Tidepool Loop

K203689 · Tidepool Project · QJI · Jan 23, 2023 · Clinical Chemistry

Device Facts

• Record ID: K203689
• Device Name: Tidepool Loop
• Applicant: Tidepool Project
• Product Code: QJI · Clinical Chemistry
• Decision Date: Jan 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

Tidepool Loop, 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 recommend, and with the user's confirmation, control the delivery of 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 patient use. Tidepool Loop is Rx - For Prescription Use Only.

Device Story

Tidepool Loop is a mobile application (SaMD) for iPhone/Apple Watch that functions as an interoperable automated glycemic controller (iAGC). It receives real-time glucose data from an iCGM and communicates with an ACE insulin pump via Bluetooth. The algorithm predicts glucose levels up to 6 hours into the future based on CGM readings, insulin delivery history, and user-entered data (carbohydrates, exercise). It automatically adjusts or suspends basal insulin delivery every 5 minutes and recommends correction boluses for user confirmation. Used at home by patients or caregivers, the device aims to improve glycemic control and reduce hypoglycemia. Healthcare providers configure initial therapy settings (e.g., correction ranges, insulin sensitivity). The system includes safety guardrails like a user-configurable Glucose Safety Limit to prevent hypoglycemia. It provides patients with more choice in automated dosing algorithms and integrates into their existing diabetes management strategy.

Clinical Evidence

Clinical evidence provided via the 'Loop Observational Study,' a real-world, prospective, virtual observational study. Sample size included 175 participants in the intended use population (ages 6+). Primary endpoints included safety (incidence of severe hypoglycemia/DKA) and glycemic outcomes (Time in Range 70-180 mg/dL). Results showed improvement in mean Time in Range from 62% at baseline to 70% at 6 months. No unexpected safety signals were identified, though FDA noted the study population was not fully representative of the general population, leading to a required postmarket surveillance study.

Technological Characteristics

Software-only device (SaMD) running on qualified mobile platforms (e.g., iPhone). Uses proprietary algorithm for automated insulin dosing. Interoperability via Bluetooth and IEEE 11073 standards. Features include user-configurable safety limits (67-110 mg/dL) and correction ranges (87-180 mg/dL). Employs rigorous data logging and cybersecurity controls, including penetration testing and software bill of materials. Validated for use only with specific iCGM and ACE pump hardware.

Indications for Use

Indicated for management of type 1 diabetes mellitus in persons 6 years of age and older. For prescription use only. Contraindicated for those unable to notice alerts/alarms, unable to monitor glucose as recommended, unable to maintain contact with healthcare provider, or unable to follow instructions for use. MR Unsafe.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Control-IQ Technology (K200467)

Submission Summary (Full Text)

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January 23, 2023

Tidepool Project Howard Look CEO 3340 Hillview Ave Palo Alto, California 94304

Re: K203689

Trade/Device Name: Tidepool Loop Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: May 26, 2022 Received: May 26, 2022

Dear Howard Look:

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. 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 located 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.

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FDA's substantial equivalence determination also included the review of your specific procedures, validation strategies, and pre-specified acceptance criteria for software, cybersecurity, device interoperability, human factors, labeling, and training materials for modifications as described in SOP-0016, "Tidepool Loop Connected Device Integration and Validation Process and Plan," and SOP-0018, "Tidepool Loop Regulatory Determination Process." Under 21 CFR 807.81(a)(3), a new premarket submission 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. Changes made that are inconsistent with the modifications described in SOP-0016 and SOP-0018 that were reviewed in this submission could be significations that could significantly affect the safety and/or effectiveness of this device (e.g., such changes could compromise the clinical functionality or performance specifications that are directly associated with the intended use of the device), in which case a new premarket submission would be required (see 21 CFR 807.81(a)(3)). Additional information about changes to software that may require a new premarket submission is provided in FDA's guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, and Deciding When to Submit a 510(k) for a Software Change to an Existing Device.

Failure to submit a new premarket submission for the changes described above would constitute adulteration and misbranding under sections 501(t)(1)(B) and 502(0) of the Act, respectively. Your device is also subject to, among other requirements, the quality systems (QS) regulation (21 CFR 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 820.90 Nonconforming product; and 820.100 Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the QS regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

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(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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Acting Director 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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510(k) Number (if known) K203689

Device Name

Tidepool Loop

Indications for Use (Describe)

Tidepool Loop, 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 recommend, and with the user's confirmation, control the delivery of 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 patient use.

