(31 days)
Not Found
No
The description focuses on data management and standard statistical/graphical tools, with no mention of AI or ML terms or concepts.
No
The device is described as software and a connecting cable used for data management of blood glucose results, not for directly treating or diagnosing a medical condition.
No
The device is described as software that provides "data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data." It transfers data from blood glucose monitoring systems and helps in reviewing the data, but it does not independently diagnose conditions or make diagnostic interpretations.
No
The device description explicitly states that the device consists of a CD and a connecting cable, which are hardware components.
Based on the provided information, the Ascensia "Glucofacts and the Ascensia WinGlucofacts Professional software are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the software is an accessory to blood glucose monitoring systems and is used for data transfer and management of blood glucose results. It facilitates the review of data.
- Device Description: The description confirms it's software and a cable used with a blood glucose meter and PC for data management and analysis using statistical and graphical tools.
- Lack of Diagnostic Function: The software itself does not perform any diagnostic test on a biological sample. It processes and presents data that was generated by an IVD (the blood glucose meter).
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility of transplant tissues, organs, or blood.
This software is a tool for managing and analyzing data from an IVD, but it is not an IVD itself.
N/A
Intended Use / Indications for 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.
The Ascensia WirGlucofacts 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
individuals or health care professionals (home and in healthcare facilities)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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.
0
510(k) Summary of Safety and Effectiveness
JAN 2 3 2003
Submitter Information
| Contact person: | George M. Tancos |
|---|---|
| Address: | 1884 Miles Avenue |
| Elkhart, 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).
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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