Go Dose System

K160949 · Eli Lilly and Company · NDC · Dec 22, 2016 · Anesthesiology

Device Facts

• Record ID: K160949
• Device Name: Go Dose System
• Applicant: Eli Lilly and Company
• Product Code: NDC · Anesthesiology
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

The Go Dose System, comprised of the Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose Pro applications are for prescription use only.

Device Story

Mobile application system (iOS) for type 2 diabetes management; aids HCPs and patients in titrating prandial Humalog U-100 insulin. Input: patient-entered blood glucose values. Operation: algorithm calculates insulin dose recommendations based on effectiveness of previous insulin response, current blood glucose, and target range. Output: prandial insulin dosing recommendations. Used in home and clinical settings; operated by patients and HCPs. HCPs use Go Dose Pro to review historical data and manage treatment plans; patients use Go Dose to view dose recommendations. Benefits: supports evidence-based insulin titration to achieve glycemic targets; provides safety constraints (e.g., no dosing for hypoglycemia, 1-unit max increase per day, 30-unit max dose).

Clinical Evidence

No clinical performance studies conducted on the mobile application itself. Evidence relies on a clinical trial (Edelman et al. 2014, Trial IOQC) of the underlying paper-based dosing algorithm. Study was a multinational, multicenter, randomized, open-label, parallel-group trial in adult T2DM patients failing to achieve glycemic control on optimized insulin glargine. Safety and efficacy of the titration logic were established via this study.

Technological Characteristics

Mobile software application for iOS (iPad/iPhone). Cloud-based data storage. Algorithm: rule-based titration logic derived from clinical trial protocols. Safety features: hypoglycemia lockout, 1-unit/day increase limit, 30-unit/dose maximum. Software class: Major level of concern. Cybersecurity and risk management per ISO 14971.

Indications for Use

Indicated for patients aged 18-85 years with type 2 diabetes mellitus failing to achieve glycemic targets on insulin glargine (with/without metformin) requiring intensification with Humalog U-100, for whom a blood glucose target range of 85-114 mg/dL is appropriate.

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

• Intelligent Dosing System For Insulin - my Insulin Doser (K082512)

Reference Devices

• Accu-chek Advisor Insulin Guidance Software (K043529)

Submission Summary (Full Text)

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May 17, 2024

Eli Lilly and Company Sumitra Ghate Director, Global Regulatory Affairs - CMC Devices Lilly Corporate Center Indianapolis, Indiana 46285

Re: K160949

Trade/Device Name: Go Dose System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC

Dear Sumitra Ghate:

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 December 22, 2016. 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 Quality Center for Devices and Radiological Health

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Eli Lilly and Company Sumitra Ghate Director-Regulatory CMC Devices Lilly Corporate Center Indianapolis, Indiana 46285

Re: K160949

Trade/Device Name: Go Dose System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC, LNX Dated: November 21, 2016 Received: November 29, 2016

Dear Sumitra Ghate:

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 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 [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 yours, Tina Kiang -S

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) K160949

Device Name Go Dose System

#### Indications for Use (Describe)

#### Go Dose System

The Go Dose System, comprised of the Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose Pro applications are for prescription use only.

#### Indications for Use - Go Dose

Go Dose is for prescription use only by persons who are:

- · Diagnosed with type 2 diabetes mellitus (DM)
- · Aged 18-85 years
- · Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
- · Requiring treatment intensification with Humalog 100 units per mL (U-100)
- · For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations.

The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

Indications for Use - Go Dose Pro Application

Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria:

- · Diagnosed with type 2 diabetes mellitus (DM)
- · Aged 18-85 years
- · Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
- · Requiring treatment intensification with Humalog 100 units per mL (U-100)
- · For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

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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# K160949 510(K) SUMMARY

| Manufacturer's Name: | Eli Lilly and Company<br>Lilly Corporate Center<br>Indianapolis, IN 46285 |
|------------------------------------|-------------------------------------------------------------------------------------|
| Corresponding Official: | Sumitra M Ghate<br>Director-Regulatory CMC Devices<br>Global Regulatory Affairs CMC |
| Telephone Number:<br>E-mail: | 317-433-3486<br>[e-mail] |
| Preparation Date: | December 13, 2016 |
| Trade Name: | Go Dose System |
| Common or Usual Name: | Dose calculator |
| Classification Name and<br>Number: | 21 CFR 868.1890, Predictive pulmonary-function value<br>calculator |
| | Product Code: NDC<br>Additional Product Code: LNX |
| Primary Predicate Device: | Intelligent Dosing System For Insulin - my Insulin Doser<br>(K082512) |
| Reference Device: | Accu-chek Advisor Insulin Guidance Software (K043529) |

# Device Description

The Go Dose System, comprised of Go Dose Pro mobile medical applications (apps), aids patients under the supervision of their health care provider (HCP) in the management of type 2 diabetes mellitus (T2DM).

