← Product Code [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG) · K191679

# Omnipod DASH Insulin Management System with interoperable technology (K191679)

_Insulet Corporation · QFG · Sep 20, 2019 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K191679

## Device Facts

- **Applicant:** Insulet Corporation
- **Product Code:** [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG.md)
- **Decision Date:** Sep 20, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5730
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Therapeutic

## Indications for Use

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.

## Device Story

Subcutaneous insulin delivery system; consists of disposable wearable Pod and Bluetooth Low Energy (BLE) enabled Personal Diabetes Manager (PDM). PDM features touch screen interface; bolus calculator uses carbohydrates, blood glucose, correction factor, insulin-to-carbohydrate ratio, target glucose, and Insulin on Board (IoB). Pod adheres to skin (arm, back, abdomen, thigh); provides 3-day insulin delivery. System supports interoperability with external controllers (e.g., Automated Insulin Delivery (AID) systems); external controller reads Pod status and iCGM sensor values, computes delivery, and commands Pod. Pod maintains programmed basal rate during communication loss. Used in home setting by patients; aids in glycemic management; provides audit logs of delivery and connectivity events.

## Clinical Evidence

Bench testing only. No clinical data. Performance verified via basal/bolus delivery accuracy testing, occlusion detection timing, and system integration testing. Biocompatibility, sterility, and insulin stability (extractables/leachables) verified per ISO standards.

## Technological Characteristics

Insulin infusion pump; BLE connectivity; disposable Pod (3-day wear) and handheld PDM. Software-controlled basal/bolus delivery. Biocompatible adhesive pad. Complies with ISO 14971 risk management. ACE pump classification (21 CFR 880.5730).

## Regulatory 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.

## Special Controls

Alternate controller enabled infusion pumps must comply with the following special controls:

*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 <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >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.

## Predicate Devices

- t:slim X2 insulin pump with interoperable technology ([DEN180058](/device/DEN180058.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information

A 510(k) Number
K191679

B Applicant
Insulet Corporation

C Proprietary and Established Names
Omnipod DASH Insulin Management System with interoperable technology

D Regulatory Information
|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Infusion Pump | CH - Clinical Chemistry  |

## E Purpose for Submission

This submission seeks changes to the indications for use for the previously cleared Omnipod DASH Insulin Management System (k180045). As an ACE pump, the device can reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices.

## II Intended Use/Indications for Use

A Intended Use(s)
See Indications for Use below.

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B Indication(s) for Use

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.

C Special Conditions for Use Statements

This device is for prescription use only.

The Pod and Personal Diabetes Manager (PDM) may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove and dispose of your Pod and place your PDM outside the treatment area. Check with your healthcare provider on Pod removal guidelines.

The Omnipod DASH System is designed to use rapid-acting U-100 insulin. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog, Humalog, Admelog, or Apidra. NovoLog, Humalog, and Admelog are compatible with the Omnipod DASH System for use up to 72 hours (3 days). Apidra is compatible with the Omnipod DASH System for use up to 48 hours (2 days). Before using a different insulin with the Omnipod DASH System, check the insulin drug label and consult your healthcare provider. Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace the Pod.

III Device Description

The hardware and software of the device is identical to the device cleared under k182630. The Omnipod DASH Insulet management system with interoperable technology is a body-worn, battery operated, rate programmable infusion pump designed for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. 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 is provided with the DASH PDM, but future alternate controllers may be established. The PDM includes a wireless internet interface to allow for software updates.

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

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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 Dosing (AID) systems. In this design, a controller may contain an algorithm and connect to an integrated continuous glucose monitoring (iCGM) system (21 CFR 862.1355). In such an integrated system, the AID controller would be responsible for coordinating the interoperable devices (Omnipod DASH and iCGM) in order to automate dosing. It would read the Pod for insulin delivery status, read the iCGM for the sensor value, compute an automated dose 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 default back to the programmed basal rate in the case of extended loss of communication.

