DBLG2, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when glucose values are predicted to exceed a predefined threshold. To do this, the DBLG2 software takes into account the patient's profile, glycemia (current and predicted), announced meals and physical activities.

DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater.

DBLG2 is intended for single patient use.

DBLG2 is Rx - For Prescription Use Only.

Device Description

Diabeloop DBLG2 is an Android application installed on patient personal mobile phone, intended for managing glucose levels in people with type 1 diabetes, using a hybrid closed loop approach (automated insulin delivery). It is designed to be connected with a compatible Automated Controller Enabled (ACE) insulin pump and integrated Continuous Glucose Monitors (iCGM).

DBLG2 has a regulation algorithm to automatically manage the patient's blood glucose level. It takes as input glycemia value received from the CGM, personal patient medical parameters and patient input related to meals and physical activities, and it calculates every 5 minutes the amount of insulin to deliver in order to keep the patient in the normoglycemia bounds. It sends this information to the pump that automatically delivers this quantity of insulin.

The software can ask the pump to deliver:

A meal bolus
A correction bolus (small amount of insulin)
A basal rate over a given period of time.

The software can also ask the patient to take a calculated amount of carbohydrates if the system determines that the patient would go into hypoglycemia even if the insulin basal rate is brought down to zero.

DBLG2 acts mostly by modulating the basal rate of insulin delivery, but in some cases can deliver, automatically, correction boluses. It includes a patient-confirmed meal bolus calculator that simplifies meal dosing by allowing the patient to enter their meal carbohydrate amount while the system retrieves the patient's personalized insulin dosing parameters from their profile. The system calculates and displays a recommended meal bolus dose, which the patient must review and confirm before delivery is initiated.

In addition, DBLG2 has a self-learning module that applies improvements to the patient's algorithm parameters, based on estimated glycemia history and insulin delivery quantities, from the patient's history.

DBLG2 is designed to be secure, with by-design and structural security mechanisms that prevent from both hypoglycemia and hyperglycemia:

Hypoglycemia: by detecting an existing or upcoming hypoglycemia:
- The algorithm cuts down insulin delivery if a risk of hypoglycemia exists within the next fifteen minutes, the system will ask the user to take carbohydrates (by an alert).
- If the patient is in hypoglycemia below 55mg/dL (= 3.1 mmol/L), an alarm is triggered.
Hyperglycemia: the algorithm orders the delivery of insulin correction bolus to reduce the glycemia.

The software also guarantees patient's safety by returning to the pre-programmed basal pattern if the automatic regulation cannot be done for any reason (including loss of communication with the CGM or pump) or if the patient wishes to return to manual control by stopping the automatic regulation.

The algorithm includes appropriate alerts/alarms in case of any malfunction of one of the components.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for Diabeloop DBLG2:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the DBLG2 software's clinical performance has been demonstrated through "consistent results in 6 prospective clinical trials." While specific numerical acceptance criteria (e.g., minimum Time in Range percentage, maximum hypoglycemia duration) are not clearly detailed in the provided text as a formal table of acceptance criteria, the document implies that the device is deemed safe and effective based on improvements in several glycemic outcomes compared to current treatment or a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (DBLG2)
Improved Glycemic Outcomes	Demonstrated "various improvements in glycemic outcomes" including:
- Time in Range (TIR) 70-180 mg/dL	Improved
- Time in Hypoglycemia	Improved
- Time in Hyperglycemia	Improved
- Mean Continuous Glucose Monitoring (CGM) value	Improved
- HbA1c	Improved
- Occurrence of severe metabolic episodes	Improved
User Satisfaction	High satisfaction reported in various studies
Safety and Effectiveness for Intended Users/Uses	Human factors and clinical validation demonstrated that Diabeloop software performed as designed and intended for the intended users, uses, and use environments.
Substantial Equivalence to Predicate	"DBLG2 software is substantially equivalent to the predicate Tidepool Loop cleared in K203689. The differences... do not raise different questions of safety or effectiveness."

