(767 days)
Not Found
No
The summary describes an "algorithm technology" that predicts glucose values based on historical data and user input, and adjusts insulin delivery accordingly. While this involves prediction and control, the description does not use terms like "AI," "ML," "neural networks," or describe a training process characteristic of machine learning. The prediction appears to be based on a defined algorithm rather than a learned model.
Yes
The device actively manages Type 1 diabetes by adjusting insulin delivery based on glucose readings and predictions, which directly treats a medical condition.
No
The device is intended for the management of type 1 diabetes mellitus by automatically adjusting insulin delivery based on CGM readings and predicted glucose values, and recommending correction boluses. While it uses glucose values, its primary function is therapeutic (insulin delivery control), not diagnostic (identifying or characterizing a disease).
Yes
The device is described as a "mobile application with algorithm technology" and is intended to be installed on an iPhone and optionally an Apple Watch. While it interacts with external hardware (iCGM and insulin pump), the device itself, as described, is the software application and its embedded algorithm. The description does not indicate that the submission includes any hardware components or hardware-specific verification/validation for the device itself.
Based on the provided information, Tidepool Loop is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Tidepool Loop's Function: Tidepool Loop is a mobile application that uses data from an external device (iCGM) and user input to control an insulin pump and predict glucose values. It does not directly analyze or examine a specimen from the human body.
- Input Data: While it uses glucose readings from an iCGM, the iCGM itself is the device that performs the in vitro measurement (of glucose in interstitial fluid). Tidepool Loop uses this data but doesn't perform the diagnostic test.
- Intended Use: The intended use is for the management of type 1 diabetes by automatically adjusting insulin delivery and recommending boluses based on glucose data and predictions. This is a therapeutic and management function, not a diagnostic one.
Therefore, Tidepool Loop falls under the category of a medical device, specifically a software-based device that acts as an automated insulin delivery system controller, but it is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
QJI
Device Description
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 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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
six years of age and greater
Intended User / Care Setting
Prescription only device with the patient or caregiver as the principal operator.
At home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: Observational Study
Study Type: Observational
Sample Size: 1,127 participants were enrolled, with 872 initiating the study (606 in Cohort A: new DIY Loop users, and 266 in Cohort B: existing DIY Loop users). Minimum exposure targets were exceeded: 535/606 (88%) of Cohort A reached 6-month time point, and 222/266 (83%) of Cohort B reached 9-month time point. A total of 483 person-years of DIY Loop exposure (over 175,000 person-days) were collected.
Data Source: Jaeb Center for Health Research, in collaboration with clinical research centers and Tidepool. Data was collected continuously from a user's iPhone, securely sent to Tidepool's cloud, and retrieved by Jaeb Center for Health Research for database replication. Weekly web-based surveys were used for Adverse Events (AE) collection.
Key Results - Cohort A (New Users, N=606):
- Primary Safety Analysis: 92% reported no severe hypoglycemia (SH) from baseline-12 months. Overall SH incidence rate was 22.6 events per 100 person-years, significantly lower than baseline (181.5 events per 100 person-years). No SH events adjudicated as "Related to Loop". One DKA event occurred (0.3 DKA events per 100 person-years), lower than baseline (17.2 events per 100 person-years).
- Primary Glycemic Outcomes: Mean time-in-range 70-180 mg/dL (TIR) increased from 67% at baseline to 73% (p
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
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.
1
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
2
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Sponsor Information:
| Sponsor: | Mailing address:
Tidepool Project
555 Bryant St. #429
Palo Alto CA 94301
Registration facility address:
Tidepool Project
3340 Hillview Ave.
Palo Alto, CA 94304 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Howard Look, CEO |
| Email: | regulatory@tidepool.org |
| 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
(this submission, K203689) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | |
| Product Code | QJI | QJI | |
| Regulation Name | 21 CFR 862.1356, Interoperable
Automated Glycemic Controller | 21 CFR 862.1356,
Interoperable Automated Glycemic
Controller | |
| Indications for Use, User Population | | | |
| Indication For
Use | Control-IQ technology 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
deliver correction boluses when the | 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 | |
| | glucose value is predicted to exceed a
predefined threshold.
