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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 1, 2018

Insulet Corporation Matthew King Director, Regulatory Affairs & Design Ouality Assurance 600 Technology Park Drive, Suite 200 Billerica, Massachusetts 01821

Re: K180045

Trade/Device Name: Omnipod DASH™ Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: May 3, 2018 Received: May 4, 2018

Dear Matthew King:

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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180045

Device Name

Omnipod DASH Insulin Management System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 short, vertical lines arranged in a ring shape. Below the circular design, the word "omnipod" is written in lowercase letters, with a small circle containing the letter 'r' next to it. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, all-caps letters.

510(K) SUMMARY COMPLYING WITH 21 CFR 807.92

Date Prepared:	January 5, 2018
Submitter Name:	Insulet Corporation
Submitter Address:	600 Technology Park Drive, Suite 200Billerica, MA 01821
FDA Establishment Owner/OperatorNumber:	9056196
FDA Establishment Registration Number:	3004464228
Contact Person:	Matthew KingDirector of Regulatory Affairs and Design QualityAssurance
Phone:	(978) 600-7427 (office)(603) 459-9755 (mobile)
Fax:	(978) 600-0120
Device Trade / Proprietary Name:	Omnipod DASH™ Insulin Management System
Device Common Name:	Pump, Infusion, Insulin
Regulation Description:	Infusion pump
Regulation Medical Specialty:	General Hospital
Review Panel(s):	General Hospital
Product Code(s):	LZG (Pump, Infusion, Insulin)
	NDC (Calculator, Drug Dose)
Regulation Numbers:	21 CFR 880.5725 (Infusion Pump)
Submission Type:	Traditional 510(k)
Device Class:	Class II
Model Number (Pod):	BLE-11-529
Model Number (PDM):	USA1-D001-MG-USA1
Device Predicate:	K162296 Omnipod® Insulin Management System

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Image /page/4/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, vertical lines, resembling a stylized sun or gear. Below the circular design, the word "omnipod" is written in lowercase letters, with a small circle symbol next to it. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

Device Description:

Indications for Use:

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 blood glucose measurements.

Summary of Technological Characteristics Compared to Predicate Device:

The subject and predicate device are each continuous insulin delivery systems that provide all of the proven benefits of Continuous Subcutaneous Insulin Infusion (CSII) therapy. This allows a user to place up to 200 Units of their U100 insulin into a reservoir within the Pod and have it delivered subcutaneously at set and variable rates, depending upon their own individual program and needs. Both devices utilize a pump (Pod) with a hard needle/soft-cannula assembly for infusion. The soft cannula surrounds the hard needle. The hard needle has a beveled distal end that pierces the skin and drives into the subcutaneous space. The design of the hard needle is such that it drives into the subcutaneous space between 4mm and 7mm on recommended sites

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Image /page/5/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, parallel lines, resembling a stylized ring or halo. Below the circular design, the word "omnipod" is written in lowercase letters, and below that, the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

on the anatomy of the user. The hard needle immediately retracts back into the Pod housing. leaving the soft cannula behind in the subcutaneous space. allowing for the infusion of the insulin.

In both, the subject and predicate device, insulin is delivered from the Pod reservoir via the same pumping mechanism, which is driven in accordance with commands from the PDM. Both devices enable wireless communication between the Pod and PDM; the subject device communicates via Bluetooth Low Energy (BLE); the predicate device via proprietary Radio Frequency (RF) communication. In the case of each device, the programs communicated from the PDM to the Pod are carried out by the Pod software and hardware, including basal and bolus delivery of insulin. The PDM of both devices has an insulin dose calculator that the user can access in determining their insulin requirements. The dose calculator is the same in both devices, utilizing blood glucose measurement, insulin on board, insulin to carbohydrate ratios, carbohydrate values, and correction factors to assist in calculating doses. Both the subject and predicate devices are able to automatically display blood glucose measurements from a compatible blood glucose meter (BGM), with the subject device communicating wirelessly with a compatible BGM, while the predicate has a BGM embedded in the PDM hardware.

At a high level, the subject and predicate devices are based on the same technological elements including:

Intended use and intended users ●
Components
- o Pod (used to deliver the insulin)
- PDM (used to control the Pod) о
Subcutaneous delivery of insulin ●
Needle/cannula insertion mechanism
Pod and PDM communicate wirelessly ●
Dose calculation algorithm and parameters
Fluid path and body contacting components (same design and materials)
Insulin delivery mechanism
Pod has same source of power ●

The following technological differences exist between the subject and predicate devices:

Use of an Android device as the PDM ●
Bluetooth Low Energy communication ●
Re-designed User Interface
Interoperable with BLE compatible BGM

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Image /page/6/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, blue lines arranged in a ring shape. Below the circular design, the word "omnipod" is written in a blue, sans-serif font, with a small circle symbol next to it. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in a smaller, sans-serif font.

