(254 days)
Not Found
No
The summary describes a standard insulin pump system with a controller app. There is no mention of AI, ML, or automated dosing algorithms that would typically utilize such technologies. The functions described are basic insulin delivery control and system status reporting.
Yes
The device is intended for the management of diabetes mellitus by delivering insulin, which is a therapeutic intervention.
No
The device is an insulin delivery system designed for the management of diabetes, which involves delivering insulin at set and variable rates, rather than diagnosing a medical condition.
No
The device description clearly states that the system includes a "disposable insulin delivery device (referred to as a Patch)" which is a physical hardware component responsible for delivering insulin. While the system also includes a software controller, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as an "insulin delivery device" and a "patch pump device." Its functions are related to delivering insulin, setting basal and bolus doses, and providing system status. These are all related to treatment, not diagnosis.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on such samples.
- Anatomical Site: The device is applied subcutaneously, which is for delivering medication into the body, not for collecting samples for analysis.
In summary, the embecta Insulin Delivery System is a therapeutic device used for administering insulin, not a diagnostic device used for testing biological samples to diagnose or monitor a condition.
Yes
The clearance letter explicitly states: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This sentence directly confirms that the device is authorized under a PCCP.
Intended Use / Indications for Use
The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 Patch 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 embecta Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus (DM) management. The embecta Insulin Delivery System is a disposable insulin delivery device (referred to as a Patch) that is operated by a Controller which consists of Controller software application provided on a locked down smartphone with Bluetooth Low Energy (BLE) and Wi-Fi capabilities.
The embecta Insulin Delivery System performs the following functions:
-
- Deliver user-set daily basal insulin
-
- Deliver user-set or user-entered mealtime (prandial) or correction insulin doses
-
- Generate system status and notifications
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age and older.
Intended User / Care Setting
single patient, home use
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)
Summary of Non-Clinical Performance Data
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.
Human Factors Validation: embecta executed a human factors and usability engineering process which demonstrated the embecta Insulin Delivery System has been found to be safe and effective for the intended users, performing the expected tasks, in the expected use environments. It has been determined that the embecta Insulin Delivery System does not raise different questions of safety and effectiveness based on its technological characteristics. Evidence of this statement was collected through HF validation testing following focused usability activities consistent with FDA-recognized standards IEC 62366:2015-1 and HE75:2009 as well as the FDA's quidance document. Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016.
Analytical Performance: The embecta Insulin Delivery System was tested for dose delivery accuracy and occlusion detection. All tests passed.
Accuracy and Occlusion Detection: Accuracy for basal delivery, bolus delivery, and occlusion detection were evaluated and confirmed to be acceptable.
Basal Delivery: To assess basal delivery accuracy, 89 embecta patch pumps were tested by delivering insulin at minimum. intermediate, and max basal rates (0.05. 1.00. and 30.0 U/hr). All 89 patch pumps were pre-conditioned for simulated shipping and handling, and 44 of which were treated by accelerated aging for simulated 6 month of shelf life.
Results: Low Basal Rate Delivery Performance (0.05 U/hr) - Amount Delivered: 0.048 U (1 hour), 0.29 U (6 hours), 0.58 U (12 hours). Medium Basal Rate Delivery Performance (1.00 U/hr) - Amount Delivered: 0.99 U (1 hour), 5.98 U (6 hours), 11.97 U (12 hours). High Basal Rate Delivery Performance (30.00 U/hr) - Amount Delivered: 30.13 U (1 hour), 180.49 U (6 hours).
Bolus Delivery: To assess bolus delivery accuracy, 30 patch pumps were tested for each bolus size by delivering a minimum, intermediate, and maximum bolus amounts (0.05, 6.00, and 30.00 Units). All 90 pumps were pre-conditioned for simulated shipping and handling, and 45 of which were treated by accelerated aging for simulated 6 month of shelf life.
Results: Min Bolus Delivery Performance (n = 15000 boluses) - Target: 0.05 U, Mean: 0.049 U. Intermediate Bolus Delivery Performance (n = 750 boluses) - Target: 6.00 U, Mean: 5.99 U. Max Bolus Delivery Performance (n = 300 boluses) - Target: 30.00 U, Mean: 30.09 U.
