(400 days)
Not Found
No
The summary mentions an "Automated Insulin Delivery System" and an "Interoperable Automated Glycemic Controller (iAGC)" which performs calculations for automated insulin delivery. However, it does not explicitly state that these calculations or the iAGC utilize AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus, which is a therapeutic purpose.
No
Explanation:
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the subcutaneous delivery of insulin... for the management of diabetes mellitus in persons requiring insulin." This indicates a therapeutic or management function rather than a diagnostic one. While it connects to an iCGM (integrated Continuous Glucose Monitor) to receive data, its primary function as described is to deliver insulin, not to diagnose a condition.
No
The device description explicitly states that the Omnipod 5 ACE Pump is a "tubeless insulin pump (the Pod)" which is a physical hardware component that delivers insulin. While it utilizes software (the App and iAGC), it is not solely software.
Based on the provided text, the Omnipod 5 ACE Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "subcutaneous delivery of insulin" for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical delivery of insulin via a pump and its interaction with other components of an automated insulin delivery system. It does not describe any function related to analyzing samples from the human body (like blood, urine, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: The text describes the device receiving data from a compatible iCGM (interoperable Continuous Glucose Monitor), but the pump itself is not performing the diagnostic measurement of glucose levels. The iCGM is the device that would be considered an IVD in this system, as it measures glucose in interstitial fluid. The pump uses this data for insulin delivery decisions.
In summary, the Omnipod 5 ACE Pump is a therapeutic device for delivering insulin, not a diagnostic device for analyzing samples to provide information about a patient's health status.
N/A
Intended Use / 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, execute, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.
Product codes (comma separated list FDA assigned to the subject device)
QFG
Device Description
The Omnipod 5 alternate controller enabled (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 Application (App), which is installed on a locked-down controller device or a user's personal compatible smartphone device.
The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 Interoperable Automated Glycemic Controller (iAGC), Omnipod 5 Bolus Calculator, and the third-party Dexcom G6 iCGM. Omnipod 5 iAGC and Bolus Calculator functions are functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to the iCGM, the iAGC, and the Bolus Calculator.
The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on user-programmed 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 the Omnipod 5 iAGC, whose software is pre-installed on the Pod and the App. Future alternate controllers (iAGCs) may be established for use with the Pod, in which case the software modules of the Omnipod 5 iAGC would be disabled.
The Pod is a body-wearable 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 an Android software application installed on a handheld touchscreen device 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 Omnipod 5 Bolus 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 the Omnipod 5 iAGC and Omnipod 5 Bolus 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. In addition, data from the App uploads regularly to the Insulet Cloud for data management purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, requires a prescription.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Risk Management: Risk management was completed in accordance with ISO 14971:2007. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use.
- Human Factors Validation: Insulet executed a comprehensive human factors and usability engineering process that followed and complied with the FDA-recognized standards IEC 62366:2015-1 and HE75:2009 as well as the FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices lssued February 3, 2016. A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod 5 ACE Pump with intended users in the expected use environments, including associated training and accompanying documentation. The results of the validation demonstrate that the Omnipod 5 ACE Pump has been found to be safe and effective for the intended users, uses, and use environments.
- Software Validation: software verification and validation testing was performed in accordance with IEC 62304:2015 and FDA's guidance document, General Principles of Software Validation - Issued January 11, 2002.
- Performance Testing: Verification testing has demonstrated that the device delivers insulin accurately at various flow rates and that it can effectively detect when an occlusion occurs and promptly notify the user.
- Data Logging: 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 special controls.
- Interoperability: Interoperability documentation was provided 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 and 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 Omnipod 5 ACE Pump using the FDA quidance. Content of Premarket Submissions for Management of Cybersecurity in Medical devices - Issued October 18. 2020, and the principles outlined in the FDA guidance, Postmarket Management of Cybersecurity in Medical Devices - Issued December 28, 2020. Insulet has provided a software bill of materials and penetration testing.
- Biocompatibility: All patient-contacting materials and manufacturing processes of the Omnipod 5 ACE Pump (Pod) are the same as those of the currently marketed Omnipod DASH System. Therefore, previous biocompatibility testing of the predicate device is still applicable.
- Sterilization: A product adoption was completed to adopt the Omnipod 5 ACE Pump into the family of devices under the sterilization validation.
- Electrical Safety and EMC Testing: Testing was performed to verify that the Omnipod 5 ACE Pump meets its requirement to comply with IEC 60601-1: 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: Collateral Standard: Electromagnetic Disturbances-Requirements and Tests.
- Special Controls: Evaluation of the Special Controls for this device (requlation 21 CFR 880.5730) assures the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 27, 2022
Insulet Corporation Alexander Hamad Regulatory Affairs Specialist 100 Nagog Park Acton, MA 01720
Re: K203768
Trade/Device Name: Omnipod 5 ACE Pump (Pod) Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate controller enabled infusion pump Regulatory Class: Class II Product Code: QFG Dated: September 2, 2021 Received: September 3, 2021
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm. Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203768
Device Name Omnipod 5 ACE Pump (Pod)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Date Prepared: | January 27, 2022 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park, Acton, MA, 01720 |
| FDA Establishment Owner/Operator Number: | 9056196 |
| FDA Establishment Registration Number: | 3014585508 |
| Contact Person: | Alexander Hamad |
| Sr. Regulatory Affairs Specialist | |
| Phone: | 978-600-2432 (Office) |
| Fax: | 978-600-0120 |
| Device Trade/Proprietary Name: | Omnipod 5 ACE Pump (Pod) |
| Device Common Name: | Omnipod 5 ACE Pump |
| Regulation Description: | 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: | K191679, Omnipod DASH Insulin |
| Management System with Interoperable | |
| Technology |
4
Device Description:
The Omnipod 5 alternate controller enabled (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 Application (App), which is installed on a locked-down controller device or a user's personal compatible smartphone device.
