(261 days)
Accu-chek Advisor Insulin Guidance Software (K043529)
No
The description explicitly states the device is based on a "paper-based" algorithm approach and mentions "daily adjusted dosing algorithm," which suggests a deterministic, rule-based system rather than AI/ML. There is no mention of training data, models, or learning processes.
Yes
The device provides recommendations for titrating prandial Humalog dosing and supports type 2 diabetes mellitus management, indicating it has a therapeutic purpose by influencing patient treatment.
No
The text explicitly states: "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." This indicates it is not a diagnostic device.
Yes
The device is described as "mobile medical applications (apps)" and relies on standard mobile devices (iPad or iPhone) for operation. The description focuses on the software's functionality (algorithm, data input, recommendations) and mentions software verification and validation testing, without indicating any proprietary or specialized hardware components included as part of the medical device itself.
Based on the provided information, the Go Dose System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Go Dose System Function: The Go Dose System uses manually entered blood glucose values as input. It does not perform any analysis or testing of a biological specimen itself. Its function is to process existing blood glucose data and provide dosing recommendations based on a pre-defined algorithm.
- Intended Use: The intended use clearly states it's for "review, analysis, and evaluation of historical blood glucose test values" and to "support type 2 diabetes mellitus management" by providing dosing recommendations. It does not claim to diagnose or test biological samples.
While the system relies on blood glucose values, the device itself is a software application that processes data, not a device that performs the in vitro diagnostic test to obtain those values. The blood glucose testing itself would be performed by a separate IVD device (like a blood glucose meter).
N/A
Intended Use / 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, 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.
Product codes
NDC, LNX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18-85 years
Intended User / Care Setting
Home and clinical settings; patient under supervision of their health care provider (HCP); health care providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Intelligent Dosing System For Insulin - my Insulin Doser (K082512)
Reference Device(s)
Accu-chek Advisor Insulin Guidance Software (K043529)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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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
1
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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.
2
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
3
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)
4
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5
K160949 510(K) SUMMARY
| Manufacturer's Name: | Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 |
|------------------------------------|-------------------------------------------------------------------------------------|
| Corresponding Official: | Sumitra M Ghate
Director-Regulatory CMC Devices
Global Regulatory Affairs CMC |
| Telephone Number:
E-mail: | 317-433-3486
sg@lilly.com |
| Preparation Date: | December 13, 2016 |
| Trade Name: | Go Dose System |
| Common or Usual Name: | Dose calculator |
| Classification Name and
Number: | 21 CFR 868.1890, Predictive pulmonary-function value
calculator |
| | Product Code: NDC
Additional 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
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.
6
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.
7
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
Go Dose and Go Dose Pro
applications) (K160949) | My Insulin Doser/IDS
(K082512) | ACCU-CHEK Advisor Insulin
Guidance Software (K043529) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Go Dose System, comprised
of the Go Dose application and
Go Dose Pro application, is for
use in home and clinical settings
to aid in the review, analysis, and
evaluation of historical blood
glucose test values to support
diabetes management.
The Go Dose System is a mobile
application for use with iPad®,
iPhone®, or iPod touch® mobile
devices. The Go Dose System
provides recommendations for
titrating mealtime doses of
Humalog, one meal at a time,
using blood glucose values
entered by the patient. Go Dose
and Go Dose Pro 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
and Go Dose Pro are for
prescription use only. | My Insulin Doser/IDS
allows a person with
diabetes to calculate the
best next dose of insulin to
achieve a personal glucose
target. | The software is intended for use
in home and clinical settings to
aid people with diabetes and their
health care providers in review,
analysis and evaluation of
historical blood glucose test
results to support diabetes
management, including providing
direction within the scope of a
preplanned treatment program for
adjustments to prescribed insulin,
similar to the directions
physicians provide to patients as a
part of routine clinical practice.