Performance Data and Standards Compliance:

Safety Assurance Case: An assurance case is provided for the Omnipod DASH™ Insulin Management System as recommended in the FDA Guidance "Infusion Pumps Total Product Life Cycle" dated December 2, 2014. The stated goal of the safety assurance case is:

The Omnipod DASH™ Insulin Management System with dose calculator is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis.

The three high level arguments in the Safety Assurance Case are:

The Omnipod DASH™ Insulin Management System is acceptably safe for the infusion of 1. U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis, and has been adequately evaluated for risk mitigations arising from identified hazards.
1. The Omnipod DASH™ Insulin Management System is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis, and has been adequately designed to function for the intended use and the intended period of use defined for the device system.
1. The Omnipod DASH™ Insulin Management System is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis, and the design specifications have been adequately verified and validated.

The supporting evidence demonstrates that the following general categories of hazards have been adequately addressed:

Infusion Delivery Errors: ●
- Incorrect set up of the PDM leading to over-infusion, under-infusion or delay in O infusion of insulin.
- Incorrect entry of insulin prescription leading to overdose or underdose (due to о error, incorrect key strokes, accidentally pressing wrong key, confusion, or inadvertently tapping keys).
- User workaround or bypassing of software limits on insulin dose parameters о leading to overdose or underdose of insulin.
- User error in insulin infusion during pump activation due to misunderstanding of O pump operation, leading to overdose or underdose of insulin.
- User error in insulin infusion during pump activation due to inputting incorrect O insulin values, leading to overdose or underdose of insulin.

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Image /page/7/Picture/0 description: The image shows the logo for Omnipod Insulin Management System. The logo consists of a circular design made up of many small, evenly spaced lines, resembling a stylized sun or gear. Below the circular design, the word "omnipod" is written in lowercase letters, with a small circle containing a registered trademark symbol to the right of the word. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

User activates incorrect Pod, leading to over-infusion or under-infusion of insulin. O
Accidental use of another user's PDM after Pod activation, leading to over- O infusion or under-infusion of insulin.
EMC or EMI interference causing device malfunction, leading to over-infusion or O under-infusion of insulin.
Battery disconnection or component damage resulting in surge caused by O dropping of PDM, leading to over-infusion or under-infusion of insulin.
Electronic component damage caused by shipping of PDM, leading to incorrect O signal to the Pod resulting in over-infusion or under-infusion of insulin.
PDM exposed to water causing a short resulting in incorrect signals to Pod, o leading to over-infusion or under-infusion of insulin.
PDM screen cracks preventing user from adequately programming bolus, leading о to over-infusion or under-infusion of insulin.
User receives incorrect blood glucose readings from a compatible BGM, resulting о in over-infusion or under-infusion of insulin.
User receives over-infusion of insulin due to stuck PDM keys giving a continual O bolus delivery signal to the Pod.
PDM software algorithm error results in errant insulin infusion program on the O Pod causing over-infusion or under-infusion of insulin.
Device is occluded and insulin flow into subcutaneous tissue is restricted, leading о to hyperglycemia.
Flow from Pod is higher than expected during the basal program or a bolus o resulting in over-infusion of insulin.
PDM loses backup power and loses the date and time resulting in a Pod being o rendered unusable, leading to an unanticipated delay in insulin infusion and hyperglycemia.
Pod encounters partial deploy/partial retraction of needle mechanism upon firing o into subcutaneous tissue resulting in under-infusion and hyperglycemia.
Pod encounters partial deploy, failed deploy, or partial retract due to lack of о clearance between components of needle mechanism resulting in under-infusion of insulin and hyperglycemia.
Pod encounters partial deploy or partial retract due to interference of needle o mechanism resulting in under-infusion of insulin and hyperglycemia.

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Image /page/8/Picture/0 description: The image shows the logo for Omnipod Insulin Management System. The logo features a circular design made up of many small, evenly spaced lines, resembling a stylized sun or gear. Below the circular design, the word "omnipod" is written in lowercase letters, followed by the phrase "INSULIN MANAGEMENT SYSTEM" in smaller, uppercase letters.

