(88 days)
Yes
The description explicitly mentions the capability for "Automated Insulin Delivery (AID) systems" which would contain an "algorithm" to compute and command automated delivery based on sensor values and insulin delivery status. While not explicitly stating "AI" or "ML," this describes a closed-loop system with an algorithm making decisions, which is a common application of ML in medical devices.
Yes
The device is described as an "Insulin Management System" and its intended use is for "subcutaneous delivery of insulin... for the management of diabetes mellitus," which directly addresses a health condition.
No
Explanation: The device is an insulin pump designed for delivering insulin to manage diabetes. While it uses blood glucose readings and calculations to determine insulin dosage, its primary function is therapeutic (insulin delivery), not diagnostic (identifying or characterizing a disease).
No
The device description clearly states it is comprised of two primary components: a disposable insulin infusion pump (Pod) and an associated Bluetooth Low Energy (BLE) enabled remote controller (DASH PDM). This includes significant hardware components beyond just software.
Based on the provided information, the Omnipod DASH Insulin Management System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the subcutaneous delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as an insulin infusion pump system. It delivers insulin based on user input and calculations, and can receive commands from other devices. It does not analyze biological samples (like blood or urine) to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro testing, such as reagents, sample collection, or analysis of biological specimens.
While the system uses blood glucose readings (likely obtained from a separate device like a blood glucose meter or continuous glucose monitor) to aid in insulin dosage calculations, the Omnipod DASH itself is not performing the in vitro diagnostic test. It is acting as a delivery system based on the results of those tests.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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.
Product codes
QFG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue
Indicated Patient Age Range
persons requiring insulin.
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)
Performance testing of the Omnipod DASH™ Insulin Management System with interoperable technology demonstrated that the subject device met all device specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 20, 2019
Insulet Corporation Julie Perkins Sr. Director, Quality Assurance and Regulatory Affairs 100 Nagog Park Acton, MA 01720
Re: K191679
Trade/Device Name: Omnipod DASH Insulin Management 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: June 21, 2019 Received: June 24, 2019
Dear Julie Perkins:
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 mediation-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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K191679
Device Name
Omnipod DASH Insulin Management System with interoperable technology
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Omnipod Insulin Management System. The logo features a circular design made up of many small, vertical lines. Below the circular design, the word "omnipod" is written in lowercase letters, with the trademark symbol next to it. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.
5.0 510(K) SUMMARY
| Date Prepared: | September 11, 2019 |
|---|---|
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park, Acton, MA, 01720 |
| FDA Establishment Owner/Operator | |
| Number: | 9056196 |
| FDA Establishment Registration Number: | 3014585508 |
| Contact Person: | Julie Perkins |
| Sr. Director, Quality Assurance and | |
| Regulatory Affairs | |
| Phone: | 978-600-7951 (office) |
| Fax: | 987-600-0120 |
| Device Trade / Proprietary Name: | Omnipod DASH™ Insulin Management |
| System with interoperable technology | |
| Device Common Name: | Alternate controller enabled infusion pump |
| Regulation Description: | Infusion pump |
| Regulation Medical Specialty: | Hematology |
| Review Panel(s): | Clinical Chemistry |
| Product Code(s): | QFG |
| Regulation Numbers: | 21 CFR 880.5730 |
| Submission Type: | Traditional 510(k) |
| Device Class: | Class II |
| Model Number (Pod): | BLE-11-529 |
| Model Number (PDM): | USA1-D001-MG-USA1 |
| Device Predicate: | DEN180058, t:slim X2 insulin pump with |
| interoperable technology |
4
Purpose of Submission:
Modification to legally marketed device to expand the indications for use.
Device Description:
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.
Indications for Use: 12.1
The Omnipod DASH Insulin Management System (the Pump) 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 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.
5
Summary of Technological Characteristics Compared to Predicate Device:
The subject device and predicate device use similar operating principles to achieve the intended therapeutic effect. The subject device and predicate device are both insulin infusion pumps composed of a software-controlled, programmable pump capable of both basal and bolus delivery of insulin. The technological characteristics differ from the predicate, however the system is the same as the currently marketed Omnipod DASH system (K182630). The differences between predicate and subject device do not raise any questions about safety and effectiveness, therefore, the Omnipod DASH System with interoperable technology is substantially equivalent to its predicate.
| Special Control | Omnipod DASH with interoperable
technology (Subject Device) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
i. Design input requirements must include
delivery accuracy specifications under
reasonably foreseeable use conditions,
including ambient temperature changes,
pressure changes (e.g., headheight,
backpressure, atmospheric), and, as
appropriate, different drug fluidic
properties.
ii. 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. | All the performance testing provided in K182630
and K180045 are applicable to the subject
device. Further characterization has been
conducted and submitted in this 510(k). |
| 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 | The subject device is identical to the DASH
system in K182630 (initially cleared in
K180045). All testing, except delivery accuracy,
was completed to demonstrate the ability of
Omnipod DASH with interoperable technology
to detect relevant hazards associated with insulin
delivery and was provided in K182630 and |
| appropriate for the intended use of the device
and testing must validate appropriate
performance under the conditions of use for the
device. | K180045. Delivery accuracy was conducted for
this submission.
Traceability of hazards to risk controls and
verification evidence is included in the System
Hazard Analysis provided in this submission. |
| Validation testing results demonstrating
compatibility with drugs which may be used
with the pump based on its labeling. Testing
must include assessment of drug stability under
reasonably foreseeable use conditions which
may affect drug stability (e.g., temperature,
light exposure, or other factors as needed). | The subject device is identical to the DASH
system in K182630 (initially cleared in
K180045). All validation testing to demonstrate
the Omnipod DASH Insulin Management
System with interoperable technology is
compatible with insulin was provided in
K180045 and K182630. |
| 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. | The subject device is identical to the DASH
system in K182630 (initially cleared in
K180045). The biocompatibility of parts that
directly contact the patient (adhesive pad) was
demonstrated with cytotoxicity, sensitization,
and skin irritation studies- with the exception of
chronic toxicity and carcinogenicity as it was
determined that the Omnipod DASH with
interoperable technology is not a risk for these.
