ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE

K043529 · Roche Diagnostics Corp. · NDC · Apr 8, 2005 · Anesthesiology

Device Facts

• Record ID: K043529
• Device Name: ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
• Applicant: Roche Diagnostics Corp.
• Product Code: NDC · Anesthesiology
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

ACCU-CHEK Advisor Insulin Guidance Software is a diabetes management tool for home and clinical use. It ingests historical blood glucose test results, carbohydrate intake, insulin dosage, and event codes via meter data upload or manual entry. The software processes this data to generate reports, graphs, and insulin adjustment guidance based on a pre-planned treatment program. It functions as a decision-support tool, providing directions similar to those a physician would offer during routine care. Healthcare providers and patients use the output to evaluate diabetes management and adjust insulin regimens. The device does not provide medical diagnoses.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and functional comparison to the predicate device.

Technological Characteristics

Software-based diabetes management system; operates on computer media; features include data upload, storage, manual entry, and report generation. No specific hardware materials or energy sources defined as it is a software application.

Indications for Use

Indicated for people with diabetes and their healthcare professionals to assist in the review, analysis, and evaluation of historical blood glucose data and to provide guidance for insulin adjustments within a pre-planned treatment program. Not intended for diagnostic purposes.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• Diacare Monitoring System Software

Submission Summary (Full Text)

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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

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APR 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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.

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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 [phone]. 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 [phone] or [phone] 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

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### 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

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#### 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 <p>9115 Hague Rd.</p> <p>Indianapolis, IN 46250</p> <p>[phone] ext. 3362</p> <p>Contact Person: Scott Thiel</p> <p>Date Prepared: December 17, 2004</p> |
| 2) Device name | Proprietary name: ACCU-CHEK® Advisor Insulin Guidance Software <p>Common name: diabetes management software</p> <p>Classification name: computers and software, medical</p> <p>Product Code: LNX</p> |
| 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. |

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## 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<br>upload | Yes. |
| Support | Yes; through call center support, labeling and health care<br>professionals. |
| Data storage | On computer media. |
| Reports and<br>graphs | Similar graphs and reports can be generated for viewing<br>on a display screen, and hard copy printout. |
| Manual Data<br>Entry | Similar methods of manually entering data into the<br>software. |
| Delete Data | Similar methods of deleting data. |
| Track non-<br>blood glucose<br>data | Tracks similar data sets. (i.e. Carbohydrates, insulin,<br>timeblocks, event codes). |