(58 days)
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Not Found
No
The description mentions "analyzes and reports blood glucose test results" and "provides coaching messages... based on real-time blood glucose values and trends," but it does not explicitly state or imply the use of AI or ML for these functions. The analysis and coaching could be based on pre-programmed rules or algorithms.
No.
The device's stated purpose is to aid in diabetes self-management by analyzing and reporting blood glucose data, supporting medication adherence, and providing educational information and coaching messages. It explicitly states that it is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
No
The description explicitly states, "The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment." This indicates it does not perform diagnostic functions.
Yes
The description explicitly states that the system "includes software intended for use on mobile phones or personal computers" and focuses on the functions of this software (capture, storage, transmission, analysis, reporting, adherence support, coaching messages, data entry, educational information). There is no mention of any accompanying hardware components that are part of the regulated medical device itself.
Based on the provided information, the DiabetesManager® and DiabetesManager®-Rx systems are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the DiabetesManager systems is to capture, store, transmit, analyze, and report blood glucose data, as well as provide information and coaching for diabetes self-management. While blood glucose data is derived from the body, the device itself is not performing a test on a specimen. It's processing data that is presumably entered or transmitted from a separate blood glucose meter (which would be an IVD).
- The device's function is focused on data management, analysis, and providing information/coaching. It's a software system designed to help patients and HCPs manage diabetes based on existing data, not to perform a diagnostic test itself.
Therefore, the DiabetesManager systems fall under the category of software for diabetes management, not IVDs.
N/A
Intended Use / Indications for Use
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®)-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The DiabetesManager®-Rx System analyzes and reports blood alucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Product codes
MRZ, LNX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients - aged 21 years and older
Intended User / Care Setting
healthcare providers (HCPs) and their adult patients; home or in professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logos are displayed against a white background.
May 17, 2024
WellDoc, Incorporated Lauren Bronich-Hall Director, Quality System 1501 Saint Paul Street, Suite 118 Baltimore, Maryland 21202
Re: K112370
Trade/Device Name: WellDoc DiabetesManager® System and DiabetesManager®-Rx System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ
Dear Lauren Bronich-Hall:
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 October 14, 2011. Specifically, FDA is updating this SE letter as an administrative correction. A second product code was inadvertently included.
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.
Sincerely,
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 Ouality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing the wings and three wavy lines representing the body. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Lauren Bronich-Hall Director, Quality System WellDoc Incorporated 1501 Saint Paul Street. Suite 118 Baltimore, Maryland 21202
OCT 1 4 2011
Re: K112370
Trade/Device Name: WellDoc DiabetesManager® System and DiabetesManager®-Rx System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, LNX Dated: September 19, 2011 Received: September 21, 2011
Dear Ms. Bronich-Hall:
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 ffor 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.
2
Page 2 - Ms. Bronich-Hall
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers. International and Consumer Assistance 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 yours,
Anthony D. Aux
Anthony D. Watson, B.S., M.S., M.B.A. 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): K112370
Device Name: WellDoc DiabetesManager® System and DiabetesManager®-Rx
Indications for Use:
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kelli C. Cooper 10/13/14
General Hospital
Page 1 of 2
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112376
4
DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®)-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes selfmanagement. The DiabetesManager®-Rx System analyzes and reports blood alucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare
settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhl C. Chyna 10/13/i
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 2 of 2
510(k) Number: K112370