Occlusion (Blockage) Detection: Occlusion detection testing was conducted using 160 pumps and 3 delivery profiles: >5.5U bolus, 1.0 U/hr basal rate, and 0.05 U/hr basal rate. All 160 pumps were pre-conditioned for simulated shipping and handling, and 80 of which were treated by accelerated aging for simulated 6 month of shelf life. Each pump was tested for the time between occlusion and pump alarm sequentially and for the 3 delivery profiles. All samples tested met performance that is presented in the table below.
Results: 5.35 U Bolus* - Typical time to occlusion alarm: 2 minutes and 15 seconds, Maximum time to occlusion alarm: 3 minutes and 34 seconds. 1.0 U/hr Basal - Typical time to occlusion alarm: 4 hours 4 minutes, Maximum time to occlusion alarm: 5 hours 27 minutes. 0.05 U/hr Basal - Typical time to occlusion alarm: 79 hours 59 minutes, Maximum time to occlusion alarm: 80 hours (Pump expiration).
Other Supportive Test Data: Biocompatibility, Sterility, Insulin Compatibility, Electrical EMC and Safety, Packaging/ Shipping Integrity and Mechanical Tests were conducted. The embecta Insulin Delivery System and accessories were subjected to the above tests as applicable. All tests passed.
Data logging and Interoperability: The embecta Insulin Delivery System has been validated for logging timestamped events, including information related to its state, user inputs, interoperability with qualified controllers and device settings, as required by special controls. All tests passed. The embecta Insulin Delivery System software has been validated to be interoperable with all qualified connected devices.
Cybersecurity: The embecta Insulin Delivery System has incorporated adequate mitigations for cybersecurity risks. The embecta ACE Pump complies with Section 524B of the FD&C Act and follows FDA quidance on cybersecurity for medical devices. A robust cybersecurity risk assessment was conducted, and appropriate security controls and safeguards are in place to mitigate potential threats. A cybersecurity analysis was performed using the FDA guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September, 2023.
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.
K191679 - Omnipod DASH Insulin Management System with interoperable technology
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).
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
§ 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
August 30, 2024
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
embecta Medical I, LLC Andrew Harrell Director, Regulatory Affairs, New Product Development 200 Bulfinch Drive, Suite 100 Andover, Massachusetts 01810
Re: K234027
Trade/Device Name: embecta Insulin Delivery System Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: July 22, 2024 Received: July 22, 2024
Dear Andrew Harrell:
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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device,
1
or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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).
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 (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.
2
For comprehensive regulatory information about medical devices and radiation-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
Enclosure
3
Indications for Use
510(k) Number (if known) K234027
Device Name embecta Insulin Delivery System
Indications for Use (Describe)
The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 patch is intended for single patient, home 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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510(k) Summary
| 510(k): | K234027 |
|---|---|
| Submitted By: | Andrew Harrell |
| Director, Requlatory Affairs | |
| embecta | |
| 200 Bulfinch Ave | |
| Andover, MA 01810 | |
| Tel: 352-701-9489 | |
| Date Prepared: | August 29, 2024 |
| Device Name: | |
| Common Name: | |
| Classification: | embecta Insulin Delivery System |
| Infusion pump | |
| Class II device; 21 CFR 880.5730 | |
| Product Code: | QFG (Alternate Controller Enabled Insulin Infusion Pump) |
Legally marketed predicate devices to which substantial equivalence is being claimed: K191679 - Omnipod DASH Insulin Management System with interoperable technology
Device Description:
The embecta Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus (DM) management. The embecta Insulin Delivery System is a disposable insulin delivery device (referred to as a Patch) that is operated by a Controller which consists of Controller software application provided on a locked down smartphone with Bluetooth Low Energy (BLE) and Wi-Fi capabilities. See Figure 1.