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

Test Set Description: The clinical performance is supported by "6 prospective clinical trials."
Sample Size:
- Adults: Total of 15,325 patient-weeks of data collected.
- Adolescents (with T1D): Total of 1,594 patient-weeks of data collected.
Data Provenance: The trials were "prospective clinical trials." The provided text doesn't explicitly state the country of origin for the data collection, but the submitter is based in Grenoble, France, which suggests these studies could have been conducted in Europe or internationally.

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

The document does not provide details on the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth within the clinical trials. The phrase "ground truth" generally refers to definitive, objectively measured outcomes. For a glycemic control system, the primary ground truth would be the continuous glucose monitoring (CGM) data itself, along with lab-measured HbA1c, and recorded hypoglycemic/hyperglycemic events, which are direct physiological measurements rather than expert interpretations.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (like 2+1, 3+1, none) for the test set. Given the nature of objective physiological measurements (CGM, HbA1c), manual adjudication of "ground truth" by multiple experts is less common than in, for example, image interpretation studies. The "ground truth" is largely the direct physiological data collected.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically relevant for diagnostic aids where human readers interpret medical images or data, and the AI's assistance is being evaluated regarding its impact on their diagnostic accuracy. This device is an automated glycemic controller, not a diagnostic interpretation tool, so an MRMC study is not applicable. Therefore, there is no mention of an effect size for human reader improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the studies evaluate the performance of the DBLG2 software, which is an "algorithm technology" designed to "automatically increase, decrease, and suspend delivery of basal insulin" and "deliver correction boluses." While it integrates with user input (meal announcements, physical activities) and requires patient confirmation for meal boluses, the core "automatic regulation" of insulin delivery based on CGM readings and predictions represents its standalone algorithmic performance within the hybrid closed-loop system. The clinical trials assess the overall system performance, which inherently includes the algorithm's performance without constant human override of every automated decision.

7. The Type of Ground Truth Used:

The ground truth used is primarily physiological outcomes data, specifically:

Continuous Glucose Monitoring (CGM) values, from which Time in Range (TIR), time in hypoglycemia, time in hyperglycemia, and mean CGM values are derived.
HbA1c measurements.
Documented occurrence of severe metabolic episodes.
Patient feedback on satisfaction.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for the training set for the DBLG2 algorithm. The provided information focuses on the data used for clinical validation/testing. The DBLG2 system also includes a "self-learning module that applies improvements to the patient's algorithm parameters, based on estimated glycemia history and insulin delivery quantities, from the patient's history," which implies ongoing, personalized "training" within each patient's use. However, the initial development and training data for the core algorithm are not detailed here.

9. How the Ground Truth for the Training Set was Established:

The document does not detail how the ground truth for the training set was established. Given the nature of the device, it is highly likely that for the initial algorithm development and training, retrospective or simulated physiological data, potentially from a variety of sources (e.g., historical patient data, simulated diabetes models), would have been used. The "self-learning module" uses the patient's own glycemia history and insulin delivery quantities to refine parameters, establishing its internal "ground truth" from these real-time individual patient data points.

Summary

FDA 510(k) Clearance Letter - Diabeloop DBLG2

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 19, 2025

Diabeloop
Erik Huneker
Director QA, RA & CA and co-founder
17 rue Felix Esclangon
Grenoble, 38000
France

Re: K251152
Trade/Device Name: DBLG2
Regulation Number: 21 CFR 862.1356
Regulation Name: Interoperable Automated Glycemic Controller
Regulatory Class: Class II
Product Code: QJI
Dated: April 3, 2025
Received: April 14, 2025

Dear Erik Huneker:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new

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K251152 - Erik Huneker
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premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

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K251152 - Erik Huneker
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803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JOSHUA BALSAM -S

Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251152

Device Name
DBLG2

Indications for Use (Describe)

DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater.

DBLG2 is intended for single patient use.

