(73 days)
Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values.
Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater.
Basal-IQ technology is intended for single patient use and requires a prescription.
Basal-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.
The bolus calculator is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.
Basal-IQ technology is a Predictive Low Glucose Suspend (PLGS) algorithm for the management of diabetes mellitus and is compatible with an Alternate Controller Enabled Infusion Pump (cleared under 21 CFR 880.5730)(ACE pump). Basal-IQ technology is only compatible with the Tandem t:slim X2 insulin pump (DEN180058). The Basal-IQ software and algorithm can receive interstitial sensor glucose values from a compatible iCGM system (cleared under 21 CFR 862.1355), via Bluetooth Low Energy (BLE) communication. Compatible iCGM systems are cleared and marketed separately from the Basal-IQ algorithm and are identified in device labeling.
Basal-IQ assesses glucose information provided by a paired iCGM and sends commands to a compatible ACE pump to temporarily suspend insulin delivery in cases of impending or detected low blood glucose. Every 5 minutes, the Basal-IQ feature assesses glucose information provided by the iCGM to predict whether glucose values will fall below 80 mg/dL in the next 30 minutes or detect if glucose levels are currently below 70 mg/dL. Under these conditions it will command the compatible pump to suspend insulin delivery; otherwise insulin delivery continues as normal. After insulin delivery is suspended, insulin delivery resumption is commended when the system detects glucose values begin to rise. A sustained suspension period when blood glucose is above the sensor suspend threshold is mitigated by a maximum suspend time where Basal-IQ will command resume insulin delivery after 120 minutes of suspension within a 150-minute window. The Basal-IQ technology uses CGM sensor readings to send commands to a compatible insulin pump to stop and resume insulin based on the current sensor value and a 30-minute future predicted value along with the following rules:
- Insulin delivery is suspended if the current CGM sensor reading is less than 70 mg/dL 1.
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- Insulin delivery is suspended if the glucose value is predicted to be less than 80 mg/dL in 30 minutes.
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- Basal insulin delivery is resumed once the current CGM sensor reading increases compared to the previous reading.
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- Basal insulin delivery will also be resumed if the 30-minute predicted CGM reading is above 80 mg/dL, even if the CGM reading has not increased compared to the previous reading.
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- Basal insulin delivery is resumed if insulin delivery has been suspended for 2 hours in a 2.5 hour window.
The software comprising the Basal-IQ algorithm also includes an insulin bolus dose calculator. This calculator is for assisting patients with Type 1 diabetes who use insulin pumps as their insulin delivery therapy. It is used to calculate insulin bolus doses of rapid acting U-100 insulin analogs (Humalog and Novolog).The bolus calculator is used with manually-inputted glucose values and pump insulin delivery data to generate bolus size recommendations.
Here's an analysis of the acceptance criteria and study information for the Basal-IQ Technology, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets and the corresponding reported performance. Instead, it describes the functions of the Basal-IQ technology, which inherently define its intended performance. The clinical study then validated that the device functions as intended.
