OMNIPOD INSULIN MANAGEMENT SYSTEM

{0}------------------------------------------------ ### 510(k) Summary | Submitter: | Insulet Corporation<br>9 Oak Park Drive<br>Bedford, MA 01730<br>USA | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Contact Person: | Tara N. Turney, MS, RAC<br>Regulatory Affairs Manager<br>Phone: 781-457-5284<br>Fax: 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, LZG<br>Pump, Infusion, Insulin<br>880.5725 | | | Predicate Device: | OmniPod Insulin Management System<br>K122953, Cleared December 7th, 2012 | | | Device<br>Description: | The OmniPod Insulin Management System is a tubeless<br>insulin pump and is intended for intended for subcutaneous<br>delivery of insulin at set and variable rates for the<br>management of diabetes mellitus in persons requiring insulin.<br>This system is comprised of two primary components, the<br>insulin pump (pod) and the remote controller (Personal<br>Diabetes Manager). The proposed device is a modification to<br>the OmniPod Insulin Management System that removes the<br>integrated blood glucose meter from the Personal Diabetes<br>Manager. | | | Statement of<br>Intended Use: | The OmniPod® Insulin Management System is intended for<br>subcutaneous (below the skin) delivery of insulin at set and<br>variable rates for the management of diabetes mellitus in<br>persons requiring insulin. | | | Summary of<br>Technological<br>Characteristics: | The proposed device has the same technological<br>characteristics and is similar in design and configuration as<br>compared to the predicate device. | | | Summary of<br>Clinical Data: | Clinical data was not required for a determination of<br>substantial equivalence for this device modification. | | | Conclusion from<br>Data: | Insulet believes that the information and data provided in this<br>submission clearly describes the proposed device and<br>demonstrates that the device is adequately designed for the<br>labeled indication for use. Performance, verification and | | {1}------------------------------------------------ #### 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ ## 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' Page 1 of