The device is not intended to
provide any diagnosis on patient
results. |
| Algorithm Feature | Patients aged 18-85 years who
have type 2DM, requiring | person with diabetes | patients with diabetes and their
health care providers |
| | treatment intensification with
Humalog 100 units per mL (U-
100), and for whom the set blood
glucose target
range of 85-114 mg/dL (4.7-6.3
mmol/L) is appropriate; and their
healthcare provider | | |
| Environment of
Use | Home under direction of HCP and
clinical settings | Home under direction of
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
media | On local computer media |
| Insulin Dose
Calculation | yes | yes | yes |
| Purpose of
Algorithm | To initiate and titrate insulin
therapy (to help HCP arrive at
stable Humalog dose, titrate
additional doses or stop dose) to
improve diabetes management | Same | Same |
| Patient Input
variables related
to dose
calculation | Blood glucose | Blood glucose | Blood glucose Carbohydrates Optional: Alternate state (allows the
user to declare a
physiologic condition
such as mild stress, mild
illness or light exercise) Entry notes - adds
context; can customize |
| Algorithm Output | Prandial Insulin dosing
recommendation | Insulin dosing
recommendation | Prandial Insulin dosing
recommendation |
| How is the
algorithm
employed for a
dose
recommendation? | The dose recommendation is
based on effectiveness of the
individual's insulin response, as
evident by the post dose blood
glucose value. Algorithm is
employed by using the current BG
to determine that it is safe to dose.
Then the last insulin dose, post
dose BG, and glucose target range
are utilized for the calculation | The dose recommendation
is based on the
effectiveness of the
individual's insulin
response, as evident by the
BG. The current BG is used
to determine if it is safe to
dose. Algorithm is
employed using the current
BG, last dose, current dose,
desired glucose target,
previous BG and predicted
BG for the calculation | The dose recommendation is
based on predetermined
individualized settings such as
glucose target range, insulin to
carbohydrate ratio,
insulin sensitivity, insulin dosing
interval and trends (lifestyle and
timing of dosing). The algorithm
is employed by using the current
BG to see if it is safe to dose and
then the settings are used for the
calculation |
| Target blood
glucose | HCP determines if glucose target
range of 85-114 mg/dL (4.7-6.3
mmol/L) is appropriate for
individual | HCP or patient sets
expected glucose target. | HCP sets desired glucose target
range. |
| How is starting
dose determined? | First dose is calculated based on
percentage of total daily long
acting insulin; HCP can edit
default dose; HCP determines
starting dose | HCP determines starting
dose | HCP determines starting dose |
| How is HCP
involved in
doses/settings? | HCP can adjust doses/settings | Same | Same |
| How is patient
involved with
doses/settings? | Patient can edit dose | Same | Same |
| Information on
Diabetes
Management | Provides warnings when blood
glucose values exceed
hypoglycemic or hyperglycemic
limits; provides recommended
adjustments to the prescribed
Humalog dose; tracks blood
glucose and insulin data | Provides warnings when
blood glucose values and
amounts of insulin taken
are outside specified range | Provides dose adjustments to
prescribed insulin; blood glucose
data graphs and reports: tracks
non-blood glucose data |
| Limits for Safety | No dosing recommendation for
hypoglycemia; algorithm is
constrained to a 1 unit dosage
increase per day; maximum
Humalog dose is 30 units per dose | No dosing increase for
hypoglycemia; percentage
constraint based on
previous insulin dose | No dosing recommendation for
hypoglycemia or if missing
manual BG input within a meal
time window |
| Warnings | Hypoglycemia and
Hyperglycemia; aberrant dose
recommendation; Uses numeric
"fixed" targets for corresponding
numeric alerts | Hypoglycemia,
Hyperglycemia; warnings
are presented when values
are out of range and/or
insulin doses are , or > 20%
of the most recent dose | Hypoglycemia, Hyperglycemia;
when safety limits for BG and
insulin are exceeded |
Substantial Equivalence Discussion
8
9
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).