Tidepool Loop is Rx - For Prescription Use Only.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# I. Sponsor Information:

| Sponsor: | Mailing address:<br>Tidepool Project<br>555 Bryant St. #429<br>Palo Alto CA 94301<br><br>Registration facility address:<br>Tidepool Project<br>3340 Hillview Ave.<br>Palo Alto, CA 94304 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Howard Look, CEO |
| Email: | [e-mail] |
| Phone: | 650-353-2352 |

## II. Device Name

| Device Classification Name: | Interoperable Automated Glycemic Controller (iAGC) |
|-----------------------------|----------------------------------------------------|
| Device Classification | Class II, 21 CFR 862.1356 |
| Product Code: | QJI |
| Device Proprietary Name: | Tidepool Loop |

# III. Predicate Device Information

| Device Name | Control – IQ Technology |
|---------------------------|----------------------------------------------------|
| Manufacturer: | Tandem Diabetes Care, Inc. |
| Premarket Notification #: | K200467 |
| Classification Name: | Interoperable Automated Glycemic Controller (iAGC) |
| Classification: | Class II, 21 CFR 862.1356 |
| Product Code: | QJI |

### IV. Date Summary Prepared: January 23, 2023

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#### V. Description of Device

Tidepool Loop is a mobile application with algorithm technology that works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by Tidepool Loop. Tidepool Loop can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds.

Tidepool Loop predicts glucose levels up to 6 hours in 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 exercise, and in some cases fingerstick glucose) and uses that prediction to adjust insulin delivery. Tidepool Loop can be used to adjust or suspend basal insulin delivery every 5 minutes based on actual CGM sensor and predicted glucose readings. iCGM values are automatically used by the Tidepool Loop Bolus Recommendation Tool (TLBRT) when the Tidepool Loop Algorithm technology is active, i.e. when the device is operating in closed-loop mode with an active iCGM sensor session. When closed-loop mode is off, such as when it is manually disabled or when there is no active iCGM sensor session, the Tidepool Loop Bolus Recommendation Tool (TLBRT) is disabled. The user will use Tidepool Loop's simple bolus calculator. into which iCGM values are not automatically populated into the glucose field.

Users must manually enter information about carbohydrates to initiate a meal bolus. When closed-loop mode is on, recommended bolus delivery is calculated using the Tidepool Loop Bolus Recommendation Tool (TLBRT) and can be manually adjusted.

The Tidepool Loop app requires that specific, initial therapy settings are established by a health care provider as part of creating the prescription order. These settings include:

- Target Correction Ranges for normal operation, Pre-Meal and Workout Presets .
- Carb to Insulin Ratios .
- Insulin Sensitivity Factors ●
- Basal Rates ●
- Max Basal Rate ●
- Max Bolus .

Tidepool Loop uses two glucose-specific settings that may be different from the user's experience with traditional glucose monitoring or CGM therapy. These are Correction Range and Glucose Safety Limit.

Correction Range is the range of glucose values that the user wants Tidepool Loop to work to bring their glucose to. Correction Range can be set as low as 87 mg/dL and as high as 180 mg/dL. Tidepool Loop will warn the user if values outside the recommended bounds of 100-115 mg/dL are selected. The user can add different Correction Ranges for different times of day. Tidepool Loop supports up to 48 Correction Range segments in a 24-hour period.

Tidepool Loop Traditional 510(k) Premarket Notification, K203689 January 23, 2023

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Tidepool Loop allows these user-customizable target Correction Ranges:

- . Normal operation
- Pre-meal Preset
- . Workout Preset

Glucose Safety Limit (mg/dL) is a safety feature of the Tidepool Loop algorithm. If the current CGM value or any future predicted glucose value is below this safety limit. Tidepool Loop will suspend insulin delivery in an effort to prevent low glucose. The algorithm will also not recommend a bolus.

Glucose Safety Limit can be set as low as 67 mg/dL. It can be set as high as 110 mg/dL or to the Correction Range minimum, whichever qlucose value is lower. Tidepool Loop will warn the user if values outside Tidepool's recommended bounds of 74 to 80 mg/dL are selected.

The Glucose Safety Limit is also part of the Dosing Safety Threshold, which is part of the Tidepool Loop insulin delivery algorithm. The Dosing Safety Threshold is a period of time that has the same duration as the insulin activity duration (i.e., 6 hours). The Dosing Safety Threshold is equal to the user's Glucose Safety Limit for the first half of the insulin activity duration (i.e., 3 hours), and then increases until it is at the midpoint of the Correction Range at the end of the insulin activity duration (i.e., 6 hours). The graph below summarizes the operation of the Tidepool Loop algorithm.

