(254 days)
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.
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: 1) Deliver user-set daily basal insulin 2) Deliver user-set or user-entered mealtime (prandial) or correction insulin doses 3) Generate system status and notifications. 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 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). 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 embecta-provided 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.
The provided text is a 510(k) Summary for the embecta Insulin Delivery System. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance data. There is no mention of a study involving AI/ML components or human reader performance. Therefore, I cannot provide information regarding:
- Number of experts used to establish ground truth
- Adjudication method
- Multi Reader Multi Case (MRMC) comparative effectiveness study
- Effect size of human readers improving with AI assistance
- Standalone (algorithm only) performance
- Sample size for the training set
- How the ground truth for the training set was established
However, based on the non-clinical performance data provided, I can construct a table of acceptance criteria (implicit from the reported performance) and the reported device performance for dose delivery accuracy and occlusion detection.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the reported performance data, which demonstrates the device's capability within specific tolerances.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (embecta Insulin Delivery System) |
|---|---|
| Basal Delivery Accuracy | |
| At rates ≥ 1U/hr | ±5% accuracy (e.g., 1.00 U/hr delivered 0.99 U, 30.00 U/hr delivered 30.13 U) |
| At 0.05U/hr | ±15% accuracy (e.g., 0.05 U/hr delivered 0.048 U) |
| Bolus Delivery Accuracy | |
| For amounts ≥ 1.0 U | ±5% accuracy (e.g., 6.00 U delivered 5.99 U; 30.00 U delivered 30.09 U) |
| For amounts < 1.0 U | ±0.05 U accuracy (e.g., 0.05 U delivered 0.049 U) |
| Occlusion Detection Timeliness | |
| For 5.35 U Bolus | Typical: 2 minutes 15 seconds; Maximum: 3 minutes 34 seconds |
| For 1.0 U/hr Basal | Typical: 4 hours 4 minutes; Maximum: 5 hours 27 minutes |
| For 0.05 U/hr Basal | Typical: 79 hours 59 minutes; Maximum: 80 hours (Pump expiration) |
Study Details that Prove the Device Meets Acceptance Criteria
-
Sample Size Used for the Test Set and Data Provenance:
- Basal Delivery Accuracy: 89 embecta patch pumps were tested. 44 of these were subjected to accelerated aging (simulated 6-month shelf life), and all 89 were pre-conditioned for simulated shipping and handling.
- Bolus Delivery Accuracy: 30 patch pumps were tested for each bolus size (0.05 U, 6.00 U, 30.00 U). A total of 90 pumps (30 for each bolus size) were pre-conditioned for simulated shipping and handling, and 45 of these were treated by accelerated aging (simulated 6-month shelf life).
- Min Bolus Delivery (0.05 U): 15,000 boluses measured.
- Intermediate Bolus Delivery (6.00 U): 750 boluses measured.
- Max Bolus Delivery (30.00 U): 300 boluses measured.
- Occlusion Detection: 160 pumps were tested. All 160 were pre-conditioned for simulated shipping and handling, and 80 of these were treated by accelerated aging (simulated 6-month shelf life).
- Data Provenance: The document does not specify the country of origin of the data. The studies described are non-clinical performance tests (bench testing), designed to verify the physical and functional aspects of the device in a controlled laboratory environment. They are not human subject studies (neither retrospective nor prospective in the typical clinical trial sense).
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for this medical device (an insulin pump) is established through precise physical measurements of insulin delivery and occlusion detection in a lab setting, using calibrated equipment. This is a technical performance verification, not an AI/ML diagnostic or image interpretation task requiring human expert adjudication.
-
Adjudication Method for the Test Set:
- Not applicable, as the performance is based on direct physical measurements against engineering specifications, not observational data requiring human adjudication.
-
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, a MRMC comparative effectiveness study was not done. The device is an insulin delivery system, not an AI/ML-driven diagnostic tool that assists human readers.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the performance tests described are "standalone" in that they evaluate the device's mechanical and software performance directly (e.g., its ability to deliver insulin accurately and detect occlusions) without a human user actively influencing the measurement outcome, beyond initiating the tests. These are bench performance tests of the device itself.
-
The Type of Ground Truth Used:
- The ground truth is established through physical measurement and engineering specifications. For example, the "target bolus" or "requested units" for insulin delivery is the ground truth against which the actual delivered amount is measured. Similarly, the presence of an occlusion is the ground truth for occlusion detection tests. This is a technical/physical ground truth, not expert consensus, pathology, or outcomes data in a diagnostic context.
-
The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set of data in the common sense. It's an electromechanical device with embedded software. Its "performance" is verified through engineering tests against predefined specifications.
