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 capillary whole blood (in vitro) from the fingertip.

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

OneTouch® Verio™ Test Strips are used with the built-in blood glucose meter with One Touch Verio technology for the quantitative measurement of blood glucose in fresh capillary whole blood drawn from the fingertips.

OneTouch Verio Control Solutions are used to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

The OmniPod® Insulin Management System is a tubeless insulin pump 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 capillary whole blood (in vitro) from the fingertip. This System is comprised of two primary components, the insulin pump (Pod) and the remote controller (Personal Diabetes Manager). The Personal Diabetes Manager incorporates LifeScan OneTouch Verio blood glucose measurement capability through a built in blood glucose meter. The blood glucose meter uses One Touch Verio Test Strips. OneTouch Verio Level 3 (Mid) and OneTouch Verio Level 4 (High) Control Solutions are used to check that the meter and test strips are working together properly. OneTouch Verio Test Strips are included in the Starter Kit. OneTouch Verio Control Solutions are not included in the Starter Kit and must be purchased separately.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OmniPod Insulin Management System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (OmniPod Insulin Management System K122953). Therefore, the "acceptance criteria" are generally that the new device meets the performance and safety standards established for the predicate and relevant industry guidance/standards (e.g., ISO, IEC). The reported performance is that the device met these criteria.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance*
Physical Characteristics	Met physical dimension and weight requirements.	Met
Drop and Vibration	Met all relevant requirements for drop and vibration testing per IEC 60601-2-24.	Met
Hardware	Meets all associated hardware specifications.	Met
Software	Documentation prepared and submitted for a MAJOR level of concern device in accordance with FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.	Met
Electrical Safety	Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety.	Met
RF Wireless Safety & Perf	Verified to ensure proper wireless communication between the Pod and PDM.	Met
Electromagnetic Interfer.	Successfully met all relevant sections (Radiated emissions, Electrostatic discharge immunity, electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance.	Met
Alarm Sound Level	Successfully met requirements for sound pressure level.	Met
Environmental	Successfully met IEC 60601-2-24 requirements for temperature, humidity and atmospheric pressure.	Met
Battery Life	Successfully met the requirement of sufficient battery power for expected use.	Met
Shipping	Successfully met requirements for aesthetic and functional integrity after shipping.	Met
BGM Performance (General)	Repeatability, Precision, Intermediate Precision, Method Comparison (System Accuracy Capillary Sample), Device Comparison (Accuracy Equivalence), Linearity, Effect of Temperature and Relative Humidity, Hematocrit, Sample Identification, Sample Volume, Interferences (Exogenous and Endogenous), Altitude, Pre and Post Cleaning and Disinfection (System Accuracy). Specific values for these are not provided in this document, only that the predicate manufacturer (LifeScan) completed appropriate testing to verify product design and performance accuracy.	Completed testing, verified accurate
BGM Operating Cond.	Operating temperature: 50°F to 104°F (10°C to 40°C), Operating relative humidity range: 20% to 90%.	Met
Clinical Study (BGM)	Fulfillment of the requirements of ISO 15197:2003 (E) – Section 8 User Performance Evaluation.	Fulfilled

Note: The document consistently states that the device "met" or "successfully met" these requirements, or that testing was "completed" and "confirmed" the device to be substantially equivalent. Specific quantitative performance figures are generally not provided in this summary.

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

Sample Size for Test Set: Not explicitly stated for any of the individual tests. The document mentions "LifeScan completed appropriate testing" and "LifeScan completed a clinical study," suggesting the test sets were those used in LifeScan's validation of the integrated OneTouch Verio technology.
Data Provenance: Not explicitly stated. The manufacturer (Insulet) is based in the USA. LifeScan, the developer of the integrated blood glucose meter technology, is also a US-based company generally. The clinical study for the BGM fulfilled requirements of ISO 15197:2003 (E), which is an international standard. It is most likely US-based data, but not definitively stated.
Retrospective or Prospective: Not explicitly stated. Clinical studies are typically prospective, but this is not confirmed here.

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

This information is not provided in the document. For the blood glucose measurement component, the "ground truth" would typically come from laboratory reference methods, but the number and qualifications of technicians/experts are not mentioned. For the overall system, the ground truth is established by meeting the specified performance and safety standards.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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. This device is an insulin management system with an integrated blood glucose meter, not an AI-powered diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study and AI assistance effect size are not applicable here.

