Search Results
Found 4 results
510(k) Data Aggregation
(26 days)
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
The Omnipod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
The subject devices provide for the management of insulin therapy by patients with diabetes mellitus. The devices are comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporates a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.
The systems are for prescription use only.
This document is a 510(k) premarket notification for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It primarily discusses a labeling change to add Fiasp U100 insulin as compatible and asserts substantial equivalence to a previously cleared device (K182630). Therefore, the information typically found for acceptance criteria and a study proving device performance in a de novo or original 510(k) submission (which often includes specifics on a clinical trial or performance study with detailed metrics) is not present here.
Based on the provided document, I can extract the following relevant information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance metrics in the way a clinical study report would. Instead, it states that:
- Acceptance Criteria Mentioned: "Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the devices are safe for use." However, the specific criteria themselves are not listed.
- Reported Device Performance:
- "Drug Stability and Compatibility; In-use stability and leachables testing was conducted with Fiasp U100 insulin to verify and validate that the systems do not adversely affect the insulin."
- "Fiasp stability testing in Omnipod Pods"
- "Leachables study"
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the stability and leachables testing, nor does it provide information about the provenance of the data (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of testing described (drug stability and leachables) and is therefore not present in the document. These tests are laboratory-based and do not involve expert interpretation or ground truth establishment in the same way a diagnostic device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the type of testing described (drug stability and leachables) and is therefore not present in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an insulin management system, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable in the context of the described modifications. The primary device function (insulin delivery) is not an algorithm-only standalone performance that would be assessed in this manner for the stated purpose of the submission. The "dose calculator" is mentioned within the context of the PDM, implying human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the stability and leachables testing, the "ground truth" would be established by scientific analytical methods (e.g., chemical assays, chromatography) to measure insulin degradation, chemical composition of leachates, and ensure the drug substance remains within predefined acceptable ranges, as per established pharmaceutical and medical device testing standards. The document does not explicitly detail these laboratory "ground truth" methods but refers to "Fiasp stability testing in Omnipod Pods" and a "Leachables study."
8. The sample size for the training set
The document describes a 510(k) submission for a modification (labeling change for compatible insulins) to existing devices. There is no mention of a "training set" as would be used for machine learning or AI algorithm development because that is not the nature of this submission. The testing described (stability, leachables) does not involve training sets.
9. How the ground truth for the training set was established
As there is no "training set" reported for this submission, this question is not applicable.
Ask a specific question about this device
(88 days)
Omnipod DASH Insulin Management System with interoperable technology
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 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.
The Omnipod DASH™ Insulin Management System with interoperable technology provides for the management of insulin therapy by patients with diabetes mellitus. It is comprised of two primary components: the disposable insulin infusion pump (Pod), and an associated Bluetooth Low Energy (BLE) enabled remote controller. The Omnipod DASH System with interoperable technology is provided with the DASH Personal Diabetes Manager (PDM), but future alternate controllers may be established. The DASH PDM incorporates a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The DASH PDM is a handheld device that controls the Pod. The user interfaces with the device system through the DASH PDM using a touch screen, similar to a smartphone, where they control basal and bolus delivery and various insulin program settings and calculations. The DASH PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The device system is for prescription use only.
The remote control design of the Pod inherently enables connectivity to other interoperable controllers with new functionality. Capabilities can be built into compatible controllers to add functionality such as Automated Insulin Delivery (AID) systems. In this design, a controller may contain an algorithm and connect to an iCGM system. In such an integrated system, the AID controller would be responsible for coordinating the interoperable devices (Omnipod DASH and iCGM) in order to automate delivery. It would read the Pod for insulin delivery status, read the iCGM for the sensor value, compute an automated delivery amount and then command the Pod to deliver the required insulin amount. For this automated delivery to occur, the Controller is required to be in range of the Pod. The Pod is designed to the programmed basal rate in the case of extended loss of communication.
This document describes the Omnipod DASH™ Insulin Management System with interoperable technology. It is a 510(k) premarket notification for a Class II medical device, an alternate controller enabled infusion pump.
