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. 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 regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator functions 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 OP5 Pod and OP5 Controller (which contains the OP5 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™ alqorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

AI/ML Overview

This document is an FDA 510(k) clearance letter and summary for the Insulet SmartAdjust™ technology. It states that the device is substantially equivalent to a previously cleared predicate device (K220394), with the only change being an update to the specifications for glucose sensor performance for compatible integrated continuous glucose monitors (iCGMs). This means the core algorithm and its performance were already established with the original clearance.

Therefore, the document does not contain the detailed study information typically found in a new device submission or a clinical trial report that directly proves the device meets specific acceptance criteria in a new clinical study. Instead, it relies on the substantial equivalence argument, implying that the previous studies for the predicate device, or studies demonstrating the updated iCGM performance, are sufficient.

Based on the provided text, here's what can be extracted and what cannot:

Information Available:

Device Name: SmartAdjust™ technology
Predicate Device: SmartAdjust™ technology (K220394)
Change: Updated iCGM Performance Specifications per 21 CFR 862.1356(1)(iv).
Conclusion: The subject device is substantially equivalent to its predicate. The differences do not raise new questions of safety and effectiveness.

Information NOT Available (because this is a substantial equivalence submission for a minor update, not a new clinical trial submission document):

A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for a new study, as it's an update to an already cleared device. The performance requirements were presumably met by the predicate device and the updated iCGM.
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method: Not applicable/provided for this type of submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an algorithm/software, but the clinical performance data related to its efficacy (how well it manages glucose) would typically be from human-with-device studies from the original predicate submission. No new standalone study details are here.
The type of ground truth used: Not specified, but for a glycemic controller, this would typically involve actual blood glucose measurements.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Reconstruction of "Acceptance Criteria" based on the document's type:

Since this is a 510(k) for an update, the "acceptance criteria" revolve around demonstrating that the change (updated iCGM specifications) does not negatively impact safety or effectiveness, and that the device still meets the requirements for its classification.

Table of "Acceptance Criteria" and "Reported Device Performance" as implied by a 510(k) for an update:

Acceptance Criteria (Implied for this 510(k) update)	Reported Device Performance (as stated in the 510(k) summary)
1. Equivalence in Intended Use and Indications for Use The updated device must have the	The subject device has the same intended use and indications for use as the predicate device.
2. Equivalence in Technological Characteristics No new questions of safety/effectiveness raised by changes.	There are no changes to the design or technology of SmartAdjust™ technology itself, other than the updated iCGM performance specifications. The differences do not raise any different questions about safety and effectiveness.
3. Compliance with Special Controls (21 CFR 862.1356) The device must continue to meet the specific requirements for an Interoperable Automated Glycemic Controller.	The subject device has been shown to meet the special controls for an Interoperable Automated Glycemic Controller.
4. Performance with updated iCGM Specifications The device's performance (safety and effectiveness in automating insulin delivery) must remain acceptable when integrated with iCGMs meeting the updated performance specifications.	Implied by the statement that the "differences in the performance specifications for compatible iCGMs do not raise different questions of safety and effectiveness." The previous clinical data for the original predicate device (K220394) would have supported the device's efficacy with compatible iCGMs. This update likely references test data from the iCGMs themselves or in-silico/bench testing to confirm continued compatibility.
5. Substantial Equivalence to Predicate The overall assessment must confirm substantial equivalence.	SmartAdjust™ technology is substantially equivalent to its predicate.

Study Information (based on the context of a 510(k) for an update):

Sample size used for the test set and data provenance: No specific sample size for new clinical testing is mentioned. The approval hinges on the existing data for the predicate device and the updated iCGM meeting its own specifications. The data provenance for the original predicate would have included clinical trial data (likely prospective).
Number of experts and qualifications, Adjudication method, MRMC study, Standalone performance: These details are not relevant to this specific 510(k) summary, as it's establishing equivalence based on a minor technical update, not presenting new clinical efficacy data for the core algorithm from scratch. Such studies would have been part of the original K220394 submission.
Type of ground truth used: For the underlying technology (which is unchanged here), the ground truth for an automated glycemic controller would be actual blood glucose measurements, measured by a reference method (e.g., lab venous plasma glucose, or accurate point-of-care devices).
Training Set Sample Size and Ground Truth Establishment: Not mentioned, as this is an established, already-trained algorithm.

In summary, this document is a regulatory approval for a minor update to an already-cleared medical device software, rather than a detailed report of a new clinical study. The "proof" lies in the argument of substantial equivalence to the predicate device, with the specific change (iCGM specifications) not introducing new safety or effectiveness concerns.

