The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

Device Description

The Omnipod 5 ACE Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 App, which is installed on a locked-down Android controller device or a user's personal smartphone device. The predicate device allowed the user to download the Omnipod 5 App to an Android compatible phone. This submission includes an iOS compatible Omnipod 5 App to allow users to download it to a compatible iPhone.

The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes SmartAdjust Technology (iAGC), and the SmartBolus Calculator. SmartAdjust Technology and the SmartBolus Calculator functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to a third party iCGM, SmartAdjust Technology, and the SmartBolus Calculator.

The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on userprogrammed basal rates, or in Automated Mode, where insulin is automatically delivered based on the calculations and command of a compatible iAGC. Currently, the Omnipod 5 ACE Pump is compatible with SmartAdjust Technology, the software which is pre-installed on the Pod and the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator.

The Omnipod 5 App has the ability to wirelessly connect to the Insulet Cloud which it utilizes for registering new devices, authenticating users, ensuring hardware devices and host operating systems are compatible, and completing over the air software (OTA) and firmware (FOTA) updates.

AI/ML Overview

The provided text is a 510(k) summary for the Omnipod 5 ACE Pump, which describes the addition of an iOS compatible mobile application. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K203768).

Based on the provided text, the acceptance criteria and study details are primarily related to software verification and validation, interoperability, cybersecurity, electrical safety and EMC, and human factors validation for the new iOS application, rather than clinical performance of the insulin delivery itself (as the Pod itself was not modified).

Here's an attempt to structure the information based on your request, highlighting what is and isn't explicitly stated in the document:

Device: Omnipod 5 ACE Pump (with added iOS compatible Omnipod 5 App)
Purpose of Submission: To add a new mobile application compatible with iOS mobile devices. The Omnipod 5 App (iOS) is the new configuration being added to the previously cleared Omnipod 5 ACE Pump.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several types of performance testing and their adherence to standards and regulations. It doesn't present specific quantitative acceptance criteria or detailed performance metrics in a tabular format that is typically seen for accuracy, sensitivity, or specificity in AI/ML medical devices. Instead, it states that tests were performed and demonstrated that predetermined acceptance criteria were met and the device is safe and effective for use.

Category	Acceptance Criteria / Standard Compliance	Reported Device Performance
Risk Management	Compliance with ISO 14971:2019.	"Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use."
Software Validation	Compliance with IEC 62304:2015-06 and FDA’s guidance “General Principles of Software Validation – Issued January 11, 2002,” and “Content of Premarket Submissions for Device Software Functions - Issued June 2023.”	"Software verification and validation testing were performed..." "Software documentation was provided..." "Software verification testing has demonstrated the device records timestamped critical events, including information related to its state, user inputs, and device settings, as required by the ACE Pump special controls." (for Data Logging)
Interoperability	Adherence to FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff - Issued September 6, 2017.” Specifies validated interface specifications, partnership agreements, and post-market reporting.	"Interoperability documentation was provided as is relates to changes due to the Omnipod 5 App (iOS) according to the FDA Guidance..."
Cybersecurity	Compliance with various FDA cybersecurity guidances (2014, 2016, March 2023, April 2022 draft).	"a cybersecurity analysis was performed for the OP5 ACE Pump with the Omnipod 5 App (iOS)... In addition, Insulet has provided a software bill of materials and penetration testing."
Electrical Safety & EMC	Compliance with IEC 60601-1:2020-08 and IEC 60601-1-2:2020-9, and FDA guidances on Electromagnetic Compatibility and Radio Frequency Wireless Technology.	"testing was performed to verify that the Omnipod 5 ACE Pump with the Omnipod 5 App (iOS) meets its requirement to comply with IEC 60601-1:2020-08... and IEC 60601-1-2:2020-9..."
Human Factors Validation	Compliance with IEC 62366:2015-06, HE75:2009(R)2018, and FDA’s guidance “Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016.”	"A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod 5 App (iOS) with intended users in the expected use environments, including associated training and accompanying documentation. The results of the validation demonstrate that the device has been found to be safe and effective for the intended users, uses, and use environments."
Special Controls (21 CFR 880.5730)	Evaluation supports safety and effectiveness.	"evaluation of the Special Controls for this device (regulation 21 CFR 880.5730) supports the safety and effectiveness of the device." "Through performance testing, the Subject device has been shown to meet the Alternate Controller Enabled Insulin Pump special controls..."