Key takeaway: This documentation confirms that the Omnipod DASH system is a medical device for insulin delivery, and the submission is for expanding its indications for use to include interoperable technology, allowing it to communicate with compatible digital devices. The FDA has determined it is substantially equivalent to existing devices.
Here's an analysis based on the provided text, focusing on the requested criteria for an AI/ML device, even though this document is for an infusion pump. It's important to note that the provided text is for an insulin pump, not an AI/ML diagnostic or assistive device. Therefore, many of the requested criteria (like ground truth, MRMC studies, expert adjudication) are not applicable in their typical sense for this type of medical device.
However, I will interpret the acceptance criteria in the context of a medical device submission, particularly for an infusion pump, and extract information where parallels can be drawn.
Acceptance Criteria for Omnipod DASH™ Insulin Management System with Interoperable Technology
The acceptance criteria for this device, as outlined in the "Special Control" section, predominantly focus on the safety and performance of the insulin pump itself, especially given its new interoperable functionality. The performance data presented demonstrates how the device meets these controls, often by stating that the subject device is identical to previous cleared versions (K182630 and K180045) and that previous testing is applicable, with some additional characterization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Special Control) | Reported Device Performance and Evidence Provided |
|---|---|
| Infusion Delivery Accuracy: Device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions (includes specifications for ambient temp, pressure, fluid properties; testing met design input requirements for programmable range of rates/volumes, statistically valid number of devices). | All performance testing from K182630 and K180045 is applicable. Further characterization conducted and submitted in this 510(k). Delivery accuracy was specifically conducted for this submission (though specific results are not detailed in this summary). |
| Hazard Detection: Ability of the pump to detect relevant hazards (occlusions, air in line) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Appropriate performance validation under conditions of use. | The subject device is identical to DASH system in K182630/K180045. All testing (except delivery accuracy) was completed to demonstrate hazard detection in K182630 and K180045. Traceability of hazards to risk controls and verification evidence is included in the System Hazard Analysis. |
| Drug Compatibility: Compatibility with specified drugs, including assessment of drug stability under reasonably foreseeable use conditions (temp, light, etc.). | The subject device is identical to DASH system in K182630/K180045. All validation testing demonstrating compatibility with insulin was provided in K180045 and K182630. Device is only intended for U-100 insulin delivery. |
| Biocompatibility: Device parts directly or indirectly contacting the patient must be demonstrated to be biocompatible (chemical, particulate characterization, risk of harm from residues). | The subject device is identical to DASH system in K182630/K180045. Biocompatibility of patient-contacting parts (adhesive pad) demonstrated with cytotoxicity, sensitization, skin irritation studies (all passing). Biocompatibility of fluid-path parts demonstrated with cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility (all passing). |
| Reliability over Use Life: Evidence verifying and validating that the device is reliable over the ACE pump use life in terms of all device functions and pump performance. | The subject device is identical to DASH system in K182630/K180045. No additional shelf life testing was completed for Omnipod DASH with interoperable technology. |
| Electrical Safety, EMC, RF Wireless Safety: Designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements. | The subject device is identical to DASH system in K182630/K180045. No additional electrical safety and electromagnetic compatibility testing was completed for Omnipod DASH with interoperable technology. |
| Cross-channeling (for multi-drug devices): Risk of cross-channeling drugs must be adequately mitigated. | Omnipod DASH is only intended for U-100 insulin delivery. (Therefore, cross-channeling is not applicable). |
| Reprocessing (for multi-patient use): Validation of reprocessing procedures if intended for multiple patient use, demonstrating all functional and performance requirements are met after reprocessing. | Omnipod DASH with interoperable technology is intended only for single-patient use. The Pod is a single-use disposable. The PDM is a non-sterile single-use patient component. (Therefore, reprocessing is not applicable). |
| Interoperable Interface Specifications: Validated interface specifications for digitally connected devices (secure authentication, secure/accurate/reliable data transmission, sharing necessary state information, safe operation with out-of-bounds data, detailed process for sharing/validating protocol). | The interface between the Omnipod DASH controller (PDM) and pump (DASH Pod) has been specified and validated. Insulet has a detailed process for sharing the pump interface specification and validating correct implementation. |
