(115 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and standard software/electrical safety testing.
Yes
The device is described as an "Insulin Management System" intended for the "subcutaneous (below the skin) delivery of insulin" for the "management of diabetes mellitus in persons requiring insulin." This clearly indicates its role in treating a medical condition.
No
The device description and intended use clearly state that the OmniPod Insulin Management System is for the "subcutaneous delivery of insulin" and "management of diabetes mellitus." It acts as an insulin pump, delivering a therapeutic substance rather than diagnosing a condition. While it interacts with diabetes management, its primary function is therapeutic delivery, not diagnosis. The modification explicitly removes an integrated blood glucose meter, which would have been a diagnostic component, further confirming its non-diagnostic role in its current form.
No
The device description explicitly states it is comprised of two primary components: an insulin pump (pod) and a remote controller (Personal Diabetes Manager). It also details hardware testing (drop, vibration, electrical safety, RF wireless, electromagnetic interference), indicating it is a physical device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as an insulin pump system for subcutaneous delivery of insulin. It's a delivery mechanism, not a device that analyzes biological samples to provide diagnostic information.
- Lack of Diagnostic Function: The description explicitly mentions a modification that removes the integrated blood glucose meter, which is a diagnostic component. This further reinforces that the core function of the modified device is not diagnostic.
- No Mention of Sample Analysis: IVD devices typically involve the analysis of biological samples (blood, urine, etc.) to diagnose or monitor a condition. There is no mention of this type of analysis in the provided text.
Therefore, the OmniPod Insulin Management System, as described in this submission, is a therapeutic device for insulin delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous (below the skin)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data was not required for a determination of substantial equivalence for this device modification.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
| Submitter: | Insulet Corporation
9 Oak Park Drive
Bedford, MA 01730
USA | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Tara N. Turney, MS, RAC
Regulatory Affairs Manager
Phone: 781-457-5284
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
Pump, Infusion, Insulin
880.5725 | |
| Predicate Device: | OmniPod Insulin Management System
K122953, Cleared December 7th, 2012 | |
| 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. | |
| Statement of
Intended Use: | 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. | |
| Summary of
Technological
Characteristics: | The proposed device has the same technological
characteristics and is similar in design and configuration as
compared to the predicate device. | |
| Summary of
Clinical Data: | Clinical data was not required for a determination of
substantial equivalence for this device modification. | |
| 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 | |
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