## IV Substantial Equivalence Information

### A Predicate Device Name(s)

t:slim X2 insulin pump with interoperable technology

### B Predicate 510(k) Number(s)

DEN180058

### C Comparison with Predicate(s)

|  Device & Predicate Device(s): | k191679 | DEN180058  |
| --- | --- | --- |
|  Device trade name | Omnipod DASH
Insulin Management System with interoperable technology | t:slim X2 insulin pump with interoperable technology  |
|  General Device Characteristic Similarities |  |   |
|  Intended use/Indications for use | Intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Intended to be interoperable with connected devices | Same  |

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|   | including CGMs and automated insulin dosing algorithms |   |
| --- | --- | --- |
|  Communication | Bluetooth Low Energy | Same  |
|  Memory | 90 days on average of insulin delivery, blood glucose results, carbohydrate intake, and alarm data. | Same  |
|  General Device Characteristic Differences |  |   |
|  Compatible drug products | Novolog, Humalog, Apidra, or Admelog U-100 Insulin | Novolog or Humalog U-100 Insulin  |
|  Pump design | Single-use on-body pump with wireless controller | Reusable pump with integrated controller  |
|  Administration sets and reservoir | Integrated reservoir and patient activated cannula insertion system | Disposable reservoir and disposable infusion sets.  |
|  User interface | Hand-held touchscreen locked mobile device | Integrated touchscreen on infusion pump  |
|  Flow rates and profiles | Basal: 0.05 – 30 units/hour in 0.05 unit increments | Basal: 0.1 – 15 units/hour in 0.001 unit increments  |
|   |  Bolus: 0.05 – 30 units in 0.05 unit increments | Bolus: 0.05 – 25 units in 0.01 unit increments  |
|   |  12 basal profiles | 6 insulin delivery profiles (basal and bolus)  |
|  Maximum bolus flow rate | 1.5 units / minute | 2.97 units / minute  |

V Standards/Guidance Documents Referenced

- FDA Guidance “Infusion Pumps Total Product Life Cycle” dated December 2, 2014
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
- FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” dated May 11, 2005
- FDA Guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” dated October 2, 2014
- FDA Guidance “General Principles of Software Validation” dated January 11, 2002

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- ISO 10993-1:2009 (4th Edition) Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- ISO 10993-3:2014 Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-4:2002(A-2006) Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-6:2007 Biological Evaluation of Medical Devices – Part 6: Test for Local Effects After Implantation
- ISO 10993-7:2008 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
- ISO 14971 Second Edition 2007-03-01 Medical Devices – Application of Risk Management to Medical Devices
- IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2 Ed. 4.0 b: 2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances- Requirements and Tests
- IEC 60601-1-6 Ed. 3.1 b. 2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8 Ed. 2.1 b: 2012 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
- IEC 60601-1-11 Issued: 2015/01/20 Ed.2 Medical Electrical Equipment – Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard- Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 62304:2006 Medical Device Software – Software Life Cycle Processes
- IEC 62366-1 Ed. 1.0 Medical Devices – Part 1: Application Of Usability Engineering To Medical Devices
- AAMI/ANSI/ISO 11135:2014 Sterilization of Health Care Products – Ethylene Oxide – Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
- AAMI TIR 28:2016 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization
- AAMI/ANSI ST 72:2011 Bacterial Endotoxins – Test Methods, Routine Monitoring and Alternatives to Batch Testing
- ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [including Amendment 1 (2014)]

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VI Performance Characteristics

A Analytical Performance

1. Basal delivery accuracy

To assess basal delivery accuracy, 12 Omnipod pumps were tested by delivering insulin at low, medium, and high basal rates (0.05, 1.00, and 30.0 U/hr). Water was used as a substitute for insulin. The water was pumped into a container on a scale and the weight of the liquid at various time points was used to assess basal delivery accuracy.

The following tables report the typical basal performance (median) observed, along with the lowest and highest results observed for the low, medium, and high basal rate settings for all pumps tested with no warmup period. For each time period, the tables show the volume of insulin requested in the first row and the volume that was delivered as measured by the scale in the second row.

