DEKA Loop

K234055 · Deka Research and Development · QJI · Mar 13, 2024 · Clinical Chemistry

Device Facts

• Record ID: K234055
• Device Name: DEKA Loop
• Applicant: Deka Research and Development
• Product Code: QJI · Clinical Chemistry
• Decision Date: Mar 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate controller enabled (ACE) insulin infusion pump 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. DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. DEKA Loop is intended for single patient use and requires a prescription.

Device Story

DEKA Loop is an interoperable Automated Glycemic Controller (iAGC) that manages Type 1 diabetes. It receives input from an integrated continuous glucose monitor (iCGM) and uses a predictive algorithm to adjust basal insulin delivery via an Alternate Controller Enabled (ACE) insulin pump. The system predicts glucose levels up to 6 hours into the future based on iCGM readings, insulin history, and user inputs (carbohydrate intake, exercise). It automatically increases, decreases, or suspends basal insulin and recommends correction boluses, which the user must confirm. The device is operated by the patient in home environments via an iOS app. It benefits patients by automating insulin delivery to maintain glucose within user-configurable thresholds, reducing the burden of manual adjustments.

Clinical Evidence

No new clinical trials were conducted. Substantial equivalence is supported by leveraging clinical validation data from the predicate (Tidepool Loop) and extensive in-silico simulation testing. In-silico testing included 24 million simulated-use hours across 1 million random scenarios, demonstrating 99.76% clinical equivalence. Discrepancies in 0.24% of scenarios were attributed to floating-point calculation differences between hardware platforms and determined not to impact clinical safety. Human factors validation confirmed the device is safe for its intended use.

Technological Characteristics

Software-only iAGC embedded in DEKA ACE pump. Interoperable via Bluetooth LE with iCGMs (e.g., Dexcom G6). Operates on user-defined therapy settings (basal rates, insulin sensitivity, carb ratios). Complies with ANSI/AAMI/UL 2800-1:2019 for interoperability. Software is a ported version of Tidepool Loop algorithm.

Indications for Use

Indicated for management of Type 1 diabetes mellitus in persons 6 years of age and older. Requires prescription. For use with compatible iCGM and ACE insulin infusion pumps.

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

• Tidepool Loop (K203689)

Submission Summary (Full Text)

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March 13, 2024

Deka Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101

Re: K234055

Trade/Device Name: DEKA Loop Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: December 21, 2023 Received: December 22, 2023

Dear Paul Smolenski:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-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,

# Joshua Balsam -S

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

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## Indications for Use

510(k) Number (if known) K234055

Device Name DEKA Loop

#### Indications for Use (Describe)

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate controller enabled (ACE) insulin infusion pump 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.

DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.

DEKA Loop is intended for single patient use and requires a prescription.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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#### 510(k) Summary: K234055

#### Submitter Information

510(k) Sponsor: DEKA Research & Development 340 Commercial Street Manchester, NH 03101

Contact Person: Paul Smolenski Regulatory Affairs DEKA Research & Development Corporation Phone: [phone] Fax: [phone] psmolenski(@dekaresearch.com

Date Prepared: 2/29/2024

#### Proposed Device

Common/Usual Name: DEKA Loop Trade/Proprietary Name: DEKA Loop Classification Name: interoperable Automated Glycemic Controller Device Classification: 21 CFR 862.1356 Product Code: QJI Class: II Device Panel: Clinical Chemistry

### Predicate Device

The predicate device for this submission is Tidepool Loop cleared in K203689.

### Device Description

DEKA Loop is an interoperable Alternate Glycemic Controller (iAGC) and works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by DEKA Loop. DEKA 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. It is controlled by an iOS app that is downloaded to a user's iPhone.

#### Intended Use

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed user configurable thresholds. DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. DEKA Loop is intended for single patient use and requires a prescription.

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### Technological Characteristics

DEKA Loop is used with an ACE pump and an iCGM to deliver basal insulin.

#### Performance Data

Software verification and validation testing was performed per FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification 510(k) Submissions Guidance. Additionally, in-silico software challenge testing demonstrated clinical equivalence to the predicate device.