Note on Insulin Delivery Accuracy: The document states that the "Pod Delivery Accuracy (tested per IEC 60601-2-24)" for basal and bolus rates is a characteristic of the predicate device and is unchanged for the subject device. It is listed as:

Basal: ± 5% at rates ≥ 0.05 U/hr
Bolus: ± 5% for all set values ≥ 1.0 unit, ± 0.05 unit for set values < 1.0 unit
However, the current submission focuses on the new mobile app, not the Pod's fundamental insulin delivery mechanism.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify quantitative sample sizes for the various testing protocols (e.g., software validation, human factors validation). It broadly refers to "performance testing" being completed.

Data Provenance: Not explicitly stated as retrospective or prospective data in the context of clinical studies for direct performance evaluation. The testing described is primarily non-clinical, involving software validation, cybersecurity analysis, and human factors validation. The device is a pump with an app, not an AI/ML algorithm that analyzes patient data to provide a diagnosis or risk assessment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This submission is for an Alternate Controller Enabled Pump (ACE Pump) with a new mobile application. It's not an AI/ML diagnostic or prognostic device where expert ground truth interpretation of images or other clinical data would be required. The "ground truth" for this device's validation is adherence to engineering and usability standards and ensuring the software functions as intended and securely.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 typically apply to the establishment of ground truth in image-based diagnostic AI/ML models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on how AI assistance impacts human reader performance, typically in diagnostic tasks. The Omnipod 5 ACE Pump with its iOS app is an insulin delivery system and its controlling interface, not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The "algorithm only" performance for an insulin pump would refer to its ability to accurately deliver insulin based on programmed rates or commands. The document states that the Omnipod 5 ACE Pump's Pod (insulin pump itself) has not been modified, and therefore, performance testing applicable only to the Pod was not completed for this submission. The original validation of the Pod's insulin delivery accuracy (referenced in the table) would be considered its standalone performance. The new submission focuses on the software application for iOS as the controller. The software's performance is validated through various non-clinical tests (software validation, interoperability, cybersecurity, human factors) to ensure it reliably sends commands to the Pod.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established technical standards, regulatory guidelines, and functional requirements for medical device software, cybersecurity, electrical safety, and human factors. For instance:

Software Validation: Ground truth is defined by the functional specifications and requirements of the software.
Cybersecurity: Ground truth is defined by cybersecurity best practices and regulatory guidance.
Human Factors Validation: Ground truth is defined by usability engineering principles and standards, demonstrated by the device being "safe and effective for the intended users, uses, and use environments" after testing.

8. The Sample Size for the Training Set

N/A. The Omnipod 5 ACE Pump and its associated app are not explicitly described as an AI/ML device that uses a "training set" in the context of supervised learning for a diagnostic or prognostic task. The software development process would involve iterative testing and debugging, but this is distinct from training a machine learning model on a labeled dataset.

9. How the Ground Truth for the Training Set Was Established

N/A, as there is no mention of an AI/ML training set in the context of this device and its submission.

Summary

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October 18, 2023

Insulet Corporation Maria Brower Senior Specialist Regulatory Affairs 100 Nagog Park Acton, MA 01720

Re: K231826

Trade/Device Name: Omnipod 5 ACE Pump Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: September 18, 2023 Received: September 19, 2023

Dear Maria Brower:

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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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) K231826

Device Name Omnipod 5 ACE Pump

Indications for Use (Describe)

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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K231826 510(K) SUMMARY

Date prepared:	October 16, 2023
Submitter Name:	Insulet Corporation
Submitter Address:	100 Nagog Park, Acton, MA 01720
FDA Establishment Owner/OperatorNumber:	9056196
FDA Establishment RegistrationNumber:	3014585508
Primary Contact Person	Maria Brower,Senior Specialist, Regulatory Affairs, Digital Health
Phone:	978-600-7000
Secondary Contact Person	Katie Pacheco, Director Regulatory Affairs,Digital Health
Phone:	978-600-7000
Fax:	978-600-0120
Device Trade / Proprietary Name:	Omnipod 5 ACE Pump (Pod)
Device Common Name:	Alternate Controller Enabled Insulin Infusion Pump
Review Panel (s):	Clinical Chemistry
Product Code(s):	QFG
Regulation Numbers:	21 CFR 880.5730
Submission Type:	Traditional 510(k)
Device Class:	Class II
Device Predicate:	K203768 (Omnipod 5 ACE Pump)

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Image /page/4/Picture/0 description: The image shows the word "Insulet" in a large, purple font. Below the word "Insulet" is the phrase "maker of Omnipod" in a smaller, gray font. The text is left-aligned and the background is white. The image is a logo for Insulet, a company that makes the Omnipod insulin management system.