DBLG2 is Rx - For Prescription Use Only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
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UD-FDA-3881_12-25-13 release 1

UD-FDA-3881_12-25-13

Object: NA

Nature of changes: Creation

Attached files: UD-FDA-3881_12-25-13.pdf

Status: Active
Submitted on: 14/12/2025
Approved on: 14/12/2025
Activated on: 14/12/2025
Next review on: 14/12/2027

Authors: VICENTE Alexandre

Editors: KROISS Cecilia - QA Specialist

Signatory:

Author - VICENTE Alexandre - R&D Project Coordinator digitally signed on 14/12/2025 10:30
Reviewer - HUNEKER Erik - Director QA, RA & CA digitally signed on 14/12/2025 12:37
Approver - KROISS Cecilia - QA Specialist digitally signed on 14/12/2025 15:32

Distribution groups: Tous les utilisateurs actifs - Reading

Users in distribution: Bot Qualios Slack - E-Mail

Document history:
UD-FDA-3881_12-25-13 release 1 : UD-FDA-3881_12-25-13
Approved on 14/12/2025
Activated on 14/12/2025
Nature of changes : Creation

Consulted on: 14/12/2025 17:53

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510(k) Summary

Form name: N/A
Revision: N/A
Record name: DBLG2US-RA-SUM-001-Rev5

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter information

Sponsor: Diabeloop SA
17 Rue Félix Esclangon
38000 Grenoble
France

Contact Person: Erik Huneker, Director QA, RA & CA and co-founder
Email: fda@diabeloop.fr
Phone: +33 (0)4 76 09 54 18

2. Proposed device

Device Classification Name: Interoperable Automated Glycemic Controller (iAGC)
Device Classification: Class II, 21 CFR 862.1356
Product Code: QJI
Device Proprietary Name: Diabeloop DBLG2

3. Predicate Device

Device Name: Tidepool Loop
Manufacturer: Tidepool
Premarket Notification #: K203689
Device Classification Name: Interoperable Automated Glycemic Controller (iAGC)
Device Classification: Class II, 21 CFR 862.1356
Product Code: QJI

4. Date Prepared: 12/19/2025

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5. Device description

The software can ask the pump to deliver:

A meal bolus
A correction bolus (small amount of insulin)
A basal rate over a given period of time.

DBLG2 is designed to be secure, with by-design and structural security mechanisms that prevent from both hypoglycemia and hyperglycemia:

Hypoglycemia: by detecting an existing or upcoming hypoglycemia:
- The algorithm cuts down insulin delivery if a risk of hypoglycemia exists within the next fifteen minutes, the system will ask the user to take carbohydrates (by an alert).
- If the patient is in hypoglycemia below 55mg/dL (= 3.1mmol/L), an alarm is triggered.
Hyperglycemia: the algorithm orders the delivery of insulin correction bolus to reduce the glycemia.

The algorithm includes appropriate alerts/alarms in case of any malfunction of one of the components.

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6. Indication for Use

DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater.
DBLG2 is intended for single patient use.
DBLG2 is Rx - For Prescription Use Only.

Contraindications

DBLG2 should not be used by anyone who is unable to notice alerts, alarms, and reminders because of physical limitations, such as severe uncorrected hearing impairment or severe uncorrected problems of visual acuity.
DBLG2 should not be used by anyone who is unwilling or unable to follow the instructions for use.
DBLG2 should not be used by anyone that is unable to maintain contact with their healthcare provider.
DBLG2 should not be used by patients suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology (e.g. irregular treatment by steroids) and which might interfere with the medical device
DBLG2 should not be used by patients receiving a total daily dose of insulin lower than 8 units.
DBLG2 should not be used by patients using any insulin that is not 100U/mL rapid-acting insulin analog.

MR Unsafe: DBLG2 should not be used during Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. Components of the DBLG2 system may not have been tested in magnetic fields and heat could damage the compatible iCGM or ACE pump being used with DBLG2 and prevent accurate sensor glucose readings or accurate insulin delivery. This could result in overdelivery or under-delivery of insulin, which can lead to low or high blood glucose. Please follow Healthcare Provider instructions and refer to the individual component manuals for more information.

Clinical Warnings:

The safety and effectiveness of the DBLG2 System have not been tested or approved for the following categories of people:

Patients with type 2 diabetes
Patients with highly unstable diabetes
Patients with gestational diabetes
Pregnant women with type 1 diabetes
Patients whose pancreas has been removed or is not functioning altogether
Patients with severely altered renal function (creatinine clearance < 30 mL/min)
Patients with a decreased feeling of hypoglycemia symptoms
Patients with islet/pancreas transplants
Patients on dialysis
Critically ill patients

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7. Comparison to Predicate Device

DBLG2 software is substantially equivalent to the predicate device, Tidepool Loop, as cleared in K203689. The table below shows a comparison of the technological, functional, and performance characteristics between the subject and predicate devices.