Here's an interpretation of the implicit operational criteria and the general statement of performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (General Statement in Document) |
|---|---|
| Prediction and Suspension for Low Glucose: | |
| • Suspend insulin delivery if glucose values are predicted to fall below 80 mg/dL in the next 30 minutes. | |
| • Suspend insulin delivery if current glucose levels are currently below 70 mg/dL. | "The performance data demonstrates that the Basal-IQ Technology… functions as intended to stop and resume insulin delivery in response to low and high glucose levels, respectively." |
| "A human factors study was conducted to confirm that the intended users can safely and effectively use the Basal-IQ Technology..." | |
| Resumption of Insulin Delivery: | |
| • Resume insulin delivery when current CGM sensor reading increases compared to the previous reading. | |
| • Resume insulin delivery if the 30-minute predicted CGM reading is above 80 mg/dL, even if the CGM reading has not increased. | |
| • Resume insulin delivery if insulin delivery has been suspended for 2 hours within a 2.5-hour window. | "The performance data demonstrates that the Basal-IQ Technology… functions as intended to stop and resume insulin delivery in response to low and high glucose levels, respectively." |
| Bolus Calculator Functionality: | |
| • Accurately calculate insulin dose or carbohydrate intake based on user-entered data. | "The t:slim X2 Bolus Calculator is the same calculator, as reviewed in P180008, therefore no additional testing was conducted." (Implies previous validation was sufficient and performance is maintained.) |
| Safety and Effectiveness (Overall): | |
| • Device can be used safely. | |
| • Software meets all specified requirements and performs as intended. | |
| • Intended users can safely and effectively use the Basal-IQ Technology (including turning on/off PLGS, setting/modifying alerts, comprehending alerts). | |
| • Input specifications from iCGM sensors are adequate to assure reasonable safety and effectiveness. | "The performance data presented demonstrates that the Basal-IQ Technology... can be used safely and that it functions as intended." |
| "Comprehensive verification and validation testing was conducted to confirm that the software... met all specified requirements and performed as intended." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Clinical Study (Test Set):
- Total enrolled: 107 subjects with Type 1 Diabetes
- Completed the study: 102 subjects
- Data Provenance:
- Country of Origin: United States (4 sites)
- Retrospective or Prospective: Prospective (clinical study with enrolled subjects)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the clinical study data in the traditional sense of independent readers reviewing output. The "ground truth" for this type of system is typically defined by real-time physiological data (CGM readings, blood glucose measurements) and the predefined algorithm logic. The clinical study assessed the device's performance against these physiological realities and its own built-in rules, observed by clinical investigators.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and study design. The study evaluated the automated system's performance and user interaction, rather than requiring expert adjudication of outputs against a reference standard in the way an imaging AI algorithm might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or performed. The study was a crossover design comparing the Basal-IQ enabled pump to a Sensor Augmented Pump (SAP) in individuals with Type 1 Diabetes. This is a comparative effectiveness study but not in the MRMC format typically used for diagnostic or imaging AI.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this was not an MRMC study and the primary focus was on the direct performance and safety of the automated insulin suspension, not human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the core of the clinical study evaluates the standalone performance of the Basal-IQ algorithm (when enabled) in managing glucose levels by automatically suspending and resuming insulin delivery. While the device is used by a human, the algorithm's action (suspending/resuming basal insulin) is automatic based on CGM data. The "human factors study" later confirmed user interaction with the system, but the clinical efficacy portion inherently assesses the algorithm's automated functions.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Basal-IQ algorithm's performance is based on:
- Physiological Data: Continuous Glucose Monitoring (CGM) readings and, presumably, corroborating blood glucose measurements (though not explicitly detailed as the "ground truth" method for the algorithm itself, these are the inputs).
- Pre-defined Algorithm Rules: The "ground truth" for whether the algorithm should have acted in a certain way is its own pre-programmed logic (e.g., predicted glucose below 80 mg/dL, current glucose below 70 mg/dL). Efficacy is then measured by how well applying these rules impacts patient outcomes (e.g., reduction in hypoglycemia).
8. The Sample Size for the Training Set
The document explicitly states: "No new non-clinical laboratory studies were needed for the separation from that system... The Basal-IQ Technology is the same algorithm, and the t:slim X2 Bolus Calculator is the same calculator, as reviewed in P180008, therefore no additional testing was conducted."
This implies that the algorithm was previously developed and validated. The current submission (K193483) is for a modification/reclassification rather than a new algorithm requiring a new training set. Therefore, information about the original training set sample size is not provided in this document.
9. How the Ground Truth for the Training Set Was Established
Since the document states it's the "same algorithm" as previously reviewed (under P180008), the process for establishing ground truth for the original training set is not detailed in this K193483 submission. It would have been part of the P180008 documentation.
§ 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.