iSage Rx

K242066 · Amalgam Rx, Inc. · NDC · Aug 21, 2024 · Anesthesiology

Device Facts

• Record ID: K242066
• Device Name: iSage Rx
• Applicant: Amalgam Rx, Inc.
• Product Code: NDC · Anesthesiology
• Decision Date: Aug 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Indications for Use

iSage Rx™ software is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers (HCP), who are seeking a digital tool to provide ongoing support for patients to understand and follow their Healthcare Providers' treatment plans for the following medications, with the goal of reaching an optimal dose of medication and/or reaching target fasting blood glucose control: - Titration of basal insulins - Titration of combinations of basal insulin and GLP-1 receptor agonists

Device Story

iSage Rx is a prescription-only, stand-alone software system comprising a patient mobile app and a web-based HCP portal. It enables HCPs to digitize and deploy basal insulin and basal insulin/GLP-1 receptor agonist titration plans. Patients input fasting blood glucose (FBG) data manually or via Bluetooth-connected glucose meters. The system uses rule-based protocols—configured by the HCP—to calculate and present insulin dose adjustments on titration days. The HCP portal allows providers to customize titration parameters, including starting dose, FBG targets, hypoglycemia thresholds, and maximum daily units. The device provides educational and coaching messages to patients. It is used in non-acute, home settings to help patients reach fasting blood glucose targets and maintenance insulin doses, potentially reducing hypoglycemic events. The system includes a white-labeled version, Dose Check, which is functionally identical.

Clinical Evidence

No clinical efficacy data provided. Human factors validation testing was conducted in simulated home and clinical environments with 15 adult patients (21+ years) with Type 2 diabetes and 17 healthcare providers (physicians, nurse practitioners, physician assistants). No training was provided prior to testing.

Technological Characteristics

Standalone software (mobile app and web portal). Rule-based titration algorithm. Connectivity via Bluetooth for wireless glucose meters. Configurable for specific geographic markets. Software documentation level: Basic.

Indications for Use

Indicated for adult patients with type 2 diabetes and their healthcare providers to support titration of basal insulins and combinations of basal insulin and GLP-1 receptor agonists. Contraindicated for patients with type 1 diabetes, gestational diabetes, or those using an insulin pump.

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

• iSage Rx (iSage Rx Basal Insulin Titration) (K161865)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K242066

B Applicant

Amalgam Rx, Inc.

C Proprietary and Established Names

iSage Rx

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NDC | II | 21 CFR 868.1890 | Clinical Chemistry |

E Purpose for Submission:

Modification to a cleared device to add titration of basal insulins that contain GLP-1 agonists to the device.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

iSage Rx™ software is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers (HCP), who are seeking a digital tool to provide ongoing support for patients to understand and follow their Healthcare Providers' treatment plans for the following medications, with the goal of reaching an optimal dose of medication and/or reaching target fasting blood glucose control:

- Titration of basal insulins
- Titration of combinations of basal insulin and GLP-1 receptor agonists

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Special Conditions for Use Statement(s):

Not applicable

III Device Description

iSage Rx is a stand-alone, prescription-use only (Rx-only) software device that has the capability to titrate basal insulin and medications that combine basal insulin and GLP-1 receptor agonists, via rule-based protocols as part of a Titration Plan ordered by a Health Care Provider (HCP). Upon input of required fasting blood glucose data, the device generates an insulin dose according to the prescribed titration plan. Patients record their fasting blood glucose daily and the dose presented follows the prescribed protocol. Patient data, either manually entered or entered via connected device, are available for view in the provider portal on the Patient Activity screen.

Patients are informed of provider updates or changes to the prescribed titration plan through notifications.

IV Substantial Equivalence Information:

A Predicate Device Name(s):

iSage Rx (iSage Rx Basal Insulin Titration)

B Predicate 510(k) Number(s):

K161865

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K242066 | K161865 |
| --- | --- | --- |
| Device Trade Name | iSage Rx | iSage Rx (iSage Rx Basal Insulin Titration) |
| General Device Characteristic Similarities | | |
| Intended Use | Same | Intended to provide titration of basal insulin for adults with type 2 diabetes using fasting blood glucose. |
| Intended Patient Population | Same | Adults with type 2 diabetes and their healthcare providers |
| Environment of Use | Same | Home and Clinic (HCP) |

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| | | only) |
| --- | --- | --- |
| Type of Insulin Dose Calculation | Same | Basal Insulin Titration with fasting blood glucose |
| Operating Platforms | Same | iOS and Android for adults with type 2 diabetes
Web-based portal for HCPs |
| General Device Characteristic Differences | | |
| Bluetooth Connectivity | Bluetooth enabled self-monitored blood glucose meters, Smart insulin pens and pen caps | Connectivity with Agamatrix Jazz Wireless 2 Meter (K152365) |
| Insulin Types | Basal Insulin and Basal Insulin-GLP-1 Agonist combinations | Basal Insulin |

V Standards/Guidance Documents Referenced:

FDA Guidance:
- Applying Human Factors and Usability Engineering to Medical Devices (February 2016)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023)
- Content of Premarket Submissions for Device Software Functions (June 2023)

VI Performance Characteristics:

A. Analytical Performance

Not applicable

B. Other Supportive Instrument Performance Characteristics Data

Human Factors:
Human Factors validation testing for the subject device was conducted in a simulated home use environment for adults with Type 2 diabetes and a clinical use environment for healthcare providers in the United States. The two distinct user groups validated to use the subject device were:
1) 15 Adults, 21+ years or older with Type 2 Diabetes who use long acting insulin

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2) 17 Healthcare providers consisting of:
a. Physicians
b. Nurse Practitioners
c. Physicians Assistants

No training was provided to the users prior to the start of validation testing, however there are videos available to users to watch regarding starting up use of the subject device, the prescribed insulin, and general information about managing diabetes.

VII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

VIII Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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