This medical device system is based on a "paper-based" algorithm approach that was studied for safety and efficacy in 2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial, F3Z-MC-IOQC (Trial IOQC) as described in Edelman et al. 2014'. This study enrolled adult patients with T2DM who were not under glycemic control after optimizing the dose of insulin glargine for fasting blood glucose, with or without metformin. The medical device provides HCPs and patients with an evidence-based approach to initiate and titrate Humalog® 100 units/mL (insulin lispro) therapy for patients continuing insulin glargine, with or without metformin.

¹ Edelman, S.V. (2014) AUTONOMY: The first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes. Diabetes Care 3:2132-2140.

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The HCP determines the meal selection for Humalog titration and the Go Dose Pro app, and sends the dose recommendation to the patient's Go Dose app. The patient uses the Go Dose app to view the initial dose recommendation. The Go Dose app uses blood glucose values manually entered by the patient as an input to determine ongoing individualized dose recommendations. This titration process continues until the HCP determines that the dose can be stabilized (i.e., no further titration required) or stopped (i.e., discontinue that dose). At that point, the HCP will determine whether to select a new meal for dose titration, stop any additional use of the Go Dose System, or select additional stable pre-meal dose(s).

# Intended Use

Go Dose and Go Dose Pro are for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes management. Go Dose Pro is intended for use by health care providers who have experience prescribing meal time insuling direction to patients within the scope of a preplanned treatment program for adjustments to prescribed insulin. Go Dose determines the patients' Humalog doses using blood glucose values entered by the patient. Go Dose Pro are not intended to replace the care provided by a licensed health care provide any diagnosis on patient blood glucose values.

## Indications for Use

Go Dose System

The Go Dose System, comprised of the Go Dose Pro applications, is for use in home and clinical settings to aid in the review, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. The Go Dose System is a mobile application for use with iPad or iPhone mobile devices. The Go Dose System provides recommendations for titrating prandial Humalog dosing one meal at a time using blood glucose values entered by the patient. Go Dose Pro applications are not intended to replace the care provided by a licensed health care provider or to provide any diagnosis on patient blood glucose values. Go Dose Pro applications are for prescription use only.

Indications for Use - Go Dose

Go Dose is for prescription use only by persons who are:

- Diagnosed with type 2 diabetes mellitus (DM)
- · Aged 18-85 years
- · Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
- · Requiring treatment intensification with Humalog 100 units per mL (U-100)
- · For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

Go Dose should be used multiple times per day, as directed by your healthcare provider, for entering blood glucose values and getting Humalog dosing recommendations.

The Go Dose daily adjusted dosing algorithm was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

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Indications for Use - Go Dose Pro Application

Go Dose Pro is intended for use by health care providers who have experience prescribing mealtime insulin, including providing direction to patients within the scope of a preplanned treatments to prescribed insulin. Health care providers should use the Go Dose Pro to aid in the review, analysis and evaluation of historical blood glucose test values to support diabetes management in patients that meet the following criteria:

- Diagnosed with type 2 diabetes mellitus (DM)
- · Aged 18-85 years
- · Failing to achieve glycemic targets despite optimization of insulin glargine, with or without metformin
- · Requiring treatment intensification with Humalog 100 units per mL (U-100)
- · For whom the set blood glucose target range of 85-114 mg/dL (4.7-6.3 mmol/L) is appropriate

The Go Dose design is based on a dosing algorithm that was tested using Humalog 100 units per mL (U-100) in patients with type 2 diabetes who were also taking insulin glargine, with or without metformin. The algorithm for Go Dose is not designed for the titration of NPH, regular insulin, or basal and analog insulins at concentrations other than 100 unit/mL.