Plunger is changed and fails to operate as intended, leading to a defective Pod, о leading to a delay in use which may lead to hyperglycemia.
Pod software fails prior to or during operation, stopping infusion and resulting in о an alarm, which could cause delay in treatment and hyperglycemia.
Pod does not activate upon command, spring latch does not release drive O mechanism, resulting in a failed Pod and hyperglycemia.
Pod top housing loses structural integrity and all function is lost, resulting in delay о in treatment and hyperglycemia.
Pod has no audible alarm that user can hear resulting in a missed occlusion alarm, O which could lead to hyperglycemia.
Software corruption due to software updates to the device, which may lead to O hyperglycemia.
User activates Pod and the needle does not deploy, leading to hyperglycemia. O
Pod needle does not achieve required depth and angle for adequate infusion, O leading to hyperglycemia.
User miscalculates the amount of carbs they have consumed resulting in a bolus O that is too high or too low to account for their insulin requirement, which may lead to hypoglycemia or hyperglycemia.
The user selects a bolus that is greater than what is needed and experiences O hypoglycemia.
The user does not correct their current BG from their target BG and thus does not O calculate their bolus correctly and experiences hyperglycemia.
The user miscalculates their correction bolus by not taking insulin already present O in their body (insulin on board) into account and experiences hypoglycemia.
The user is not able to calculate a meal bolus and experiences hyperglycemia. O
The user is not able to calculate the insulin on board with a meal bolus and O experiences hypoglycemia.
The user experiences an occlusion at the time of a bolus infusion. When the O occlusion clears, the bolus is delivered and the user experiences hypoglycemia (post-occlusion bolus).

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Image /page/9/Picture/0 description: The image shows the Omnipod logo. The logo consists of a blue circle made up of many small lines, with the word "omnipod" in blue below it. Underneath the word "omnipod" is the phrase "INSULIN MANAGEMENT SYSTEM" in smaller, blue letters.

. Incorrect therapy or treatment
Harm resulting from non-secure communication (cybersecurity)
Biological or chemical contamination
- Insulin potency impacted by material leaching out of the fluid path materials, O leading to chemical contamination, hypoglycemia, or hyperglycemia.
- Insulin sterility not maintained over the Pod wear period, resulting in infection. O
- Body contacting parts of System cause biocompatibility issues to the user's skin O and other bodily tissues, resulting in inconvenience to serious injury.
- Insulin fill syringe is manufactured with materials that leach into subcutaneous O tissue and patient experiences toxic response and is injured.
- Fluid path of Pod manufactured with materials that leach into subcutaneous tissue o and patient experiences toxic response and is injured.
Traumatic injury ●
- User receives electrical shock from PDM O
- User receives electrical shock from Pod o

Risk Management: Performed and completed in accordance with ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. Verification activities, as required by the risk analysis, demonstrate that the predetermined acceptance criteria were met and the device is free of unacceptable risk.

Biocompatibility: 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.

Safety, Electrical Safety, and Electromagnetic Compatibility (EMC): 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.

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Image /page/10/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, vertical lines. Below the circular design, the word "omnipod" is written in lowercase letters, and below that, the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

Software: Software verification and validation testing was conducted and documentation provided in accordance with IEC 62304, FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. Cybersecurity testing was conducted and documented in accordance with FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014. The software for this medical device system is considered as a "major" level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient.

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 60601-1
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

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Image /page/11/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, evenly spaced lines, resembling a stylized sun or gear. Below the circular design, the word "omnipod" is written in a lowercase, sans-serif font, followed by the registered trademark symbol. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in a smaller, sans-serif font.

Testing to Support System Verification
Environmental Safety Testing to 60601-1-11
Safety and Essential Performance Testing to 60601-1
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
Regression Analysis and Testing

Human Factors: Validation of the device system was performed in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" dated February 3, 2016 and IEC 62366-1, in which safety critical tasks were identified, had safeguards identified and implemented, then tested for their residual risk. The Omnipod DASH™ System validation demonstrated that the device is validated for its intended use.

Compliance to Standards: The Omnipod DASH™ Insulin Management System has had its design considered in accordance with the Guidance for Industry and FDA Staff: Infusion Pumps Total Product Life Cycle, released December 2, 2014. According, the system complies with the following standards as documented in the applicable test reports provided in this 510(k) submission. Verification and validation reports demonstrate that the Omnipod DASH™ Insulin Management System is validated for its intended use.

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

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Image /page/12/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small lines, with the word "omnipod" written in lowercase letters below it. Underneath the word "omnipod" is the text "INSULIN MANAGEMENT SYSTEM" in smaller, uppercase letters. The logo is blue.

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
A AMI/ANSI ST 72:2011 Bacterial Endotoxins Test Methods, Routine Monitoring ● and Alternatives to Batch Testing

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Image /page/13/Picture/0 description: The image shows the Omnipod logo. The logo consists of a circular design made up of many small, equally spaced lines. Below the circular design, the word "omnipod" is written in lowercase letters, with a small circle containing an R in the upper right corner. Below the word "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

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)]

Applicable FDA Guidance Documents:

The following FDA Guidance documents were used to demonstrate substantial equivalence of the Omnipod DASH™ Insulin Management System to the predicate device:

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 ●

Substantial Equivalence Conclusion:

The Omnipod DASH™ Insulin Management System uses the same technology, indications for use, and modes of operation as the predicate Omnipod® Insulin Management System cleared under K162296. The proposed modifications in the Omnipod DASH™ Insulin Management System results in a device that is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness. Performance testing of the Omnipod DASH™ Insulin Management System demonstrated that the subject device met all device specifications. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).