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.

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.

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.

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.

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).

AI/ML Overview

The Go Dose System is a mobile medical application designed to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management. It provides recommendations for titrating prandial Humalog dosing.

Here's an analysis of the acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly list a table of "acceptance criteria" against "reported device performance" for the Go Dose System as one might find for a hardware device's technical specifications (e.g., accuracy of a measurement). Instead, the submission relies on the historical clinical validation of the underlying algorithm and extensive software verification and validation.

The "acceptance criteria" are implied through the statement that "the predetermined acceptance criteria were met" during summative and supplemental validation studies (Page 11). The primary performance validation for the algorithm itself is derived from the "Trial IOQC" study. The device's performance, therefore, is directly linked to the outcomes of this clinical trial in terms of its ability to initiate and titrate prandial insulin lispro (Humalog) therapy and improve diabetes management.

Implied Acceptance Criteria (from the clinical study and device's purpose):

Acceptance Criteria (Implied)	Reported Device Performance (from Trial IOQC)
Effective initiation and titration of prandial Humalog dosing	The algorithm, implemented in the Go Dose System, demonstrated its ability to initiate and titrate prandial insulin lispro in adult patients with T2DM who were not under adequate glycemic control, comparing favorably to other patient-driven approaches. (Based on Edelman et al. 2014)
Safety of dosing recommendations (avoiding hypoglycemia/hyperglycemia risks)	The algorithm included safety limits, such as no dosing recommendation for hypoglycemia, a 1-unit dosage increase limit per day, and a maximum Humalog dose of 30 units per dose. The clinical trial results (Edelman et al. 2014) would implicitly support the safety profile.
Software functionality and reliability	Software verification and validation activities (including a Safety Assurance Case and Human Factors testing) demonstrated that software specifications were correctly implemented, and the system is substantially equivalent to the predicate device.
User-friendliness and effective patient/HCP interaction	Human Factors testing demonstrated substantial equivalence to the predicate device, implying usability and effective interaction for patients and HCPs.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: No specific "test set" for the device software is described with a distinct sample size in the context of the clinical trial. However, the clinical algorithm was tested in a large clinical trial.
Sample Size for Algorithm Validation (Trial IOQC): The details state that Trial IOQC 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." While the exact number isn't provided in the excerpt, the paper referenced (Edelman et al. 2014) would contain this information. The description mentions "2 multinational, multicenter, randomized, open-label, parallel-group studies within a single clinical trial." This implies a substantial sample size.
Data Provenance: "multinational, multicenter" indicates data from multiple countries and clinical sites. The studies were prospective as they were described as "randomized, open-label, parallel-group studies within a single clinical trial."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The "ground truth" for the algorithm was established through the clinical trial's outcomes, where patient blood glucose levels and insulin doses were collected and analyzed directly. There is no mention of a separate panel of experts establishing ground truth for the clinical algorithm retrospective evaluation against a "test set" in the traditional sense of an AI model's validation. The experts involved would be the clinical investigators and trial statisticians of the "Trial IOQC."

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the clinical trial (randomized, open-label, parallel-group), outcomes were likely adjudicated based on pre-defined clinical endpoints and statistical analysis rather than a consensus of experts retrospectively labeling data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic aids where multiple human readers interpret cases with and without AI assistance. The Go Dose System is an insulin dosing calculator, not an image interpretation tool. Its effectiveness is measured by clinical outcomes related to glycemic control.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the underlying algorithm's performance was evaluated in a standalone manner within the clinical trial. The "paper-based" algorithm, which is the foundation of the Go Dose System, was studied for safety and efficacy in "Trial IOQC" before being implemented in the mobile application. The mobile application then underwent software verification and validation, but the core clinical performance relied on the prior clinical validation of the algorithm itself.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation of the algorithm (Trial IOQC) was outcomes data, specifically:

Blood glucose values (objective physiological measurements).
Patient health status, including glycemic control.
Insulin dosing regimens.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the algorithm in the context of machine learning. The algorithm's design is stated to be "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 suggests a rule-based algorithm derived from established clinical evidence and refined through traditional clinical trials, rather than a data-driven machine learning approach requiring a distinct training set. The clinical trial itself serves as the validation of the algorithm's effectiveness.

9. How the Ground Truth for the Training Set Was Established

Since it's a rule-based algorithm and not a machine learning model with a distinct "training set," the concept of "ground truth for the training set" doesn't directly apply in the same way. The algorithm's rules and parameters would have been established based on medical knowledge, clinical guidelines, and insights gained from extensive research and prior clinical experience with insulin titration, potentially informed by observational data or previous pilot studies, eventually validated in Trial IOQC. The efficacy and safety were then prospectively evaluated in the aforementioned clinical trial (Trial IOQC) against observed patient blood glucose values and clinical outcomes.

Summary

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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 (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 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

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.

Indications for Use - Go Dose Pro Application

· 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

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 CompanyLilly Corporate CenterIndianapolis, IN 46285
Corresponding Official:	Sumitra M GhateDirector-Regulatory CMC DevicesGlobal Regulatory Affairs CMC
Telephone Number:E-mail:	317-433-3486sg@lilly.com
Preparation Date:	December 13, 2016
Trade Name:	Go Dose System
Common or Usual Name:	Dose calculator
Classification Name andNumber:	21 CFR 868.1890, Predictive pulmonary-function valuecalculator
	Product Code: NDCAdditional Product Code: LNX
Primary Predicate Device:	Intelligent Dosing System For Insulin - my Insulin Doser(K082512)
Reference Device:	Accu-chek Advisor Insulin Guidance Software (K043529)

Device Description

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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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.