Table 1: Amount of fluid delivered after 1, 6, and 12 hours with 30 U/hr (high) basal rate setting

|  30 U/hr Basal Duration | 1 hour | 6 hours  |
| --- | --- | --- |
|  Total expected delivery volume | 30 U | 180 U  |
|  Median amount delivered
[min, max] | 29.8 U
[28.9, 31.4] | 179 U
[177, 181]  |

Note: A measurement at the 12-hour period with 30.0 U/hr basal rate is not applicable to the DASH System as the reservoir will empty at approximately 6 ⅔ hours at this rate.

Table 2: Amount of fluid delivered after 1, 6, and 12 hours with 1 U/hr (medium) basal rate setting

|  1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours  |
| --- | --- | --- | --- |
|  Total expected delivery volume | 1 U | 6 U | 12 U  |
|  Median amount delivered
[min, max] | 0.99 U
[0.65, 1.55] | 5.97 U
[5.06, 6.87] | 11.9 U
[10.5, 13.3]  |

Table 3: Amount of fluid delivered after 1, 6, and 12 hours with 0.05 U/hr (low) basal rate setting

|  0.05 U/hr Basal Duration | 1 hour | 6 hours | 12 hours  |
| --- | --- | --- | --- |
|  Total expected delivery volume | 0.05 U | 0.3 U | 0.6 U  |
|  Median amount delivered
[min, max] | 0.049 U
[0.00, 0.12] | 0.30 U
[0.13, 0.57] | 0.59 U
[0.34, 0.99]  |

2. Bolus delivery accuracy

To assess bolus delivery accuracy, 12 Omnipod pumps were tested by delivering a minimum, intermediate, and maximum bolus amount (0.05, 5.00, and 30.0 Units). Water was used as a

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substitute for insulin. The water was pumped into a container on a scale and the weight of the liquid delivered was used to assess pumping accuracy. The number of total and consecutive boluses delivered in this testing for each delivery volume is described in Table 4 below:

Table 4: Summary of bolus testing protocol

|  Bolus size (units) | Number of pumps tested | Consecutive boluses per pump | Total boluses  |
| --- | --- | --- | --- |
|  0.05 units | 12 | 500 | 6000  |
|  5.0 units | 12 | 25 | 300  |
|  30 units | 12 | 6 | 72  |

Water was used as a substitute for insulin for this testing. The water was pumped into a container on a scale, and the weight of the liquid at various times points was used to assess bolus delivery accuracy. The actual bolus volume delivered was compared to the expected bolus volume for minimum, intermediate, and maximum boluses. Tables 5-7 below show the number (and %) of boluses within the specified range of each target bolus volume.

Table 5: Amount of fluid delivered after a 0.05 U bolus request

|  Units delivered after a 0.05 U bolus request (% of commanded units)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <0.0125 | 0.0125 - 0.0375 | 0.0375- 0.045 | 0.045- 0.0475 | 0.0475- 0.0525 | 0.0525- 0.0550 | 0.055- 0.0625 | 0.0625- 0.0875 | 0.0875- 0.125 | >0.125  |
|   | (<25%) | (25-75%) | (75-90%) | (90-95%) | (95-105%) | (105-110%) | (110-125%) | (125-175%) | (175-250%) | (>250%)  |
|  Number and percent of boluses | 61/5987 (1%) | 639/5987 (10.7%) | 1284/5987 (21.4%) | 504/5987 (8.4%) | 1100/5987 (18.4%) | 504/5987 (8.4%) | 1192/5987 (19.9%) | 582/5987 (9.7%) | 121/5987 (2%) | 0/5987 (0%)  |