Control-IQ technology is intended for
the management of Type 1 diabetes
mellitus in persons 6 years of age and
greater.
Control-IQ technology is intended for
single patient use and requires a
prescription.
Control-IQ technology is indicated for
use with NovoLog or Humalog U-100
insulin. | 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
patient use.
Tidepool Loop is Rx - For Prescription Use
Only. | |
| Target Patient
Population | Type 1 diabetes mellitus in persons six
years of age and greater. | Type 1 diabetes mellitus in persons six
years of age and greater. | |
| Principal
Operator | Prescription only device with the patient
or caregiver as the principal operator | Prescription only device with the patient or
caregiver as the principal operator | |
| Use Location | At home | At home | |
| Number of Users | Single user only | Single user only | |
| Technological Characteristics | | | |
| Principle of
Operation | Control-IQ technology predicts glucose
levels 30 minutes in the future based
on prior iCGM readings, insulin delivery
history, and user input (e.g.,
carbohydrate intake, exercise, and
sleep schedule ) and uses that
prediction to adjust insulin delivery.
Control-IQ technology 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 deliver meal
boluses they can calculate using the
integrated bolus calculator and can
manually adjust insulin delivery (change
basal rates and deliver insulin boluses) | 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 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 | |
| | when the Control-IQ technology is
active | | insulin boluses) when Tidepool Loop is
active. |
| Type of Algorithm | Hybrid Closed Loop - predictive control | | Hybrid Closed Loop - predictive control |
| Compatible iCGM | Dexcom G6 | | Dexcom G6 |
| Compatible ACE
Pump | Tandem X2 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
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. |
| Device Design or
Material | Control-IQ Technology is software in a
medical (SiMD) device, installed on a
Tandem t:slim X2 pump | | Tidepool Loop is a mobile application
and a Software as Medical Device
(SaMD) installed on a host mobile
device |
| Algorithm
Platform | Tandem X2 Pump | | iPhone |
| User Experience
Platform | Tandem X2 Pump | | iPhone and Apple Watch |
| Insulin
Compatibility | Novolog or Humalog U-100 | | Same |
| Functional Characteristics | | | |
| User-controlled
Target Range
Settings | Not customizable.
Default: 112.5 - 160 mg/dL
Sleep Mode 112.5 - 120 mg/dL
Exercise Mode 140 - 160 mg/dL | | Customizable settings
Correction Range:
87 - 180 mg/dL
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 | |
| Auto-populating
bolus
recommendation
based on iCGM
value: | | | |
| In closed loop
mode
In open loop
mode | Yes
No | Yes
No | |
| Data List &
Logging | Yes | Yes | |
| Daily Activity
Records | Yes | Yes | |
| Average Data
Display | Yes | Yes | |
| Changing Pump
Settings | Yes | Yes | |
| Invite others to
view data
through
authorization | Yes | Yes | |
| Password
required | Yes | Yes | |
| Performance Characteristics | | | |
| Bench
Performance | Control-IQ performance was verified
and validated through software
verification testing including special
controls, cybersecurity, wireless, and
connected devices compatibility testing. | Tidepool Loop performance was verified
and validated through software verification
testing including special controls,
cybersecurity, wireless, and connected
devices compatibility testing. | |
| Clinical
Performance | Control-IQ clinical performance was
supported by
- 168 participants in a 6-month
randomized trial, with 112 in the
intervention arm and 56 in the control
arm. - 101 pediatric participants in a
4-month randomized trial, with 78 in the | 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
pediatric and adult participants. | |
| | intervention arm and 23 in the control arm. | | |
| Patient
Preference | Control-IQ assessed Patient
Preferences through written statements
and also obtained through discussion
with patients and patient advocacy
groups at public forums regarding
patient experiences with automated
insulin dosing systems and digitally
connected diabetes devices. | Tidepool Loop assessed Patient
Preference through written or video
testimonials. | |
| Risk
Assessment | Control-IQ performed Risk Assessment
including detailed hazard analysis
based on ISO 14971. | Tidepool Loop performed Risk
Assessment including detailed hazard
analysis based on ISO 14971. | |
| Labeling | | | |
| Training | Control-IQ provides mandatory user
training before the user can use their
device. | Tidepool Loop includes mandatory in-app
learning and setup (user training) before
the user can use Tidepool Loop. | |
| User Guide | Control-IQ electronic User Guide
includes all special controls, clinical
performance information and other
information needed per cybersecurity
and interoperability requirements. | Tidepool Loop electronic User Guide also
includes all special controls, clinical
performance information and other
information needed per cybersecurity and
interoperability requirements. | |
Differences with the predicate device are shown in bold italic.
