(74 days)
Yes
The device description mentions "predicted glucose values" and the technology "automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values." While not explicitly stating "AI" or "ML," the concept of predicting future glucose values based on current readings and user inputs strongly suggests the use of predictive algorithms, which are a core component of many ML applications in this domain. The predicate device (K232382, Control-IQ Technology) is also known to utilize predictive algorithms for automated insulin delivery.
Yes
The device is intended for the management of Type 1 and Type 2 diabetes mellitus by automatically increasing, decreasing, and suspending delivery of basal insulin, and delivering correction boluses, which are therapeutic actions.
No
This device is designed for the management of diabetes by automatically adjusting insulin delivery based on glucose readings, not for diagnosing a condition.
Yes
The device description explicitly states "Control-IQ+ technology (Control-IQ+, the device) is a software-only device".
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Control-IQ+ Function: Control-IQ+ technology is a software-only device that controls insulin delivery based on inputs from a continuous glucose monitor (which is an IVD) and user inputs. It does not perform any tests on biological samples itself.
- Intended Use: The intended use clearly states it's for the management of diabetes by automatically adjusting insulin delivery. It doesn't mention any diagnostic testing.
- Device Description: The description focuses on the software's function in controlling an insulin pump based on external data.
- Lack of IVD-related information: The document does not mention any aspects typical of IVDs, such as sample types, analytical methods, or performance metrics like sensitivity and specificity related to a diagnostic test.
While Control-IQ+ relies on data from an IVD (the iCGM), it is not an IVD itself. It's a device that uses the results of an IVD to manage a condition.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications 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 glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
Product codes
QJI
Device Description
Control-IQ+ technology (Control-IQ+, the device) is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided by the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ+ technology is meant to be installed on a compatible ACE pump.
Control-IQ+ technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 - 160 mg/dL. During sleep mode, this range is changed to 112.5-120 mg/dL. and it is changed to 140-160 mg/dL during exercise mode.
Control-IQ+ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when Control-IQ + technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.
Control-IQ+ technology requires users to input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.
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
Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Intended User / Care Setting
single patient use and requires a prescription.
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)
Usability/Human Factors: A Summative Human Factors validation was performed and followed FDA recognized standard IEC 62366-1 as well as the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). The validation study evaluated a total of 30 individuals with Type 2 diabetes. The purpose of the validation was to ensure individuals can safely and effectively perform critical tasks associated with the use of Control-IQ+ technology.
Software Verification and Validation: No new software testing was performed to support this 510(k) Notification.
Special Controls: Evaluation and adherence to the Special Controls of the Predicate Device (K232382) demonstrates continued assurance of the safety and effectiveness of the Subject Device.
Clinical Testing: A pivotal clinical study was conducted to evaluate the safety and effectiveness of Control-IQ+ technology in individuals with Type 2 diabetes ages 18 years and older. This randomized controlled trial enrolled 319 subjects and the subjects were randomly assigned to Control-IQ+ or CGM with continued insulin injections in a 2:1 ratio. The primary outcome of this study was change in HbA1C between arms at 13 weeks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K232382, Control-IQ Technology
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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February 24, 2025
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Tandem Diabetes Care, Inc. Geena George Director, Regulatory Affairs 12400 High Bluff Drive San Diego, California 92130
Re: K243823
Trade/Device Name: Control-IO+ technology Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: December 12, 2024 Received: December 12, 2024
Dear Geena George:
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).
1
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Control-IQ+ technology
Indications for Use (Describe)
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, 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 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside it. To the right of the square is the text "TANDEM" in bold, dark blue letters. Below "TANDEM" is the text "Diabetes Care" in a lighter shade of blue.
| Company | Tandem Diabetes Care, Inc
12400 High Bluff Drive
San Diego, CA 92130 |
|-----------------------------|-------------------------------------------------------------------------------|
| Prepared | 12 Dec 2024 |
| Contact | Geena George
Director of Regulatory Affairs
ggeorge@tandemdiabetes.com) |
| Trade Name | Control-IQ+ technology |
| Common Name | Interoperable Automated Glycemic Controller |
| Classification Product Code | QJI |
| Classification Name | Interoperable Automated Glycemic Controller |
| Regulation Number | 21 CFR 862.1356 |
| Device Class | Class II |
| Predicate Device | K232382, Control-IQ Technology |
510(k) SUMMARY
I. Device Under Review
Control-IQ+ technology (Control-IQ+, the device) is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided by the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ+ technology is meant to be installed on a compatible ACE pump.