Table 6: Amount of fluid delivered after a 5.0 U bolus request

|  Units delivered after a 5.0 U bolus request (% of commanded units)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <1.25 | 1.25-3.75 | 3.75-4.50 | 4.50-4.75 | 4.75-5.25 | 5.25-5.50 | 5.50-6.25 | 6.25-8.75 | 8.75-2.50 | >12.50  |
|   | (<25%) | (25-75%) | (75-90%) | (90-95%) | (95-105%) | (105-110%) | (110-125%) | (125-175%) | (175-250%) | (>250%)  |
|  Number and percent of boluses | 0/300 (0%) | 0/300 (0%) | 1/300 (0.3%) | 4/300 (1.3%) | 287/300 (95.7%) | 8/300 (2.7%) | 0/300 (0%) | 0/300 (0%) | 0/300 (0%) | 0/300 (0%)  |

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Table 7: Amount of fluid delivered after a 30 U bolus request

|  Units delivered after a 30 U bolus request (% of commanded 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%) | 33-37.5
(110-125%) | 37.5-52.5
(125-175%) | 52.5-75.0
(175-250%) | >75.0
(>250%)  |
|  Number and percent of boluses | 0/72
(0%) | 0/72
(0%) | 0/72
(0%) | 0/72
(0%) | 72/72
(100%) | 0/72
(0%) | 0/72
(0%) | 0/72
(0%) | 0/72
(0%) | 0/72
(0%)  |

## 3. Occlusion detection

An occlusion hazard alarm sounds when an average of 3 units to 5 units of missed insulin occurs. The following table depicts occlusion detection for three different situations when using U-100 insulin. For example, if the pod's cannula becomes occluded when delivering a 5 U bolus, 35 minutes may pass before the Pod sounds a hazard alarm.

Table 8: Timing of occlusion detection alarms

|   | Typical time to occlusion detection | Maximum time to occlusion detection  |
| --- | --- | --- |
|  5.0 U Bolus | 33 minutes | 35 minutes  |
|  1.0 U/hr Basal | 3.0 hours | 5.5 hours  |
|  0.05 U/hr Basal | 51 hours | 80 hours (Pod expiration)  |

Occlusion detection testing was conducted using 64 pumps. To test the time between occlusion and pump alarm, pumps were physically occluded and insulin delivery was activated. Log files from the PDM were downloaded once the pumps triggered an occlusion alarm to gather the time when the PDM sent the delivery command and when the pump reported it triggered the alarm. This was used to calculate the time between occlusion and pump alarm. The typical time is the average for the samples and the maximum time is the absolute maximum.

## B Other Supportive Instrument Performance Characteristics Data

### 1. Hazard Analysis

A comprehensive hazard analysis for this device was reviewed in k182630 and k180045, in which design inputs and outputs, risks, and risk mitigations for hardware and software associated with proper functioning of the insulin pump component of those systems were reviewed in those 510(k) submission. The sponsor provided a revised hazard analysis in this submission to account for the unique design elements, intended use, and risks of the Omnipod DASH Insulin Management System which had not been previously reviewed. In

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particular, this revised hazard analysis accounted for the risks associated with interoperability between the device and other third party digital devices which met predefined criteria but were not specifically identified, including scenarios in which the device was put into an environment in which both compatible and incompatible digital devices attempted to communicate with the device and deliver commands. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated.

## 2. Human Factors

Human factors testing was performed with the Insulet-supplied PDM as the controller for the Pod under k180045. The user interface for the DASH Insulin Management System is identical to that in k180045. For future interoperable controllers with Omnipod DASH Pod as an alternate controller enabled pump, additional human factors testing will need to be completed.

## 3. Biocompatibility

All of the materials and manufacturing processes of the subject Omnipod DASH Insulin Management System with interoperable technology are identical to those of the currently marketed system found in k182630 (and also in k180045), therefore no additional biocompatibility testing was conducted with the subject device for this 510(k).

Verification testing completed in accordance with ISO 10993 – Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity – Part 4: Selection of tests for interactions with blood – Part 5: Tests for in vitro cytotoxicity – Part 6: Tests for local effects after implantation – Part 10: Tests for irritation and skin sensitization – Part 11: Tests for systemic toxicity – Part 17: Establishment of allowable limits for leachable substances and Part 18: Chemical Characterizations of Materials.