Image /page/6/Figure/7 description: The image shows the Tidepool Loop Algorithm 1.0.0. The algorithm is based on therapy settings, glucose momentum and recent history, carbohydrates, and insulin. The graph shows glucose levels over time, with the x-axis representing time and the y-axis representing glucose levels in mg/dL. The graph includes a target range, a glucose safety limit, and the duration of insulin action.

### Principle of Operation of Tidepool Loop Algorithm

Tidepool Loop Traditional 510(k) Premarket Notification, K203689 January 23, 2023

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Tidepool Loop is designed to be installed on an iPhone running iOS operating systems (version 15 or higher). The Tidepool Loop application includes an optional extension for Apple Watch devices running watchOS operating system (version 6.1 or higher).

#### VI. Indications for Use

Tidepool Loop, a mobile application with alqorithm technology, is intended for use with compatible integrated continuous dlucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user's confirmation, control the delivery of 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 patient use. ●
- Tidepool Loop is Rx - For Prescription Use Only.

### Contraindications

- Tidepool Loop should not be used by anyone who is unable to notice alerts, alarms and reminders because of physical limitations.
- . Tidepool Loop should not be used by anyone that is unable to monitor glucose as recommended by their healthcare provider.
- . Tidepool Loop should not be used by anyone that is unable to maintain contact with their healthcare provider.
- Tidepool Loop should not be used by anyone who is unwilling or unable to follow the . instructions for use and intended uses of compatible insulin pumps and continuous glucose monitor devices.
- MR Unsafe - Tidepool Loop should not be used during Maqnetic Resonance Imaging ● (MRI), Computed Tomography (CT) scan, Positron Emission Tomography (PET) scan, or high-frequency electrical heat (diathermy) treatment. Components of the Tidepool Loop system may not have been tested in magnetic fields and heat could damage the CGM or insulin pump being used with Tidepool Loop 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.

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#### VII. Comparison to Predicate Device

Tidepool Loop is substantially equivalent to the predicate device, Control-IQ Technology, currently legally marketed under K200467.

Tidepool Loop and Control-IQ are similar in that they have:

- the same general intended use, ●
- the same indications for use, .
- the same or similar technological characteristics, .
- the same principle of operation. .

The devices primarily differ in that:

- Control-IQ currently operates only on Tandem's t:slim X2 insulin pump, while Tidepool . Loop operates on iPhone devices;
- Control-IQ automatically delivers correction boluses, while Tidepool Loop only . recommends correction boluses if a user elects to open the Bolus Entry screen:
- . Tidepool Loop predicts glucose values farther into the future than Control-IQ;
- . Tidepool Loop allows for more user-configurable correction ranges and other settings than Control-IQ.

Specific differences between Tidepool Loop and its predicate device are detailed in the table below.

