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

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

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

Device Description

The OmniPod Insulin Management System provides for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. It is 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) with an embedded blood glucose meter.

AI/ML Overview

The provided document (K122953) describes the OmniPod Insulin Management System, but it does not contain acceptance criteria or study results for a device that uses Artificial Intelligence (AI). The submission focuses on the mechanical, electrical, and biocompatibility aspects of an insulin pump system with an integrated blood glucose meter, and its substantial equivalence to predicate devices. There is no mention of AI, machine learning, or complex algorithms that would require a study proving the device meets AI-specific acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding AI acceptance criteria and studies from this document.

However, I can extract the general performance criteria and test results for various components of the OmniPod Insulin Management System as described in the submission, which are analogous to acceptance criteria in a non-AI context.

General Performance Criteria and Reported Device Performance (Non-AI)

Since the document does not relate to an AI device, the table below reflects the described performance and verification activities for the OmniPod Insulin Management System, which are general device performance criteria rather than AI-specific acceptance criteria.

Acceptance Criteria (General Device Performance)	Reported Device Performance (Study Results)
Usability	Device usability has been fully validated in accordance with IEC 62366:2007, AAMI HE75, and FDA's Medical Device Use-Safety guidance.
Risk Management	Verification activities, required by ISO 14971:2007, demonstrated that predetermined acceptance criteria were met and the device is safe for use.
Fluid Path Integrity	Testing verified that the fluid path within the Pod can withstand required internal pressures.
PDM Environmental Performance	The PDM met environmental testing requirements (temperature, humidity, pressure per IEC 60601-2-24) and passed all functional tests.
Soft Cannula Depth and Angle	All Pod samples tested met the requirements for soft cannula insertion depth and angle.
Priming Volume	The Pod met the priming volume requirements after soft cannula deployment as part of the activation sequence, verifying appropriate insertion mechanism release and priming.
Rotational Sensor Functionality	Testing confirmed that the rotational sensor meets its design intent and is capable of making and maintaining electrical contact in all installed positions.
Reliability and Useful Life (PDM)	Testing verified that the PDM met the reliability and useful life requirements, confirming mechanical and functional integrity of common use features over the labeled warranty life.
Basal Flow Accuracy	Accuracy of +/- 5% at rates of 0.05 U/hr – 30.00 U/hr was met as per IEC 60601-2-24.
Bolus Flow Accuracy	Bolus accuracy of +/- 5% for all set values of 0.05 – 30.00 units was confirmed as per IEC 60601-2-24.
Basal Accuracy at Max/Min Temperature	The Pod passed basal flow rates at the minimum and maximum operational temperatures.
Nominal Flow Basal with Vacuum Transition	The proposed Pod was developed and confirmed to provide a nominal flow basal with vacuum transition at nominal temperature.
Power Interruptions (Pod Battery)	The proposed Pod battery connections were tested and determined to perform as intended.
Cam Finger Functionality	The cam finger design has been verified to perform as defined by its requirements.
Cannula Insertion Indicator	An indicator has been provided and tested to confirm when the cannula is fully inserted.
Pod Temperature Operation	The Pod has been tested and confirmed to operate at a temperature range of 40°F to 98.6°F.
Biocompatibility	Assessment consistent with FDA's Blue Book Memorandum G95-1 showed fluid path components and surface pad/adhesive pose no concerns for human use due to biocompatibility, toxicity, or dermal sensitization. Tested under GLP conditions.
Insulin Compatibility	The system has been tested and is considered compatible with NovoLog®, HumaLog®, and Apidra® U-100 insulin.
Sterilization	The proposed device (Pod) and disposable set have been tested and will be sterilized by 100% ethylene oxide.
Software	Documentation was prepared and submitted for a MAJOR level of concern device in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (Note: No specifics on performance of software beyond documentation compliance are given.)
Electrical Safety	The system successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
RF Wireless Safety and Performance	The system has been tested and verified to ensure proper wireless communication between the Pod and PDM.
Electromagnetic Interference (EMI)	The system successfully met all relevant sections for EMI compliance, including Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and Power frequency magnetic field immunity test.