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Indications for Use - Go Dose Pro Application

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

Feature	Go Dose System (comprised ofGo Dose and Go Dose Proapplications) (K160949)	My Insulin Doser/IDS(K082512)	ACCU-CHEK Advisor InsulinGuidance Software (K043529)
Intended Use	The Go Dose System, comprisedof the Go Dose application andGo Dose Pro application, is foruse in home and clinical settingsto aid in the review, analysis, andevaluation of historical bloodglucose test values to supportdiabetes management.The Go Dose System is a mobileapplication for use with iPad®,iPhone®, or iPod touch® mobiledevices. The Go Dose Systemprovides recommendations fortitrating mealtime doses ofHumalog, one meal at a time,using blood glucose valuesentered by the patient. Go Doseand Go Dose Pro are not intendedto replace the care provided by alicensed health care provider or toprovide any diagnosis on patientblood glucose values. Go Doseand Go Dose Pro are forprescription use only.	My Insulin Doser/IDSallows a person withdiabetes to calculate thebest next dose of insulin toachieve a personal glucosetarget.	The software is intended for usein home and clinical settings toaid people with diabetes and theirhealth care providers in review,analysis and evaluation ofhistorical blood glucose testresults to support diabetesmanagement, including providingdirection within the scope of apreplanned treatment program foradjustments to prescribed insulin,similar to the directionsphysicians provide to patients as apart of routine clinical practice.The device is not intended toprovide any diagnosis on patientresults.
Algorithm Feature	Patients aged 18-85 years whohave type 2DM, requiring	person with diabetes	patients with diabetes and theirhealth care providers
	treatment intensification withHumalog 100 units per mL (U-100), and for whom the set bloodglucose targetrange of 85-114 mg/dL (4.7-6.3mmol/L) is appropriate; and theirhealthcare provider
Environment ofUse	Home under direction of HCP andclinical settings	Home under direction ofHCP	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 computermedia	On local computer media
Insulin DoseCalculation	yes	yes	yes
Purpose ofAlgorithm	To initiate and titrate insulintherapy (to help HCP arrive atstable Humalog dose, titrateadditional doses or stop dose) toimprove diabetes management	Same	Same
Patient Inputvariables relatedto dosecalculation	Blood glucose	Blood glucose	Blood glucose Carbohydrates Optional: Alternate state (allows theuser to declare aphysiologic conditionsuch as mild stress, mildillness or light exercise) Entry notes - addscontext; can customize
Algorithm Output	Prandial Insulin dosingrecommendation	Insulin dosingrecommendation	Prandial Insulin dosingrecommendation
How is thealgorithmemployed for adoserecommendation?	The dose recommendation isbased on effectiveness of theindividual's insulin response, asevident by the post dose bloodglucose value. Algorithm isemployed by using the current BGto determine that it is safe to dose.Then the last insulin dose, postdose BG, and glucose target rangeare utilized for the calculation	The dose recommendationis based on theeffectiveness of theindividual's insulinresponse, as evident by theBG. The current BG is usedto determine if it is safe todose. Algorithm isemployed using the currentBG, last dose, current dose,desired glucose target,previous BG and predictedBG for the calculation	The dose recommendation isbased on predeterminedindividualized settings such asglucose target range, insulin tocarbohydrate ratio,insulin sensitivity, insulin dosinginterval and trends (lifestyle andtiming of dosing). The algorithmis employed by using the currentBG to see if it is safe to dose andthen the settings are used for thecalculation
Target bloodglucose	HCP determines if glucose targetrange of 85-114 mg/dL (4.7-6.3mmol/L) is appropriate forindividual	HCP or patient setsexpected glucose target.	HCP sets desired glucose targetrange.
How is startingdose determined?	First dose is calculated based onpercentage of total daily longacting insulin; HCP can editdefault dose; HCP determinesstarting dose	HCP determines startingdose	HCP determines starting dose
How is HCPinvolved indoses/settings?	HCP can adjust doses/settings	Same	Same
How is patientinvolved withdoses/settings?	Patient can edit dose	Same	Same
Information onDiabetesManagement	Provides warnings when bloodglucose values exceedhypoglycemic or hyperglycemiclimits; provides recommendedadjustments to the prescribedHumalog dose; tracks bloodglucose and insulin data	Provides warnings whenblood glucose values andamounts of insulin takenare outside specified range	Provides dose adjustments toprescribed insulin; blood glucosedata graphs and reports: tracksnon-blood glucose data
Limits for Safety	No dosing recommendation forhypoglycemia; algorithm isconstrained to a 1 unit dosageincrease per day; maximumHumalog dose is 30 units per dose	No dosing increase forhypoglycemia; percentageconstraint based onprevious insulin dose	No dosing recommendation forhypoglycemia or if missingmanual BG input within a mealtime window
Warnings	Hypoglycemia andHyperglycemia; aberrant doserecommendation; Uses numeric"fixed" targets for correspondingnumeric alerts	Hypoglycemia,Hyperglycemia; warningsare presented when valuesare out of range and/orinsulin doses are , or > 20%of the most recent dose	Hypoglycemia, Hyperglycemia;when safety limits for BG andinsulin 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).

Regulation Number and Section

§ 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).