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VIII. Standards Compliance
Tidepool Loop complies with the following standards as documented in the applicable test reports provided in this 510(k) submission:
- Special controls established under 21 CFR 862.1356. ●
- . ISO 14971:2019: Medical Devices - Application of Risk Management to Medical Devices FDA Recognition No: 5-125
- ANSI/AAMI/IEC 62366-1:2015: Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices, FDA Recognition No: 5-114
- ANSI/AAMI/IEC HE75:2009: Human factors engineering, design of medical ● devices FDA Recognition No:5-57
- IEEE 802.15.1-2005, IEEE Standard for Information technology-- Local and . metropolitan area networks-- Specific requirements-- Part 15.1a: Wireless Medium Access Control (MAC) and Physical Layer (PHY) specifications for Wireless Personal Area Networks (WPAN)
- Bluetooth Core Specification (Bluetooth SIG) .
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- . ISO/IEEE 11073, Health informatics - Medical / health device communication standards
- ANSI IEEE C63.27, American National Standard For Evaluation Of Wireless Coexistence
- AAMI TIR69, Risk Management Of Radio-Frequency Wireless Coexistence For ● Medical Devices And Systems
In addition, the following standard was used in the design and development of Tidepool Loop:
- ANSI/AAMI/UL 2800-1: 2019, Standard for Safety for Medical Device Interoperability, . FDA Recognition No: 13-109
IX. Non-Clinical Performance Testing
The information presented in this 510(k) submission demonstrates the safety and effectiveness of Tidepool Loop with compatible ACE pump and iCGM devices. Non-clinical performance testing included the following:
- Risk Management: Risk management was performed and documented in accordance with ISO 14971:2019. 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 Tidepool Loop iAGC. In particular, this hazard analysis accounted for the risks associated with interoperability between the software device and the third-party digital devices it communicates with which met predefined criteria. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated.
- Human Factors Validation: A human factors (HF) validation study was conducted in accordance with ANSI/AAMI/IEC 62366-1:2015 and ANSI/AAMI/IEC HE75:2009. The study was conducted to confirm that intended users can safely and effectively use the Tidepool Loop Mobile Application. The final device design was evaluated in a summative study performed with 51 representative participants interacting with the device in a simulated use environment. All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assessed comprehension and usability of the device for critical device tasks including those tasks that involved information from a connected device with representative interoperable technology. Results of the study demonstrated that the device could be used safely by intended users in the intended use environment.
- . Patient Perspective Data: Patient Perspective data collected by Tidepool included summarized information provided by the patients in written statements and also obtained through discussion with patients and patient advocacy groups at public forums regarding
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patient experiences with Tidepool Loop and digitally connected diabetes devices. Patients value that Tidepool Loop will allow them, in conjunction with their healthcare providers, to have more choice in the automated insulin dosing alqorithm that integrates with other elements of their diabetes management strategy and works best for their body and their care.
