k) summary for the GLUCOFACTS® Express Data Management Software. This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria or a comprehensive study design with technical performance metrics.
Therefore, much of the requested information (like specific quantitative acceptance criteria, detailed performance metrics, sample sizes for test and training sets, ground truth establishment methods in a technical sense, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text. The "Performance Assessment" section is qualitative and user-focused.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in a Quantitative Manner) | Reported Device Performance (Explicitly Stated in a Quantitative Manner) |
|---|---|
| Not explicitly stated in a quantitative manner. The assessment focuses on ease of use and understandability. | The study showed that the program is easy to use and the results are understandable by the users. |
Note: The document emphasizes ease of use and understandability as the key performance indicators for this software. It does not provide numerical or statistical acceptance criteria typical for diagnostic devices (e.g., sensitivity, specificity, accuracy).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: 51 people
- 43 lay users
- 8 healthcare professionals
- Data Provenance (Country of Origin): Not specified.
- Retrospective or Prospective: Not specified, but given the nature of a user study assessing "ease of use" and "understandability," it would most likely be a prospective study where users interact with the software.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of this study. The "ground truth" for ease of use and understandability is derived from the users' experience and perceptions, not from expert consensus on a diagnostic outcome. The study involved 8 healthcare professionals, but their role was as study participants providing feedback, not as adjudicators establishing a "ground truth" for diagnostic accuracy.
- Qualifications of Experts: Not applicable for establishing ground truth. The 8 healthcare professionals were participants, but their specific qualifications beyond being "healthcare professionals" are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a user-focused study assessing subjective metrics (ease of use, understandability), not a diagnostic performance study requiring adjudication of results against a reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The text does not describe an MRMC study. The study focused on user experience with the software itself, not on comparing human reader performance with or without AI assistance for a diagnostic task.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, in a sense. The software itself is the "device," and its standalone performance (ease of use, understandability of reports) was assessed by users interacting directly with it. However, this is not a "standalone performance" in the typical diagnostic AI context, which would involve algorithmic accuracy against a ground truth.
7. Type of Ground Truth Used
- Type of Ground Truth: User feedback and perception regarding "ease of use" and "understandability" served as the primary "ground truth" for this software's performance assessment. It did not involve expert consensus, pathology, or outcomes data in the traditional sense for diagnostic accuracy.
8. Sample Size for the Training Set
- Sample Size for the Training Set: Not applicable. This software is described as a "data management software program" that allows "viewing and printing reports." It is not an AI/ML model that would typically have a "training set" in the context of learning patterns for prediction or diagnosis.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set or an AI/ML model being trained.
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Bayer HealthCare
Diabetes Care
OCT 0 8 2008
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510(k) SUMMARY
GLUCOFACTS® Express 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 | K082484 |
|---|---|
| Prepared: | August 25, 2008 |
| Submitter: | Bayer HealthCare Diabetes Care |
| Address: | 430 South Beiger StreetMishawaka, IN 46544Phone (574) 256-3441; FAX (574) 256-3519 |
| Contact: | Roger Sonnenburg, Sr. Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: GLUCOFACTS® Express 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: | Ascensia® Glucofacts® Data Management System,K024234 |
| Device Description: | This software application allows the transfer of bloodglucose results, along with time, date, and certain datamarkers, from a Bayer blood glucose meter to a personalcomputer through the use of a serial or USB cable. Dataanalysis includes allowing the home-user or healthcareprofessional to view the data in five different ways:1. Electronic logbook where all of the data can be seen2. Glucose trend of the results by date3. Daily blood glucose trend (standard day)4. Weekly blood glucose trend (standard week)5. Summary chart (histogram or pie chart) |
| Intended Use: | GLUCOFACTS® Express Diabetes Management Software is anover-the-counter software program for use by health care |
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| professionals and patients with diabetes for transferringblood glucose data from a blood glucose meter to a personalcomputer for the purpose of viewing and printing reports thatdisplay blood glucose readings from Bayer's CONTOUR®,CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucosemeters. | |
|---|---|
| Technological Characteristics: | There were no changes to the fundamental scientifictechnology. |
| Comparison toPredicate device: | GLUCOFACTS® Express Diabetes Management Software issimilar in function to the predicate device, AscensiaGlucofacts Data Management System, K024234, but hasbeen updated to make it compatible with the most recentBayer blood glucose meters and to improve the ease of use. |
| Assessment ofPerformance: | The performance was assessed in a study that included 51people - 43 lay users and eight healthcare professionals.The study showed that the program is easy to use and theresults are understandable by the users. |
| Conclusion: | The results of the verification and validation studies of theGLUCOFACTS® Express Diabetes Management Softwaredemonstrated that the product is safe and effective in thehands of lay users and healthcare professionals. Theproduct is substantially equivalent to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 8 2008
Bayer Healthcare, LLC c/o Mr. Roger Sonnenburg 430 South Beiger St. Mishawaka, IN 46544
Re: K082486 Trade/Device Name: Glucofacts Express Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: September 16, 2008 Received: September 17, 2008
Dear Mr. Sonnenburg:
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).
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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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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.
Féan 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
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: GLUCOFACTS® Express Diabetes Management Software
Indications For Use: GLUCOFACTS® Express Diabetes Management Software is an overthe-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitm Diagnostic Device Evaluation and Safety
§ 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.