| Critical Event Logging: Record of critical events stored and accessible for auditing of communications and sharing information with responsible parties. Minimum events: drug delivery, commands/confirmations, malfunctions, alarms/alerts, connectivity events. | Insulin delivery commands are logged in the PDM's memory. Execution of commands stored in Pod's memory (basal/bolus pulses) and confirmed with PDM. Pod/PDM logs allow auditing of failures (includes all special controls requirements). PDM stores 90 days of alarms/alerts/acknowledgements. PDM stores short duration (~3 days) of communication connectivity. Insulet ensures logging requirements met/verified for external controllers. |
| Human Factors Study: Design verification and validation includes human factors study demonstrating safe use by intended user. | Not explicitly detailed in this summary, but implied by the statement "No additional shelf life testing was completed for Omnipod DASH with interoperable technology" and the general nature of device clearance. The larger context of a 510(k) submission would typically include this or refer to previous submissions where it was performed. |
| Device Labeling: Labeling must include: compatible drugs/concentration, min/max basal/bolus rates/increments, pump accuracy description (bolus/basal at min/intermediate/max), hazard alarm perf (occlusion), wireless QoS, reprocessing instructions (if applicable). | Omnipod DASH User Guide updated to contain information from special controls. The performance testing provided in K182630 and K180045 are applicable to the subject device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for tests. It generally refers to previous clearances (K182630, K180045) for most testing, stating that the subject device is "identical" or that previous testing is "applicable," with "further characterization" or "delivery accuracy" specifically conducted for this submission.
- Sample Size: Not explicitly stated for specific tests in this summary. It mentions "statistically valid number of devices" as a requirement for delivery accuracy testing in the special control.
- Data Provenance: The data comes from the manufacturer's (Insulet Corporation) internal testing and previous FDA submissions (K182630, K180045). The country of origin for the data is not specified but is implied to be within Insulet's testing facilities (Acton, MA, USA is their address). The data would be prospective in nature, generated specifically for these regulatory submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable in the context of this device. The Omnipod DASH Insulin Management System is an infusion pump, not a diagnostic device that relies on human expert interpretation of data (like medical images) to establish ground truth. The "ground truth" for this device relates to its physical and functional performance (e.g., accurate insulin delivery, proper communication), which is established through engineering and performance testing against predefined specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data or making diagnoses, and their initial assessments need to be reconciled to establish a consensus ground truth. For an infusion pump, performance is measured objectively via test equipment and quantitative outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done or applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging or similar fields. This device is an insulin pump, not a diagnostic tool where human interpretation is being augmented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is partially applicable but in a different context. The "algorithm" here is the pump's internal software controlling insulin delivery and communication. The "standalone" performance would be the pump's ability to deliver insulin accurately and communicate reliably based on pre-programmed settings or commands, independent of a human directly monitoring every millisecond. The performance tests (delivery accuracy, hazard detection, interoperability) are essentially evaluations of the pump's "standalone" (or automated) functional performance. The human (user) interacts with the PDM to initiate commands, but the core function (insulin delivery) is automated by the pump's internal algorithms.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, established physical measurement methods, and regulatory standards for insulin pump function and safety.
Examples:
- For "infusion delivery accuracy," the ground truth is the precisely measured volume of fluid delivered compared to the commanded volume, determined using calibrated equipment.
- For "hazard detection," the ground truth is a simulated hazard (e.g., occlusion) and the objective measurement of the time taken for the pump to detect and alarm, compared against predefined safety limits.
- For "biocompatibility," the ground truth is the absence of adverse biological reactions, confirmed by standardized in-vitro and in-vivo tests according to ISO standards.
