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.

Device Description

The OmniPod Insulin Management System is a tubeless insulin pump and is intended for intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. This system is comprised of two primary components, the insulin pump (pod) and the remote controller (Personal Diabetes Manager). The proposed device is a modification to the OmniPod Insulin Management System that removes the integrated blood glucose meter from the Personal Diabetes Manager.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and reported device performance for each criterion. Instead, it broadly states that "All testing met acceptance criteria." and "predetermined acceptance criteria was met."

The document focuses on demonstrating substantial equivalence to a predicate device (OmniPod Insulin Management System, K122953) through various verification and validation activities. The acceptance criteria for these tests were to successfully meet the relevant requirements of established standards and guidance documents.

Acceptance Criterion Category	Reported Device Performance
Physical Characteristics	Met acceptance criteria.
Drop and Vibration	Successfully met all relevant requirements per IEC 60601-2-24.
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, meeting acceptance criteria.
Electrical Safety	Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
RF Wireless Safety and Performance	Tested and verified to ensure proper wireless communication between the Pod and PDM, meeting acceptance criteria.
Electromagnetic Interference	Successfully met all relevant sections (Radiated emissions, Electrostatic discharge test, radiated radio frequency immunity electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance.

Study Details

Based on the provided text, the submission is focused on demonstrating substantial equivalence for a device modification (removal of an integrated blood glucose meter). Therefore, the "study" described is a series of non-clinical verification and validation tests rather than a traditional clinical study with human subjects.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test. The document refers to "the proposed device" implying a general set of test units.
- Data Provenance: Not specified. It's implied to be from Insulet Corporation's internal testing. The country of origin of the data is not mentioned, but the company is based in Bedford, MA, USA. The tests are prospective in the sense that they were performed on the modified device to confirm its performance.
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)
- Not applicable. This was a non-clinical device performance and safety testing, not a study requiring expert interpretation or establishment of ground truth in a diagnostic or clinical sense. The "ground truth" for these tests would be the requirements outlined in the specified international standards (e.g., IEC 60601-2-24, IEC 60601-1) and FDA guidance documents.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to consensus among multiple human reviewers for certain types of studies, which is not relevant to this submission. The tests were objective measurements against predefined criteria.
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 comparative effectiveness study was done. This information is typically relevant for AI/radiology devices, which is not the nature of this submission (an insulin pump).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described in terms of "standalone" algorithm performance. The device itself (insulin pump) operates without continuous "human-in-the-loop" once programmed, but the software verification was done for the device as a whole. This question is more aligned with AI diagnostic tools.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of clinical ground truth. The "ground truth" for assessing the modified device's performance relies on adherence to established international standards and FDA guidance for medical device safety and efficacy (e.g., IEC standards for electrical safety, drop and vibration, EMC).
The sample size for the training set
- Not applicable. This is a medical device modification submission, not a machine learning or AI algorithm development that would have a "training set."
How the ground truth for the training set was established
- Not applicable, as there was no training set for an AI algorithm.

Summary

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510(k) Summary

Submitter:	Insulet Corporation9 Oak Park DriveBedford, MA 01730USA
Contact Person:	Tara N. Turney, MS, RACRegulatory Affairs ManagerPhone: 781-457-5284Fax: 781-457-5011	AUG 2 9 2013
	Email: tturney@insulet.com
Date Prepared:	August 27, 2013
Trade Name:	OmniPod Insulin Management System
Common Name:	Insulin Infusion Pump
Classification:	Class II, LZGPump, Infusion, Insulin880.5725
Predicate Device:	OmniPod Insulin Management SystemK122953, Cleared December 7th, 2012
DeviceDescription:	The OmniPod Insulin Management System is a tubelessinsulin pump and is intended for intended for subcutaneousdelivery of insulin at set and variable rates for themanagement of diabetes mellitus in persons requiring insulin.This system is comprised of two primary components, theinsulin pump (pod) and the remote controller (PersonalDiabetes Manager). The proposed device is a modification tothe OmniPod Insulin Management System that removes theintegrated blood glucose meter from the Personal DiabetesManager.
Statement ofIntended Use:	The OmniPod® Insulin Management System is intended forsubcutaneous (below the skin) delivery of insulin at set andvariable rates for the management of diabetes mellitus inpersons requiring insulin.
Summary ofTechnologicalCharacteristics:	The proposed device has the same technologicalcharacteristics and is similar in design and configuration ascompared to the predicate device.
Summary ofClinical Data:	Clinical data was not required for a determination ofsubstantial equivalence for this device modification.
Conclusion fromData:	Insulet believes that the information and data provided in thissubmission clearly describes the proposed device anddemonstrates that the device is adequately designed for thelabeled indication for use. Performance, verification and

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Summary of Non-Clinical Data:

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 guidance, as applicable. The following performance and safety testing has confirmed that the proposed device to be substantial equivalent to the predicate device:

Physical Characteristics .
Drop and Vibration; the proposed device has been . tested and successfully met all of the relevant requirements for drop and vibration testing per IEC 60601-2-24.
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 test. Joradiated radio frequency. immunity electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance.

All testing met acceptance criteria.

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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 modified 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person embracing another person.

Public Health Service

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

August 29, 2013

Ms. Tara Turney Regulatory Affairs Manager Insulet Corporation 9 Oak Park Dr. Bedford, Massachusetts 01730

Re: K131294

Trade/Device Name: Omnipod Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Pump, Infusion, Insulin Regulatory Class: Class II Product Code: LZG Dated: July 19, 2013 Received: July 29, 2013

Dear Ms. Turney:

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 that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I edolar Jaha 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 Of It Fat 807), 2007. good manufacturing practice requirements as set

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Page 2 - [Ms. Turney]

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,

Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division 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): K131294

Device Name: OmniPod Insulin Management System

The OmniPod® Insulin Management System is intended for Indications for Use: subcutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.08.27 14:02:21 -04'00'

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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).