-
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no mention of an AI/ML training set as part of this submission. The device's functionality is based on its physical design and embedded deterministic software, which is verified through testing, not trained on data.
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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,
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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.
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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
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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 HarrellDirector, Requlatory Affairsembecta200 Bulfinch AveAndover, MA 01810Tel: 352-701-9489 |
| Date Prepared: | August 29, 2024 |
| Device Name:Common Name:Classification: | embecta Insulin Delivery SystemInfusion pumpClass 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
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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: embectaInsulin Delivery Systemwith interoperabletechnology | Predicate Device: OmnipodDASH Insulin ManagementSystem with interoperabletechnology | Comparison ofSubject & PredicateDevice |
| 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 DeliverySystem (the Patch) withinteroperable technology isintended for subcutaneousdelivery of insulin at set andvariable rates for themanagement of diabetesmellitus in persons requiringinsulin, for individuals 18years of age and older.The Patch is able to reliablyand securely communicatewith compatible, digitallyconnected devices, includingautomated insulin dosingsoftware, to receive, executeand confirm commands fromthese devices. The Patch isintended for single patient,home use and requires aprescription. | The Omnipod DASH InsulinManagement System (thePump) with interoperabletechnology is intended forsubcutaneous delivery ofinsulin at set and variablerates for the management of diabetesmellitus in persons requiringinsulin. The Pump isable to reliably and securelycommunicate withcompatible, digitallyconnected devices, includingautomated insulin dosingsoftware, to receive, executeand confirm commands fromthese devices. The Pump isintended for single patient,home use and requires aprescription. The Pump isindicated for use withNovoLog®, Humalog®,Admelog®, or Apidra® U-100insulin. | Same overall use, thesubject device isindicated for adultpatients and NovoLog®and Humalog® insulinonly. |
| 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 reservoircapacity |
| Insulin Concentration | U-100 | U-100 | Same |
| Microprocessor | Yes | Yes | Same |
| Power Source | Battery Operated | Battery Operated | Same |
| Programming Method | Basal - WCBolus - WC | Basal - WCBolus - WC | Same |
| System Notifications andAlarms | Yes | Yes | Same |
| Cannula Material | Integrated soft cannula | Integrated soft cannula | Same |
| Replacement Frequency | Disposable pump replacedevery 72 hours | Disposable pump replacedevery 72 hours | Same |
| Provided Sterile | Pump - YesWC - No | Pump - YesWC - No | Same |
| Insulin Container | Integrated patient filledcontainer | Integrated patient filledcontainer | Same |
| Pump is packaged with filingsyringe 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 equivalentcoverages |
| 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 < 1.0 U | ± 5% for amounts ≥ 1.0 U± 0.05 U for amounts < 1.0 U | Same |
| Bolus Dose Presets | Up to 8 | Up to 7 | Different |
| Additional Features | |||
| Bolus Calculator | Yes | Yes | Same |
| Suspend Insulin | Yes | Yes | Same |
| Correction Factor | Up to 6 time segments perday (1 to 400 mg/dL in 1mg/dL) | Up to 8 time segments perday (1 to 400 mg/dL in 1mg/dL) | Similar |
| Insulin-to-Carb Ratio | Up to 6 segments per day (1to 150g carb/U) | Up to 8 segments per day (1to 150g carb/U) | Similar |
| WC History Storage | At least 90 days of data | At least 90 days of data | Same |
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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.
Standards Compliance:
- . ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - 2018 (5th Edition)
- ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity. . carcinogenicity, and reproductive toxicity - 2014 (3rd Edition)
- ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for . interactions with blood - 2017 (3rd Edition)
- ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity . - 2009 (3rd Edition)
- ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation - 2016 (3rd Edition)
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (2nd Edition)
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization - 2021 (4th Edition)
- . ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - 2017 (3rd Edition)
- . ISO 14971 Medical Devices – Application of risk management to medical devices - 2019 (3rd Edition)
- IEC 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
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - 2020 (4.1 Edition)]
- . IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability - 2020 (3.2 Edition)
- IEC 60601-1-8 Medical Electrical Equipment Part 1-8: General requirements for basic . safety and essential performance - Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems - 2020 (2.2 Edition)
- IEC 62304 Medical Device Software Software Life-cycle processes 2015 (1.1 Edition) ●
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- . IEC 62366-1 Medical Devices -Part 1: Application of usability engineering to medical devices, including Amendment 1 - 2020 (1.1 Edition)
- . ANSI/AAMI ST72 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing - 2019
- ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems - 2019 (2nd Edition)
- RTCA DO-160 Category R.
