(31 days)
The Ascensia ""Glucofacts and the Ascensia WinGlucofacts Professional software are accessories to the AscensiaTM Blood Glucose monitoring systems. The Ascensia ""Glucofacts and the Ascensia """Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.
The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software consist of a CD, and a connecting cable. It is to be used with a compatible blood glucose meter and a Personal Computer (PC). The software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.
The provided text is a 510(k) Summary for the Ascensia™ WinGlucofacts® and WinGlucofacts® Professional software. It details the device, its intended use, and states that performance studies were conducted. However, it does not provide detailed acceptance criteria or numerical performance data.
Based on the provided text, here is what can and cannot be extracted regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states that "Internal and external Performance/Validation studies were conducted." and that these "demonstrate satisfactory performance." However, specific quantitative or qualitative acceptance criteria are not mentioned, nor are the actual performance metrics achieved. | Not explicitly quantified or detailed. The document broadly claims "satisfactory performance" and that the devices are "equivalent in performance to the predicate devices." No numerical results, such as accuracy, precision, or reliability metrics, are provided. |
Summary: The document claims "satisfactory performance" and "equivalence" to a predicate device but does not specify the criteria or provide concrete performance data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document only mentions "Internal and external Performance/Validation studies were conducted." It does not provide details on the source, nature (retrospective/prospective), or location (country) of the data used in these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Summary: This information is not mentioned in the provided text. The device is software for managing blood glucose results, which would typically involve comparing software outputs to known blood glucose values from meters or laboratory tests. The concept of "experts establishing ground truth" in the diagnostic imaging sense might not directly apply here, but rather a validation against instrument readings or laboratory standards. However, the document does not elaborate on the process or personnel involved in this validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
Summary: This information is not mentioned in the provided text.
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
- MRMC Study Done: Not applicable/Not specified. This device is data management software for blood glucose results, which primarily facilitates review by individuals or healthcare professionals. It is not an AI-assisted diagnostic tool in the sense of imaging analysis where human readers "improve" with AI assistance. The software provides data management and statistical/graphical tools, rather than directly interpreting data in a way that would lead to a comparative effectiveness study of human reader improvement with/without AI assistance.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study Done: Yes, implicitly. The "Performance Data" section states that "Internal and external Performance/Validation studies were conducted." While not explicitly called "standalone," the validation of software performance typically involves testing its functionality, accuracy of calculations, and data display capabilities independently of a human's ultimate interpretation beyond basic user interaction. The objective is to demonstrate that the software itself functions correctly and accurately processes the blood glucose data.
Summary: The document implies that the software's performance was validated without explicit human interpretative involvement beyond its intended use as a data management tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified directly. For blood glucose data management software, the "ground truth" would generally be the actual blood glucose values as read by the compatible blood glucose meter or, in a more rigorous validation, potentially values confirmed by a laboratory reference method. The document refers to "capturing blood glucose meter results," implying the meter readings themselves (or a validated source of those readings) serve as the reference for the software's accuracy in data handling and display.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This device is described as data management software that uses "standard statistical and graphical tools/techniques." It does not appear to be an AI/machine learning model that requires a "training set" in the conventional sense. Its functionality is based on established algorithms for data storage, calculation, and visualization, rather than learning from data.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. As noted above, a "training set" and associated ground truth establishment for such a set are not relevant for this type of software as described.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
JAN 2 3 2003
Submitter Information
| Contact person: | George M. Tancos |
|---|---|
| Address: | 1884 Miles AvenueElkhart, IN 46515 |
| Phone: | 574.262.6928 |
| FAX: | 574.262.4945 |
| E-mail: | george.tancos.b@bayer.com |
| Date Prepared: | December 19, 2002 |
Device Information
| Proprietary Name: | The Ascensia™ WinGlucofacts® |
|---|---|
| Ascensia™ WinGlucofacts® Professional | |
| Common Name: | Software and connecting Cable |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code 21 CFR 862.2100 | |
| (75 JQP Calculator/Data Processing Module, for Clinical Use) |
Predicate Device Information
| Name: | Glucofacts® Data Management System |
|---|---|
| Manufacturer: | Bayer Diagnostics |
| 430 S. Bieger Street | |
| Mishawaka, In 46544 | |
| 510(k) Number: | K861844 |
Device Description
The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software consist of a CD, and a connecting cable. It is to be used with a compatible blood glucose meter and a Personal Computer (PC). The software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.
{1}------------------------------------------------
Statement of Intended Use:
The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of data by individuals or health care professionals.
Summary of Technological Characteristics:
The Ascensia ***Glucofacts and the Ascensia ***Glucofacts Professional software is used to capture blood glucose meter results and graphically display the information. It uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.
Performance Data:
Internal and external Performance/Validation studies were conducted. The studies demonstrate satisfactory performance of the Ascensia ""Glucofacts and the Ascensia Win Glucofacts Professional software in the hands of end users.
Conclusion:
The results of in-house and external evaluations of the Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software demonstrate that these devices are equivalent in performance to the predicate devices and suitable of its intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 3 2003
Mr. George M. Tancos R.A. C. Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46514-0070
K024234 Trade/Device Name: Ascensia™ WINGlucofacts® Ascensia™M WNGlucofacts® Professional Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: December 19, 2002 Received: December 23, 2002
Dear Mr. Tancos:
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).
{3}------------------------------------------------
Page 2 -
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): K
Device Name:
Ascensia™ WinGlucofacts® Ascensia™ WinGlucofacts® Professional
The Ascensia WirGlucofacts and the Ascensia Indications for Use: WinGlucofacts Professional software are accessories to the AscensiaTM Blood Glucose monitoring systems. The Ascensia ""Glucofacts and the Ascensia """Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.
Ham Coogen
(Division Sign-Off)
Division Clinical Laboratory Devices
510(k Mumber. K024234
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109) OR
Over-The-Counter
§ 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.