### Comparison Table, Tidepool Loop vs. Tandem Control-IQ

| Characteristic | Control-IQ Technology (K200467) | Tidepool Loop<br>(this submission, K203689) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | |
| Product Code | QJI | QJI | |
| Regulation Name | 21 CFR 862.1356, Interoperable<br>Automated Glycemic Controller | 21 CFR 862.1356,<br>Interoperable Automated Glycemic<br>Controller | |
| Indications for Use, User Population | | | |
| Indication For<br>Use | Control-IQ technology is intended for<br>use with compatible integrated<br>continuous glucose monitors (ICGM)<br>and alternate controller enabled (ACE)<br>pumps to automatically increase,<br>decrease, and suspend delivery of basal<br>insulin based on iCGM readings and<br>predicted glucose values. It can also<br>deliver correction boluses when the | Tidepool Loop is a mobile application<br>and algorithm technology that is<br>intended for use with compatible<br>integrated continuous glucose monitors<br>(iCGM) and alternate controller enabled<br>(ACE) pumps to automatically increase,<br>decrease, and suspend delivery of basal<br>insulin based on iCGM readings and<br>predicted glucose values. It can also | |
| | glucose value is predicted to exceed a<br>predefined threshold.<br>Control-IQ technology is intended for<br>the management of Type 1 diabetes<br>mellitus in persons 6 years of age and<br>greater.<br>Control-IQ technology is intended for<br>single patient use and requires a<br>prescription.<br>Control-IQ technology is indicated for<br>use with NovoLog or Humalog U-100<br>insulin. | recommend and deliver correction<br>boluses when glucose values are<br>predicted to exceed user configurable<br>thresholds.<br>Tidepool Loop is intended for the<br>management of Type 1 diabetes mellitus<br>in persons six years of age and greater.<br>Tidepool Loop is intended for single<br>patient use.<br>Tidepool Loop is Rx - For Prescription Use<br>Only. | |
| Target Patient<br>Population | Type 1 diabetes mellitus in persons six<br>years of age and greater. | Type 1 diabetes mellitus in persons six<br>years of age and greater. | |
| Principal<br>Operator | Prescription only device with the patient<br>or caregiver as the principal operator | Prescription only device with the patient or<br>caregiver as the principal operator | |
| Use Location | At home | At home | |
| Number of Users | Single user only | Single user only | |
| Technological Characteristics | | | |
| Principle of<br>Operation | Control-IQ technology predicts glucose<br>levels <b>30 minutes in the future</b> based<br>on prior iCGM readings, insulin delivery<br>history, and user input (e.g.,<br>carbohydrate intake, exercise, <b>and<br/>sleep schedule</b> ) and uses that<br>prediction to adjust insulin delivery.<br>Control-IQ technology can be used to<br>adjust or suspend basal insulin delivery<br>every 5 minutes and <b>automatically</b><br>deliver correction boluses of insulin<br>based on actual and predicted CGM<br>sensor readings.<br>Users must manually deliver meal<br>boluses they can calculate using the<br>integrated bolus calculator and can<br>manually adjust insulin delivery (change<br>basal rates and deliver insulin boluses) | Tidepool Loop predicts glucose levels <b>up<br/>to 6 hours in the future (the<br/>approximate duration of insulin action<br/>for U-100 rapid-acting insulin)</b> based on<br>prior iCGM readings, insulin delivery<br>history, and user input (e.g., carbohydrate<br>intake and exercise) and uses that<br>prediction to adjust insulin delivery.<br>Tidepool Loop can be used to adjust or<br>suspend basal insulin delivery every 5<br>minutes and deliver correction boluses of<br>insulin based on actual and predicted<br>CGM sensor readings.<br>Users must manually deliver meal boluses<br>they can calculate using the <b>Tidepool<br/>Loop Bolus Recommendation Tool<br/>(TLBRT)</b> and can manually adjust insulin<br>delivery (change basal rates and deliver | |
| | when the Control-IQ technology is<br>active | | insulin boluses) when Tidepool Loop is<br>active. |
| Type of Algorithm | Hybrid Closed Loop - predictive control | | Hybrid Closed Loop - predictive control |
| Compatible iCGM | Dexcom G6 | | Dexcom G6 |
| Compatible ACE<br>Pump | Tandem X2 Pump | | An ACE pump that has the specifications<br>and meets the pre-specified acceptance<br>criteria for software, cybersecurity, device<br>interoperability, human factors, labeling,<br>and training materials as described in<br>SOP-0016, "Tidepool Loop Connected<br>Device Integration and Validation Process<br>and Plan," and SOP-0018, "Tidepool Loop<br>Regulatory Determination Process."<br>Tidepool Loop must not be distributed until<br>the pre-specified acceptance criteria in the<br>SOPs are met. |
| Device Design or<br>Material | Control-IQ Technology is software in a<br>medical (SiMD) device, installed on a<br>Tandem t:slim X2 pump | | Tidepool Loop is a mobile application<br>and a Software as Medical Device<br>(SaMD) installed on a host mobile<br>device |
| Algorithm<br>Platform | Tandem X2 Pump | | iPhone |
| User Experience<br>Platform | Tandem X2 Pump | | iPhone and Apple Watch |
| Insulin<br>Compatibility | Novolog or Humalog U-100 | | Same |
| Functional Characteristics | | | |
| User-controlled<br>Target Range<br>Settings | Not customizable.<br>Default: 112.5 - 160 mg/dL<br>Sleep Mode 112.5 - 120 mg/dL<br>Exercise Mode 140 - 160 mg/dL | | Customizable settings<br>Correction Range:<br>87 - 180 mg/dL<br>Pre-Meal Range:<br>Glucose Safety Limit (which can be set<br>from 67-110 mg/dL) - 130 mg/dL<br>Workout Range: |
| | | the higher of 85 mg/dL or the Glucose<br>Safety Limit (which can be set from<br>67-110 mg/dL) - 250 mg/dL | |
| Auto-populating<br>bolus<br>recommendation<br>based on iCGM<br>value: | | | |
| In closed loop<br>mode<br>In open loop<br>mode | Yes<br>No | Yes<br>No | |
| Data List &<br>Logging | Yes | Yes | |
| Daily Activity<br>Records | Yes | Yes | |
| Average Data<br>Display | Yes…