- . IEC TR 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems - (1.0 Edition 2016-05)
- . IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- . 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes
- . ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
- IEEE Std 11073-40102:2020 Health informatics Device interoperability. Part 40102: . Foundational - Cybersecurity - Capabilities for mitigation.
- . ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for ● Medical Devices
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. The following tables report the basal performance (median) observed, as well as the lowest and highest observed results for each of the basal rates, minimum, intermediate, and maximum for the pumps tested,
| Low Basal Rate Delivery Performance (0.05 U/hr) | |||
|---|---|---|---|
| Basal Duration(Number of unitsrequested | 1 hour(0.05 U) | 6 hours(0.30 U) | 12 hours(0.60 U) |
| Amount Delivered | 0.048 U | 0.29 U | 0.58 U |
| [min, max] | [0.00, 0.18] | [0.07, 0.45] | [0.27, 0.72] |
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| Medium Basal Rate Delivery Performance (1.00 U/hr) | |||
|---|---|---|---|
| Basal Duration(Number of unitsrequested) | 1 hour(1.00 U) | 6 hours(6.00 U) | 12 hours(12.00 U) |
| Amount Delivered | 0.99 U | 5.98 U | 11.97 U |
| [min, max] | [0.74, 1.20] | [5.21, 6.14] | [10.94, 12.26] |
| High Basal Rate Delivery Performance (30.00 U/hr) | |||
| Basal Duration(Number of unitsrequested) | 1 hour(30.00 U) | 6 hours(180.00 U) | |
| Amount Delivered | 30.13 U | 180.49 U | |
| [min, max] | [29.77, 30.58] | [180.10, 180.93] |
Note: A measurement at the 12-hour period with a 30.0 U/hr basal rate is not applicable to the system the reservoir will empty at approximately 10 hours at this rate.
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. For each bolus size represented in the tables below the number of boluses measured, as well as the number of boluses which were observed to be within the specified range of the target bolus volume, are provided.
| Individual Bolus AccuracyPerformance | Target BolusSize (Units) | Mean BolusSize (Units) | Min BolusSize (Units) | Max BolusSize (Units) |
|---|---|---|---|---|
| Min Bolus Delivery Performance (n= 15000 boluses) | 0.05 U | 0.049 U | 0.001 U | 0.068 U |
| Intermediate Bolus DeliveryPerformance(n = 750 boluses) | 6.00 U | 5.99 U | 5.48 U | 6.14 U |
| Max Bolus Delivery Performance(n = 300 boluses) | 30.00 U | 30.09 U | 29.49 U | 30.63 U |
The tables below show for each requested bolus size, the range of amount of insulin that was observed delivered compared to the requested amount. Each table provides the number and percent of delivered bolus sizes observed within the specified range.
Amount of Insulin Delivery for a Minimum (0.05 U) Bolus Request
| Amount(Units) | <0.0125 | 0.0125-0.0375 | 0.0375-0.045 | 0.045-0.0475 | 0.0475-0.0525 | 0.0525-0.055 | 0.055-0.0625 | 0.0625-0.0875 | 0.0875-0.125 | >0.125 |
|---|---|---|---|---|---|---|---|---|---|---|
| (% of target) | (<25%) | (25-75%) | (75-90%) | (90-95%) | (95-105%) | (105-110%) | (110-125%) | (125-175%) | (175-250%) | (>250%) |
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| Number andpercent ofboluses | 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) | <1.5 | 1.5-4.5 | 4.5-5.4 | 5.4-5.7 | 5.7-6.3 | 6.3-6.6 | 6.6-7.5 | 7.5-10.5 | 10.5-15 | >15 |
|---|---|---|---|---|---|---|---|---|---|---|
| (% of target) | (<25%) | (25-75%) | (75-90%) | (90-95%) | (95-105%) | (105-110%) | (110-125%) | (125-175%) | (175-250%) | (>250%) |
| Number and percentof 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(<25%) | 7.5-22.5(25-75%) | 22.5-27.0(75-90%) | 27.0-28.5(90-95%) | 28.5-31.5(95-105%) | 31.5-33.0(105-110%) | 33.0-37.5(110-125%) | 37.5-52.5(125-175%) | 52.5-75.0(175-250%) | >75.0(>250%) |
|---|---|---|---|---|---|---|---|---|---|---|
| (% of target) | ||||||||||
| Number andpercent ofboluses | 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 occlusiondetection alarms | Typical time toocclusion alarm | Maximum time toocclusion 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 (Pumpexpiration) |
*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.
§ 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.