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Comparison Table, Diabeloop DBLG2 vs. Tidepool Loop

Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
Regulatory Information
Product Code	QJI	QJI	Same
Regulation Name	21 CFR 862.1356, Interoperable Automated Glycemic Controller	21 CFR 862.1356, Interoperable Automated Glycemic Controller	Same
Indications for Use, User population
Indication for use	Tidepool Loop is a mobile application and algorithm technology that is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. Tidepool Loop is intended for single	DBLG2, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when glucose values are predicted to exceed a predefined threshold. To do this, the DBLG2 software takes into account the patient's profile, glycemia (current and predicted), announced meals and physical activities.	Equivalent. Target population age is more restrictive for DBLG2 than for Tidepool Loop which is more generic.

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	patient use. Tidepool Loop is Rx - For Prescription Use Only.	DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater. DBLG2 is intended for single patient use. DBLG2 is Rx - For Prescription Use Only.
Prescription Use	Yes	Yes	Same
Intended population	Type 1 diabetes mellitus in persons six years of age and greater.	Patients with type 1 diabetes who are more than 12 years of age.	Same
Environment of use	Home environments	Home environments	Same
Number of Users	Single user only	Single user only	Same
Technological characteristics
Principle of operation	Tidepool Loop predicts glucose levels up to 6 hours in the future (the approximate duration of insulin action for U-100 rapid-acting insulin) based on prior iCGM readings, insulin delivery history, and user input (e.g., carbohydrate intake and	DBLG2 software has a regulation algorithm to automatically manage the patient's blood glucose level, making glucose level prediction up to 5 hours in the future and insulin delivery prediction up to 2 hours. It takes as input glycemia value received from	Equivalent. The time associated with glucose level prediction on DBLG2 software is more conservative than Tidepool Loop.

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	exercise) and uses that prediction to adjust insulin delivery. Tidepool Loop can be used to adjust or suspend basal insulin delivery every 5 minutes and deliver correction boluses of insulin based on actual and predicted CGM sensor readings. Users must manually deliver meal boluses they can calculate using the Tidepool Loop Bolus Recommendation Tool (TLBRT) and can manually adjust insulin delivery (change basal rates and deliver insulin boluses) when Tidepool Loop is active.	the CGM and patient input related to meals and physical activities and it calculates the amount of insulin to deliver. It sends this information to the pump that automatically delivers this quantity. DBLG2 can be used to adjust or suspend basal insulin delivery every 5 minutes and automatically deliver correction boluses of insulin based on actual and predicted CGM sensor readings. Users must manually confirm meal boluses, when calculated by the DBLG2 recommendation or determine and enter the boluses manually, and can also adjust insulin delivery themselves by modifying basal rates and administering additional insulin boluses as needed.
Type of Algorithm	Hybrid Closed Loop - predictive control	Hybrid Closed Loop - predictive control	Same
Compatible iCGM	Dexcom G6	Dexcom G6	Same
Compatible ACE Pump	An ACE pump that has the specifications and meets the pre-specified acceptance criteria for software, cybersecurity, device interoperability, human factors, labeling, and training materials as described in	An ACE pump that has the specifications and meets the pre-specified acceptance criteria for software, cybersecurity, device interoperability, human factors, labeling, and training materials as described in	Equivalent. Both require cleared ACE Pumps.

