(73 days)
Not Found
No
The description mentions a "Predictive Low Glucose Suspend (PLGS) algorithm" that uses rules based on current and predicted glucose values. While this involves prediction, the rules are explicitly defined and do not indicate learning or adaptation from data, which are hallmarks of AI/ML. The term "algorithm" in this context refers to a set of predefined instructions, not necessarily an AI/ML model.
Yes
The device, Basal-IQ technology, is intended for the management of diabetes mellitus by automatically suspending and resuming insulin delivery based on glucose values and predictions, which directly treats and manages a medical condition.
No
The Basal-IQ technology, including its bolus calculator, is intended for managing diabetes mellitus by suspending insulin delivery based on predicted glucose values and calculating insulin doses. While it uses glucose readings, its primary function is therapy delivery and management based on those readings, not to diagnose a new condition or provide a diagnostic interpretation of a patient's health status. The device aids in the management of an already diagnosed condition.
No
The device is described as a "Predictive Low Glucose Suspend (PLGS) algorithm" and "software" that is compatible with and sends commands to a specific hardware device, the Tandem t:slim X2 insulin pump (an ACE pump). While the core functionality is software-based, it is intrinsically linked to and controls a physical medical device (the insulin pump) for its intended use of delivering insulin. Therefore, it is not a standalone software-only medical device.
Based on the provided information, the Basal-IQ technology itself is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Basal-IQ technology receives glucose values from a compatible iCGM system. While the iCGM system is an IVD because it measures glucose in interstitial fluid (a bodily fluid), the Basal-IQ technology uses that data to make decisions about insulin delivery. It does not perform the analysis of the bodily fluid itself.
- The intended use is to manage diabetes by controlling insulin delivery. The primary function of Basal-IQ is to automatically suspend and resume insulin delivery based on glucose predictions and current values. This is a therapeutic action, not a diagnostic one.
- The device description focuses on the algorithm and its interaction with the pump and iCGM. It describes how the algorithm processes glucose data and sends commands to the pump. It does not describe any process of analyzing a biological specimen.
In summary, the Basal-IQ technology is a software algorithm that utilizes data from an IVD (the iCGM) to manage insulin delivery, which is a therapeutic function. It does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QJS, NDC
Device Description
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.
- Insulin delivery is suspended if the glucose value is predicted to be less than 80 mg/dL in 30 minutes.
- Basal insulin delivery is resumed once the current CGM sensor reading increases compared to the previous reading.
- 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.
- 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.
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
six 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)
Study Type: Multi-center, randomized, at home, crossover design evaluation.
Sample Size: A total of 107 subjects with Type 1 Diabetes were enrolled, with 102 subjects participating in the crossover design study.
Key Results: The performance data demonstrates that the Basal-IQ Technology of the already approved t:slim X2 Insulin Pump paired with the Dexcom G5 CGM (P140015/S020) can be used safely and that it functions as intended. The analysis of input specifications is adequate to assure reasonable safety and effectiveness when iCGM sensors are used with the system as well. Additionally, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DEN190034, Control-IQ technology, K192841, InPen Dose Calculator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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February 28, 2020
Tandem Diabetes Care, Inc. Trevor Denbo Sr. Manager, Regulatory Affairs 11075 Roselle Street San Diego, California 92121
Re: K193483
Trade/Device Name: Basal-IQ Technology Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJS, NDC Dated: December 16, 2019 Received: December 17, 2019
Dear Trevor Denbo:
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 mediation-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,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193483
Device Name Basal-IQ technology
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X 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 is the logo for Tandem Diabetes Care. The logo consists of a blue square with rounded corners and a white "T" inside. To the right of the square is the word "TANDEM" in black, with a registered trademark symbol next to it. Below "TANDEM" is the phrase "DIABETES CARE" in a smaller, black font.
510(k) Summary
Prepared: February 28, 2020
| I. | Company | Tandem Diabetes Care, Inc |
|---|---|---|
| II. | Contact | Trevor J. Denbo, M.S., RAC |
| Sr. Manager, Regulatory Affairs | ||
| 858-224-6136 | ||
| III. | Product Trade Name | Basal-IQ Technology |
| IV. | Common Name | |
| Algorithm | ||
| Calculator | Insulin Pump Algorithm | |
| Bolus Calculator | ||
| V. | Classification Name | |
| Algorithm | ||
| Calculator | Interoperable Automated Glycemic Controller, | |
| Insulin Suspend | ||
| Predictive pulmonary-function value calculator | ||
| VI. | Regulation Number | |
| Algorithm | ||
| Calculator | 21 CFR 862.1356 | |
| 21 CFR 868.1890 | ||
| VII. | Device Class | Class II |
| VIII. | Classification Product Code | |
| Algorithm | ||
| Calculator | QJS | |
| NDC | ||
| IX. | Predicate Device | |
| Algorithm | ||
| Calculator | DEN190034, Control-IQ technology | |
| K192841, InPen Dose Calculator | ||
| X. | Description |
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.
4
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.
-
- Insulin delivery is suspended if the glucose value is predicted to be less than 80 mg/dL in 30 minutes.
-
- Basal insulin delivery is resumed once the current CGM sensor reading increases compared to the previous reading.
-
- 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.
-
- 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.
XI. Indications for Use
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 people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.