All results were passing.
The biocompatibility of parts that indirectly
contact the patient, those that are in the fluid
path, was demonstrated with cytotoxicity,
sensitization, intracutaneous reactivity, acute
system toxicity, material mediated pyrogenicity,
subacute/subchronic toxicity, genotoxicity,
implantation, and hemocompatibility. All results
were passing. |
| 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. | The subject device is identical to the DASH
system in K182630 (initially cleared in
K180045). No additional shelf life testing was
completed for Omnipod DASH with
interoperable technology. |
| The device must be designed and tested for
electrical safety, electromagnetic compatibility,
and radio frequency wireless safety and | The subject device is identical to the DASH
system in K182630 (initially cleared in
K180045). No additional electrical safety and |
| availability consistent with patient safety | electromagnetic compatibility testing was |
| requirements in the intended use environment. | completed for Omnipod DASH with
interoperable technology. |
| For any device that is capable of delivering
more than one drug, the risk of cross-
channeling drugs must be adequately mitigated. | Omnipod DASH is only intended for U-100
insulin delivery. |
| 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. | Omnipod DASH with interoperable technology
is only intended for single-patient use. The
DASH Pod is a single-use disposable component
which provided insulin delivery for 3 days. The
PDM is a non-sterile single-use patient
component. |
| The device shall include validated interface
specifications for digitally connected devices.
These interface specifications shall, at a
minimum, provide for the following:
a. Secure authentication (pairing) to external
devices.
b. Secure, accurate, and reliable means of data
transmission between the pump and
connected devices.
c. Sharing of necessary state information
between the pump and any digitally
connected alternate controllers (e.g., battery
level, reservoir level, pump status, error
conditions).
d. Ensuring that the pump continues to operate
safely when data is received in a manner
outside the bounds of the parameters
specified.
e. A detailed process and procedure for
sharing the pump interface specification
with digitally connected devices and for
validating the correct implementation of
that protocol. | The interface between the Omnipod DASH
controller (PDM) and pump (DASH Pod has
been specified and validated.
Insulet has a detailed process established for
sharing the pump interface specification with
digitally connected devices and for validating the
correct implementation of that protocol. |
| 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 | The design intent of the Omnipod DASH with
interoperable technology is for all insulin
delivery commands that the controller (PDM) |
| information with the responsible parties for | sends to the pump (DASH Pod) be logged in the |
| those connected devices. Critical events to be | PDM's memory. |
| stored by the system must, at a minimum,
include:
a. A record of all drug delivery
b. Commands issued to the pump and pump
confirmations
c. Device malfunctions
d. Alarms and alerts and associated
acknowledgements
e. Connectivity events (e.g., establishment or
loss of communications) | a. The execution of insulin delivery commands
is stored in the DASH Pod's memory as a
record of basal and bolus pulses delivered.
b. In addition to storing a record of insulin
delivery commands sent, the PDM also stores
a record of the execution of the commands
once it receives confirmation from the DASH
Pod that the command was executed.
c. The combination of the DASH Pod log and
PDM log allows Insulet to audit failures of the
system and determine root causes. This log
includes all of the requirements outlined in the
special controls.
d. The PDM stores 90 days' worth of a records
of all alarms, alerts and acknowledgements.
e. The PDM stores a short duration
(approximately 3 days, depending on activity)
of records of communication connectivity
events.
Insulet's intention with any partner for an
integrated system incorporating Omnipod DASH
with interoperable technology is to ensure these
logging requirements are met and verified for an
external controller, in order to ensure full
capability to audit for failures of the integrated
system. Additionally, as with the current PDM,
an external controller will have the ability to
query the DASH Pod data.
The Omnipod DASH Insulin Management
System with interoperable technology (subject
device) has an expanded indication from the
currently marketed version (cleared via
K182630). This expanded indication as an
alternate controller enabled (ACE) pump did not
require any design or manufacturing
modifications to the currently cleared Omnipod
DASH system, therefore, all the performance |
| 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. | |
| Device labeling must include the following:
a. A prominent statement identifying the drugs
that are compatible with the device, including
the identity and concentration of those drugs as
appropriate.
b. 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.
c. 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% of the commanded
amount.
d. 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
warm-up 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 | testing provided in K182630 and K180045 are
applicable to the subject device.
The Omnipod DASH User Guide has been
updated to contain the information from the
special controls. |
| the drug delivered) may be provided as follows, as applicable: | |
| i. 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. | |
| e. 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. | |
| f. For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. | |
| g. For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses. | |
Performance Data and Compliance with Special Controls
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Insulet Corporation
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Compliance to Standards: The modified indications for use for the does not require any additional testing in accordance with recognized standards. Updated risk assessments for modified intended use was done in accordance with ISO 14971 Medical Devices – Application of Risk Management to Medical Devices, second edition (2007-03-01).
Substantial Equivalence Conclusion:
The Omnipod DASH™ Insulin Management System with interoperable technology has the indications for use and modes of operation as the predicate t:slim X2 insulin pump with interoperable technology (DEN180058). The evidence provided in this 510(k) demonstrates the Omnipod DASH™ Insulin Management System with interoperable technology to be a device that is as safe and effective as the predicate device and does not raise new questions of safety and effectiveness. Performance testing of the Omnipod DASH™ Insulin Management System with interoperable technology demonstrated that the subject device met all device specifications. Therefore, the subject device is substantially equivalent to the predicate device.