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	SOP-0016, "Tidepool Loop Connected Device Integration and Validation Process and Plan," and SOP-0018, "Tidepool Loop Regulatory Determination Process." Tidepool Loop must not be distributed until the pre-specified acceptance criteria in the SOPs are met.	DBL-RD-SPECSUP-007 ACE pump specifications. Diabeloop DBLG2 must not be distributed until the pre-specified acceptance criteria in the DBL-RD-SPECSUP-007 are met.
Device Design or Material	Tidepool Loop is a mobile application and a Software as Medical Device (SaMD) installed on a host mobile device	Diabeloop DBLG2 is a mobile application and a Software as Medical Device (SaMD) installed on a host mobile device	Same
Algorithm Platform	iPhone	Android	Equivalent. Both the subject and predicate devices have equivalent risks and mitigations for each use profile. No new or modified risks.
Functional characteristics
User-controlled Target Range Settings	Customizable settings Correction Range: 87 - 180 mg/dL	Customizable settings Target glucose level and thresholds: • Target glucose level: 100 - 130 mg/dL (default value 110 mg/dL) • Hyperglycemia threshold: 170 - 220 mg/dL (default value 180 mg/dL)	Equivalent. The DBLG2 software uses a glucose target set point (110 mg/dL by default) with customizable hypoglycemia and hyperglycemia thresholds, rather than a glucose target range compared to Tidepool Loop. The DBLG2 software also adjusts the target

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	Pre-Meal Range: Glucose Safety Limit (which can be set from 67-110 mg/dL) - 130 mg/dL Workout Range: the higher of 85 mg/dL or the Glucose Safety Limit (which can be set from 67-110 mg/dL) - 250 mg/dL	• Hypoglycemia threshold: 60 - 85 mg/dL (default value 70 mg/dL) No target change required for meal management Target during physical activities automatically adjusted by the DBLG2 application during the physical activity declaration. Calculated amount of carbohydrates proposed to the patient to compensate for an existing or upcoming hypoglycemia. Self-learning module that applies improvements to the patient's algorithm parameters, based on estimated glycemia history and insulin delivery quantities, from the patient's history.	based on activities declared by the user. Additionally, carbohydrates intake, and so the alarm system associated, is part of the risk control measures to avoid hypoglycemia episodes. Carbohydrates intakes confirmed by the patient as "taken" into DBLG2 application are then taken into account for the next iterations of the algorithm, for predicted glycemia evolution and future insulin delivery, each 5 min. At last, DBLG2 software also includes a module for long term learning which impacts 3 situations : meals, correction boluses, and basal rate. All combined, these DBLG2 software features and settings aim at avoiding excursions beyond the hypo/hyperglycemia thresholds, just like the predicate with its correction, pre-meal and workout ranges. Both DBLG2 software and predicate devices have equivalent risks and mitigations to handle hyperglycemia and hypoglycemia episodes with their respective alarm systems and features. No new or modified risks.
Auto-populating bolus			Same

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
recommendation based on iCGM value:
In closed loop mode	Yes	Yes	Same
In open loop mode	No	No
Data List and Logging	Yes	Yes	Same
Daily Activity Records	Yes	Yes	Same
Average Data Display	Yes	Yes	Same
Password Required	Yes	Yes	Same
Performance Characteristics
Bench Performance	Tidepool Loop performance was verified and validated through software verification testing including special controls, cybersecurity, wireless, and connected devices compatibility testing.	Diabeloop DBLG2 performance was verified and validated through software verification testing including special controls, cybersecurity, wireless, and connected devices compatibility testing.	Same
Clinical Performance	Tidepool Loop clinical performance is supported by representative 1,250 participants in a 15 months duration real-world, observational, single arm study of DIY Loop including both	Overall, the Diabeloop Software's clinical performance has been demonstrated through consistent results in 6 prospective clinical trials, collecting a total of 15,325 patient-weeks in adults and 1,594	Equivalent. Overall, the clinical data supporting the Diabeloop 510(k) submission were collected in the entire intended population

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	pediatric and adult participants.	patient-weeks in adolescents with T1D. Real-world studies involving large patient cohorts and post-hoc analyses have confirmed these findings and addressed specific questions, such as the applicability of clinical data collected with various software versions, unannounced meals, insulin types and requirements, specific operating modes, and customizable settings.	(in terms of age, sex, baseline HbA1c and previous treatment), in thousands of patients and with long-term follow-up, similar to the Tidepool study. A summary of the strategy for demonstrating clinical performance is provided in section "Clinical Testing".
Risk Assessment	Tidepool Loop performed Risk Assessment including detailed hazard analysis based on ISO 14971.	Diabeloop DBLG2 performed Risk Assessment including detailed hazard analysis based on ISO 14971.	Same
Labeling
Training	Tidepool Loop includes mandatory in-app learning and setup (user training) before the user can use Tidepool Loop.	All users must complete the training provided by a certified trainer before using DBLG2 for the first time (e-learning and face to face training).	Equivalent ; in both products, training is a mandatory step of the process ; the difference remains in the media used. Additionally, training on features associated with the DBLG2 software and the impact on safety and effectiveness were evaluated through Human Factors testing and found to be safe and effective for the intended users, uses, and use environments.
User Guide	Tidepool Loop electronic User Guide also includes all special controls, clinical	DBLG2 application User Guide also includes all special controls, clinical	Same