Image /page/4/Picture/5 description: The image shows a smartphone and a medical device. The smartphone displays the logo of "embecta" and the text "Starting Application". The medical device is white and rectangular with rounded edges, and it appears to be attached to a patch. The device is likely a wearable sensor or monitoring device, possibly related to the application on the smartphone.
Figure 1. embecta Insulin Delivery System Controller and Patch
The embecta Insulin Delivery System performs the following functions:
-
- Deliver user-set daily basal insulin
-
- Deliver user-set or user-entered mealtime (prandial) or correction insulin doses
-
- Generate system status and notifications
Insulin Delivery Device (Patch)
The Patch is a single use disposable patch pump device intended to be worn by the patient for a Patch Life period of up to 72 hours (3 Days). The Patch is adhered to the patient using a medical grade adhesive patch. The Patch features a syringe pump design that operates dose increment
5
mechanism which controls the dose size. It stores and administers 300 U of user-filled U-100 insulin with variable basal and bolus dosage settings that are agreed upon between the user and their healthcare practitioner or provider. It is indicated for U-100 NovoLog® (insulin aspart) and U-100 Humaloq® (insulin lispro).
embecta Insulin Delivery System Controller App
The Controller App is a smartphone app running on a locked-down Android smartphone that is rechargeable with the provided charger. The Controller App will control the Patch. The embectaprovided smartphone will be non-sterile and is locked to run only the embecta Controller App to program the Patch discreetly. The Controller App will enable the user to pair, prime, and program basal and bolus dose via wireless transmission to the Patch as well as provide users with system alerts, including status information, and notifications. This includes, but is not limited to, controller battery life, total insulin delivered, calculation of a low insulin reservoir volume, occlusion, and other possible device faults. The Controller App is designed to program and display the patient's basal insulin delivery rate, delivered bolus doses, and insulin usage data on a color display touch screen.
Indications for Use:
The embecta Insulin Delivery System (the Patch) with interoperable technology is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 Patch is intended for single patient, home use and requires a prescription.
Comparison with Predicate Devices:
The overall intended use is the predicate device, and the subject device indications for use statement differs from the predicate device is indicated for adult use (18 years or older) and indicated for NovoLog® and Humalog® U-100 insulin.
The subject device has the same intended use as its predicate for the subcutaneous delivery of insulin. It also shares similarities in technology compared to its predicate device. These technological characteristics include the feature of an injection mechanism integrated into the delivery unit, basal and bolus delivery modes, battery operated, generation of system status and notifications, up to 72-hour wear, and a user filled reservoir. The subject device has a 300 U reservoir compared to the predicate device 200 U reservoir.
The subject device has a similar fundamental scientific technology as an electromechanical insulin delivery system as its predicate device. The main technological differences include larger reservoir, different basal settings, and needle insertion mechanism. Testing conducted supports substantial equivalence of the subject device despite these technological differences.
The table below provides a side-by-side comparison of the subject device compared to its predicate.
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| Table 1: Predicate Device Comparison for embecta Insulin Delivery System | |||
|---|---|---|---|
| Feature | Subject Device: embecta | ||
| Insulin Delivery System | |||
| with interoperable | |||
| technology | Predicate Device: Omnipod | ||
| DASH Insulin Management | |||
| System with interoperable | |||
| technology | Comparison of | ||
| Subject & Predicate | |||
| Device | |||
| General | |||
| 510(k) Number | N/A | K191679 | N/A |
| Classification | II | II | Same |
| Product Code | QFG | QFG | Same |
