(265 days)
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No
The document describes a standard insulin pump system with a built-in glucose meter. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
Yes
The device is intended for the management of diabetes mellitus by delivering insulin and measuring glucose, which are therapeutic actions.
Yes
The device quantitatively measures glucose in fresh capillary whole blood, which is a diagnostic function. Although the glucose measurements should not be used for the diagnosis of diabetes, the act of measuring a physiological parameter (blood glucose) to monitor a disease (diabetes mellitus) is a form of diagnostic testing. The system aids in the management of diabetes by providing critical data for treatment adjustments.
No
The device description explicitly states the system is comprised of two primary components: the insulin pump (Pod) and the remote controller (Personal Diabetes Manager), which incorporates a built-in blood glucose meter. These are hardware components, making it a hardware and software system, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Mention of In Vitro Measurement: The "Intended Use / Indications for Use" section clearly states the device is intended "for the quantitative measurement of glucose in fresh capillary whole blood (in vitro) from the fingertip." The term "in vitro" specifically refers to tests performed outside of a living organism, which is the definition of an IVD.
- Description of Blood Glucose Measurement Components: The "Device Description" details the inclusion of a built-in blood glucose meter, the use of OneTouch Verio Test Strips, and the use of OneTouch Verio Control Solutions. These are all components typically associated with in vitro diagnostic devices for blood glucose monitoring.
- Purpose of Glucose Measurement: The glucose measurement component is used for the management of diabetes, which involves analyzing a biological sample (blood) to provide information about a patient's health status.
While the device also has an insulin delivery component (which is not an IVD function), the inclusion and intended use of the blood glucose measurement capability classify it as an IVD.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZG, NBW, LFR
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
subcutaneous (below the skin)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data: Insulet completed validation and verification activities including:
- Physical Characteristics: met physical dimension and weight requirements.
- Drop and Vibration: met requirements per IEC 60601-2-24.
- Hardware: met all associated hardware specifications.
- Software: documentation prepared for a MAJOR level of concern device in accordance with FDA's Guidance.
- Electrical Safety: successfully passed relevant sections of IEC 60601-1.
- RF Wireless Safety and Performance: verified proper wireless communication between Pod and PDM.
- Electromagnetic Interference: met relevant sections for compliance.
- Alarm Sound Level: met requirements for sound pressure level.
- Environmental: met IEC 60601-2-24 requirements for temperature, humidity and atmospheric pressure.
- Battery Life: met requirement of sufficient battery power for expected use.
- Shipping: met requirements for aesthetic and functional integrity after shipping.
LifeScan completed testing to verify product design and laboratory/non-clinical blood glucose meter performance accuracy. Evaluations performed include:
- 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)
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.
Key Results: Performance, verification and validation testing was conducted and acceptance criteria was met, documenting that the proposed device is substantially equivalent to the predicate device and suitable for the labeled indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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
1
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™ 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.
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
EF
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510(k) Summary
| Submitter: | Insulet Corporation
600 Technology Park Drive
Suite 200
Billerica, MA 01821
USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Antonette M. DeLeo, MS, RAC
Senior Regulatory Affairs Specialist
Telephone: 978-600-7443
Fax: 781-600-4329
E-mail: adeleo@insulet.com |
| Date Prepared: | November 7, 2014 |
| Trade Name: | OmniPod Insulin Management System |
| Common Name: | Insulin Infusion Pump |
| Classification
Name: | Pump, Infusion, Insulin |
| Product Code
(Classification): | LZG |
| Product Code
(Subsequent): | NBW |
| Product Code
(Subsequent): | LFR |
| Predicate Device: | OmniPod Insulin Management System
K122953 |
| 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 |
4
| | 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. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
Intended Use: | The OmniPod Insulin Management System is intended for use
in the management of insulin therapy and optional blood
glucose monitoring by patients with diabetes mellitus. |
| Statement of
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 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. |
| 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 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 the proposed device to be
substantially equivalent to the predicate device: |
| | ● Physical Characteristics: the proposed device has
been tested and successfully met physical dimension
and 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. |