(243 days)
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No
The summary does not mention AI, ML, or any related terms, and the description of the device as "software" for basal insulin titration does not inherently imply the use of AI/ML.
No
The device is software designed to help titrate basal insulin, but it explicitly states it is "not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes." This indicates it's a tool to assist, rather than a standalone therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" states that iSage Rx is "software indicated for use...to titrate basal insulin." Titrating insulin is a treatment adjustment, not a diagnostic act of identifying a disease or condition. While it aids in managing a diagnosed condition (Type 2 diabetes), it doesn't perform the diagnosis itself.
Yes
The device description explicitly states that iSage Rx is "software". There is no mention of any accompanying hardware components.
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 description of iSage Rx indicates it is software used by patients and healthcare providers to titrate basal insulin based on patient data (likely blood glucose readings, but this is not explicitly stated as the input). It does not mention analyzing any biological specimens.
- The intended use is for managing a disease (diabetes) through insulin titration. This is a clinical management tool, not a diagnostic test performed on a specimen.
The information provided focuses on the software's function in guiding insulin dosage, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, or patients using an insulin pump.
Product codes
NDC
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 and above
Intended User / Care Setting
adult patients aged 21 and above who have type 2 diabetes and their healthcare providers
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 7, 2017
iSage Rx, Inc. Ryan Sysko Chief Executive Officer 206 Alapocas Dr Wilmington, Delaware 19803
Re: K161865
Trade/Device Name: iSage Rx (iSage Rx Basal Insulin Titration) Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: January 31, 2017 Received: February 2, 2017
Dear Ryan Sysko:
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,
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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) K161865
Device Name
iSage RxTM (iSage Rx Basal Insulin Titration)
Indications for Use (Describe)
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, or patients using an insulin pump.
| 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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