(87 days)
Yes
The intended use explicitly mentions "predicted glucose values," which strongly suggests the use of algorithms that learn from data to make predictions, a core characteristic of machine learning.
Yes
The device is described as "intended for the management of Type 1 diabetes mellitus" and "controls insulin delivery," which are direct therapeutic actions.
No.
The device uses iCGM readings and predicted glucose values to automatically manage insulin delivery, rather than providing a diagnosis of a medical condition.
Yes
The device description explicitly states "Control-IQ technology (Control-IQ, the device) is a software-only device intended for the management of type 1 diabetes mellitus." It also describes the software being installed on a compatible ACE pump, further indicating its software-only nature.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Control-IQ Technology's Function: Control-IQ technology is a software-only device that controls insulin delivery based on inputs from a continuous glucose monitor (which measures glucose in interstitial fluid, not a collected specimen) and user inputs. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for the management of Type 1 diabetes by automatically adjusting insulin delivery, not for diagnosing or analyzing a biological sample.
While it uses data from a glucose monitor, the Control-IQ technology itself is not performing an in vitro diagnostic test on a specimen. It's an automated insulin delivery system that utilizes glucose data as an input.
No
The input text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention or approval of a PCCP for this 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.
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 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 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 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 the 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 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
2 years of age and greater
Intended User / Care Setting
Not Found
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)
A pivotal clinical study was conducted to evaluate the safety and effectiveness of Control-IQ Technology in individuals 2-5 years of age. This randomized controlled trial enrolled 102 subjects and the subjects were randomly assigned to Control-IQ or Standard Care (SC) in a 2:1 ratio. The subjects used the t:slim X2 insulin pump with Control-IQ Technology for 13 weeks. Upon completion of the 13 week study, participants could then enroll in an optional 13 week extension phase with the modified Control-IQ technology. Individuals assigned to the SC group were then moved to the Control-IQ group during this extension phase. The primary outcome of the study was CGM measured percent time in range 70-180 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 3, 2023
Tandem Diabetes Care, Inc. Christin Dunn Senior Regulatory Affairs Specialist 12400 High Bluff Drive San Diego, California 92130
Re: K232382
Trade/Device Name: Control-IQ Technology Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: August 7, 2023 Received: August 8, 2023
Dear Christin Dunn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
Indications for Use
510(k) Number (if known) K232382
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, 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.
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/3/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside on the left. To the right of the square is the text "TANDEM" in a dark blue, bold font, with the words "Diabetes Care" underneath in a lighter blue font.
510(K) SUMMARY FOR K232382
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for Control-IQ Technology is provided below:
Submitter Information
| Name | Tandem Diabetes Care, Inc. |
|---|---|
| 12400 High Bluff Drive | |
| San Diego, CA 92130 | |
| Phone: 858-366-6900 | |
| Applicant Contact | Christin Dunn |
| Senior Regulatory Affairs Specialist | |
| Phone: 858-401-1641 | |
| cdunn@tandemdiabetes.com | |
| Tandem Diabetes Care, Inc. | |
| 12400 High Bluff Drive | |
| San Diego, CA 92130 | |
| Secondary Contact | Lan Herrington |
| Director, Regulatory Affairs | |
| (858) 255-6378 | |
| LHerrington@tandemdiabetes.com | |
| Tandem Diabetes Care, Inc. | |
| 12400 High Bluff Drive | |
| San Diego, CA 92130 | |
| Date Prepared: | October 26, 2023 |
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Image /page/4/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo is a blue square with rounded corners. Inside the square is a white "T". To the right of the square is the text "TANDEM" in a dark blue font, with the text "Diabetes Care" in a lighter blue font below it.
| Trade name | Control-IQ Technology |
|---|---|
| Common name | interoperable automated glycemic controller |
| Regulation Name | interoperable automated glycemic controller |
| Classification number | 21 CFR 862.1356 |
| Product code | QJI |
| Regulatory class | II |
| Predicate devices | Control-IQ Technology (K200467) |
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.
Description
Control-IQ technology (Control-IQ, the device) is a software-only device intended for the management of type 1 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 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
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Image /page/5/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left is a blue square with rounded corners, inside of which is a white "T". To the right of the square is the word "TANDEM" in a dark blue, sans-serif font. Below that is the phrase "Diabetes Care" in a lighter blue, sans-serif font.
targets are not 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 the 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 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/6/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo is a blue square with rounded corners, and a white "T" inside. To the right of the square is the text "TANDEM" in a dark blue, and below that is the text "Diabetes Care" in a lighter blue.
