(67 days)
SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.
SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.
SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.
The SmartAdjust™ technology software is installed on both the Omnipod 5 Pod and Omnipod 5 Controller (which contains the Omnipod 5 App), the 2 physical components that make up the Omnipod 5 System.
The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document describes the 510(k) premarket notification for the SmartAdjust™ Technology, which is an interoperable automated glycemic controller. The submission aims to expand the indications for use to include individuals with Type 2 Diabetes Mellitus aged 18 years and older, in addition to the existing indication for Type 1 Diabetes Mellitus.
1. A table of acceptance criteria and the reported device performance
The provided text doesn't explicitly list a table of "acceptance criteria" with numerical targets in a typical performance study format. However, it does report on a primary safety endpoint from a clinical study which effectively serves as a key performance metric for the expanded indication.
Here's a table based on the information provided, focusing on the clinical study's primary safety endpoint:
| Acceptance Criteria (Implied from Clinical Study Focus) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Non-inferiority in change in HbA1c (margin 0.3%) | Mean change in HbA1c was -0.8% (P<0.001 for non-inferiority) |
| No safety concerns associated with device use | No safety concerns identified during the study |
| No unexpected or serious adverse device effects | No unexpected or serious adverse device effects reported |
| No DKA events | No DKA events reported |
| No hospitalizations or emergency visits for severe hypoglycemic events | No hospitalizations or emergency visits for severe hypoglycemic events reported |
| No instances of hyperosmolar hyperglycemic syndrome | No instances of hyperosmolar hyperglycemic syndrome reported |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set (Clinical Study): 343 participants
- Data Provenance: The document doesn't explicitly state the country of origin. It indicates it was a "clinical study" performed by Insulet, implying it was prospective within the context of validating the device for T2DM.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The clinical study evaluated patient outcomes (HbA1c, adverse events) rather than relying on expert consensus for ground truth on specific assessments.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human experts read cases and the AI provides assistance. The SmartAdjust™ technology is an automated glycemic controller that directly delivers insulin based on algorithms, not an interpretive aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical study essentially assessed the standalone performance of the SmartAdjust™ algorithm (within the Omnipod 5 System) in a human-in-the-loop context. While users interact with the system, the key performance metrics (HbA1c, safety events) are a direct consequence of the algorithm's automated insulin delivery decisions. The document states: "When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values." The clinical study then validated this control for T2DM.
7. The type of ground truth used
The ground truth for the clinical study was based on clinical outcomes data, specifically:
- HbA1c measurements (a standard biochemical marker for long-term glucose control)
- Observation and reporting of adverse events (DKA, severe hypoglycemia, hyperosmolar hyperglycemic syndrome)
8. The sample size for the training set
The document does not provide information on the sample size used for the training set of the SmartAdjust™ algorithm. This information is typically not included in a 510(k) summary for a device like an automated insulin delivery system, as the algorithm's development and validation might involve proprietary datasets and methods outside the scope of the premarket notification for an expanded indication.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set (if any specific to machine learning) was established. Given the nature of a glycemic control algorithm, training might involve simulated data, retrospective patient data with known glucose values and insulin needs, or data from prior clinical trials. However, the document does not specify this. The clinical study described in the summary is for validation of the algorithm's performance with the expanded indication, not for its initial training.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font compared to the rest of the text.
August 26, 2024
Insulet Corporation Alexander Hamad Manager, Regulatory Affairs 100 Nagog Park Acton, Massachusetts 01720
Re: K241777
Trade/Device Name: SmartAdjust™ Technology Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: OJI Dated: June 20, 2024 Received: June 20, 2024
Dear Alexander Hamad:
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 (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/cdrb/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 QS 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 (QS) 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.
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.
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,
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
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
SmartAdjust™ Technology
Indications for Use (Describe)
SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 vears of age and older. SmartAdiust™ technology is intended for single patient use and requires a prescription.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font. The logo is simple and clean, and the colors are eye-catching.
