(682 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like neural networks, training data, or specific algorithms typically associated with AI/ML in medical devices. The focus is on standard insulin pump functionality, interoperability, and performance metrics related to insulin delivery accuracy and occlusion detection.
Yes
The device is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus, which is a therapeutic purpose.
No
The Accu-Chek Solo micropump system is an insulin delivery system, not a diagnostic device. Its intended use is the subcutaneous delivery of insulin for diabetes management, and it delivers insulin based on prescribed rates rather than diagnosing a condition.
No
The device description explicitly states it is a "portable programmable insulin pump" comprised of a disposable reservoir and a reusable pump with "pumping mechanism and electronic components," indicating it includes hardware.
Based on the provided information, the Accu-Chek Solo micropump system 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". This is a therapeutic action, delivering a substance into the body.
- Device Description: The description details a "portable programmable insulin pump" that "adheres to the patient's skin" and "delivers basal and bolus insulin doses". This describes a device that administers treatment, not one that performs tests on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, etc.) or the use of reagents to detect or measure substances in those samples, which are hallmarks of IVD devices.
- Anatomical Site: The anatomical site is "subcutaneous", indicating delivery into the body, not collection of a sample from the body for testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Accu-Chek Solo micropump system's function is to deliver insulin, which is a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Accu-Chek Solo micropump system 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 Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.
Product codes
QFG
Device Description
The Accu-Chek Solo micropump is a portable programmable insulin pump, which adheres to the patient's skin. The patch is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The patch is controlled via a connected Device. The Accu-Chek Solo micropump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician.
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
2 years of age and greater
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)
Non-Clinical & Clinical Testing Summary and Conclusions
- Human Factors: Validation of the device system was performed in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" dated February 3, 2016 and IEC 62366-1. Safety critical tasks were identified, safeguards identified and implemented, then tested for their residual risk. The System validation demonstrated that the device is validated for its intended use.
- Biocompatibility: Verification testing completed in accordance with ISO 10993 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 4, 2020. This included tests for genotoxicity, carcinogenicity, reproductive toxicity, in vitro cytotoxicity, local effects after implantation, Ethylene Oxide Sterilization Residuals, irritation and skin sensitization, systemic toxicity, and chemical characterizations of materials.
- Sterility: The sterile parts are sterilized with Ethylenoxid. For the process the ISO 11135 was considered. The tests for the sterile barrier include the requirements of ISO 11607.
- Insulin Compatibility and Stability: Tested with NovoLog, Apidra, Fiasp and Humalog U-100 insulin. In vitro tests showed compatibility.
- Safety, Electrical Safety, Essential Performance and Electromagnetic Compatibility (EMC): Conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-11.
- Software: Verification and validation testing conducted and documentation provided in accordance with IEC 62304 and FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
- Cybersecurity: Analysis and testing conducted and documented in accordance with FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014.
- Interoperability: An approach was shared regarding how to deal with potential interoperable devices, including responsibilities for testing, complaints, reporting, and data exchange. The content considered the Guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices" (September 6, 2017).
- Testing to Support System Reliability: Electrical Specification Testing, Wire Drive Testing, RF Throughput Test Report, Design Visual Inspection.
- Testing to Support System Safety: Environmental Safety Testing to 60601-1-11, Safety and Essential Performance Testing to 60601-1, Pump Activation and Deactivation Testing, Pump/Controller Connectivity Testing, Insulin Delivery Verification Testing.
- Clinical tests of the insertion process: The aim was to prove that the insertion process for the Accu-Chek Solo Cannula is safe, robust, and virtually pain-free when the cannula is inserted into the subcutaneous fat tissue by the intended user.
