(261 days)
The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
The Glooko MIDS system will be an optional new module to support the titration of long acting basal insulin doses. Health care providers (HCPs) will be able to opt-in to this new MIDS module and use it with a subset of their patients. Although the Glooko App may interact with Blood Glucose (BG) meters, insulin pumps and Continuous Glucose Meters (CGM), the MIDS interface will get data ONLY from the BG meters.
Glooko MIDS consists of the following two interfaces:
- MIDS Provider Interface on the Glooko Web Application for use by HCP's to prescribe long acting insulin doses for their patients
- MIDS Patient interface on the Glooko mobile application for use by patients on compatible iOS and Android phones
Glooko MIDS provides directions to the patient based on a pre-planned treatment program as suggested by their HCP for titrating long acting insulin doses. Glooko MIDS is for titrating long acting insulin doses only.
The provided document is a 510(k) Summary for the Glooko Mobile Insulin Dosing System (MIDS). It describes the device, its indications for use, comparison to predicate and reference devices, and performance data to demonstrate substantial equivalence.
However, the document does not contain specific details about acceptance criteria or a clinical study proving the device meets those criteria in the format requested (e.g., a table of performance metrics, sample sizes, expert qualifications, etc.).
Instead, it states that:
- "The Glooko MIDS software was validated pursuant to the Major Level of Concern requirements."
- "Design validation testing and human factors study results confirmed that the Glooko MIDS software performs according to the stated intended use."
- "Software evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol. All of the software tests were documented according to FDA's guidance document - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). All test results fell within the pre-determined specification parameters and acceptance criteria."
This indicates that internal functional and design validation testing, along with human factors validation, was performed, and acceptance criteria were met. However, the specific acceptance criteria, detailed performance metrics, sample sizes for these tests, information about ground truth establishment, or expert involvement are not explicitly provided in the public 510(k) summary.
Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The document refers to "pre-determined specification parameters and acceptance criteria" but does not detail what those are, nor does it provide the results of any specific study (like an MRMC study or standalone performance study measuring clinical accuracy vs. human performance) that would typically prove such criteria were met.
Based on the provided text, I can state the following limitations in responding to your request:
- No explicit table of acceptance criteria and reported device performance is available. The document only states that "All test results fell within the pre-determined specification parameters and acceptance criteria," without listing them.
- Sample sizes for the test set are not specified.
- Data provenance (country of origin, retrospective/prospective) is not specified for any performance testing.
- Number and qualifications of experts for ground truth establishment are not specified.
- Adjudication method for the test set is not specified.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is described with effect sizes.
- No standalone (algorithm-only) performance metrics are detailed beyond stating functional tests were performed.
- The type of ground truth used is not specified. (It's a software for calculating insulin doses based on physician configuration, implying correctness would be against a predefined algorithm or manual calculation, not necessarily pathological or outcomes data in a clinical sense for this type of device).
- Sample size for the training set is not applicable/specified as this is not an AI/ML device that requires a training set in the typical sense. It states "Software evaluation consisted of functional testing," implying rule-based or logic-based software rather than a learned model.
- How ground truth for the training set was established is not applicable/specified.
The submission focuses on demonstrating substantial equivalence to a predicate device (Insulia Diabetes Management Companion) through similar indications for use, technological characteristics, and "functional testing." It is not a submission for a novel AI/ML device requiring extensive clinical validation against human performance or a complex ground truth.
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February 2, 2018
Glooko, Inc. Tejasvi Pasi Senior Regulatory Manager 899 West Evelyn Avenue Mountain View, California 94041
Re: K171450
Trade/Device Name: Glooko Mobile Insulin Dosing System (MIDS) Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: December 29, 2017 Received: January 2, 2018
Dear Tejasvi Pasi:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K171450
Device Name
Glooko Mobile Insulin Dosing System (MIDS)
Indications for Use (Describe)
The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
| 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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Image /page/3/Picture/0 description: The image contains the word "glooko" in a stylized, cursive font. The word is rendered in a bright blue color, which stands out against the white background. The font has rounded edges and a playful feel, giving the word a friendly and approachable appearance.
