(108 days)
Not Found
Not Found
No
The summary describes software for reviewing and analyzing historical blood glucose data and providing directions based on a pre-planned treatment program, which is consistent with rule-based or algorithmic logic rather than AI/ML. There are no mentions of AI, ML, training sets, test sets, or performance metrics typically associated with AI/ML models.
Yes
The software provides "direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin," which directly influences patient treatment and management for diabetes. While it doesn't diagnose, its role in guiding insulin adjustments makes it a therapeutic tool in managing the disease.
No
The text explicitly states: "The device is not intended to provide any diagnosis on patient results."
Yes
The device description explicitly states it is "An accessory software" and the intended use focuses on the review, analysis, and evaluation of historical blood glucose data, which are software-based functions. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is intended to "aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results". Blood glucose testing is a classic example of an in vitro diagnostic test. The software is processing and analyzing the results of these tests.
- Device Description: The description reinforces the intended use by stating it "enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results".
- Predicate Device: The mention of a "Diacare Monitoring System Software" as a predicate device further supports the IVD classification. Diabetes monitoring systems that process blood glucose data are typically classified as IVDs.
While the software itself doesn't perform the blood glucose test, it is designed to process and analyze the results of an in vitro diagnostic test (blood glucose). This function falls under the scope of IVD regulation.
The statement "The device is not intended to provide any diagnosis on patient results" is important, but it doesn't negate the IVD classification. Many IVDs provide data and analysis to aid in diagnosis or management, without making a definitive diagnosis themselves.
Therefore, based on the intended use of processing and analyzing in vitro diagnostic test results (blood glucose), this software is likely considered an IVD.
N/A
Intended Use / Indications for Use
The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.
Product codes
NDC, LNX
Device Description
An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice.
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
home and clinical settings; people with diabetes and their health care professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Diacare Monitoring System Software
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Roche Diagnostics Corporation Scott Thiel Regulatory Affairs Program Principal Patient Care Division 9115 Hague Road Indianapolis. Indiana 46250
May 17, 2024
Re: K043529
Trade/Device Name: ACCU-CHEK® Advisor Insulin Guidance Software Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: NDC
Dear Scott Thiel:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 8, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code NDC.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Juliane Lessard, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6126, Juliane.Lessard(@fda.hhs.gov.
Sincerelv.
Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery, General Hospital and Human Factors Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
APR 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs Program Principal Roche Diagnostics Corporation Patient Care Division 9115 Hague Road Indianapolis. Indiana 46250
Re: K043529
Trade/Device Name: ACCU-CHEK® Advisor Insulin Guidance Software Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LNX Dated: March 30, 2005 Received: March 31, 2005
Dear Mr. Thiel:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Thiel
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KO43529
Device Name: ACCU-CHEK® Advisor Insulin Guidance Software
Indications For Use:
The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cim Vur
il Aneshesiology, General Hospital, tion Control, Dental Devices
Page I of
:) Number
4
:
APR 8 2005
510(k) Summary
్రాల్య
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-2000 ext. 3362 Contact Person: Scott Thiel Date Prepared: December 17, 2004 |
| 2) Device name | Proprietary name: ACCU-CHEK® Advisor Insulin Guidance Software Common name: diabetes management software Classification name: computers and software, medical Product Code: LNX |
| 3) Predicate device | We claim substantial equivalence to the current legally cleared Diacare Monitoring System Software. |
| 4) Device Description | An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. |
| 5) Intended use | The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results. |
Continued on next page
:
5
510(k) Summary, Continued
Comparison to Predicate Device
The Roche Diagnostics ACCU-CHEK Advisor Insulin Similarities Guidance is substantially equivalent to the current legally cleared version Diacare Monitoring System Software. The following is a list of some of the claims and features found to be similar to the predicate device.
| Feature/Claim | Detail |
|---|---|
| Meter data | |
| upload | Yes. |
| Support | Yes; through call center support, labeling and health care |
| professionals. | |
| Data storage | On computer media. |
| Reports and | |
| graphs | Similar graphs and reports can be generated for viewing |
| on a display screen, and hard copy printout. | |
| Manual Data | |
| Entry | Similar methods of manually entering data into the |
| software. | |
| Delete Data | Similar methods of deleting data. |
| Track non- | |
| blood glucose | |
| data | Tracks similar data sets. (i.e. Carbohydrates, insulin, |
| timeblocks, event codes). |