My Dose Coach

K163099 · Sanofi, Inc. · NDC · Mar 22, 2017 · Anesthesiology

Device Facts

• Record ID: K163099
• Device Name: My Dose Coach
• Applicant: Sanofi, Inc.
• Product Code: NDC · Anesthesiology
• Decision Date: Mar 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. My Dose Coach is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin titration) that are based on the patient's Fasting Blood Glucose ( FBG) as well as hypoglycemia occurrence. My Dose Coach is not intended to replace the care or advice of a physician or HCP.

Device Story

My Dose Coach is a mobile application for Type 2 Diabetic patients prescribed once-daily long-acting basal insulin. The device functions as a titration aid; it requires an HCP to configure patient-specific dose instructions and activate the application. Patients input Fasting Blood Glucose (FBG) values and report hypoglycemia occurrences. The software processes these inputs against the HCP-defined titration plan to generate insulin dose suggestions. Used by patients at home; the output serves as a decision-support tool for insulin management. The device aims to assist patients in following their prescribed titration regimen, potentially improving glycemic control while maintaining the HCP's oversight.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Software-based mobile application for insulin titration. Operates via user-inputted FBG data and hypoglycemia reports processed against HCP-configured titration rules. Standalone software application.

Indications for Use

Indicated for single patient use by previously diagnosed Type 2 Diabetics prescribed once-daily long-acting basal insulin. Used outside the clinic setting for insulin titration assistance.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2017

Sanofi, Inc. Robert Ezzell Sr. Manager, Global Regulatory Affairs, CMC & Devices 640 Memorial Drive Cambridge, Massachusetts 02139

Re: K163099

Trade/Device Name: My Dose Coach Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: March 8. 2017 Received: March 9, 2017

Dear Robert Ezzell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K163099

Device Name My Dose Coach

## Indications for Use (Describe)

My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. My Dose Coach is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin titration) that are based on the patient's Fasting Blood Glucose ( FBG) as well as hypoglycemia occurrence.

My Dose Coach is not intended to replace the care or advice of a physician or HCP.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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