The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 Interoperable Automated Glycemic Controller (iAGC), Omnipod 5 Bolus Calculator, and the third-party Dexcom G6 iCGM. Omnipod 5 iAGC and Bolus Calculator functions are functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to the iCGM, the iAGC, and the Bolus 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 the Omnipod 5 iAGC, whose software is pre-installed on the Pod and the App. Future alternate controllers (iAGCs) may be established for use with the Pod, in which case the software modules of the Omnipod 5 iAGC would be disabled.
The Pod is a body-wearable 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 an Android software application installed on a handheld touchscreen device 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 Omnipod 5 Bolus Calculator based on the user's settings and userentered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with the Omnipod 5 iAGC and Omnipod 5 Bolus Calculator.
5
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. In addition, data from the App uploads regularly to the Insulet Cloud for data management purposes.
Summary of Technological Characteristics Compared to Predicate Device:
The subject device and predicate device use the same operating principles to achieve the intended therapeutic effect. The subject device has the same intended use and similar indications for use, principles of operation, and use environment as the predicate device. The subject device and predicate device are both software-controlled, programmable ACE pumps capable of both basal and bolus delivery of insulin.
The differences between the subject device and predicate device with respect to the Pod include additional hardware components on the Printed Circuit Board Assembly (PCBA) and additional software to optimize compatibility with the iAGC. All aspects of the Pod related to patient and drug contacting materials and components, as well as the mechanical aspects for cannula deployment and insulin delivery, are identical. The differences between the subject device and predicate device on the App side include an update to the user interface, additional screens used for connection to iCGM and automated delivery, and the ability to be installed and operated on a user's personal compatible smartphone, as an alternative to the locked-down device.
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 1 below illustrates the equivalence of the subject device to the predicate.
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| Element of Comparison | Subject Device: | Predicate Device: |
|---|---|---|
| Omnipod 5 ACE Pump | Omnipod DASH™ Insulin | |
| Management System (K191679) | ||
| 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 DASH Insulin | |
| Management System (the Pump) with | ||
| interoperable technology is intended | ||
| for the subcutaneous delivery of | ||
| insulin, at set and variable rates, for | ||
| the management of diabetes mellitus | ||
| in persons requiring insulin. | ||
| The 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 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 ACE Pump is intended for single | ||
| patient, home use and requires a | ||
| prescription. | The Pump is intended for single | |
| patient, home use and requires a | ||
| prescription. The Pump is indicated for | ||
| use with NovoLog, Humalog, Admelog, | ||
| or Apidra U-100 insulin. | ||
| Pump Type | Alternate controller enabled (ACE) | |
| infusion pump | Alternate controller enabled (ACE) | |
| infusion pump | ||
| U-100 Insulin | U-100 Insulin | |
| Specific Drug/Biologic | ||
| Use | System has been tested with | |
| NovoLog®, Humalog®, and | ||
| Admelog® | System has been tested with | |
| NovoLog® Humalog®, Apidra®, and | ||
| Admelog® | ||
| Prescription Status | Prescription Device | Prescription Device |
| Labeling | Package Labels, User's Guide | |
| (contains Instructions for Use) | Package Labels, User's Guide | |
| (contains Instructions for Use) | ||
| Component and | ||
| Accessories | OP5 Pod (insulin pump), hand- held | |
| OP5 Controller/or user's smartphone | ||
| (interoperable controller) fill-needle | ||
| and fill syringe. | DASH Pod (insulin pump), hand-held | |
| DASH PDM (interoperable controller), | ||
| fill-needle and fill syringe | ||
| Communication with | ||
| compatible iAGC | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) |
| Element of Comparison | Subject Device: | |
| Omnipod 5 ACE Pump | Predicate Device: | |
| Omnipod DASH™ Insulin Management System (K191679) | ||
| Controller host device | Controlled by OP5 Locked Down | |
| Controller or user's compatible mobile | ||
| smartphone with OP5 App installed | Controlled by DASH PDM (Locked | |
| Down Controller) | ||
| Pumping Mechanism | Step Drive Mechanism is activated by | |
| microprocessor; turns leadscrew; | ||
| presses on syringe style reservoir to | ||
| deliver insulin through a cannula into a | ||
| patient's subcutaneous tissue. | Step Drive Mechanism is activated by | |
| microprocessor; turns leadscrew; | ||
| presses on syringe style reservoir to | ||
| deliver insulin through a cannula into a | ||
| patient's subcutaneous tissue. | ||
| Administrative Sets | ||
| and Reservoir | Integrated reservoir and patient | |
| activated cannula insertion system. | ||
| No separate infusion set or reservoir. | Integrated reservoir and patient | |
| activated cannula insertion system. | ||
| No separate infusion set or reservoir. | ||
| Flow Rates and | ||
| Profiles | Basal: 0.05 - 30 units/hour in 0.05 unit | |
| increments. | ||
| Bolus: 0.05 - 30 units in 0.05 unit | ||
| increments. | Basal: 0.05 - 30 units/hour in 0.05 unit | |
| increments. | ||
| Bolus: 0.05 - 30 units in 0.05 unit | ||
| increments. | ||
| Maximum Bolus Flow | ||
| Rate | 1.5 units per minute | 1.5 units per minute |
| Delivery Accuracy | ||
| (tested per IEC 60601-2- |
- | Basal: ± 5% at rates ≥ 0.05 U/hr
Bolus: ± 5% for all set values ≥ 1.0
unit, ± 0.05 unit for set values