The Omnipod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

The glucose measurements should not be used for the diagnosis or screening for diabetes. The PDM glucose meter is intended for single patient use and should not be shared.

Abbott FreeStyle® test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.

Omnipod DASH Insulin Management System

The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

Device Description

The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).

The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.

Both systems are for prescription use only.

AI/ML Overview

The provided document is a 510(k) summary for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It describes modifications to an existing device rather than a new device and thus does not contain the specific information requested in the prompt regarding a study that proves the device meets specific acceptance criteria with detailed statistical analysis.

However, based on the Performance Data and Standards Compliance section, I can extract information about the types of testing performed and the general conclusions, even if the detailed acceptance criteria and study designs are not fully elaborated.

Here's an attempt to answer using the available information, noting where specific details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Drug Stability and Compatibility	In-use stability and leachables testing with Admelog U100 insulin verified and validated that the systems do not adversely affect the insulin.
Soft Cannula Design	Testing was conducted to verify that the modified soft cannula design met the insertion depth and new insulin infusion depth specifications.
Safety and Effectiveness	A real-world data analysis of post-market data gathered from devices with the modified soft cannula concluded that the modification did not raise any new questions of safety and effectiveness. Safety Assurance Cases for both Omnipod and Omnipod DASH systems with the modified cannula and Admelog were provided, with the stated goal that the systems are "acceptably safe for the infusion of U100 insulin...for use in the home setting by people with diabetes mellitus who require insulin on a daily basis."
Sterilization	A sterilization product adoption was conducted in accordance with AAMI TIR28:2016, and bioburden testing was conducted in accordance with ISO 11737-1 for the modified soft cannula design.
Risk Management	Risk management was completed in accordance with ISO 14971:2007. Verification activities demonstrated that the predetermined acceptance criteria were met and the devices are safe for use.
Other Standards Compliance	The devices comply with ISO 10993-1 (biological evaluation), ISO 14971 (risk management), ISO 11737-1 (sterilization - microbiological methods), and ISO 11135 (sterilization - ethylene oxide).

Missing Information: The document does not provide the specific numerical acceptance criteria (e.g., specific thresholds for leachables, precise depth specifications, or quantitative results from the stability/compatibility testing). It states that criteria were "met" or "verified" or "validated."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Real-world data analysis: An analysis of post-market data gathered from devices with the modified soft cannula was conducted..."

Sample Size: Not specified.
Data Provenance: Retrospective, post-market data. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable as this was not a diagnostic image-based AI study relying on expert ground truth. The "ground truth" for cannula performance or insulin stability would be derived from laboratory measurements and clinical outcomes, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable for this type of device modification study. Adjudication methods like 2+1 or 3+1 typically refer to reconciliation of discrepancies among multiple expert readers in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI. The document focuses on performance testing of the device's physical and chemical properties and post-market safety.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

The device is an insulin pump system with a bolus calculator, not a standalone AI algorithm for diagnosis. Therefore, this question isn't directly applicable in the typical sense of AI standalone performance. The "algorithm" for dose calculation is part of the system's intended function, and its overall safety and effectiveness were assessed as part of the system.

7. The Type of Ground Truth Used

For Drug Stability and Compatibility: Laboratory analytical results for insulin integrity (e.g., potency, purity, presence of leachables).
For Soft Cannula Studies: Engineering measurements and specifications for insertion depth and insulin infusion depth.
For Safety and Effectiveness (Real-world data): Clinical outcomes, adverse event reports, and other post-market surveillance data.
For Sterilization: Microbiological test results (bioburden) and compliance with sterilization standards.
For Risk Management: Verification activities demonstrating that risks identified were mitigated to an acceptable level as defined by ISO 14971.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing device, and the "real-world data analysis" was for post-market validation, not for training a machine learning model in the context of an AI device. The bolus calculator is rule-based and user-programmed, not an AI model requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a traditional "training set" for an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue font.

February 11, 2022

Insulet Corporation Julie Perkins Director, Regulatory Affairs/Quality Assurance 100 Nagog Park Acton, Massachusetts 01720

Re: K182630

Trade/Device Name: Omnipod Insulin Management System, Omnipod DASH Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LZG, NBW, NDC

Dear Julie Perkins:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 8, 2019. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Courtney Lias, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, at courtneyu.lias@fda.hhs.gov.

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

January 8, 2019

Insulet Corporation Julie Perkins Director, Regulatory Affairs/Quality Assurance 100 Nagog Park Acton, Massachusetts 01720

Re: K182630

Trade/Device Name: Omnipod Insulin Management System, Omnipod DASH Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG, NBW, NDC Dated: December 5, 2018 Received: December 6, 2018

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/cfpmp/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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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.

Alan M.
Stevens -S

for 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) K182630

Device Name

Omnipod Insulin Management System and Omnipod DASH Insulin Management System

Indications for Use (Describe)

Omnipod Insulin Management System

The glucose measurements should not be used for the diagnosis or screening for diabetes. The PDM glucose meter is intended for single patient use and should not be shared.

Omnipod DASH Insulin Management System

The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

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

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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 vertical lines, resembling a stylized sun or gear. 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.