8. The Sample Size for the Training Set
This is not applicable in the AI/ML sense. This device is a traditional medical device (an infusion pump) with embedded software. It does not learn or get "trained" from data in the way a machine learning algorithm does. Its operation is based on deterministic algorithms and hardware.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for an AI/ML model for this device. The ground truth for its development and validation (e.g., engineering specifications, performance requirements) is established through established medical device development processes, risk analysis, and compliance with national and international standards (e.g., ISO, FDA guidance).
Ask a specific question about this device
(106 days)
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Omnipod Insulin Management System
The Omnipod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis or screening for diabetes. The PDM glucose meter is intended for single patient use and should not be shared.
Abbott FreeStyle® test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
Omnipod DASH Insulin Management System
The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.
Both systems are for prescription use only.
The provided document is a 510(k) summary for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It describes modifications to an existing device rather than a new device and thus does not contain the specific information requested in the prompt regarding a study that proves the device meets specific acceptance criteria with detailed statistical analysis.
However, based on the Performance Data and Standards Compliance section, I can extract information about the types of testing performed and the general conclusions, even if the detailed acceptance criteria and study designs are not fully elaborated.
Here's an attempt to answer using the available information, noting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Drug Stability and Compatibility | In-use stability and leachables testing with Admelog U100 insulin verified and validated that the systems do not adversely affect the insulin. |
| Soft Cannula Design | Testing was conducted to verify that the modified soft cannula design met the insertion depth and new insulin infusion depth specifications. |
| Safety and Effectiveness | A real-world data analysis of post-market data gathered from devices with the modified soft cannula concluded that the modification did not raise any new questions of safety and effectiveness. Safety Assurance Cases for both Omnipod and Omnipod DASH systems with the modified cannula and Admelog were provided, with the stated goal that the systems are "acceptably safe for the infusion of U100 insulin...for use in the home setting by people with diabetes mellitus who require insulin on a daily basis." |
| Sterilization | A sterilization product adoption was conducted in accordance with AAMI TIR28:2016, and bioburden testing was conducted in accordance with ISO 11737-1 for the modified soft cannula design. |
| Risk Management | Risk management was completed in accordance with ISO 14971:2007. Verification activities demonstrated that the predetermined acceptance criteria were met and the devices are safe for use. |
| Other Standards Compliance | The devices comply with ISO 10993-1 (biological evaluation), ISO 14971 (risk management), ISO 11737-1 (sterilization - microbiological methods), and ISO 11135 (sterilization - ethylene oxide). |
Missing Information: The document does not provide the specific numerical acceptance criteria (e.g., specific thresholds for leachables, precise depth specifications, or quantitative results from the stability/compatibility testing). It states that criteria were "met" or "verified" or "validated."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Real-world data analysis: An analysis of post-market data gathered from devices with the modified soft cannula was conducted..."
- Sample Size: Not specified.
- Data Provenance: Retrospective, post-market data. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable as this was not a diagnostic image-based AI study relying on expert ground truth. The "ground truth" for cannula performance or insulin stability would be derived from laboratory measurements and clinical outcomes, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable for this type of device modification study. Adjudication methods like 2+1 or 3+1 typically refer to reconciliation of discrepancies among multiple expert readers in diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI. The document focuses on performance testing of the device's physical and chemical properties and post-market safety.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The device is an insulin pump system with a bolus calculator, not a standalone AI algorithm for diagnosis. Therefore, this question isn't directly applicable in the typical sense of AI standalone performance. The "algorithm" for dose calculation is part of the system's intended function, and its overall safety and effectiveness were assessed as part of the system.
7. The Type of Ground Truth Used
- For Drug Stability and Compatibility: Laboratory analytical results for insulin integrity (e.g., potency, purity, presence of leachables).
- For Soft Cannula Studies: Engineering measurements and specifications for insertion depth and insulin infusion depth.
- For Safety and Effectiveness (Real-world data): Clinical outcomes, adverse event reports, and other post-market surveillance data.
- For Sterilization: Microbiological test results (bioburden) and compliance with sterilization standards.
- For Risk Management: Verification activities demonstrating that risks identified were mitigated to an acceptable level as defined by ISO 14971.