510(K) Summary for K171450
- 5.1 Submitter Information
Name: Address:
| Phone: | |
|---|---|
| Fax: | |
| Contact Name: | |
| Date of Summary: |
5.2 Subject Device
Trade Name: Common Name: Classification Name: Regulation Number: Regulation Name:
Requlatory Class: Product code: Classification Panel:
5.3 Predicate Device
- Trade Name: (K161433) Common Name: Classification Name: Regulation Number: Regulation Name:
Requlatory Class: Product code: Classification Panel:
5.4 Reference Device
Trade Name: (K132272) Common Name: Glooko Inc. 303 Bryant Street, Mountain View, CA 94041, USA (650) 720-5310 (650)-720-5310 Tejasvi Pasi 02/01/2018
Glooko Mobile Insulin Dosing System (MIDS) Diabetes Management Software Calculator, Druq Dose 21 CFR 868.1890 Predictive pulmonary - function value calculator Class II NDC General Hospital
Insulia Diabetes Management Companion
Diabetes Management Software Calculator, Drug Dose 21 CFR 868.1890 Predictive pulmonary - function value calculator Class II NDC General Hospital
Glooko Device System for Glooko Application
Blood Glucose Meter and Data Management System
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Glucose Test System, Calculator Data Classification Name: Processing Module for Clinical Use Requlation Number: 21 CFR 862.1345
Regulatory Class: Product code: Classification Panel:
21 CFR 862.2100 Class II, Class I NBW, JQP Clinical Chemistry
5.5 Device Description
The Glooko MIDS system will be an optional new module to support the titration of long acting basal insulin doses. Health care providers (HCPs) will be able to opt-in to this new MIDS module and use it with a subset of their patients. Although the Glooko App may interact with Blood Glucose (BG) meters, insulin pumps and Continuous Glucose Meters (CGM), the MIDS interface will get data ONLY from the BG meters
Glooko MIDS consists of the following two interfaces:
- . MIDS Provider Interface on the Glooko Web Application for use by HCP's to prescribe long acting insulin doses for their patients
- MIDS Patient interface on the Glooko mobile application for use by . patients on compatible iOS and Android phones
Glooko MIDS provides directions to the patient based on a pre-planned treatment program as suggested by their HCP for titrating long acting insulin doses. Glooko MIDS is for titrating long acting insulin doses only.
5.6 Indications for Use
The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not
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Image /page/5/Picture/0 description: The image contains the word "glooko" in a stylized, cursive font. The word is rendered in a bright blue color, which stands out against the white background. The font has rounded edges and a playful feel, making it appear friendly and approachable. The overall design is simple and clean, with the focus entirely on the brand name.
intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
5.7 Comparison to Predicate Device
| Feature | Glooko Mobile Insulin DosingSystem(Subject device) | Insulia Diabetes Management Companion(Predicate device) |
|---|---|---|
| Code | NDC | NDC |
| Class | II | II |
| RegulationName/Regulation | Predictive pulmonary-function valuecalculator/21 CFR 868.1890 | Predictive pulmonary-function valuecalculator/21 CFR 868.1890 |
| K Number | K171450 | K161433 |
| Indications for Use* | The Glooko Mobile Insulin DosingSystem (MIDS) is indicated for themanagement of type 2 diabetes bycalculating appropriate long-actingbasal insulin doses for titrating insulinlevels based on configuration by aphysician or healthcare providerknowledgeable in the care andmanagement of diabetes. The physicianor healthcare provider must activate theMIDS dose calculator and configure thepatient-specific parameters. The systemis not intended to provide treatmentdecisions or to be used as a substitutefor professional healthcare advice. | Insulia Diabetes Management Companion isindicated for use by healthcare professionals(HCPs) and their type 2 adult diabetespatients treated with long-acting insulinanalog. Insulia Diabetes ManagementCompanion is intended to provide securecapture, storage and transmission ofdiabetes-related healthcare information, toenhance data management, to displayreports and graphs, and to aid the HCP andthe patient in the review, analysis, andevaluation of patient data in order to supporteffective diabetes management. InsuliaDiabetes Management Companion includes abasal calculator intended to provide directionto the patient in response to blood glucoseand health events, within the scope of a pre-planned treatment program from a healthcareprofessional for insulin adjustments, similar tothe directions provided to patients as a part ofroutine clinical practice. Insulia DiabetesManagement Companion includes softwareintended for use on commercially available |
