(111 days)
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 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-IO technology is indicated for use with NovoLog or Humalog U-100 insulin.
The Control-IQ technology, is an interoperable automated glycemic controller. This 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 divcemic 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 qlycemic control.
The provided text is a 510(k) summary for Tandem Diabetes Care's Control-IQ technology. While it states that a clinical study was performed, it does not provide any specific acceptance criteria or detailed results of that study (e.g., specific metrics like mean glucose, time in range, or hypoglycemia rates). It only generically states that it "demonstrates that the device is safe and effective in the population evaluated (ages ≥ 6 and ≤ 13 years old)."
Therefore, I cannot fulfill all parts of your request with the given information. However, I can extract what is provided.
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Description of Acceptance Criteria and Proving Study
The provided 510(k) summary for the Control-IQ technology indicates that a clinical study was performed to assess the efficacy and safety of the device. However, the document does not explicitly state the specific acceptance criteria used for this study, nor does it provide detailed performance metrics or results from the study. It only makes a general statement about the device being safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Specific quantitative thresholds for glucose control, hypoglycemia, or other clinical outcomes were not provided in the document. | Specific quantitative results from the clinical study (e.g., mean HbA1c, time in range, standard deviation of glucose) were not provided in the document. |
| Safety endpoints (e.g., severe hypoglycemia, DKA rates) were not explicitly defined with thresholds. | General statement: "The study demonstrates that the device is safe and effective in the population evaluated (ages ≥ 6 and ≤ 13 years old)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "randomized controlled trial" but does not specify the sample size of participants in this trial.
- Data Provenance: The document does not specify the country of origin of the data. It implies the study was prospective ("randomized controlled trial").
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not applicable for this type of device. The "ground truth" for glycemic control in a clinical study is typically established by objective physiological measurements (e.g., CGM readings, lab glucose values) rather than expert review of images or medical records.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Adjudication methods are typically used when there's subjective interpretation involved, such as in image-based diagnostics. For a glycemic control device, the primary "data" are objective glucose measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for this type of device (automated glycemic controller). These studies are typically used for diagnostic devices that involve human interpretation of medical images or other data. This device is an automated system designed to manage glucose levels directly.
6. Standalone Performance Study
- Yes, implicitly. The clinical study performed on the Control-IQ technology assessed the device's performance (efficacy and safety) as an automated system. While it interacts with an iCGM and an ACE pump, the "Control-IQ technology" itself is the algorithm and software component being evaluated for its standalone ability to manage glucose. The study evaluated its performance, not how it assists a human to perform a task.
7. Type of Ground Truth Used
- The ground truth for evaluating an automated glycemic controller in a clinical study would be based on physiological measurements such as:
- Continuous Glucose Monitoring (CGM) data
- Laboratory-confirmed blood glucose values
- Clinical outcomes data (e.g., episodes of hypoglycemia/hyperglycemia, hospitalizations, DKA events).
- The document does not explicitly state the specific ground truth metrics used, but these are standard for such studies.
8. Sample Size for the Training Set
- Not provided. The document does not mention the sample size or details of any training set used for developing or training the Control-IQ algorithm. It only refers to a "Clinical study" for validation.
9. How the Ground Truth for the Training Set Was Established
- Not provided. Since details about a training set are not mentioned, how its ground truth was established is also not available in this document.
§ 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.