## 4. Sterility

The subject device is identical to the currently marketed Omnipod DASH Insulin Management System (k182630). The sterilization and shelf life information has not changed from that which was submitted in k182630.

## 5. Insulin Compatibility and Stability

In vitro testing was performed to assess extractables and leachables and insulin compatibility with Humalog, Novolog, Apidra, and Admelog U-100 insulin drugs. To support the compatibility of these insulin analogs the stability of these drugs was evaluated under stressed, worst-case conditions. The studies observed acceptable results of degradation

K191679 - Page 9 of 12

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products, extractables, and leachables, and support the compatibility with these insulin analogs.

## 6. Additional Bench Testing

In addition to the performance testing described above, mechanical testing, simulated use testing, and other device verification testing was conducted to demonstrate that the system meets its intended use and is safe, reliable, and all safety and reliability critical requirements have been adequately verified. Summaries for reliability, safety, and verification testing follow:

|  Testing to Support System Reliability  |
| --- |
|  Electrical Specification Testing  |
|  Hardware Control Testing  |
|  Real Time Clock Testing  |
|  BLE Carrier Frequency Accuracy Testing  |
|  Wire Drive Testing  |
|  RF Throughput Test Report  |
|  Design Visual Inspection  |
|  System Integration Testing  |
|  Testing to Support System Safety  |
| --- |
|  Environmental Safety Testing to 60601-1-11  |
|  Safety and Essential Performance Testing to 60601-Occlusion Detection Testing  |
|  Suspend and Resume Testing  |
|  Alarms Testing  |
|  Data Handling Testing  |
|  Pump Activation and Deactivation Testing  |
|  Pump/Controller Connectivity Testing  |
|  User Guide Testing  |
|  BGM Functions Testing  |
|  Insulin Delivery Verification Testing  |
|  Testing to Support System Verification  |
| --- |
|  Environmental Safety Testing to 60601-1-11  |
|  Safety and Essential Performance Testing to 60601-Occlusion Detection Testing  |
|  Suspend and Resume Testing  |
|  Alarms Testing  |
|  Data Handling Testing  |
|  Pump Activation and Deactivation Testing  |
|  Pump/Controller Connectivity Testing  |
|  User Guide Testing  |

K191679 - Page 10 of 12

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K191679 - Page 11 of 12

Insulin Delivery Verification Testing
Regression Analysis and Testing

7. Electromagnetic Compatibility and Wireless Coexistence

The subject device is identical to the currently marketed Omnipod DASH Insulin Management System (k182630). Safety, Electrical Safety, and EMC testing were conducted on the Omnipod DASH Insulin Management System, consisting of the Pod and PDM, in accordance with IEC 60601-1 for Basic Safety and Essential Performance, IEC 60601-1-2 for Electromagnetic Disturbances, IEC 60601-1-6 for Usability, IEC 60601-1-8 for Alarms, IEC 60601-1-11 for Systems Used in the Home Healthcare Environment.

8. Electrical Safety and Essential Performance

The sponsor demonstrated testing for safety requirements for electrical equipment in compliance with IEC 60601-1, including compliance with the following collateral standards: IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24. All tests passed acceptance criteria.

9. Data Logging

The sponsor provided a summary of pump and PDM logging capability which enable the device to record critical events including insulin delivery, pump commands and confirmations, connectivity states, malfunctions, and alarms. These were reviewed and found to be adequate.

10. Interoperability

A plan and approach for interoperability were provided according to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff" and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, their plan covered their approach to working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events).

The sponsor additionally provided validated software protocols intended to ensure secure, accurate, and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected devices. These protocols were reviewed and found to be adequate.

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K191679 - Page 12 of 12

## 11. Cybersecurity

Detailed information on cybersecurity of the device was reviewed and found to be acceptable.

## VII Proposed Labeling

The labeling supports the finding of substantial equivalence for this device.

## VIII Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K191679](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K191679)

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