Summary

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May 29, 2024

Insulet Corporation Alexander Hamad Sr. Regulatory Affairs Specialist 100 Nagog Park Acton, Massachusetts 02144

Re: K232741

Trade/Device Name: SmartAdjust™ technology Regulation Number: 21 CFR 862.1356 Regulation Name: Interoperable Automated Glycemic Controller Regulatory Class: Class II Product Code: QJI Dated: September 1, 2023 Received: September 7, 2023

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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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

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Indications for Use

510(k) Number (if known) K232741

Device Name SmartAdjust™ technology

Indications for Use (Describe)

Smart Adjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellius in persons 2 years of age and older. SmartAdjust™ 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 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 it is likely used to represent the Insulet Corporation.

510(K) SUMMARY

Date prepared:	23 May 2024
Submitter Name:	Insulet Corporation
Submitter Address:	100 Nagog ParkActon, MA 01720
FDA EstablishmentOwner/Operator Number:	9056196
FDA Establishment RegistrationNumber:	3014585508
Primary Contact Person	Alex HamadManager, Regulatory Affairs
Phone:	978-600-7000
Fax:	978-600-0120
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:	K220394 (SmartAdjust™ technology)

a) Intended Use and Indications for Use

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b) Device Description

The SmartAdjust™ technology software is installed on both the OP5 Pod and OP5 Controller (which contains the OP5 App), the 2 physical components that make up the Omnipod 5 System.

c) Summary of Technological Characteristics Compared to Predicate Device

There are no changes to the design or technology of SmartAdjust™ technology, therefore it is substantially equivalent to the predicate.

The only difference between the subject device and predicate device is an update to the specifications for glucose sensor performance for connected iCGMs in accordance with 21 CFR 862.1356(1)(iv).

The differences between predicate and subject device do not raise any different questions about safety and effectiveness and therefore, SmartAdjust™ technology is substantially equivalent to its 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.

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Table 1: SmartAdjust™ technology Substantial Equivalence Comparison

Element ofComparison	Subject Device: SmartAdjust™ technology	Predicate Device: SmartAdjust™ technology (K220394)
Intendeduse/indicationsfor 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 glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.	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. SmartAdjust™ technology is intended for single patient use and requires a prescription.
Device Type	Interoperable automated glycemic controller	Interoperable automated glycemic controller
Environment ofuse	Ambulatory use	Ambulatory use
SpecificDrug/BiologicUse	U-100 InsulinSystem has been tested withNovoLog®, Humalog®, andAdmelog®	U-100 InsulinSystem has been tested withNovoLog®, Humalog®, andAdmelog®
PrescriptionStatus	Prescription Device	Prescription Device
Principles ofOperation	Algorithmic software device intended to automatically increase,decrease, and pause delivery of insulin based on iCGM readings and predicted glucose values	Algorithmic software device intended to automatically increase,decrease, and pause delivery of insulin based on iCGM readings and predicted glucose values
Communication and Pairing	Bluetooth Low Energy (BLE) wireless technology	Bluetooth Low Energy (BLE) wireless technology
Device HostingController	Omnipod 5 ACE Pump	Omnipod 5 ACE Pump
Element ofComparison	Subject Device: SmartAdjust™technology	Predicate Device: SmartAdjust™technology (K220394)
DigitallyConnectedDevices	Cleared iCGM and ACE Pump,which includes a display device(Insulet-provided Controller phoneor user's compatible 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, andsuspend delivery of insulin based on current and predictedglucose values SmartAdjust™ technology not enabled (Manual Mode): openloop, basal delivery based onuser-defined programs	SmartAdjust™ technology enabled (Automated Mode):closed-loop, automatically increase, decrease, and suspenddelivery of insulin based on current and predicted glucosevalues SmartAdjust™ technology not enabled (Manual Mode): openloop, basal delivery based onuser-defined programs
Alarms/Alerts	Out of Range Alert Low Alert Maximum Insulin/Delivery Alert	Out of Range Alert Low Alert Maximum Insulin/Delivery Alert
Target GlucoseControl Range	110-150 mg/dl, user-customizable	110-150 mg/dl, user-customizable
iCGMPerformanceSpecificationsper 21 CFR862.1356(1)(iv)	Updated iCGM PerformanceSpecifications	iCGM Performance Specifications

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Image /page/6/Picture/0 description: The image shows the logo for Insulet Corporation. 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 it is likely used on the company's website and marketing materials.

d) Conclusion

SmartAdjust™ technology, with the modification to the iCGM Performance Specifications has the same intended use and indications for use as the predicate device. There are no differences in the technological characteristics of the subject device compared to the predicate device. The differences in the performance specifications for compatible iCGMs do not raise different questions of safety and effectiveness. The subject device has been shown to meet the special controls for an Interoperable Automated Glycemic Controller and determined to be substantially equivalent to its predicate.

Regulation Number and Section

§ 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.