5.1 Purpose of Submission

The Omnipod 5 alternate controller enabled (ACE) Pump is being modified to add a new mobile application which is compatible with iOS mobile devices. The Omnipod 5 App (iOS) is the new confiquration being added to the previously cleared Omnipod 5 ACE Pump.

5.2 Intended Use and Indications for Use

The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

5.3 Device Description

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Image /page/5/Picture/0 description: The image shows the logo for Insulet, a medical device company. The word "Insulet" is written in large, purple font. Below the company name, the words "maker of Omnipod" are written in a smaller, gray font. The logo is simple and clean, and it is likely used on the company's website and marketing materials.

the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator.

Summary of Technological Characteristics Compared to Predicate Device

The Omnipod 5 ACE Pump, with Android and iOS compatible Omnipod 5 Apps, (Subject Device) has been developed with the intent of providing the Omnipod 5 App features equivalent to the predicate device to end users. There are no changes to the intended use and indications for the Omnipod 5 ACE Pump. Due to the different mobile operating system platforms, technical differences between the applications exist, such as different programming languages, user interface, and navigation to align with iOS quidelines. There have been no modifications to the Omnipod 5 Pod or the Omnipod 5 App (Android) for the iOS compatible app.

The differences between predicate and subject device do not raise any different questions about safety and effectiveness, and performance data demonstrates the Omnipod 5 ACE Pump is substantially equivalent to its predicate. Table 5.01 below illustrates the equivalence of the subject device to the predicate.