8. The Sample Size for the Training Set
Not applicable. This document describes a modification to an existing device, and the "real-world data analysis" was for post-market validation, not for training a machine learning model in the context of an AI device. The bolus calculator is rule-based and user-programmed, not an AI model requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no mention of a traditional "training set" for an AI model.
Ask a specific question about this device
(144 days)
Omnipod DASH Insulin Management System
The Omnipod DASH™ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Additionally. the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
The Omnipod DASH™ Insulin Management System provides for the management of insulin therapy by patients with diabetes mellitus. It is comprised of two primary components: the disposable insulin infusion pump (Pod), and an associated Bluetooth Low Energy (BLE) enabled remote controller referred to as the Personal Diabetes Manager (PDM). The PDM can communicate with interoperable, compatible BLE enabled blood glucose meters. The PDM incorporates a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM using a touch screen, similar to a smartphone, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The device system is for prescription use only.
The provided text describes the Omnipod DASH™ Insulin Management System and its 510(k) submission (K180045) to the FDA. The submission asserts substantial equivalence to a predicate device (K162296 Omnipod® Insulin Management System).
However, the document does not contain a typical acceptance criteria table with reported device performance in a numerical or statistical format that is commonly used for AI/ML-based diagnostic devices. Instead, it focuses on demonstrating safety and effectiveness through compliance with various standards and guidance documents. The "acceptance criteria" are implied by the successful completion of various tests and adherence to regulatory standards.
Here's a breakdown of the requested information based on the provided text, recognizing that it pertains to an insulin pump and not a diagnostic AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or other statistical measures, as would be common for AI/ML diagnostic tools. Instead, the "acceptance criteria" are implied by successful completion of various engineering, safety, and regulatory compliance tests. The "reported device performance" is that the device met these criteria.
| Acceptance Criteria (Implied by successful test completion) | Reported Device Performance |
|---|---|
| Safety Assurance Case Goals: | |
| - Acceptable safety for infusion of U100 insulin for diabetes management in home setting. | Met - The system was found acceptably safe. |
| - Adequate risk mitigation from identified hazards. | Met - Hazards adequately addressed. |
| - Adequately designed to function for intended use and period. | Met - Design found adequate. |
| - Design specifications adequately verified and validated. | Met - Specifications verified and validated. |
| Hazard Categories Addressed (Examples): | |
| - Infusion Delivery Errors (e.g., over/under-infusion, delay). | Addressed through design and testing. |
| - Incorrect setup/entry of insulin prescription. | Addressed through design and testing. |
| - User workaround/bypassing software limits. | Addressed through design and testing. |
| - User error in pump operation/inputting values. | Addressed through design and testing. |
| - Incorrect Pod activation, accidental use of another PDM. | Addressed through design and testing. |
| - EMC or EMI interference causing malfunction. | Met - Tested according to IEC 60601-1-2. |
| - Battery disconnection, component damage from dropping/shipping. | Addressed through design and testing. |
| - PDM exposure to water, screen cracks. | Addressed through design and testing. |
| - Incorrect blood glucose readings from BGM interoperability. | Addressed through design and testing. |
| - Stuck PDM keys, software algorithm errors. | Addressed through design and testing. |
| - Occlusion, restricted insulin flow. | Met - Occlusion Detection Testing performed. |
| - Higher than expected flow. | Addressed through design and testing. |
| - PDM loses backup power, date/time. | Addressed through design and testing. |
| - Pod needle deploy/retraction issues, failed deploy, lack of clearance. | Addressed through design and testing. |
| - Plunger failure, Pod software failure, Pod not activating. | Addressed through design and testing. |
| - Pod structural integrity loss, no audible alarm. | Addressed through design and testing. |
| - Software corruption from updates. | Addressed through design and testing. |
| - Incorrect needle depth/angle. | Addressed through design and testing. |
| - User miscalculation of carbs/bolus, not accounting for IoB. | Addressed through design and testing. |
| - Hypoglycemia from post-occlusion bolus. | Addressed through design and testing. |
| - Incorrect therapy/treatment. | Addressed through design and testing. |
| - Harm from non-secure communication (cybersecurity). | Met - Cybersecurity testing performed. |