Control-IQ+ technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 - 160 mg/dL. During sleep mode, this range is changed to 112.5-120 mg/dL. and it is changed to 140-160 mg/dL during exercise mode.
Control-IQ+ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when Control-IQ + technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.
Control-IQ+ technology requires users to input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.
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Image /page/5/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside of it. To the right of the square is the word "TANDEM" in a bold, dark blue font, with the words "Diabetes Care" underneath in a lighter blue font.
II. Intended Use/ Indications 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 glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
| | Predicate Device
K232382 | Subject Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use/ Intended 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 glucose value is
predicted to exceed a predefined
threshold.
Control-IQ technology is intended
for the management of Type 1
diabetes mellitus in persons 2
years of age and greater.
Control-IQ technology is intended
for single patient use and requires
a prescription. | 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 2 years of age and greater
and of Type 2 diabetes mellitus
in persons 18 years of age and
greater.
Control-IQ+ technology is
intended for single patient use and
requires a prescription. |
| Pump Type | Alternate controller enabled
insulin pump | SAME |
| | Predicate Device
K232382 | Subject Device |
| Specific
Drug/Biological
Use | U-100 Insulin | SAME |
| Profile Delivery | When the predicted CGM value is
within the target range, the pump
will deliver insulin at the rate
determined by the active Personal
Profile settings.
The user's profile basal rate may
be set as high as 15 units/hr when
Control-IQ is off and when
Control-IQ is enabled same basal
rate is applied. | SAME |
| Basal Rate
Range | The Personal Profile correction
factor is used to determine the
predicted basal rate limits of 10 to
600 mg/dL per unit insulin. | SAME |
| Basal
Attenuation | When Control-IQ technology
predicts that the sensor glucose
value will be at or below the
target range 30 minutes in the
future, the rate of insulin
delivered will begin to decrease to
attempt to keep glucose within the
target range. | SAME |
| Automatic
Correction
Bolus | The upper limit for the automatic
correction bolus is 600 mg/dL per
unit insulin. | SAME |
| Body Weight
Setting Range | 20 lbs (9 kg) - 440 lbs (200 kg) | SAME |
| Total Daily
Insulin Setting
Range | User setting of 5 units/day - 200
units/day | SAME |
| Extended Bolus | Up to 8-hour duration while
Control-IQ is enabled or disabled
and extended boluses are
uninterrupted when enabling
Control-IQ. | SAME |
| Temporary
Basal Rate | Temp Rates can be enabled
without turning Control-IQ
Technology off | SAME |
III. Technological Characteristics Compared to Predicate Device K232382
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Image /page/6/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside, followed by the words "TANDEM" in bold, dark blue letters. Below "TANDEM" is the phrase "Diabetes Care" in a lighter shade of blue.
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Image /page/7/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside, followed by the words "TANDEM" in bold, dark blue letters. Below "TANDEM" is the phrase "Diabetes Care" in a lighter blue font.
IV. Overview of Non-Clinical and Clinical Performance Tests
Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended. See summaries below.
Usability/Human Factors:
A Summative Human Factors validation was performed and followed FDA recognized standard IEC 62366-1 as well as the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). The validation study evaluated a total of 30 individuals with Type 2 diabetes. The purpose of the validation was to ensure individuals can safely and effectively perform critical tasks associated with the use of Control-IQ+ technology.
Software Verification and Validation:
No new software testing was performed to support this 510(k) Notification.
Special Controls:
Evaluation and adherence to the Special Controls of the Predicate Device (K232382) demonstrates continued assurance of the safety and effectiveness of the Subject Device.
Clinical Testing:
A pivotal clinical study was conducted to evaluate the safety and effectiveness of Control-IQ+ technology in individuals with Type 2 diabetes ages 18 years and older. This randomized controlled trial enrolled 319 subjects and the subjects were randomly assigned to Control-IQ+ or CGM with continued insulin injections in a 2:1 ratio. The primary outcome of this study was change in HbA1C between arms at 13 weeks.
Conclusion:
The changes that have been made to the Control-IQ+ technology indications for use result in a product that is substantially equivalent to the predicate Control-IQ technology device. The design of the Control-IQ+ algorithm is unchanged. The intended use and indications for use have been previously cleared on the Tandem device except for the addition of the Type 2 users ages 18 years or older. The addition of a new user population is supported by clinical trial data that demonstrates that Control-IQ+ technology is safe and effective in patients with Type 2 diabetes. Furthermore, the human factors validation with the new user population supports the safety of Control-IQ+ technology. Thus, the modified Control-IQ+ technology does not raise any different questions of safety and effectiveness and is considered substantially equivalent to the predicate, Control-IO technology (K232382).