Conclusions: The results of bench performance and clinical performance testing demonstrate that the candidate device is substantially equivalent to the predicate device, Omnipod DASH Insulin Management System With Interoperable Technology (K191679). The results of nonclinical and clinical performance testing demonstrate that the candidate device has a substantially equivalent safety and effectiveness profile to the predicate device and should perform as intended in the specified use conditions as well as the predicate device per required standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 10, 2023
Roche Diabetes Care, Inc. Wolfgang Handel Regulatory Affairs Project Lead 9115 Hague Road Indianapolis, IN 46250-0457
Re: K213134
Trade/Device Name: Accu-Chek Solo micropump system with interoperable technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: February 10, 2023 Received: February 10, 2023
Dear Wolfgang Handel:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 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
2
Indications for Use
510(k) Number (if known) K213134
Device Name
Accu-Chek Solo micropump system with interoperable technology
Indications for Use (Describe)
The Accu-Chek Solo micropump system 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 Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.
| 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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K213134 – Accu-Chek Solo micropump system with interoperable technology 510(k) Summary
Submitter Details [21 CFR 807.92(a)(1)]
| Applicant Name: | Roche Diabetes Care, Inc. |
|---|---|
| Applicant Address: | 9115 Hague Road Indianapolis, IN 46250-0457; |
| United States | |
| Applicant Contact Telephone: | +49 621 759 8331 |
| Applicant Contact: | Mr. Wolfgang Handel |
| Correspondent Name | Roche Diabetes Care GmbH |
| Correspondent Address | 9115 Hague Road Indianapolis, IN 46250-0457; |
| United States | |
| Correspondent Contact Telephone | +49 621 759 8331 |
| Correspondent Contact | Mr. Wolfgang Handel |
| Correspondent Contact Email: | wolfgang.handel@roche.com |
| Applicant Contact Email | wolfgang.handel@roche.com |
Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: Accu-Chek Solo micropump system with interoperable technology Common Name: Infusion pump Classification Names: Alternate Controller Enabled Insulin Infusion Pump Regulation Number: 880.5725 Class II Product Code: QFG
Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #: K191679 Predicate Trade Name: Omnipod DASH Insulin Management System with Interoperable Technology Product Code: QFG
4
Device Description Summary [21 CFR 807.92(a)(4)]
The Accu-Chek Solo micropump is a portable programmable insulin pump, which adheres to the patient's skin. The patch is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The patch is controlled via a connected Device. The Accu-Chek Solo micropump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician.
Technology Description
The Accu-Chek Solo micropump System Patch Pump's technological characteristics are the same as those of its predicate devices. Same as its predicates, Accu-Chek Solo micropump is an external, portable insulin infusion pump controlled by a connected Device. Same as predicate device Accu-Chek Solo micropump System communication is by means of radio frequency. Same as predicate devices, Accu-Chek Solo micropump System insulin dispensing patch is worn on the user's skin.
Accu-Chek Solo micropump includes the same functions as the predicate devices.
5
Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
Prescription Use (Part 21 CFR 801 Subpart D)
The Accu-Chek Solo micropump system 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 Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.
Indications for Use Comparison [21 CFR 807.92(a)(5)]
The Accu-Chek Solo Micropump described in this substantially equivalent to the predicate device.
The Accu-Chek Solo Micropump System uses the same indications for use.
6
Technological Comparison [21 CFR 807.92(a)(6)]
The Accu-Chek Solo micropump System uses the same technology and modes of operation as the predicate device.
The Accu-Chek Solo micropump System is a device that is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness. The Performance testing of the Accu-Chek Solo micropump System demonstrated that the device met all device specifications. Therefore, the device is substantially equivalent to the predicate device.