Technological Characteristics Compared to Predicate Device
| | PREDICATE DEVICE
CONTROL-IQ TECHNOLOGY
(K200467) | SUBJECT DEVICE
(K232382) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indication For
Use | Control-IQ technology is
intended for use with
compatible integrated
continuous glucose monitors
(iCGM) and alternate controller
enabled (ACE) pumps to
automatically increase, decrease,
and suspend delivery of basal
insulin based on iCGM readings
and predicted glucose values. It
can also deliver correction
boluses when the glucose value
is predicted to exceed a
predefined threshold. | 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-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
indicated for use with NovoLog
or Humalog U-100 insulin | |
| Pump Type | Alternate controller enabled
insulin pump | Same |
| Classification | II | Same |
| 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, but is
clipped to 3 units/hr when
Control-IQ is enabled | 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, the same basal rate
is applied. |
| Basal Rate Range | The Personal Profile correction
factor is used to determine the
predicted basal rate limits of 10
to 200 mg/dL per unit insulin. | The Personal Profile correction
factor is used to determine the
predicted basal rate limits of 10 to
600 mg/dL per unit insulin. |
| Basal Attenuation | When Control-IQ technology | Same |
| | 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. | |
| Automatic
Correction Bolus | The upper limit for the
automatic correction bolus is
200 mg/dL per unit insulin. | The upper limit for the automatic
correction bolus is 600 mg/dL per
unit insulin. |
| Body Weight
Setting Range | 55 lbs (25 kg) – 308 lbs (140kg) | 20 lbs (9 kg) - 440 lbs (200 kg) |
| TDI Range | User setting of 10 units/day -
100 units/day. | User setting of 5 units/day - 200
units/day. |
| Extended Bolus | Up to 2-hour duration when
Control-IQ is enabled, up to 8
hour duration when Control-IQ is
disabled.
Extended bolus delivery will be
terminated when Control-IQ is
enabled. | Up to 8-hour duration while
Control-IQ is enabled or disabled
and extended boluses are
uninterrupted when enabling
Control-IQ. |
| Temporary Basal
Rates | In order to use Temp Rates,
Control-IQ technology must be
turned off | Temp Rates can be enabled
without turning Control-IQ
Technology off |
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Image /page/7/Picture/0 description: The image shows 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 dark blue font, with the words "Diabetes Care" underneath in a lighter blue font.
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Image /page/8/Picture/0 description: The image contains the logo for Tandem Diabetes Care. The logo consists of a blue square with a white "T" inside on the left. To the right of the square is the word "TANDEM" in a dark blue, sans-serif font, with the words "Diabetes Care" in a lighter blue font underneath.
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Image /page/9/Picture/0 description: The image contains the logo for Tandem Diabetes Care. On the left side of the logo is a blue square with rounded corners. Inside the square is a white "T". To the right of the square is the text "TANDEM" in a dark blue font, with the text "Diabetes Care" in a lighter blue font below it.
Software verification and validation testing was performed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes.
Evaluation and adherence to the Special Controls (21 CRF 862.1356) demonstrate continued assurance of safety and effectiveness of the Subject Device.
Clinical Performance
A pivotal clinical study was conducted to evaluate the safety and effectiveness of Control-IQ Technology in individuals 2-5 years of age. This randomized controlled trial enrolled 102 subjects and the subjects were randomly assigned to Control-IQ or Standard Care (SC) in a 2:1 ratio. The subjects used the t:slim X2 insulin pump with Control-IQ Technology for 13 weeks. Upon completion of the 13 week study, participants could then enroll in an optional 13 week extension phase with the modified Control-IQ technology. Individuals assigned to the SC group were then moved to the Control-IQ group during this extension phase. The primary outcome of the study was CGM measured percent time in range 70-180 mg/dL.
Substantial Equivalence
The changes that have been made to the Control-IQ technology indications for use and software result in a product that is substantially equivalent to the predicate Control-IQ technology device. The intended use and indications for use have been previously cleared on the Tandem device except for the change in age from 6 to 2 years of age and greater. The changes to Control-IQ technology and the change in age are supported by clinical trial data that demonstrates that the devices are substantially equivalent. Moreover, software testing demonstrates that the device performs as expected and in a manner that is substantially equivalent to the predicate device. Thus, the modified Tandem Diabetes Care Control-IQ technology is substantially equivalent to the predicate Tandem Diabetes Care Control-IQ technology (K200467).