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# Substantial Equivalence

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

| Characteristic | Predicate Device | Subject Device | Explanation of Differences |
|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Interoperable Automated Glycemic | Interoperable Automated Glycemic | Same |
| Regulation and | Controller, 21 CFR 862.1356, | Controller, 21 CFR 862.1356, | |
| Product Code | Procode QJI | Procode QJI | |
| Indications for Use | Tidepool Loop, a mobile application<br>with algorithm technology, is<br>intended for use with compatible<br>integrated continuous glucose<br>monitors (iCGM) and alternate<br>controller enabled (ACE) insulin<br>infusion pumps to automatically<br>increase, decrease, and suspend<br>delivery of basal insulin based on<br>iCGM readings and predicted<br>glucose values. It can also<br>recommend, and with the user's<br>confirmation, control the delivery of<br>correction boluses when glucose<br>values are predicted to exceed user<br>configurable thresholds.<br><br>Tidepool Loop is intended for the<br>management of type 1 diabetes<br>mellitus in persons six years of age<br>and greater.<br><br>Tidepool Loop is intended for single<br>patient use. | DEKA Loop is intended for use<br>with compatible integrated<br>continuous glucose monitors<br>(iCGM) and the DEKA alternate<br>controller enabled (ACE) insulin<br>infusion pump to automatically<br>increase, decrease, and suspend<br>delivery of basal insulin based on<br>iCGM readings and predicted<br>glucose values. It can also<br>recommend, and with the user's<br>confirmation, control the delivery of<br>correction boluses when glucose<br>values are predicted to exceed user<br>configurable thresholds.<br><br>DEKA Loop is intended for the<br>management of Type 1 diabetes<br>mellitus in persons six years of age<br>and greater.<br><br>DEKA Loop is intended for single<br>patient use and requires a<br>prescription. | Equivalent. DEKA Loop is<br>integrated into the DEKA<br>ACE Pump System. |
| Characteristic | Predicate Device | Subject Device | Explanation of Differences |
| Prescription Use | Tidepool Loop is Rx - For<br>Prescription Use Only. | Yes | Same |
| Intended Population | Yes<br>Type 1 diabetes mellitus in persons<br>six years of age and greater. | Type 1 diabetes mellitus in persons<br>six years of age and greater. | Same |
| Patient Environment | On-body wearable ambulatory<br>pump | On-body wearable ambulatory<br>pump | Same |
| Environment of Use | Home environments | Home environments | Same |
| Number of Users | Single user only | Single user only | Same |
| Technological Characteristics | | | |
| Principle of Operation | Tidepool Loop predicts glucose<br>levels up to 6 hours in the future<br>(the approximate duration of insulin<br>action for U-100 rapid-acting<br>insulin) based on prior iCGM<br>readings, insulin delivery history,<br>and user input (e.g., carbohydrate<br>intake and exercise) and uses that<br>prediction to adjust insulin delivery.<br><br>Tidepool Loop can be used to adjust<br>or suspend basal insulin delivery<br>every 5 minutes and deliver<br>correction boluses of insulin based<br>on actual and predicted CGM sensor<br>readings.<br><br>Users must manually deliver meal<br>boluses they can calculate using the<br>Tidepool Loop Bolus<br>Recommendation Tool | DEKA Loop predicts glucose levels<br>up to 6 hours in the future (the<br>approximate duration of insulin<br>action for U-100 rapid-acting<br>insulin) based on prior iCGM<br>readings, insulin delivery history,<br>and user input (e.g., carbohydrate<br>intake and exercise) and uses that<br>prediction to adjust insulin delivery.<br><br>DEKA Loop can be used to adjust<br>or suspend basal insulin delivery<br>every 5 minutes and deliver<br>correction boluses of insulin based<br>on actual and predicted CGM sensor<br>readings.<br><br>Users must manually deliver meal<br>boluses they can calculate using the<br>DEKA Loop Bolus<br>Recommendation Tool | Same |
| Characteristic | Predicate Device | Subject Device | Explanation of Differences |