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Characteristic	Tidepool Loop (K203689)	Diabeloop DBLG2 (this submission, submission Number: Q182031/S006)	Analysis
	performance information and other information needed per cybersecurity and interoperability requirements.	performance information and other information needed per cybersecurity and interoperability requirements.

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8. Standards Compliance

DBLG2 complies with the following standards as documented in the applicable reports and documents provided in this 510(k) submission.

8.1. US Regulation

US Regulation number	US Regulation name
21 CFR Part 801	Labeling requirements
21 CFR Part 803	Medical Device Reporting (MDR)
21 CFR Part 806	Medical Devices; Reports of Corrections and Removals
21 CFR Part 807	Establishment registration & medical device listing
21 CFR Part 812	Investigational Device Exemptions
21 CFR Part 820	Quality System (QS) regulation
21 CFR Part 822	Postmarket Surveillance
21 CFR Part 830	Unique Device Identification
21 CFR 862.1356	Interoperable automated glycemic controller special controls
21 CFR Part 11	Electronic records; Electronic signatures

8.2. Standards

Standard number	Standard name	Standard version	FDA recognition number
EN ISO 20417 + A11	Medical devices — Information to be provided by the manufacturer	2021	5-135
ISO 14155	Clinical investigation on medical devices for human subjects - Good clinical practice	2020	2-282
ISO 14971	Medical Devices - Application of risk management to medical devices	2019 + 2021	5-125
ISO 15223-1	Medical devices - symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements	2021	5-134
IEC 62304 + A1	Medical device software - software life-cycle processes	2006 + 2015	13-79
IEC 62366-1+A1	Medical devices. Application of usability engineering to medical devices	2015+2020	5-129
IEC 81001-5-1:2021	Health software and health IT systems safety,	2021	13-122

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9. Non-Clinical Performance Testing

The information presented in this 510(k) submission demonstrates the safety and effectiveness of Diabeloop DBLG2 with compatible ACE pump and iCGM devices.

9.1. Risk Management

Risk management was performed and documented in accordance with ISO 14971:2019+A11:2021. A comprehensive hazard analysis was provided for this device, in which design inputs and outputs, risks, and risk mitigations for software and interoperable hardware components associated with the safe and effective functioning of the device were reviewed. The hazard analysis provided in this submission accounted for the unique design elements, intended use, and risks of the Diabeloop DBLG2 iAGC.

9.2. Human Factors Validation

A human factors (HF) validation study was conducted in accordance with ANSI/AAMI/IEC 62366-1:2015. The study was conducted to confirm that intended users can safely and effectively use the Diabeloop DBLG2 Mobile Application. The final device design was evaluated in a summative study performed in Cincinnati, Ohio, with 34 participants representative interacting with the device in a simulated use environment. Results of the study demonstrated that the product has been found to be safe and effective for the intended users, uses, and use environments.

9.3. Software Verification and Validation

Software verification and validation testing was performed in accordance with IEC 62304:2006 + A1:2015 and with FDA guidance, General Principles of Software Validation, issued January 11, 2002. DBLG2 application was installed on compatible Android devices, and tested extensively using manual tests and automated simulation tests.

Testing was performed to ensure that DBLG2's functions through compatible host devices incorporating wireless technologies (BLE) performed as designed and intended.

9.4. Interoperability

DBLG2 is an interoperable automated glycemic controller (iAGC) as defined under 21 CFR § 862.1356. As an interoperable device, DBLG2 is intended to be integrated with multiple third-party ACE Pumps and iCGM devices. The list of integrated devices that are compatible with Diabeloop System is expected to grow over time.