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Element ofComparison	Subject Device: Omnipod 5 ACEPump	Predicate Device: Omnipod 5 ACEPump (K203768)
Intendeduse/indicationsfor use	The Omnipod 5 ACE Pump (Pod) isintended for the subcutaneousdelivery of insulin, at set and variablerates, for the management of diabetesmellitus in persons requiring insulin.The Omnipod 5 ACE Pump is able toreliably and securely communicatewith compatible, digitally connecteddevices, including automated insulindosing software, to receive, execute,and confirm commands from thesedevices. The Omnipod 5 ACE Pump isintended for single patient, home useand requires a prescription.	The Omnipod 5 ACE Pump (Pod) isintended for the subcutaneous delivery ofinsulin, at set and variable rates, for themanagement of diabetes mellitus inpersons requiring insulin. The Omnipod 5ACE Pump is able to reliably andsecurely communicate with compatible,digitally connected devices, includingautomated insulin dosing software, toreceive, execute, and confirm commandsfrom these devices. The Omnipod 5 ACEPump is intended for single patient,home use and requires a prescription.
Pump Type	Alternate controller enabled (ACE)infusion pump	Alternate controller enabled (ACE)infusion pump
SpecificDrug/BiologicUse	U-100 InsulinSystem has been tested withNovoLog®, Humalog®, and Admelog®	U-100 InsulinSystem has been tested with NovoLog®,Humalog®, and Admelog®
PrescriptionStatus	Prescription Device	Prescription Device
Component andAccessories	Omnipod 5 Pod (insulin pump), hand-held Omnipod 5 Controller/or user'ssmartphone (interoperable controller)fill-needle and fill syringe.	Omnipod 5 Pod (insulin pump), hand-heldOmnipod 5 Controller/or user'ssmartphone (interoperable controller) fill-needle and fill syringe.
Communicationwith CompatibleiAGC	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)
Omnipod 5 Apphost device	Hosted by Omnipod 5 Locked DownAndroid Controller or user's compatiblemobile smartphone (Android or iPhone)with Omnipod 5 App installed.	Hosted by Controlled by Omnipod 5Locked Down Android Controller or user'scompatible mobile smartphone (Android)with Omnipod 5 App installed.
Element ofComparison	Subject Device: Omnipod 5 ACEPump	Predicate Device: Omnipod 5 ACEPump (K203768)
Omnipod 5 AppOperatingSystem	iOS and Android Operating System	Android Operating System
Pod PumpingMechanism	Step Drive Mechanism is activated bymicroprocessor; turns leadscrew;presses on syringe style reservoir todeliver insulin through a cannula into apatient's subcutaneous tissue.	Step Drive Mechanism is activated bymicroprocessor; turns leadscrew; presseson syringe style reservoir to deliver insulinthrough a cannula into a patient'ssubcutaneous tissue.
PodAdministrativeSets andReservoir	Integrated reservoir and patientactivated cannula insertion system. Noseparate infusion set or reservoir.	Integrated reservoir and patient activatedcannula insertion system. No separateinfusion set or reservoir.
Pod Flow Ratesand Profiles	Basal: 0.05 - 30 units/hour in 0.05 unitincrements.Bolus: 0.05 - 30 units in 0.05 unitincrements.	Basal: 0.05 - 30 units/hour in 0.05 unitincrements.Bolus: 0.05 - 30 units in 0.05 unitincrements.
Pod MaximumBolus Flow Rate	1.5 units per minute	1.5 units per minute
Pod DeliveryAccuracy (testedper IEC 60601-2-24)	Basal: ± 5% at rates ≥ 0.05 U/hrBolus: ± 5% for all set values ≥ 1.0 unit,± 0.05 unit for set values < 1.0 unit	Basal: ± 5% at rates ≥ 0.05 U/hrBolus: ± 5% for all set values ≥ 1.0 unit, ±0.05 unit for set values < 1.0 unit
Pod Software	Pod-Controller communication viaBluetoothPod-CGM communication via BluetoothSoftware to host iAGC	Pod-Controller communication viaBluetoothPod-CGM communication via BluetoothSoftware to host iAGC
PowerRequirements	Disposable Batteries - Pod	Disposable Batteries - Pod
Element ofComparison	Subject Device: Omnipod 5 ACEPump	Predicate Device: Omnipod 5 ACEPump (K203768)
Fluid PathwayMaterials	• Fluorinated Ethylene Propylene(FEP)• Dimethylmethyl 3,3,3-trifluoropropylsiloxane• Stainless Steel• Polydimethylsiloxane• Polypropylene (PP)• Cyclic Olefin Copolymer (COC)• Polyethylene (PE)	• Fluorinated Ethylene Propylene(FEP)• Dimethylmethyl 3,3,3-trifluoropropylsiloxane• Stainless Steel• Polydimethylsiloxane• Polypropylene (PP)• Cyclic Olefin Copolymer (COC)• Polyethylene (PE)
Alarms andAlerts	Alarm Types:• Pod: Audible• Controller: Visible, vibratory, audible(dependent on settings)Alarms:• Low Reservoir• Resume Insulin• Controller Software/HardwareFailure• Pod Software/Hardware Failure• Empty Reservoir• Occlusion Detected• Pod Expiration• Auto Off• Urgent Low Glucose• Missing CGM Values	Alarm Types:• Pod: Audible• Controller: Visible, vibratory, audible(dependent on settings)Alarms:• Low Reservoir• Resume Insulin• Controller Software/Hardware Failure• Pod Software/Hardware Failure• Empty Reservoir• Occlusion Detected• Pod Expiration• Auto Off• Urgent Low Glucose• Missing CGM Values
OcclusionDetectionAlgorithm	Detects occlusion at 5.0 units.	Detects occlusion at 5.0 units.
OperatingRelativeHumidity	20 to 85%	20 to 85%
OperatingTemperature	41°F to 104°F (5°C to 40°C)	41°F to 104°F (5°C to 40°C)
Element ofComparison	Subject Device: Omnipod 5 ACEPump	Predicate Device: Omnipod 5 ACEPump (K203768)
Memory	Pod events are relayed to Omnipod 5App. Events are stored on the App forup to 90 days.	Pod events are relayed to Omnipod 5 AppEvents are stored on App for up to 90days.
Pod Sterilization	Pod: EO	Pod: EO
Shelf life	Pod: 18 months	Pod: 18 months

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5.4 Standards Compliance

The Omnipod 5 ACE Pump with Omnipod 5 App(iOS) complies with the following standards in relation to the proposed change within this submission:

Standard	Title	FDARecognition No.
ANSI AAMI ISO14971:2019	Medical devices – Application of RiskManagement to Medical Devices	5-125
IEC 62304:2015-06	Medical Devices Software - (Software life cycleprocesses)	13-79
IEC 60601-1-2:2020-07	Medical Electrical Equipment- Part 1-2:Collateral Standard: ElectromagneticDisturbances - Requirements and Tests	19-36
IEC 60601-1:2020-08	Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance	19-49
IEC 60601-1-6:2020-07	Medical Electrical Equipment - Part 1-6:Collateral standard: Usability	5-132
IEC 60601-1-8:2020-07	Medical Electrical Equipment - Part 1-8:Collateral Standard: Tests and Guidance forAlarm Systems in Medical Electrical Equipmentand Medical Electrical Systems.	5-131
IEC 60601-1-10:2020-07	Medical Electrical Equipment - Part 1-10:Collateral Standard: Requirements for thedevelopment of physiologic closed-loopcontrollers	19-37

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Standard	Title	FDARecognition No.
IEC 60601-1-11:2020-07	Medical Electrical Equipment - Part 1-11:Collateral Standard: Requirements for MedicalElectrical Equipment and Medical ElectricalSystems Used in the Home HealthcareEnvironment	19-38
ANSI AAMI IEC62366-1:2015-06	Medical Devices – Part 1: Application ofUsability Engineering to Medical Devices	5-129
ANSI AAMIHE75:2009/(R)2018	Human Factors Engineering - Design ofMedical Devices	5-57

5.6 Summary Non-Clinical Performance Data

Performance testing was focused primarily on software verification and validation for the Omnipod 5 App and at the system level. No performance testing applicable only to the OP5 Pod was completed as the Pod has not been modified.

Performance testing for the addition of an iOS compatible Omnipod 5 App included the following:

Risk Management: risk management was completed in accordance with ISO 14971:2019. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use.
Software Validation: software verification and validation testing were performed in ● accordance with IEC 62304:2015-06 and FDA's guidance document, General Principles of Software Validation – Issued January 11, 2002. Software documentation was provided in accordance with FDA guidance Content of Premarket Submissions for Device Software Functions - Issued June 2023.
- Data Logging: Software verification testing has demonstrated the device o records timestamped critical events, including information related to its

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Image /page/11/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.

state, user inputs, and device settings, as required by the ACE Pump special controls.

Interoperability: Interoperability documentation was provided as is relates o to changes due to the Omnipod 5 App (iOS) according to the FDA Guidance Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff - Issued September 6, 2017. It specifies validated interface specifications to potential interoperable devices and partnership agreements regarding contractual issues, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities.
. Cybersecurity: a cybersecurity analysis was performed for the OP5 ACE Pump with the Omnipod 5 App (iOS) using the FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical devices - Issued 2014, the principles outlined in the FDA quidance, Postmarket Management of Cybersecurity in Medical Devices, – Issued 2016, and Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Issued March 30, 2023 and Cybersecurity in Medical Devices: Quality System Considerations and Content Premarket Submission DRAFT guidance for Industry and FDA Staff -April 2022. In addition, Insulet has provided a software bill of materials and penetration testing.
. Electrical Safety and EMC Testing: testing was performed to verify that the Omnipod 5 ACE Pump with the Omnipod 5 App (iOS) meets its requirement to comply with IEC 60601-1:2020-08 (Consolidated Version) Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2:2020-9 Medical Electrical Equipment – Part 1-2: Collateral Standard: Electromagnetic Disturbances- Requirements and Tests. Guidances Electromagnetic Compatibility (EMC) of Medical Devices Issued June 6, 2022 and Radio Frequency Wireless Technology in Medical Devices -Issued August 14, 2013.

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Image /page/12/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.

. Human Factors Validation: Insulet executed a comprehensive human factors and usability engineering process that followed and complied with the FDA-recognized standards IEC 62366:2015-06 and HE75:2009(R)2018 as well as the FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016. A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod 5 App (iOS) with intended users in the expected use environments, including associated training and accompanying documentation. The results of the validation demonstrate that the device has been found to be safe and effective for the intended users, uses, and use environments.
Special Controls: evaluation of the Special Controls for this device (regulation 21 ● CFR 880.5730) supports the safety and effectiveness of the device.

5.7 Conclusion

The Omnipod 5 ACE Pump, with the addition of the iOS compatible Omnipod 5 App, has the same intended use and indications for use as the predicate device. The differences in technological characteristics of the subject device compared to the predicate device do not raise different questions of safety and effectiveness. Through performance testing, the Subject device has been shown to meet the Alternate Controller Enabled Insulin Pump special controls and determined to be substantially equivalent to its predicate.

Regulation Number and Section

§ 880.5730 Alternate controller enabled infusion pump.

(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities 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 shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) 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 validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) 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 system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.