510(k) SUMMARY
| Date prepared: | August 21, 2024 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog ParkActon, MA 01720 |
| FDA EstablishmentOwner/Operator Number: | 9056196 |
| FDA Establishment RegistrationNumber: | 3014585508 |
| Primary Contact Person | Alexander HamadManager, Regulatory Affairs |
| Phone:Fax: | 978-600-2432978-600-0120 |
| Secondary Contact Person | Lavanya RamnathSenior Regulatory Affairs Specialist |
| Phone:Fax: | 213-326-6706978-600-0120 |
| Device Trade / Proprietary Name: | SmartAdjust™ technology |
| Device Common Name: | Interoperable Automated Glycemic Controller |
| Review Panel (s): | Clinical Chemistry |
| Product Code(s): | QJI |
| Regulation Numbers: | 21 CFR 862.1356 |
| Submission Type: | Traditional 510(k) |
| Device Class: | Class II |
| Device Predicate: | K232741 (SmartAdjust™ technology) |
Page 1 of 6
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font.
Intended Use and Indications for Use
SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted qlucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.
Device Description
SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.
SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator requlated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.
The SmartAdjust™ technology software is installed on both the Omnipod 5 Pod and Omnipod 5 Controller (which contains the Omnipod 5 App), the 2 physical components that make up the Omnipod 5 System.
The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.
Summary of Technological Characteristics Compared to Predicate
Please refer to Table 1 below for a substantial equivalence table, which includes a comparison of the technological characteristics between the subject device and its predicate.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font. The logo is simple and clean, with a focus on the company name.
Table 1: SmartAdjust™ technology Substantial Equivalence Comparison
| Element ofComparison | Subject Device: SmartAdjust™technology | Predicate Device: SmartAdjust™technology (K232741) |
|---|---|---|
| Intendeduse/indicationsfor use | SmartAdjust™ technology is intendedfor use with compatible integratedcontinuous glucose monitors (iCGM)and alternate controller enabled(ACE) pumps to automaticallyincrease, decrease, and pausedelivery of insulin based on currentand predicted glucose values.SmartAdjust™ technology is intendedfor the management of type 1diabetes mellitus in persons 2 yearsof age and older and type 2 diabetesmellitus in persons 18 years or ageand older. SmartAdjust™ technologyis intended for single patient use andrequires a prescription | SmartAdjust™ technology is intendedfor use with compatible integratedcontinuous glucose monitors (iCGM)and alternate controller enabled (ACE)pumps to automatically increase,decrease, and pause delivery ofinsulin based on current and predictedglucose values. SmartAdjust™technology is intended for themanagement of type 1 diabetesmellitus in persons 2 years of age andolder. SmartAdjust™ technology isintended for single patient use andrequires a prescription. |
| Device Type | Interoperable automated glycemiccontroller | Interoperable automated glycemiccontroller |
| Environment ofuse | Ambulatory use | Ambulatory use |
| SpecificDrug/BiologicUse | U-100 InsulinSystem has been tested withNovoLog®, Humalog®, and Admelog® | U-100 InsulinSystem has been tested withNovoLog®, Humalog®, and Admelog® |
| PrescriptionStatus | Prescription Device | Prescription Device |
| Principles ofOperation | Algorithmic software device intendedto automatically increase,decrease,and pause delivery of insulin based oniCGM readings and predicted glucosevalues | Algorithmic software device intended toautomatically increase,decrease, andpause delivery of insulin based oniCGM readings and predicted glucosevalues |
| Communicationand Pairing | Bluetooth Low Energy (BLE) wirelesstechnology | Bluetooth Low Energy (BLE) wirelesstechnology |
| Element ofComparison | Subject Device: SmartAdjust™technology | Predicate Device: SmartAdjust™technology (K232741) |
| Device HostingController | Omnipod 5 ACE Pump | Omnipod 5 ACE Pump |
| DigitallyConnectedDevices | Cleared iCGM and ACE Pump, whichincludes a display device (Insulet-provided Controller phone or user'scompatible smartphone) | Cleared iCGM and ACE Pump, whichincludes a display device (Insulet-provided Controller phone or user'scompatible smartphone) |