5.1 510(K) SUMMARY

510(k) Summary Complying with 21 CFR 807.92

Date prepared:	January 8th, 2019
Submitter Name:	Insulet Corporation
Submitter Address:	100 Nagog ParkActon, MA 01720
Contact Person:	Julie PerkinsDirector of Regulatory Affairs andQuality Assurance
Phone:	(978) 600-7951(office)
Fax:	(978) 600-0120
Device Trade / Proprietary Name:	Omnipod® Insulin Management SystemOmnipod DASH TM Insulin ManagementSystem
Device Common Name:Regulation Description:Regulation Medical Specialty:Review Panel:	Pump, Infusion, InsulinInfusion pumpGeneral HospitalGeneral Hospital
Product Code:	LZG (Infusion Pump)NBW (System, Test, Blood Glucose,Over the Counter)NDC (Calculator, Drug Dose)
Submission Type:Regulation Number:Device Class:	Traditional 510(k)880.5725Class II

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Image /page/5/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, resembling a stylized gear or sun. Below the circular design, the word "omnipod" is written in lowercase letters, with a small circle next to the "d". Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

Device predicate:

K162296 Omnipod® Insulin Management System K180045 Omnipod DASH™ Insulin Management System

Purpose of Submission:

Modification to K16296 Omnipod® Insulin Management System and K180045 Omnipod DASH™ Insulin Management System to address design and labeling changes.

Device Description:

Both systems are for prescription use only.

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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, 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 an 'r' next to the 'd', indicating a registered trademark. Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

Indications for Use:

Omnipod Insulin Management System

The glucose measurements should not be used for the diagnosis or screening for diabetes. The PDM glucose meter is intended for single patient use and should not be shared.

Omnipod DASH Insulin Management System

The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

The subject devices have the same intended use and indications for use as their predicates.

Summary of Technological Characteristics Compared to Predicate Device:

The, energy source, principles of operation, and configuration of the Omnipod® Insulin Management System and Omnipod DASH Insulin Management System are not changed from those cleared in K162296 and K180045, respectively. The same modifications are being proposed to both systems as compared to the predicates include:

Hardware: The cannula design was modified. As part of this design change, the cannula depth of insertion and the depth of infusion specifications have been modified. There have been no changes to the material of the cannula.

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Image /page/7/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 next to the "d". Underneath "omnipod", the words "INSULIN MANAGEMENT SYSTEM" are written in smaller, uppercase letters.

Labeling: Addition of Admelog U100 as an insulin that has been tested for use with the Omnipod Systems.

There have been no changes to the device materials, software, sterilization method, or packaging of the systems that are subject of this 510(k).

Performance Data and Standards Compliance:

The following performance testing data were provided in support of the substantial equivalence determination.

Drug Stability and Compatibility; In-use stability and leachables testing was conducted with Admelog U100 insulin to verify and validate that the systems do not adversely affect the insulin.
Soft Cannula Studies; testing was conducted to verify that the modified soft cannula design met the insertion depth and new insulin infusion depth specifications.
Real-world data analysis: An analysis of post-market data gathered from devices with the modified soft cannula was conducted to validate the safety and effectiveness of the modified design. The analysis concluded that the modification did not raise any new questions of safety and effectiveness.
Sterilization; A sterilization product adoption was conducted in accordance with AAMI TIR28:2016 and bioburden testing was conducted in accordance with ISO 11737-1 for the modified soft cannula design.
Safety Assurance Case: An assurance case for the design modifications was O provided for each system as recommended in the FDA Guidance: Infusion Pumps Total Product Life Cycle.

The stated goal of the Omnipod Insulin Management System safety assurance case is:

The Omnipod Insulin Management System with blood glucose monitor and 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.

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Image /page/8/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, creating a ring-like shape. Below the circular design, the word "omnipod" is written in lowercase letters, followed by the phrase "INSULIN MANAGEMENT SYSTEM" in smaller, uppercase letters. The text and the circular design are both in a dark blue color.

The stated goal of the Omnipod DASH Insulin Management System 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.

Additions to the safety assurance cases from the predicate devices' cases included modified soft cannula design and use of the device with Admelog.

Risk Management; was completed in accordance with ISO 14971:2007-Medical Devices- Application of Risk Management to Medical Devices. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the devices are safe for use.
The Omnipod Insulin Management System and the Omnipod DASH Insulin Management System comply with the following standards as documented in the predicate devices (K162296 and K180045) and in the applicable test reports provided in this 510(k) submission.
ISO 10993-1 (2009)- 4th Edition Biological Evaluation of Medical Devices- Part ● 1: Evaluation and Testing within a Risk Management Process
ISO 14971 Second Edition 2007-03-01 Medical Devices- Application of Risk Management to Medical Devices
ISO 11737-1 (2018) Sterilization of health care products- Microbiological ● methods- Part 1: Determination of the population of microorganisms on products
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 TIR28 (2016) Product adoption and process equivalence for ethylene ● oxide sterilization

Substantial Equivalence Conclusion:

The subject Omnipod® Insulin Management System and Omnipod® DASH Insulin Management System use similar technology, modes of operation, and indications for use as the devices cleared in K162296 and K180045, respectively. Real-world data and performance testing demonstrate that the changes to the subject devices are substantially equivalent to the predicate devices. Therefore, the subject device is substantially equivalent to the predicate devices.

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).