7
| Accu-Chek Solo micropump system with | Omnipod DASH Insulin Management System | |
|---|---|---|
| interoperable technology | With Interoperable Technology | |
| Manufacturer | Roche Diabetes Care Inc. | Insulet Corporation |
| K number | K213134 | K191679 |
| Code | QFG | QFG |
| Indications for use | The Accu-Chek Solo micropump system 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 Accu-Chek Solo micropump | ||
| system is able to communicate with | ||
| compatible, digitally connected devices, | ||
| including automated insulin dosing | ||
| software, to receive, execute, and confirm | ||
| commands from these devices. The Accu- | ||
| Chek Solo micropump system is intended for | ||
| single patient, home use and requires a | ||
| prescription. The Accu-Chek Solo | ||
| micropump system is indicated for use in | ||
| individuals 2 years of age and greater. | 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. | ||
| Contraindications | The micropump system should not be used | |
| by children under 2 years of age or by | ||
| people who regularly require less than 0.1 | ||
| U/h of basal insulin or by people who have | ||
| an insulin sensitivity above 1.00 U : 200 | ||
| mg/dL. It is the responsibility of the | ||
| healthcare professional to decide whether | ||
| the accuracy of the delivery rate is adequate | ||
| for the patient in question. Continuous | ||
| Subcutaneous Insulin Infusion (CSII) with the | ||
| micropump system is not recommended or | ||
| only recommended with limitations for the | ||
| following groups of people: | ||
| • People who are not able or willing to | ||
| either perform at least 4 blood glucose | ||
| tests per day or use a continuous | ||
| glucose monitoring (CGM) system | ||
| reliably. | ||
| • People who are not able to be in | ||
| regular contact with their healthcare | ||
| professional. | ||
| • People who do not understand what is | ||
| required for insulin pump therapy or | ||
| who are not able to follow the | ||
| instructions for use of the micropump | ||
| system. | ||
| • People who cannot be relied upon due | ||
| to drug addiction, substance abuse or | ||
| mental illness. | Insulin pump therapy is not intended for | |
| anyone unable or unwilling to | ||
| • Unable to perform at least four (4) blood | ||
| glucose tests per day | ||
| • Unable to maintain contact with their | ||
| healthcare provider | ||
| • Unable to use the Omnipod DASH™ System | ||
| according to instructions | ||
| Accu-Chek Solo micropump system with interoperable technology | Omnipod DASH Insulin Management System With Interoperable Technology | |
| People who are exposed to high ambient temperatures on a regular basis People with skin that does not tolerate adhesive pads. People who often experience a cannula occlusion. People who are not able to notice either visual, accoustic or vibration alarms. This includes people with a combination of hearing loss, neuropathy, vision impairment or other concomitant physical limitations. | ||
| Pump design | Single use Reservoir, cannula and pump holder and resusable pump | Single-use on-body pump with wireless controller |
| Skin contact / | Pump holder with adhesive and Cannula | Pod with adhesive and Cannula |
| Administration sets | Soft cannula | |
| Insertion depth: 6 and 9 mm | Soft cannula | |
| Insertion depth: 6-7 mm | ||
| Reservoir/ cartridge lifetime | Up to 96 hours (or less, depend on the insulin type) restricted by drug labeling | Up to 72 hours |
| Reservoir / | ||
| cartridge volume (deliverable) | 200 units | 200 units |
| Communication | Bluetooth low energy | Bluetooth low energy |
| Insulin Type and Brands | U100 Insulin Humalog Novolog Apidra Fiasp | U100 Insulin Humalog NovoLog Apidra Fiasp (K) Admelog |
| Min. basal rate | 0.10 U/hr | 0.05 U/hr |
| Max. basal rate | 25 U/hr | 30 U/hr |
| Min. bolus | 0.2 Units | 0.05 |
| Max. bolus | 35 Units | 30 Units |
| Button press bolus | Yes (on pump) | Yes (on PDM) |
| Accuracy of Insulin Delivery | ||
| Basal rate | ||
| (tested per IEC 60601-2-24)) | ±18% or better at 0.1 U/h | |
| ±5% or better at 1.0 U/h | ± 5% at rates ≥ 0.05 U/hr | |
| Accuracy of Insulin Delivery | ||
| Bolus | ||
| (tested per IEC 60601-2-24 & FDA special controls) | ±30 % or better at 0.2 U up to |