| Feature | Go Dose System (comprised of<br>Go Dose and Go Dose Pro<br>applications) (K160949) | My Insulin Doser/IDS<br>(K082512) | ACCU-CHEK Advisor Insulin<br>Guidance Software (K043529) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Go Dose System, comprised<br>of the Go Dose application and<br>Go Dose Pro application, is for<br>use in home and clinical settings<br>to aid in the review, analysis, and<br>evaluation of historical blood<br>glucose test values to support<br>diabetes management.<br><br>The Go Dose System is a mobile<br>application for use with iPad®,<br>iPhone®, or iPod touch® mobile<br>devices. The Go Dose System<br>provides recommendations for<br>titrating mealtime doses of<br>Humalog, one meal at a time,<br>using blood glucose values<br>entered by the patient. Go Dose<br>and Go Dose Pro are not intended<br>to replace the care provided by a<br>licensed health care provider or to<br>provide any diagnosis on patient<br>blood glucose values. Go Dose<br>and Go Dose Pro are for<br>prescription use only. | My Insulin Doser/IDS<br>allows a person with<br>diabetes to calculate the<br>best next dose of insulin to<br>achieve a personal glucose<br>target. | The software is intended for use<br>in home and clinical settings to<br>aid people with diabetes and their<br>health care providers in review,<br>analysis and evaluation of<br>historical blood glucose test<br>results to support diabetes<br>management, including providing<br>direction within the scope of a<br>preplanned treatment program for<br>adjustments to prescribed insulin,<br>similar to the directions<br>physicians provide to patients as a<br>part of routine clinical practice.<br><br>The device is not intended to<br>provide any diagnosis on patient<br>results. |
| Algorithm Feature | Patients aged 18-85 years who<br>have type 2DM, requiring | person with diabetes | patients with diabetes and their<br>health care providers |
| | treatment intensification with<br>Humalog 100 units per mL (U-<br>100), and for whom the set blood<br>glucose target<br>range of 85-114 mg/dL (4.7-6.3<br>mmol/L) is appropriate; and their<br>healthcare provider | | |
| Environment of<br>Use | Home under direction of HCP and<br>clinical settings | Home under direction of<br>HCP | Home and clinical settings |
| Type of Insulin | Prescribed Humalog | Any prescribed insulin | Any prescribed insulin |
| Software Based | Yes | Yes | Yes |
| Hardware | Mobile (iPhone, iPad) | Mobile (Palm), desktop PC | Desktop PC |
| Data Storage | On network computer media | On network computer<br>media | On local computer media |
| Insulin Dose<br>Calculation | yes | yes | yes |
| Purpose of<br>Algorithm | To initiate and titrate insulin<br>therapy (to help HCP arrive at<br>stable Humalog dose, titrate<br>additional doses or stop dose) to<br>improve diabetes management | Same | Same |
| Patient Input<br>variables related<br>to dose<br>calculation | Blood glucose | Blood glucose | Blood glucose Carbohydrates Optional: Alternate state (allows the<br>user to declare a<br>physiologic condition<br>such as mild stress, mild<br>illness or light exercise) Entry notes - adds<br>context; can customize |
| Algorithm Output | Prandial Insulin dosing<br>recommendation | Insulin dosing<br>recommendation | Prandial Insulin dosing<br>recommendation |
| How is the<br>algorithm<br>employed for a<br>dose<br>recommendation? | The dose recommendation is<br>based on effectiveness of the<br>individual's insulin response, as<br>evident by the post dose blood<br>glucose value. Algorithm is<br>employed by using the current BG<br>to determine that it is safe to dose.<br>Then the last insulin dose, post<br>dose BG, and glucose target range<br>are utilized for the calculation | The dose recommendation<br>is based on the<br>effectiveness of the<br>individual's insulin<br>response, as evident by the<br>BG. The current BG is used<br>to determine if it is safe to<br>dose. Algorithm is<br>employed using the current<br>BG, last dose, current dose,<br>desired glucose target,<br>previous BG and predicted<br>BG for the calculation | The dose recommendation is<br>based on predetermined<br>individualized settings such as<br>glucose target range, insulin to<br>carbohydrate ratio,<br>insulin sensitivity, insulin dosing<br>interval and trends (lifestyle and<br>timing of dosing). The algorithm<br>is employed by using the current<br>BG to see if it is safe to dose and<br>then the settings are used for the<br>calculation |
| Target blood<br>glucose | HCP determines if glucose target<br>range of 85-114 mg/dL (4.7-6.3<br>mmol/L) is appropriate for<br>individual | HCP or patient sets<br>expected glucose target. | HCP sets desired glucose target<br>range. |
| How is starting<br>dose determined? | First dose is calculated based on<br>percentage of total daily long<br>acting insulin; HCP can edit<br>default dose; HCP determines<br>starting dose | HCP determines starting<br>dose | HCP determines starting dose |
| How is HCP<br>involved in<br>doses/settings? | HCP can adjust doses/settings | Same | Same |
| How is patient<br>involved with<br>doses/settings? | Patient can edit dose | Same | Same |
| Information on<br>Diabetes<br>Management | Provides warnings when blood<br>glucose values exceed<br>hypoglycemic or hyperglycemic<br>limits; provides recommended<br>adjustments to the prescribed<br>Humalog dose; tracks blood<br>glucose and insulin data | Provides warnings when<br>blood glucose values and<br>amounts of insulin taken<br>are outside specified range | Provides dose adjustments to<br>prescribed insulin; blood glucose<br>data graphs and reports: tracks<br>non-blood glucose data |
| Limits for Safety | No dosing recommendation for<br>hypoglycemia; algorithm is<br>constrained to a 1 unit dosage<br>increase per day; maximum<br>Humalog dose is 30 units per dose | No dosing increase for<br>hypoglycemia; percentage<br>constraint based on<br>previous insulin dose | No dosing recommendation for<br>hypoglycemia or if missing<br>manual BG input within a meal<br>time window |
| Warnings | Hypoglycemia and<br>Hyperglycemia; aberrant dose<br>recommendation; Uses numeric<br>"fixed" targets for corresponding<br>numeric alerts | Hypoglycemia,<br>Hyperglycemia; warnings<br>are presented when values<br>are out of range and/or<br>insulin doses are , or > 20%<br>of the most recent dose | Hypoglycemia, Hyperglycemia;<br>when safety limits for BG and<br>insulin are exceeded |

