(135 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's function relies on pre-configured dose instructions from an HCP, not adaptive learning.
No.
The device provides dose suggestions for insulin based on HCP instructions and patient FBGs, but it does not directly treat a disease or condition; it is an aid for patients to manage their medication.
No
The device provides dose suggestions based on HCP instructions and patient data, but it does not diagnose any condition; instead, it is intended for use by previously diagnosed individuals.
Unknown
The provided 510(k) summary does not contain a "Device Description" section, which is crucial for determining if the device is software-only. While the intended use describes a software-like function (providing dose suggestions based on user input and HCP configuration), the absence of a hardware description makes it impossible to definitively classify it as software-only.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of My Dose Coach is to provide dose suggestions based on the patient's Fasting Blood Glucose (FBG) and hypoglycemia occurrence. While FBG is a measurement derived from the body, the device itself is not performing the diagnostic test on the specimen. It's using the result of a diagnostic test (the FBG value) as input for its calculation.
- IVDs are used to provide information for diagnostic, monitoring, or compatibility purposes. My Dose Coach is primarily a tool for managing a pre-existing diagnosis (Type 2 Diabetes) by suggesting insulin doses. It's not used to diagnose the condition itself, nor is it performing a test to monitor the condition in the same way an IVD would (e.g., a blood glucose meter is an IVD).
- The description focuses on dose calculation and patient aid. The language used in the intended use describes the device as an "aid to the patient to provide dose suggestions" and that it "uses the dose plan instructions provided by the patient's HCP to provide dose suggestions." This aligns with a device that helps manage a condition based on existing data, rather than a device that performs a diagnostic test.
In summary, My Dose Coach is a software application that uses pre-existing diagnostic data (FBG) and a physician's instructions to help a patient manage their insulin dosage. It does not perform a diagnostic test on a specimen, which is a key characteristic of an IVD.
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
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
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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.
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 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 (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,
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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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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