5
| Algorithm | ||
|---|---|---|
| Predicate Device | ||
| (DEN190034, Control-IQ Technology) | Subject Device | |
| (Basal-IQ Technology) | ||
| 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. | 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. | ||
| Control-IQ technology is intended for | ||
| the management of Type 1 diabetes | ||
| mellitus in persons 14 years of age and | ||
| greater. | Basal-IQ technology is intended for | |
| the management of diabetes | ||
| mellitus in persons six years of age | ||
| and greater. | ||
| Control-IQ technology is intended for | ||
| single patient use and requires a | ||
| prescription. | Basal-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. | Basal-IQ technology is indicated for | |
| use with NovoLog or Humalog U- | ||
| 100 insulin. | ||
| Includes Bolus | ||
| Calculator | Yes | Yes |
| Auto-populates the | ||
| Bolus Calculator | ||
| with CGM values | Yes | Does not auto-populate any values |
| into the Bolus calculator | ||
| Suspends Insulin | ||
| when trending or | ||
| found low CGM | ||
| reading | Yes | Yes |
| Adjusts Insulin | ||
| based on CGM | ||
| readings | Yes | No |
| Adjusts or Boluses | ||
| insulin based on | ||
| high CGM readings | Yes | No |
| Intended Hardware | ||
| Device | An Alternate Controller Enabled | |
| Infusion Pump (cleared under 21 CFR | ||
| 880 5730) | Identical |
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| Calculator | ||
|---|---|---|
| Predicate Device | ||
| (K190487, InPen Dose Calculator) | Subject Device | |
| (K193483) | ||
| Indications for Use | The InPen dose calculator, a | |
| component of the InPen app, is | ||
| indicated for the management of | ||
| diabetes by people with diabetes age | ||
| 12 and older by calculating an insulin | ||
| dose or carbohydrate intake based on | ||
| user entered data. The device is | ||
| indicated for use with NovoLog® or | ||
| Humalog® U-100 insulin. For an insulin | ||
| dose based on amount of | ||
| carbohydrates, a healthcare | ||
| professional must provide patient- | ||
| specific target blood glucose, insulin- | ||
| to-carbohydrate ratio, and insulin | ||
| sensitivity parameters to be | ||
| programmed into the software prior to | ||
| use. For an insulin dose based on | ||
| fixed/variable meal sizes, a healthcare | ||
| professional must provide patient- | ||
| specific fixed doses/meal sizes to be | ||
| programmed into the software prior to | ||
| use. | The bolus calculator is indicated for | |
| the management of diabetes by | ||
| people with diabetes by calculating | ||
| an insulin dose or carbohydrate | ||
| intake based on user entered data. | ||
| Prescription Use | Yes | Yes |
| User Group | Diabetes patients treated with multiple | |
| daily insulin injection (MDI) therapy | Diabetes patients treated the | |
| insulin pump in which the | ||
| calculator is integrated. | ||
| Communication with | ||
| insulin pumps | No | Yes, the insulin pump in which the |
| calculator is integrated. | ||
| Wireless | ||
| Connectivity | Bluetooth Low Energy (BLE) | No |
| Control or effect | ||
| blood glucose | ||
| measurements | No | No |
| Control or affect | ||
| insulin delivery | No | No |
| Carbohydrate | ||
| Calculator | Calculation based either on user | |
| entered carbohydrates, meal size | ||
| estimation, or fixed meal doses. | Calculates carbohydrate intake | |
| based on user entered data | ||
| Manual data entry | Yes | Yes |
7
XII. Discussion of the Non-Clinical Testing
The t:slim X2 with Basal-IQ Technology, previously approved under P180008, contains the Basal-IQ Technology algorithm and calculator. No new non-clinical laboratory studies were needed for the separation from that system in order to be available for use on an Alternate Controller Enabled Infusion Pump (cleared under 21 CFR 880.5730). 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.
Software modifications were made to the Tandem insulin pump to add the Basal-IQ Technology algorithm. Comprehensive verification and validation testing was conducted to confirm that the software used in the pump with Basal-IQ Technology met all specified requirements and performed as intended. Testing was carried out in accordance with FDA guidance "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." Software development activities included establishing detailed software requirements, linking requirements with associated verification and validation activities, software code inspection, software code walkthrough, static code analysis, unit testing, and system testing to ensure that the software conforms to patient needs and intended uses.
A human factors study was conducted to confirm that the intended users can safely and effectively use the Basal-IQ Technology on the t:slim X2 Insulin Pump with Basal-IQ. This involved evaluating usability tasks, such as turning on/off PLGS, setting PLGS alerts, modifying PLGS alerts, and comprehending PLGS alerts. Any use difficulties did not represent serious use errors since users will still receive the other system alerts (e.g., CGM Low Alert, CGM High Alert, etc.). Therefore, results from the human factors study demonstrates users can safely and effectively use the PLGS feature of the t:slim X2 Insulin Pump.
XIII. Discussion of Clinical Testing
A total of 107 subjects with Type 1 Diabetes were enrolled at 4 sites in the United States (US). The study was a multi-center, randomized, at home, crossover design evaluation of subjects with type 1 diabetes. Study subjects enrolled were either insulin pump users, multiple daily injection of insulin (MDI) users, CGM naïve users (may be pump or MDI users), or experienced CGM users (may be pump or MDI users). Of the 107 subjects enrolled (over age f 6 years old) five subjects did not complete the study.
The 102 study subjects participated in a crossover design study, consisting of two 3- week periods with the t:slim X2 Insulin Pump with Basal-IQ enabled) used during one period and Sensor Augmented Pump (SAP) used during the other period. The crossover design study was preceded by a run-in phase in which participants received training using the study devices.
The performance data presented demonstrates that the Basal-IQ Technology of the already approved t:slim X2 Insulin Pump paired with the Dexcom G5 CGM (P140015/S020) can be used safely and that it functions as intended. The analysis of input specifications is adequate to assure reasonable safety and effectiveness when iCGM sensors are used with the system as well. Additionally, 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.