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

For the blood glucose meter component, the accuracy studies (e.g., repeatability, precision, method comparison) represent the "standalone" performance of the algorithm and sensor. The document states LifeScan completed these evaluations and they "confirmed the proposed device to be substantially equivalent to the predicate device."
For the insulin pump component, the various engineering and safety tests (e.g., physical characteristics, software, electrical safety, battery life) represent its standalone performance without a human in the loop affecting its core function.

7. The Type of Ground Truth Used

For the insulin pump components: The ground truth is established by adherence to recognized medical device standards (e.g., IEC 60601-2-24, IEC 60601-1), industry guidance from the FDA, and meeting self-defined hardware and software specifications. This is a mix of engineered specifications and regulatory compliance.
For the blood glucose meter component: The ground truth for accuracy and performance parameters (e.g., repeatability, linearity) is typically established by laboratory reference methods (e.g., YSI analyzer for glucose concentration). For the clinical user performance, it would be a comparison to a "validated method" as stated, which likely refers to these laboratory reference methods performed by trained personnel.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The OmniPod Insulin Management System, as described in this 2014 510(k) summary, does not appear to use machine learning algorithms that require a "training set" in the modern sense. It's a hardware-based electromechanical device with embedded software.

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

This information is not applicable as there is no mention of a training set for machine learning.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13,2014

Insulet Corporation Antonette M. DeLeo, MS, RAC Senior Regulatory Affairs Specialist 600 Technology Park Drive, Suite 200 Billerica, MA 01821

Re: K140439

Trade/Device Name: OmniPod Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG, NBW Dated: October 10, 2014 Received: October 14, 2014

Dear Ms. DeLeo,

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.

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. 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) K140439

Device Name OmniPod Insulin Management System

Indications for Use (Describe)

The OmniPod® Insulin Management System is intended for subcutaneous (below the skin) 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 capillary whole blood (in vitro) from the fingertip.

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

OneTouch Verio Control Solutions are used to check that the meter and test strips are working together properly and that the test is performing correctly.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Submitter:	Insulet Corporation600 Technology Park DriveSuite 200Billerica, MA 01821USA
Contact Person:	Antonette M. DeLeo, MS, RACSenior Regulatory Affairs SpecialistTelephone: 978-600-7443Fax: 781-600-4329E-mail: adeleo@insulet.com
Date Prepared:	November 7, 2014
Trade Name:	OmniPod Insulin Management System
Common Name:	Insulin Infusion Pump
ClassificationName:	Pump, Infusion, Insulin
Product Code(Classification):	LZG
Product Code(Subsequent):	NBW
Product Code(Subsequent):	LFR
Predicate Device:	OmniPod Insulin Management SystemK122953
DeviceDescription:	The OmniPod® Insulin Management System is a tubelessinsulin pump intended for subcutaneous delivery of insulin atset and variable rates for the management of diabetes mellitusin persons requiring insulin and for the quantitativemeasurement of glucose in fresh capillary whole blood (invitro) from the fingertip. This System is comprised of twoprimary components, the insulin pump (Pod) and the remotecontroller (Personal Diabetes Manager). The PersonalDiabetes Manager incorporates LifeScan OneTouch Verioblood glucose measurement capability through a built inblood glucose meter. The blood glucose meter uses One

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	Touch Verio Test Strips. OneTouch Verio Level 3 (Mid) andOneTouch Verio Level 4 (High) Control Solutions are used tocheck that the meter and test strips are working togetherproperly. OneTouch Verio Test Strips are included in theStarter Kit. OneTouch Verio Control Solutions are notincluded in the Starter Kit and must be purchased separately.
Statement ofIntended Use:	The OmniPod Insulin Management System is intended for usein the management of insulin therapy and optional bloodglucose monitoring by patients with diabetes mellitus.
Statement ofIndications for Use:	The OmniPod® Insulin Management System is intended forsubcutaneous delivery of insulin at set and variable rates forthe management of diabetes mellitus in persons requiringinsulin and for the quantitative measurement of glucose infresh capillary whole blood (in vitro) from the fingertip.
	The glucose measurements should not be used for thediagnosis of or screening for diabetes or for neonatal use. ThePDM glucose meter is intended for single-patient use andshould not be shared.
	OneTouch® Verio™ Test Strips are used with the built-inblood glucose meter with One Touch Verio technology for thequantitative measurement of blood glucose in fresh capillarywhole blood drawn from the fingertips.
	OneTouch Verio Control Solutions are used to check that themeter and test strips are working together properly and thatthe test is performing correctly.
Summary ofTechnologicalCharacteristics:	The proposed device has the same technologicalcharacteristics and is similar in design and configuration ascompared to the predicate device.
Summary of Non-Clinical Data:	Insulet completed the appropriate validation and verificationactivities required by the Guidance for Industry and FDAStaff – Total Product Life Cycle: Infusion Pump – PremarketNotification [510(k)] Submissions Draft Guidance and otherguidance, as applicable. The following performance andsafety testing has confirmed the proposed device to besubstantially equivalent to the predicate device:
	● Physical Characteristics: the proposed device hasbeen tested and successfully met physical dimensionand weight requirements;
	● Drop and Vibration: the proposed device has been