| Feature | Glooko Mobile Insulin Dosing System(Subject device) | Insulia Diabetes Management Companion(Predicate device) |
| mobile platforms, personal computers, in thehome or in professional healthcare settings,and uses generally available networks andcommunication protocols. Insulia DiabetesManagement Companion is not intended toreplace the care provided by a licensedhealthcare professional, includingprescriptions, diagnosis, or treatment. | ||
| Components | Patient mobile based application,patient and HCP web based application | Software only, patient mobile basedapplication, patient and HCP web basedapplication |
| TreatmentGuidance | Adjustments to insulin doses within thescope of a pre-planned, physicianspecified treatment program similar toroutine clinical practice | Adjustments to insulin doses within thescope of a pre-planned, physician specifiedtreatment program similar to routine clinicalpractice |
| Type of CalculatedInsulin | Basal Insulin | Basal Insulin |
| Manual BG Entry | No | Yes |
| Logbook | Yes | Yes |
| Reports & Statistics | Yes | Yes |
| Coaching Messages | No | Yes |
| Secure Database | Yes | Yes |
| Data Transfer | Internet | Internet |
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*Glooko MIDS has the same intended use as the predicate device. Both software applications are intended for use by healthcare professionals and their patients with type 2 diabetes for calculating appropriate long-acting insulin doses. Glooko MIDS and the predicate device provide HCP-configured directions within the scope of a pre-planned treatment program for titrating long-acting insulin as a part of routine clinical practice. The proposed indications for use for the subject device are similar to and consistent with that of the predicate device, and do not raise different questions of safety or effectiveness.
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5.8 Comparison to Reference Device
The reference device supports the BG entry method for the subject device. Both the subject and the reference device do not support manual entry of BG data. In both the Glooko MIDS and the reference device BG data is transferred from supported BG meters to the Glooko Application via cable(s) or Bluetooth enabled BG meters.
| Feature | Glooko Mobile Insulin Dosing System(Subject device) | Glooko Device System for GlookoApplication(Reference device) |
|---|---|---|
| K Number | K171450 | K132272 |
| BG Entry | BG data is transferred from the BG meter tothe Glooko Application via cable(s) orBluetooth enabled BG meters | BG data is transferred from the BG meter tothe Glooko Application via cable(s) orBluetooth enabled BG meters |
5.9 Performance Data Demonstrating Substantial Equivalence
The Glooko MIDS underwent Human Factors validation testing and software performance testing to support a determination of substantial equivalence.
The Glooko MIDS software was validated pursuant to the Major Level of Concern requirements. Design validation testing and human factors study results confirmed that the Glooko MIDS software performs according to the stated intended use. The Human Factors validation was documented according to FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). Software evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol. All of the software tests were documented according to FDA's guidance document - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). All test results fell within the pre-determined specification parameters and acceptance criteria.
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Image /page/8/Picture/0 description: The image shows the word "glooko" in a stylized, sans-serif font. The word is rendered in a bright blue color. The letters are connected in a cursive-like manner, giving the word a flowing appearance.
5.10 Statement of Equivalence
The Glooko MIDS is substantially equivalent to the predicate device with regards to its intended use and function.
5.11 Conclusion
Glooko MIDS has similar indications for use and similar technological characteristics as those of the predicate device Insulia Diabetes Management Companion. Performance testing of the Glooko MIDS software has demonstrated that Glooko MIDS performs as intended and is substantially equivalent to the predicate device. Based on the product technical information, intended use, human factors and validation data provided in this pre-market notification, the Glooko MIDS software has been shown to be substantially equivalent to the currently marketed predicate device.
§ 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).