| - Biological/chemical contamination (insulin potency, sterility, biocompatibility, material leaching). | Met - Biocompatibility testing to ISO 10993 standards. |
| - Traumatic injury (electrical shock). | Addressed through design and testing. |
| Risk Management: | Met - Performed in accordance with ISO 14971:2007; predetermined acceptance criteria met; device free of unacceptable risk. |
| Biocompatibility: | Met - Verification testing completed in accordance with ISO 10993 Parts 3, 4, 5, 6, 10, 11, 17, 18. |
| Safety, Electrical Safety, and EMC: | Met - Testing conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11. |
| Software: | Met - V&V testing conducted to IEC 62304 and FDA guidance; Cybersecurity tested to FDA guidance. Software classified as "major" level of concern with no unaddressed issues. |
| Bench Testing (Reliability, Safety, Verification): | Met - All specific reliability, safety, and verification tests (e.g., Electrical Spec, Occlusion Detection, Insulin Delivery Verification, Regression Analysis) were successfully completed. |
| Human Factors: | Met - Validation performed in accordance with FDA Guidance and IEC 62366-1; device validated for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various types of tests (bench testing, software V&V, human factors, biocompatibility, safety, EMC) but does not specify the sample sizes for these tests. For instance, for mechanical integrity or software testing, there's no mention of the number of devices or iterations tested. Similarly, no information is provided regarding data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically contained within the full test reports referenced by the 510(k) summary, but not elaborated here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in a way that is relevant to AI/ML ground truthing. The "ground truth" for an insulin pump's performance is typically established through engineering specifications, regulatory standards, and clinical outcomes, rather than expert consensus on diagnostic interpretations. The document states that the safety assurance case and human factors validation involved identifying and mitigating risks (suggesting expert input in risk analysis), but it doesn't specify the number or qualifications of experts in the context of "ground truth" as it would for image-based diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This detail is not mentioned. Adjudication methods like "2+1" or "3+1" are usually associated with establishing ground truth in clinical studies, particularly for diagnostic imaging. For an insulin pump, validation often relies on meeting predetermined engineering and safety specifications through direct measurement and testing, rather than a consensus-based adjudication process for interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or is referenced. This type of study is specifically designed for evaluating the impact of AI on human readers in diagnostic tasks, which is not applicable to the Omnipod DASH™ Insulin Management System as it is an insulin delivery device, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an insulin pump, and its "algorithm" (the insulin dose calculator) is inherently designed for human-in-the-loop operation, where the user makes decisions based on the device's calculations and their own blood glucose readings. Therefore, a standalone "algorithm-only" performance study in the context of removing human interaction is not relevant or described. The document does mention "PDM software algorithm error results in errant insulin infusion program on the Pod," indicating that the software's performance is tested, but not as a replacement for human decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this medical device, the "ground truth" is largely defined by:
- Engineering Specifications: The device must deliver insulin accurately, reliably, and safely according to its design parameters.
- Regulatory Standards: Compliance with international standards (e.g., ISO 14971 for risk management, ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and performance, IEC 62304 for software).
- Safety Assurance Cases: Demonstrating that identified hazards are adequately mitigated and the system is acceptably safe for its intended use.
- Intended Use Validation: Human factors studies confirm that the device can be used safely by the target population.
- Clinical Efficacy (implied by predicate): The device's primary function (insulin delivery for diabetes management) is well-established therapy. The device demonstrates substantial equivalence to a predicate device, implying similar clinical effectiveness.
It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic AI.
8. The sample size for the training set
Not applicable. The Omnipod DASH™ Insulin Management System is not an AI/ML device that undergoes "training" based on a dataset. It is a programmed medical device that operates based on predefined algorithms and user input.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of medical device.
Ask a specific question about this device
Page 1 of 1