iSage Rx (iSage Rx Basal Insulin Titration)

K161865 · Isag Rx, Inc. · NDC · Mar 7, 2017 · Anesthesiology

Device Facts

• Record ID: K161865
• Device Name: iSage Rx (iSage Rx Basal Insulin Titration)
• Applicant: Isag Rx, Inc.
• Product Code: NDC · Anesthesiology
• Decision Date: Mar 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

iSage Rx is a software application designed to assist in the titration of basal insulin for adult patients with type 2 diabetes. The device operates by receiving patient-entered blood glucose data and current insulin dosage information. It utilizes a titration algorithm to calculate and recommend adjustments to the basal insulin dose based on established clinical protocols. The output is provided to the patient and their healthcare provider to facilitate insulin management. The device is intended for use under the guidance of a healthcare professional and does not replace clinical judgment. By providing structured titration recommendations, the device aims to help patients achieve glycemic control goals more effectively while maintaining safety through adherence to prescribed titration rules.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and validation of the software algorithm to ensure it functions as intended for basal insulin titration.

Technological Characteristics

Software-based medical device (SaMD). Operates via a rule-based titration algorithm to calculate insulin dosage adjustments. Designed for use by adult patients with type 2 diabetes and their healthcare providers. Connectivity and platform details are not specified in the provided documentation.

Indications for Use

Indicated for adult patients (≥21 years) with type 2 diabetes to assist in basal insulin titration. Contraindicated for patients using prandial insulin, patients with type 1 diabetes, and patients using insulin pumps.

Regulatory Classification

Identification

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

Predicate Devices

• Glooko (K150656)

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 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.

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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 (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 [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) 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <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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