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9.5. Cybersecurity

A cybersecurity analysis was performed for Diabeloop DBLG2 using FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. DBLG2 provided a software bill of materials, which provided details on all software used in the device. This included all manufacturer-developed, commercially licensed, open source, and off-the-shelf software components, along with an identification of the hardware runtime environment in which each resides, with relevant version and/or model information, as well as details on whether each component was actively supported by its manufacturer or legacy licensed. In addition, results of internal testing and third-party penetration testing, using existing devices and configurations, were provided.

10. Clinical Testing

The clinical development strategy to demonstrate the safety and effectiveness of the Diabeloop Software incorporated prospective clinical trials conducted according to ISO:14155 and ICH E6 Good Clinical Practices, along with real-world data to address specific questions.

Collectively, the results of multiple prospective clinical trials evaluating the performance of the Diabeloop software demonstrate its safety and effectiveness over the entire intended population (in terms of age, sex, baseline glucose control, and previous treatment), in real-world settings and with long-term follow-up. With a total of 15,325 effective patient-weeks collected in adults and 1,594 in adolescents with T1D, this clinical data supports substantial equivalence to the predicate device which presented 2,080 adult patient-weeks and 2,470 pediatric (6-18 years) patient-weeks of device exposure. The results of the prospective clinical trials conducted by Diabeloop highlight various improvements in glycemic outcomes, including Time in Range (TIR) 70-180 mg/dL, time in hypoglycemia, time in hyperglycemia, mean Continuous Glucose Monitoring (CGM) value, HbA1c, and occurrence of severe metabolic episodes. High satisfaction was also reported in the various studies. Additionally, the real-world data presented addresses specific questions, such as the applicability of clinical data collected with various software versions and the device's performance when using specific operating modes and customizable settings, with different types of insulin, for patients with high total daily insulin doses and varied meal declaration habits.

11. Conclusion

DBLG2 software is substantially equivalent to the predicate Tidepool Loop cleared in K203689. The differences, summarized in this submission, do not raise different questions of safety or effectiveness. The performance of the device is supported by Diabeloop's design control process which included non-clinical testing and risk management activities.

The non-clinical and clinical performance data described above supports also the determination of substantial equivalence. Human factors and clinical validation demonstrated that Diabeloop software performed as designed and intended for the intended users, uses, and use environments.

The device meets all Special Controls for this product type as required by 21 CFR 862.1356 for interoperable Automated Glycemic Controllers, Product Code QJI.

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12. Document history

DA #	Version	Description	Effective date	Author
DA 00198	0	Creation of the document	See Qualios signature page	Alexandre VICENTE
DA 00271	1	Context : next to FDA deficiencies associated with K251152 Update of sections : - §Device description - §Indication for Use - §Comparison to Predicate Device - §Clinical Testing	See Qualios signature page	Alexandre VICENTE
DA 00281	2	Context : next to FDA deficiencies associated with K251152.S001.IR#3 Update of sections Indication for use and Comparison to Predicate Device	See Qualios signature page	Franck FOUREL
DA 00281	3	Context : next to FDA deficiencies associated with K251152.S001.IR#4a Update of section Clinical Testing	See Qualios signature page	Benjamin CHATEL
DA 00281	4	Context: next to FDA deficiencies associated with K251152.S001.IR#3 Update of contraindication - replace "8U" by "8 units"	Available on Qualios	Alexandre VICENTE
DA 00281	5	Update of contact phone Removal of "company confidential" in the footer	Available on Qualios	Erik HUNEKER

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Regulation Number and Section

§ 862.1356 Interoperable automated glycemic controller.

(a)
Identification. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (
e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
(ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
(iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (
e.g., specification of glucose sensor performance) or accept commands from (e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
(vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place (
e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
(2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures to address device system hazards;
(ii) Design decisions related to how the risk control measures impact essential performance; and
(iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to connected devices;
(ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices;
(iii) Sharing of necessary state information between the controller and any connected devices (
e.g., battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
(v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and
(vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
(4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include:
(i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
(ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (
e.g., infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
(iv) Connectivity events (
e.g., establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
(6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
(7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
(8) The labeling required under § 809.10(b) of this chapter must include:
(i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
(ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
(iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
(iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section.
(v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
(vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section.
(vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.