- Software Verification and Validation: Software verification and validation testing was performed in accordance with IEC 62304:2014 and with FDA guidance, General Principles of Software Validation, issued January 11, 2002. Software testing focused on the iAGC functionality described by the iAGC special controls as defined at 21 CFR 862.1356 including interaction with iCGM and ACE insulin pump devices. Tidepool Loop was installed on compatible iPhone devices (black box testing), and was also tested extensively using automated simulation and emulation environments (white box automated testing). Testing was also performed to ensure that Tidepool Loop's functions through compatible host devices incorporating wireless technologies IEEE 802.15 (Bluetooth) and IEEE 802.11 (WiFi) performed as designed and intended.
Given the modular nature of iAGC. ACE pumps, and iCGM devices, Tidepool isolated the implementation of an ACE pump or iCGM from the iAGC implementation using a plug-in model. This allowed Tidepool to verify the iAGC functionality of Tidepool Loop independent of a specific connected diabetes device. Therefore, the approach to verification was divided into two stages for each interoperable device type as shown in the figure below, a Generic Test Plan and Specific Test Plan(s).
Image /page/14/Figure/3 description: The image shows a diagram of the Tidepool Loop App (iAGC) and its verification and validation process. The app interacts with iCGM and ACE Pump, each having specific test plans. Generic test plans are also in place, and the diagram indicates that the Tidepool Backend is an unregulated part of the system. The diagram also mentions 510(k), suggesting a regulatory aspect to the app's development or approval process.
Tidepool Loop Interoperability Verification Approach
A generic test plan for iCGM was defined and executed using a software simulator implementation of an iCGM. The simulator is a test fixture that enables the tester to generate different types of CGM data and error conditions without using a physical iCGM device. The iCGM simulator was used to verify the correct qlucose-related functionality of Tidepool Loop for the purposes of this submission. A plan for ensuring that connected devices meet Tidepool's specifications, and that appropriate risk management, verification, and validation activities for each connected iCGM device are conducted appropriately was provided.
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A generic test plan for ACE pumps was defined and executed using a software simulator that allowed the tester to manipulate the simulated pump state including initiating, suspending and resuming insulin delivery, adjusting reservoir levels and battery power, and triggering error conditions. A plan for ensuring that connected devices meet Tidepool's specifications, and that appropriate risk management, verification, and validation activities for each connected ACE pump device are conducted appropriately was provided.
Finally, Tidepool relied heavily on automated testing to catch errors and regressions. Automated tests are run with every software change and with every software build and include confirmation that hazard mitiqations were effectively implemented. Verification testing was comprised of the following:
- Automated functional tests: These tests used simulated iCGM and ACE pump devices, as described above, on simulated iPhone devices. These tests were executed automatically and continuously every time Tidepool Loop was built from source code. The full suite of automated tests leverages multiple continuous integration and testing platforms, including CircleCl and Detox. At the time of this premarket submission, over 2,900 automated test cases covering varying aspects of every software build were conducted.
- . Manual functional tests: These per-feature tests used real or simulated iCGM and ACE pump devices on a subset of supported iPhone devices and Apple Watch devices. These tests were developed and executed as part of the development of each feature.
- Final manual functional test: This test included the overall iAGC functionality with . focus on the following areas:
- o Features that were identified by risk assessment as requiring mitigations to reduce risk to acceptable level .
- o User interface areas or features that cannot be adequately covered by automated tests due to complexity and/or time constraints
- Data Logging: Software verification testing demonstrated that Tidepool Loop records ● timestamped critical events, including information related to its state, user inputs, and device settings, as required by the iAGC special controls.