| Manufacturer | embecta | Insulet Corporation | N/A |
| Indications for Use | The embecta Insulin Delivery | ||
| System (the Patch) with | |||
| interoperable technology is | |||
| intended for subcutaneous | |||
| delivery of insulin at set and | |||
| variable rates for the | |||
| management of diabetes | |||
| mellitus in persons requiring | |||
| insulin, for individuals 18 | |||
| years of age and older. | |||
| The Patch 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 Patch is | |||
| intended for single patient, | |||
| home use and requires a | |||
| prescription. | The Omnipod DASH Insulin | ||
| Management System (the | |||
| Pump) with interoperable | |||
| technology is intended for | |||
| subcutaneous delivery of | |||
| insulin at set and variable | |||
| rates for the management of diabetes | |||
| mellitus in persons requiring | |||
| insulin. 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 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. | Same overall use, the | ||
| subject device is | |||
| indicated for adult | |||
| patients and NovoLog® | |||
| and Humalog® insulin | |||
| only. | |||
| Delivery Modes | Basal and Bolus | Basal and Bolus | Same |
| System Components | Electromechanical Pump | ||
| • Wireless Controller (WC) | |||
| running on Smartphone | Electromechanical Pump | ||
| • Wireless Controller (WC) | |||
| running on Smartphone | Same | ||
| Integration of Infusion Set | Cannula integrated into pump | ||
| (tubeless) | Cannula integrated into pump | ||
| (tubeless) | Same | ||
| Reservoir Capacity | 300 U | 200 U | Larger reservoir |
| capacity | |||
| Insulin Concentration | U-100 | U-100 | Same |
| Microprocessor | Yes | Yes | Same |
| Power Source | Battery Operated | Battery Operated | Same |
| Programming Method | Basal - WC | ||
| Bolus - WC | Basal - WC | ||
| Bolus - WC | Same | ||
| System Notifications and | |||
| Alarms | Yes | Yes | Same |
| Cannula Material | Integrated soft cannula | Integrated soft cannula | Same |
| Replacement Frequency | Disposable pump replaced | ||
| every 72 hours | Disposable pump replaced | ||
| every 72 hours | Same | ||
| Provided Sterile | Pump - Yes | ||
| WC - No | Pump - Yes | ||
| WC - No | Same | ||
| Insulin Container | Integrated patient filled | ||
| container | Integrated patient filled | ||
| container | Same | ||
| Pump is packaged with filing | |||
| syringe and needle | Yes | Yes | Same |
| Basal Delivery | |||
| Number of Basal Rates | Multiple and adjustable | Multiple and adjustable | Same |
| Basal Programs | 5 | 7 | Different |
| Basal Rates per program | Up to 6 | Up to 24 | Similar for equivalent |
| coverages | |||
| Basal Rate Range | 0 – 30 U/hr | ||
| (0-720 U/day) | 0.05 – 30 U/hr | ||
| (1.2 - 720 U/day) | Similar | ||
| Basal Rate Increments | 0.05 U/hr | 0.05 U/hr | Same |
| Basal Delivery Accuracy | ±5% at rates ≥1U/hr | ||
| ±15% at 0.05U/hr | ± 5% at rates ≥ 0.05 U/hr | Similar | |
| Temp Basal Duration | 30 mins to 12 hours | 30 mins to 12 hours | Same |
| Temp Basal Rate | Flat rate 0-max basal rate 0 ± | ||
| 95% | Flat rate 0-max basal rate | ||
| (increments 0.05U) or 0 ± | |||
| 95% | Similar | ||
| Temp Basal Presets | Up to 8 | Up to 7 | Different |
| Bolus Delivery | |||
| Bolus Dose Range | 0.05 — 30 U | 0.05 - 30 U | Same |
| Bolus Dose Increments | 0.05, 0.1, 0.5, or 1.0 U | 0.05, 0.1, 0.5, or 1.0 U | Same |
| Extended Bolus | No | Yes | Different |
| Bolus Dose Accuracy | ± 5% for amounts ≥ 1.0 U | ||
| ± 0.05 U for amounts 0.125 | |||
| ------------------- | --------- | ------------------- | ------------------ |
| (% of target) | (250%) |
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| Number and
percent of
boluses | 5/15000
(0.03%) | 66/15000
(0.44%) | 1678/1500
(11.19%) | 4259/15000
(28.39%) | 7077/15000
(47.18%) | 1105/15000
(7.37%) | 792/15000
(5.28%) | 18/15000
(0.12%) | 0/15000
(0%) | 0/15000
(0%) |
| ------------------------------------- | -------------------- | --------------------- | ----------------------- | ------------------------ | ------------------------ | ----------------------- | ---------------------- | --------------------- | ----------------- | ----------------- |
|---|
Amount of Insulin Delivery for an Intermediate (6.00 U) Bolus Request
| Amount (Units) | 15 |