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tested and successfully met all of the relevant requirements for drop and vibration testing per IEC 60601-2-24;

Hardware: the proposed device has been tested meets . all of its associated hardware specifications;
. Software: documentation was prepared and submitted for a MAJOR level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices:
. Electrical Safety: the proposed 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 proposed device has been tested and verified to ensure proper wireless communication between the Pod and PDM;
. Electromagnetic Interference: the proposed device has been tested and successfully met all of the relevant sections (Radiated emissions, Electrostatic discharge immunity frequency. electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance:
. Alarm Sound Level: the proposed device has been tested and successfully met requirements for sound pressure level;
Environmental: the proposed device has been tested and successfully met IEC 60601-2-24 requirements for temperature, humidity and atmospheric pressure;
. Battery Life: the proposed device has been tested and successfully met the requirement of sufficient battery power for expected use:
. Shipping: the proposed device has been tested and successfully met requirements for aesthetic and functional integrity after shipping.

LifeScan completed appropriate testing to verify the product design and the laboratory/non-clinical blood glucose meter performance accuracy. The following evaluations were performed and have confirmed the proposed device to be substantially equivalent to the predicate device:

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	Repeatability Precision Intermediate Precision Method Comparison (System Accuracy Capillary Sample) Device Comparison (Accuracy Equivalence) Linearity Effect of Temperature and Relative Humidity Operating temperature: 50°F to 104°F (10°C to 40°C) Operating relative humidity range: 20% to 90% Hematocrit Sample Identification Sample Volume Interferences: Exogenous and Endogenous Altitude Pre and Post Cleaning and Disinfection (System Accuracy)
Summary of Clinical Data:	LifeScan completed a clinical study, Clinical Evaluation – Lay User and HCP Comparison to a Validated Method, Instructions for Use and System Use Evaluation, to fulfill the requirements of ISO 15197:2003 (E) – Section 8 User Performance Evaluation. This evaluation confirmed the proposed device to be substantially equivalent to the predicate device:
Conclusion from Data:	Insulet believes that the information and data provided in this submission clearly describes the proposed device 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 substantially equivalent to the identified predicate.Insulet Corporation has demonstrated that the proposed OmniPod Insulin Management System is substantially equivalent to the predicate device based upon indications for use, design, test results and the same fundamental scientific technology.

Repeatability Precision Intermediate Precision Method Comparison (System Accuracy Capillary Sample) Device Comparison (Accuracy Equivalence) Linearity Effect of Temperature and Relative Humidity Operating temperature: 50°F to 104°F (10°C to 40°C) Operating relative humidity range: 20% to 90% Hematocrit Sample Identification Sample Volume Interferences: Exogenous and Endogenous Altitude Pre and Post Cleaning and Disinfection (System Accuracy)

Summary of Clinical Data:

LifeScan completed a clinical study, Clinical Evaluation – Lay User and HCP Comparison to a Validated Method, Instructions for Use and System Use Evaluation, to fulfill the requirements of ISO 15197:2003 (E) – Section 8 User Performance Evaluation. This evaluation confirmed the proposed device to be substantially equivalent to the predicate device:

Conclusion from Data:

Insulet believes that the information and data provided in this submission clearly describes the proposed device 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 substantially equivalent to the identified predicate.Insulet Corporation has demonstrated that the proposed OmniPod Insulin Management System is substantially equivalent to the predicate device based upon indications for use, design, test results and the same fundamental scientific technology.

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).