Inability to provide certain information for AI/ML aspects:

As this device predates widespread AI/ML integration in medical devices and the submission does not mention AI, the following specific questions cannot be answered from the provided text:

Sample sized used for the test set and the data provenance: Not applicable for an AI test set. This document describes bench testing and verification activities on device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no AI model for which ground truth would be established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as no AI is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no algorithm-only performance study is mentioned for AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for AI. The "ground truth" for the tests described are engineering specifications, industry standards (e.g., IEC standards), and documented design requirements.
The sample size for the training set: Not applicable, as there is no mention of an AI training set.
How the ground truth for the training set was established: Not applicable, as there is no mention of an AI training set.

Summary

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K122953

BEC 0 7 2012

Insulet Corporation OmniPod® Insulin Management System 510(k) Premarket Notification Submission

7.0 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92

9056196

3004464228

A. Submitter's Information:

Date prepared:

September 24, 2012

Name:

Insulet Corporation

Address:

9 Oak Park Drive Bedford, MA 01730 United States

FDA Establishment Owner/Operator Number:

Contact Person:

Phone: Fax:

Manufacturing Site:

Michael J. Doyle Director Regulatory & Clinical Affairs (781) 457-5244 (781) 357-4303

Insulet Corporation 9 Oak Park Drive Bedford, MA 01730 United States

FDA Establishment Registration Number:

B. Device Name:

Trade/Proprietary Name:

Device:

Regulation Description:

Regulation Medical Specialty:

Review Panel:

Product Code:

Submission Type: Regulation Number: Device Class: Model number (Pod/10-pack): Model number (PDM):

Device predicate:

OmniPod Insulin Management System Pump. Infusion. Insulin Infusion pump General Hospital General Hospital LZG NBW 510(k) 880.5725 and 862.1345 2 ZXP425 14500-5A (UST400 Series) K111669 - FreeStyle® Glucose Meter incorporated into the OmniPod Insulin Management Systems K042792 - iXL-II Diabetes Management System

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Insulet Corporation OmniPod® Insulin Management System 510(k) Premarket Notification Submission

C. Device Description/Indications for Use:

Indications for use:

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

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

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

D. Technological Characteristics:

The OmniPod Insulin Management System has the same technological characteristics and is similar in design and configuration as compared to the predicate device.

E. Summary of Non-Clinical Test/Performance Testing - Bench

Insulet completed the appropriate validation and verification activities required by the Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Draft Guidance and other quidance, as applicable. The following performance and safety testing has confirmed the OmniPod Insulin Management System to be substantial equivalent to the predicate device:

. Usability; testing was conducted in accordance with the guidance provided in IEC 62366:2007, Medical devices -- Application of usability engineering to medical devices. AAMI HE75 - Human Factors Engineering - Design of Medical Devices, and the FDA's Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management Guidance. Device usability has been fully validated.
. 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 device is safe for use.
Fluid Path Integrity Design; testing was conducted and verified that the fluid path . within the Pod can withstand the required internal pressures.
Environmental Testing, testing consisted of exposing PDMs to various environmental conditions: temperature, humidity, and pressure (atmospheric) per IEC 60601-2-24. The PDM's met the environmental testing requirements and passed all the required functional tests.

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Insulet Corporation OmniPod® Insulin Management System 510(k) Premarket Notification Submission