# Substantial Equivalence Discussion

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Abbreviations: BG=blood glucose; DM = diabetes mellitus; IDS = Intelligent Dosing System; PC= Personal Computer; HCP= health care provider

# Discussion of Differences

There are two key differences between the indications for use of the Go Dose System and the predicate (K082512) and reference (K043529) devices:

- The predicate device and reference device do not have a specific age range for the intended population in the indications for use statement. The restriction of the intended population is a subset that aligns with the clinical testing and prescribing information for Humalog insulin. Therefore, this specification of the intended population is needed to align with the drug for which this device can be used with.
- The predicate and reference devices contains a single version either intended for use by the patient or the health care provider. The Go Dose System contains 2 versions - the Go Dose. One version is for the health care provider and one version is for the patient. Both versions of the device underwent the same performance and software testing to ensure functionality. This does not raise any new questions of safety or effectiveness compared with having different accesses and privileges within the same application.

However, the intended populations and intended use are similar. The differences in the indications for use do not raise any new questions of safety or effectiveness.

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An outline of the similarities between Go Dose System and the predicate (K082512) is given below:

- Devices use patient blood glucose value to calculate a recommended insulin dose. ●
- . Devices are used by similar target populations.
- Devices are prescription use and used in home and clinical settings.
- . Devices are stand-alone software-based.
- . Stored data resides on computer media.
- Information for diabetes management is provided.
- . HCP oversight of information is provided to patients.

The following differences are noted but are not considered to raise new questions regarding safety or effectiveness:

- Go Dose System network data is stored on a cloud-based platform. .
- . Go Dose System is for use on iOS mobile platforms.

The ACCU-CHEK Advisor Insulin Guidance Software (K043529) (reference) utilizes similar scientific technology for the purposes of providing insulin dosing adjustments. The ACCU-CHEK Advisor software is provided as a reference device for insulin dose adjustment algorithms providing dosing recommendations meant to be used by patients over time to determine optimal insulin dosing.

## Performance Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This software device was considered as a "major" level of concern.

The Go Dose System submission included a Safety Assurance Case to organize and support a comprehensive evaluation of hazards.

The results of Human Factors testing have demonstrated that the GoDose System is substantially equivalent to the predicate device.

# Clinical Tests

There were no clinical performance studies conducted using the Go Dose Mobile Medical Application System. However, the algorithm employed in the Go Dose System was studied using a paper based method in clinical trial IOQC, which consisted of 2 multinational, multicenter, randomized, open-label, parallel-group studies under one protocol within a single clinical trial, F3Z-MC-IOQC (Trial IOQC) as described in Edelman et al. 2014 . This study enrolled adult patients with T2DM who were not under adequate glycemic control with an insulin glargine dose optimized for fasting blood glucose, with or without metformin.

#### Conclusions

The Go Dose System design was evaluated in comparison to the predicate device relative to the intended use, indications for use, intended users, and intended use environment.

The non-clinical evaluation included review of applicable standards, and a safety assurance case approach that incorporates clinical risk per ISO 14971 and cybersecurity risks. The results of the software verification indicate the software specifications were correctly implemented. The results of the summative validation study and supplemental

⁶ Edelman. S.V. (2014) AUTONOMY: The first randomized trial comparing two patient-driven approaches to initiate and titrate prandial insulin lispro in type 2 diabetes. Diabetes Care 3:2132-2140.

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validation study indicate the predetermined acceptance criteria were met. The safety assurance case approach was used to organize and support a comprehensive evaluation of hazards as an aid to the development team, ultimately resulting in the residual risk assessment. The residual risk assessment confirms that the remaining risk is outweighed by the benefit provided by the Go Dose System.

The conclusions drawn from the nonclinical and clinical tests conducted, demonstrate that the device is substantially equivalent to the legally marketed predicate device, My Insulin Doser/IDS (K082512).