| | (TLBRT) and can manually adjust<br>insulin delivery (change basal rates<br>and deliver insulin boluses) when<br>Tidepool Loop is active. | (DLBRT) and can manually adjust<br>insulin delivery (change basal rates<br>and deliver insulin boluses) when<br>DEKA Loop is active. | |
| Type of Algorithm | Hybrid Closed Loop – predictive<br>control | Hybrid Closed Loop – predictive<br>control | Same |
| Compatible iCGM | Dexcom G6 | Dexcom G6 | Same |
| Compatible ACE<br>Pump | An ACE pump that has the<br>specifications and meets the pre-<br>specified acceptance criteria for<br>software, cybersecurity, device<br>interoperability, human factors,<br>labeling, and training materials as<br>described in SOP-0016, "Tidepool<br>Loop Connected Device Integration<br>and Validation Process and Plan,"<br>and SOP-0018, "Tidepool Loop<br>Regulatory Determination Process."<br>Tidepool Loop must not be<br>distributed until the pre-specified<br>acceptance criteria in the SOPs are<br>met. | DEKA ACE Pump System | Equivalent. Both require<br>cleared ACE Pumps. In the<br>DEKA ACE Pump System,<br>the integration aspects of the<br>predicate device are<br>addressed by embedding<br>DEKA Loop into the DEKA<br>ACE Pump System. |
| Device Design or<br>Material | Tidepool Loop is a mobile<br>application and a Software as<br>Medical Device (SaMD) installed<br>on a host mobile device. | DEKA Loop is embedded in the<br>DEKA ACE Pump. The user<br>interface for DEKA Loop is the<br>DEKA Loop App iOS application. | Equivalent. DEKA Loop is<br>embedded in the DEKA<br>ACE pump instead of a host<br>mobile device. The user<br>interface for both systems is<br>an iOS application. Both the<br>subject and predicate devices<br>have equivalent risks and<br>mitigations for each use |
| Characteristic | Predicate Device | Subject Device | Explanation of Differences |
| Algorithm Platform | iPhone | DEKA ACE Pump System | Equivalent. Both the subject<br>and predicate devices have<br>equivalent risks and<br>mitigations for each use<br>profile. No new or modified<br>risks. |
| Insulin Compatibility | Novolog or Humalog U-100 | Novolog or Humalog U-100 | Same |
| Functional Characteristics | | | |
| User-controlled Target<br>Range Settings | Customizable settings<br>Correction Range:<br>87 - 180 mg/dL<br><br>Pre-Meal Range:<br>Glucose Safety Limit (which can be<br>set from 67-110 mg/dL) - 130<br>mg/dL<br><br>Workout Range: the higher of 87<br>mg/dL or the Glucose Safety Limit<br>(which can be set from 67-110<br>mg/dL) - 250 mg/dL | Customizable settings<br>Correction Range:<br>87 - 180 mg/dL<br><br>Pre-Meal Range:<br>Glucose Safety Limit (which can be<br>set from 67-110 mg/dL) - 130<br>mg/dL<br><br>Workout Range: the higher of 87<br>mg/dL or the Glucose Safety Limit<br>(which can be set from 67-110<br>mg/dL) - 250 mg/dL | Same |
| Auto-populating bolus<br>recommendation<br>based on iCGM value:<br>• In closed loop<br>mode<br>• In open loop<br>mode | Yes<br>No | Yes<br>No | Same |
| Characteristic | Predicate Device | Subject Device | Explanation of Differences |
| Data List and Logging | Yes | Yes | Same |
| Daily Activity Records | Yes | Yes | Same |
| Average Data Display | Yes | Yes | Same |
| Changing Pump Settings | Yes | Yes | Same |
| Invite others to view data through authorization | Yes | Yes | Same |
| Password Required | Yes | Yes | Same |
| <b>Performance Characteristics</b> | | | |
| Bench Performance | Tidepool Loop performance was verified and validated through software verification testing. | DEKA Loop performance was verified and validated through software verification testing. | Same |
| Clinical Performance | Tidepool Loop clinical performance is supported by representative 1,250 participants in a 15 months duration real-world, observational, single arm study of DIY Loop including both pediatric and adult participants. | In silico testing. | Equivalent. In silico testing proves that the DEKA Loop algorithm is clinically equivalent to the Tidepool Loop Algorithm. |
| Risk Assessment | Tidepool Loop performed Risk Assessment including detailed hazard analysis based on ISO 14971. | DEKA Loop performed Risk Assessment including detailed hazard analysis based on ISO 14971. | Same |
| <b>Labeling</b> |…