Soft Cannula Depth and Angle Studies: testing was conducted to verify that the soft . cannula insertion depth and angle of the Pod meets the specification. All Pod samples tested met the requirements.
Priming Volume; testing was performed to verify appropriate insertion mechanism . release and priming of cannula after firing of needle. The Pod met the priming volume requirements after soft cannula deployment as part of the activation sequence.
Rotational Sensor Study; testing was conducted to demonstrate that the rotational . sensor meets its design intent and maintains required electrical contact. Testing confirmed that design intent was met and the rotational sensor is capable of making and maintaining electrical contact in all installed positions.
Reliability and Useful Life; testing was conducted to verify the mechanical and . functional integrity of the common use features of the PDM and ensure that the useful (labeled warranty) life requirement is achieved. Testing verified that the PDM met the reliability and useful life requirements.
Basal Flow Accuracy; testing was performed to confirm the accuracy of basal rate . delivery per IEC 60601-2-24. Verification indicated that an accuracy of +/- 5% at rates of 0.05 U/hr – 30.00 U/hr was met.
Bolus Flow Accuracy; testing was performed to verify bolus delivery accuracy per IEC . 60601-2-24, Pods were tested and confirmed to provide a bolus accuracy of +/- 5% for all set values of 0.05 – 30.00 units.
Basal accuracy at maximum and minimum operational temperature; testing of the . Pod passed the basal flow rates at the minimum and maximum operational temperatures.
Nominal flow basal with vacuum transition at nominal temperature; the proposed . Pod was developed and confirmed to provide a nominal flow basal with vacuum transition at nominal temperature, as defined.
· Power interruptions; the proposed Pod battery connections were tested and determined to be perform as intended.
. Cam finger; the cam finger design has been verified to perform as defined by its requirements.
. Cannula insertion indicator; an indicator has been provided and tested to confirm when the cannula is fully inserted.
. Pod temperature testing; the Pod has been tested and confirmed to operate at a temperature range of 40°F to 98.6°F.
Biocompatibility; an assessment of the OmniPod Insulin Management System was . performed consistent with FDA's Blue Book Memorandum G95-1 "Use of ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" on the fluid extracts of the Pod fluid path components (Surface device, breached or compromised, permanent wear) and the surface pad and adhesive (Surface device, skin contact, permanent wear) of the Pod base. These body contacting components were tested under GLP controlled conditions. The results of the testing showed that the fluid path and Pod base adhesive pose no concerns for human use due to problems associated with biocompatibility, toxicity or dermal sensitization.

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Insulet Corporation OmniPod® Insulin Management System 510(k) Premarket Notification Submission

Insulin compatibility; the OmniPod Insulin Management System has been tested and . is considered to be compatible with NovoLog®, HumaLog®, and Apidra® U-100 insulin.
. Sterilization; the proposed device (Pod) and disposable set have been tested and will be sterilized by 100% ethylene oxide.
. Software; documentation was prepared and submitted for a MAJOR level of concern device in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical devices.
. Electrical safety; the OmniPod Insulin Management System has been tested and successfully passed all of the relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
. RF wireless safety and performance; the OmniPod Insulin Management System has been tested and verified to ensure proper wireless communication between the Pod and PDM.
. Electromagnetic interference; the OmniPod Insulin Management System has been tested and successfully met all of the relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance.

F. Conclusion

Insulet believes that the information and data provided clearly describes the OmniPod Insulin Management System and demonstrates that the device is adequately designed for the labeled indication for use. Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed device is substantially equivalent to the predicate device and is suitable for the labeled indication for use.

Therefore, the proposed OmniPod Insulin Management System is considered to be substantially equivalent to the identified predicate.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. Above the caduceus, the text "HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. Below the caduceus, the text "DEPARTMENT OF HEALTH" is arranged in a circular fashion.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Mr. Michael J. Doyle Director Regulatory & Clinical Affairs Insulet Corporation 9 Oak Park Drive Bedford, Massachusetts 01730

Re: K122953

Trade/Device Name: OmniPod Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, NBW Dated: November 26, 2012 Received: November 28, 2012

Dear Mr. Doyle:

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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Page 2 – Mr. Doyle

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony De min

Anthony D. Watson, B.S., M.S., M.B.A. 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): K122 953

Device Name: OmniPod Insulin Management System

Indications for Use:

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

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Richard C. Chapman
Date: 2012.12.07 11:33:25 -05'00'

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K122953
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Page 1 of 1

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).