- Interoperability: A plan and approach for interoperability were provided according . to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff. The plan specified expectations, requirements, and interface specifications for potential interoperable devices. In addition, the plan covered Tidepool's approach to working with connected device companies regarding contractual issues, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events). Validated software protocols were submitted, intended to ensure secure, accurate,
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and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected devices. These protocols documented testing of Tidepool Loop with a manufacturer-provided protype pump using IEEE 11073-10419 and Bluetooth SIG and a commercial, cleared iCGM with a manufacturer-provided SDK. Testing coverage is summarized in the table below.
| Testing | Interoperability with
ACE Pump | Interoperability with
iCGM | Tidepool Loop iAGC |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Verification
(bench
testing) | Tidepool-developed
ACE pump software
simulator. | Tidepool-developed
iCGM software
simulator. | Tidepool Loop
software verification
bench testing. |
| | Tidepool-developed
PumpManager for
IEEE 11073-10419
and Bluetooth SIG
compliant insulin
pump. | Manufacturer-provided
iCGM hardware
emulator board
(proprietary
communication
interface). | |
| | Manufacturer-provided
pump hardware emulator
boards (IEEE
11073-10419 and
Bluetooth SIG compliant
interface). | Manufacturer-
provided iCGM SDK
(proprietary
communication
interface). | |
| Validation
(simulated
conditions
of use) | Manufacturer-provided
prototype pump,
communicating with iAGC
via IEEE 11073-10419
and Bluetooth SIG
compliant interface. | Manufacturer-
provided cleared iCGM
devices, communicating
with iAGC via
Manufacturer-
provided SDK with
proprietary
communication
interface. | Tidepool Loop
software installed on
representative iOS
devices, capable of
communicating using
Bluetooth LE to: |
| | | | Manufacturer-provided:
a) prototype pump
b) hardware emulation
environment |
| | | | Manufacturer-provided:
a) cleared iCGM
b) hardware emulation
environment |
- Cybersecurity:A cybersecurity analysis was performed for Tidepool Loop using FDA .
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guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 18, 2020, and the principles outlined in FDA guidance, Postmarket Management of Cybersecurity in Medical Devices, issued December 28, 2020. Tidepool performed threat modeling of the interactions between Tidepool Loop app and the Tidepool Platform and applied mitigations as detailed in the hazard analysis and V&V report.
Tidepool 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, alonq 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 and third-party penetration testing, using existing devices and configurations, were provided.
X. Clinical Testing
Study Overview and Design: The Jaeb Center for Health Research, in collaboration with clinical research centers and Tidepool, conducted an observational study to collect data on the do-it-yourself (DIY) Loop system (ClinicalTrials.gov Identifier: NCT03838900). This study collected and analyzed data on the efficacy, safety, usability, and quality of life/psychosocial effects of the DIY Loop System. The study enrolled subjects diagnosed with type 1 diabetes (T1D) who were using insulin (either pump therapy or multiple daily injections [MDI]) and currently using DIY Loop or had plans to begin using DIY Loop for insulin delivery.
Subjects/Enrollment: The protocol allowed enrollment of up to 1,250 participants of any age with Type 1 diabetes with a target of at least 300 participants and a minimum of 150 as new DIY Loop users. Study participants were divided into two cohorts:
- Cohort A individuals new to using DIY Loop (had not started Loop or had used it for 6 years old, using Humalog or Novolog insulin only, and making use of the Tidepool Loop guardrails (Correction Range 87-180 mg/dL and Glucose Safety Limit 67-110 mg/dL) at least 90% of the time. Cohorts A and B included participants who used DIY Loop settings that are not possible in Tidepool Loop. The table below summarizes these different populations. The results are discussed in detail following the table.
| | Study population not limited to
intended user population | | Study population limited to
intended user population |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Users
(Cohort A) | Existing Users
(Cohort B) | (Ages 6 and up, settings within
allowable Tidepool Loop ranges
at least 90% of the time during
study follow-up) |
| N | 606 | 266 | 175 |
| Demographics | | | |
| Age | 16 Years (median)
1-72 Years (range) | 34 Years (median)
13-76 Years (range) | 23 years (mean)
6-71 (range) |
| Sex | 56% Female | 52% Female | 56% Female |
| | | | |
| Race | 91% White, 4%
Hispanic/Latinx,
2% Multiracial, 2%
Asian,