|----------------------------------|---------------|---------------|---------------|------------------|---------------------|---------------|---------------|---------------|---------------|---------------|
| (% of target) | (250%) |
| Number and percent
of boluses | 0/750
(0%) | 0/750
(0%) | 0/750
(0%) | 1/750
(0.13%) | 749/750
(99.87%) | 0/750
(0%) | 0/750
(0%) | 0/750
(0%) | 0/750
(0%) | 0/750
(0%) |
Amount of Insulin Delivery for a Maximum (30.00 U) Bolus Request
| Amount
(Units) | 7.5
(75.0
(>250%) |
|-------------------------------------|---------------|----------------------|-----------------------|-----------------------|------------------------|-------------------------|-------------------------|-------------------------|-------------------------|------------------|
| (% of target) | | | | | | | | | | |
| Number and
percent of
boluses | 0/300
(0%) | 0/300
(0%) | 0/300
(0%) | 0/300
(0%) | 300/300
(100%) | 0/300
(0%) | 0/300
(0%) | 0/300
(0%) | 0/300
(0%) | 0/300
(0%) |
Occlusion (Blockage) Detection:
Occlusion detection testing was conducted using 160 pumps and 3 delivery profiles: >5.5U bolus, 1.0 U/hr basal rate, and 0.05 U/hr basal rate. All 160 pumps were pre-conditioned for simulated shipping and handling, and 80 of which were treated by accelerated aging for simulated 6 month of shelf life. Each pump was tested for the time between occlusion and pump alarm sequentially and for the 3 delivery profiles. All samples tested met performance that is presented in the table below.
| Timing of occlusion
detection alarms | Typical time to
occlusion alarm | Maximum time to
occlusion alarm |
|-----------------------------------------|------------------------------------|------------------------------------|
| 5.35 U Bolus* | 2 minutes and 15 seconds | 3 minutes and 34 seconds |
| 1.0 U/hr Basal | 4 hours 4 minutes | 5 hours 27 minutes |
| 0.05 U/hr Basal | 79 hours 59 minutes | 80 hours (Pump
expiration) |
*Note: A 30 U bolus was commanded, reported value here represents the maximum amount of fluid at occlusion detection.
Other Supportive Test Data:
Biocompatibility, Sterility, Insulin Compatibility, Electrical EMC and Safety, Packaging/ Shipping Integrity and Mechanical Tests were conducted. The embecta Insulin Delivery System and accessories were subjected to the above tests as applicable. All tests passed.
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Data logging and Interoperability:
The embecta Insulin Delivery System has been validated for logging timestamped events, including information related to its state, user inputs, interoperability with qualified controllers and device settings, as required by special controls. All tests passed. The embecta Insulin Delivery System software has been validated to be interoperable with all qualified connected devices.
Cybersecurity:
The embecta Insulin Delivery System has incorporated adequate mitigations for cybersecurity risks. The embecta ACE Pump complies with Section 524B of the FD&C Act and follows FDA quidance on cybersecurity for medical devices. A robust cybersecurity risk assessment was conducted, and appropriate security controls and safeguards are in place to mitigate potential threats. A cybersecurity analysis was performed using the FDA guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September, 2023.
Labeling and Training:
The embecta Insulin Delivery System device labeling and training for users and healthcare practitioners was reviewed by the FDA. Labeling is sufficient and satisfies applicable requirements of 21 CFR 801 and 21 CFR 809.
Clinical Performance:
A clinical study was not required for the embecta Insulin Delivery System as insulin delivery from the device can be verified through bench performance testing and use of the device was validated through a human factors validation study (described above).
Conclusions including compliance with Special Controls
Special Controls: The embecta Insulin Delivery System was found to be compliant with all Special Controls for Alternate controller enabled infusion pump (21 CFR 880.5730, QFG).
Conclusions: The Subject Device serves the same functions of delivering insulin therapy that are the same as that of the Predicate Device. The required technical documentation provided in this Traditional 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.