| SystemFunctionalityModes | SmartAdjust™ technology enabled (Automated Mode): closed-loop, automatically increase, decrease, and suspend delivery of insulin based on current and predicted glucose values SmartAdjust™ technology not enabled (Manual Mode): open loop, basal delivery based on user-defined programs | SmartAdjust™ technology enabled (Automated Mode): closed-loop, automatically increase, decrease, and suspend delivery of insulin based on current and predicted glucose values SmartAdjust™ technology not enabled (Manual Mode): open loop, basal delivery based on user-defined programs |
| Alarms/Alerts | Out of Range Alert Low Alert Maximum Insulin/Delivery Alert | Out of Range Alert Low Alert Maximum Insulin/Delivery Alert |
| Alert/AlarmDisplay | ACE Pump alarms/alerts will bedisplayed and communicated to theuser via visual, audible, and/orvibratory cues. | ACE Pump alarms/alerts will bedisplayed and communicated to theuser via visual, audible, and/orvibratory cues. |
| Target GlucoseControl Range | 110-150 mg/dl, user-customizable | 110-150 mg/dl, user-customizable |
| Mechanism ofSoftware Update | Firmware over the Air | |
| History Storage | Up to 90 days (user insulin history) | Up to 90 days (user insulin history) |
| Labeling | Package Labels, User's Guide(contains Instructions for Use),Technical User Guide | Package Labels, User's Guide(contains Instructions for Use),Technical User Guide |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "Insulet" in a purple sans-serif font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray sans-serif font. The text is left-aligned and the background is white.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font. The logo is simple and clean, with a focus on the company name.
Summary of Non-Clinical Performance Testing
Human Factors Validation: Insulet performed a comprehensive Human Factors process that followed and complied with the FDA-recognized standards IEC 62366-1 and HE75 as well as FDA's guidance documents Applying Human Factors and Usability Engineering to Medical Devices – issued February 3, 2016, and Content of Human Factors Information in Medical Device Marketing Submissions – draft issued December 9, 2022. The validation study evaluated behavioral tasks and knowledge tasks with 16 representative study participants. The results of the validation test support the conclusion that SmartAdjust technology (as part of the Omnipod 5 System) is safe and effective for the intended users with type 2 diabetes, uses, and use environments.
Special Controls: Evaluation of the Special Controls for this device (regulation 21 CFR 862.1356) assures the safety and effectiveness of the device.
Summary of Clinical Performance Testing
Insulet performed a clinical study to validate the design of the SmartAdjust algorithm in people 18 years of age and older with type 2 diabetes. The study enrolled 343 participants diagnosed with type 2 diabetes. The primary safety endpoint was the change in HbA1c (noninferiority margin 0.3%) as measured by comparing participant values at baseline to the end of the study. The mean change in HbA1c was -0.8% (P<0.001 for non-inferiority). No safety concerns associated with the use of the device were identified during the study and there were no unexpected or serious adverse device effects. There were no DKA events, no hospitalizations or emergency visits for severe hypoglycemic events, and no instances of hyperosmolar hyperglycemic syndrome reported during the study.
Conclusion
SmartAdjust™ technology has the same intended use as the predicate device. The indications for use have been updated to add people 18 years and older with type 2 diabetes. Product labeling has been updated to include the expanded indication and clinical study results.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the Insulet logo. The word "Insulet" is written in purple, and below it, the phrase "maker of Omnipod" is written in gray. The logo is simple and modern, with a clean font.
SmartAdjust™ technology has the same technological characteristics and principles of operation as the predicate device. There have been no design or software modifications to the subject device in relation to the indication change.
The changes to SmartAdjust™ technology are supported by clinical study and human factors validation data that demonstrates that the devices are substantially equivalent.
The differences between the predicate and subject devices do not raise any different questions about safety and effectiveness, therefore, SmartAdjust™ technology is substantially equivalent to its predicate.
§ 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.