(29 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a rule-based system ("uses the dose plan instructions provided by the patient's HCP to provide dose suggestions").
No.
The device provides dose suggestions based on the HCP's instructions, but it is not intended to replace professional medical care or advice. While it aids in managing a medical condition, it does not directly treat or prevent a disease.
No
The device provides dose suggestions based on HCP instructions and patient FBGs, but it is explicitly stated that it is "not intended to replace the care or advice of a physician or HCP" and aids in providing "dose suggestions," not diagnosis. The user is also "previously diagnosed," indicating the diagnosis has already occurred.
Unknown
The provided text describes the intended use and indications for use of "My Dose Coach," which is clearly a software application providing dose suggestions. However, the "Device Description" section is explicitly marked as "Not Found." Without a description of the device itself, it's impossible to definitively confirm that it is only software and does not include or rely on any specific hardware components beyond a general computing platform (like a smartphone or tablet) for its operation.
Based on the provided information, My Dose Coach is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of My Dose Coach is to provide dose suggestions for insulin based on the patient's Fasting Blood Glucose (FBG) and hypoglycemia occurrence. While FBG is a measurement derived from a bodily fluid (blood), the device itself is not performing the test on the specimen. It is using the result of a test (the FBG value) as input.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While My Dose Coach is used in the context of treatment (insulin dosing), it is not performing a test on a specimen to provide diagnostic or monitoring information from that specimen. It's using pre-existing data (FBG and hypoglycemia) to provide a dose suggestion based on a pre-configured plan.
- The description focuses on providing dose suggestions based on patient input and a pre-configured plan. There is no mention of the device analyzing biological specimens.
My Dose Coach appears to be a software-based medical device that aids in the management of Type 2 Diabetes by providing insulin dose suggestions based on patient-provided data and a healthcare professional's instructions. It falls under the category of devices that support treatment decisions rather than performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for 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.
Product codes
NDC
Device Description
Not Found
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
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.
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): 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.
Not Found
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
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
Public Health Service
Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
Sanofi Robert Ezzell Senior Manager Global Regulatory Affairs CMC Devices 640 Memorial Drive Cambridge, Massachusetts 02142
Re: K171230
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: April 24, 2017 Received: April 27, 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang -5
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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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