(183 days)
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 whole capillary blood (in vitro) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
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 whole capillary blood (in vitro) from the finger.
The OmniPod Insulin Management system consists of two main components:
- . The Personal Diabetes Manager (PDM)
- The OmniPod (Pod) .
The Personal Diabetes Manager (PDM) handles all processes for the operation of the OmniPod System. The display uses full text language to prompt the user through the set up process. It is also utilized to initialize and program the Pod with the user's custom based insulin profile, to check the pod status, and initiate a bolus dose of insulin. Using the PDM the user can also make temporary changes to the insulin delivery profile. After set-up and initiation, the Pod will run independently of the PDM.
The PDM device incorporates the Freestyle glucose meter. The PDM receives blood glucose readings that are measured using the Freestyle blood glucose meter via an internal serial interface. The blood glucose data is stored and can be displayed by the PDM. The integrated glucose test meter is intended to be used with Abbott Freestyle test strips.
The Pod is the disposable component of the system. The Pod is intended to be filled with rapid acting insulin U-100. The brands of insulin that can be utilized with the Pod are as follows: Novolog@/NovoRapid®, Humalog®, or Apidra®.
Once the Pod has been filled with a minimum volume of insulin the tubing in the pump is primed. Once primed the user is instructed to remove the adhesive backing and place the Pod adhesive side down on the body. Once in place, the needle punctures the injection site and the cannula is deployed for insulin delivery.
The provided text describes the OmniPod Insulin Management System and studies conducted to support its safety and effectiveness, particularly concerning the integrated glucose meter's performance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the glucose meter's performance in terms of accuracy metrics (e.g., specific percentage deviation from reference, MARD scores). Instead, it states that "Verification of meter functionality was completed in accordance with ISO 15917:2003." This ISO standard would contain the specific performance requirements for blood glucose monitoring systems.
For the purpose of this summary, the reported performance is the successful verification against that standard and the clinical study results.
Table 1: Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied) | Reported Device Performance | Study Reference |
|---|---|---|---|
| Glucose Meter Accuracy | Compliance with ISO 15917:2003 for meter functionality. | "Verification of meter functionality was completed in accordance with ISO 15917:2003." | TP/TR09-217 |
| Clinical Performance (Comparison to Reference) | Blood glucose measurements by the device should be comparable to a glucose reference sample (YSI 2300 Stat Plus). | Whole capillary blood samples measured by subjects and trained users showed results comparable to a YSI 2300 Stat Plus reference. | TP/TR10-067 |
| Cleaning/Disinfection | Device remains functional after multiple cycles of cleaning/disinfection. | Demonstrated that the device could be disinfected appropriately and remain functional after multiple cycles. | TP/TR10-326 |
| Software Functionality | Software functions as intended with no defects. | Software verification, unit testing, code reviews completed. | TP/TR08-078, TP/TR08-233, TP/TR09-21 |
| Electromagnetic Compatibility (EMC) | Compliance with 60601-1-2 standard. | EMC testing completed to demonstrate compliance. | TP/TR07-273 |
| Hardware Functionality | Hardware performs as intended. | Hardware verification testing completed. | TP/TR07-176, TP/TR07-177, TP/TR07-178, TP/TR07-179 |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Clinical (TP/TR10-067): 75 subjects.
- Data Provenance: The document states "75 subjects at two sites were evaluated." It does not explicitly state the country of origin, but given the submitter (Insulet Corporation, Bedford, MA) and the FDA submission, it's highly probable the study was conducted in the United States. The study is prospective, as it involved collecting blood from subjects and measuring it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For study TP/TR10-067:
- Number of Experts: The document mentions "trained user" but does not specify the number of such users. It also mentions a "glucose reference sample measured with the YSI 2300 Stat Plus device" which would serve as the primary ground truth. The operation of a YSI 2300 Stat Plus requires trained personnel, which could be considered the "experts" in establishing the reference values.
- Qualifications of Experts: Not specified beyond "trained user" for administering the device, and implicitly, trained personnel for operating the YSI 2300 Stat Plus.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. For the clinical study (TP/TR10-067), the comparison was made between the device readings (by subjects and trained users) and the YSI 2300 Stat Plus reference. This implies a direct comparison rather than a consensus-based adjudication process.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
- The device being described is an insulin management system with an integrated glucose meter, not an AI-powered diagnostic imaging system requiring human "readers" or showing "improvement with AI vs. without AI assistance." The studies focus on the glucose meter's accuracy and the system's functionality.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance assessment was done for the glucose meter. Study TP/TR09-217 confirms "Verification of meter functionality was completed in accordance with ISO 15917:2003." This often involves testing the device's accuracy with spiked samples or reference materials in a lab setting, which is a form of standalone performance.
- Additionally, in study TP/TR10-067, the reference measurement from the YSI 2300 Stat Plus served as the independent "standalone" ground truth against which both subject and trained user device measurements were compared.
7. The Type of Ground Truth Used
- The primary ground truth for the glucose meter accuracy study (TP/TR10-067) was a glucose reference sample measured with the YSI 2300 Stat Plus device. This is considered a highly accurate laboratory reference method for glucose measurement.
8. The Sample Size for the Training Set
- The document does not provide information on a "training set" or its sample size. The studies described are verification and clinical performance validation studies for a medical device, not a machine learning model that typically requires a separate training set. If the device's internal algorithms involve machine learning, information on its training would not typically be found in this type of 510(k) summary.
9. How the Ground Truth for the Training Set was Established
- As no "training set" is explicitly mentioned for a machine learning context, this question is not applicable based on the provided document. The ground truth for the validation test set was established by the YSI 2300 Stat Plus device.
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Section 7- 510(k) Summary of Safety and Effectiveness
| 7.1Statement | This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and CFR 807.92 | |
|---|---|---|
| 7.2Submitter/Date | Insulet Corporation9 Oak Park DriveBedford, MA. 01730Date Prepared: December 14, 2011 | |
| 7.3CompanyContact | Susan FinneranSenior Director, Clinical and Regulatory Affairs9 Oak Park DriveBedford, MA.781-457-5234 | |
| 7.4Device Name | Proprietary Name: OmniPod® Insulin Management SystemCommon Name: OmniPod SystemClassification Name: Infusion pump, 21CFR 880.5725 | |
| 7.5PredicateLegallyMarketedDevices | The Insulet OmniPod Diabetes Management System that is the subject of thissubmission is substantially equivalent to the IXL-ii System that was cleared viaK042972. | |
| 7.6DeviceDescription | The OmniPod® Insulin Management System is intended forsubcutaneous delivery of insulin at set and variable rates for themanagement of diabetes mellitus in persons requiring insulinand for the quantitative measurement of glucose in fresh whole | |
| 7.7Indicationsfor Use | The OmniPod Insulin Management System is intended for subcutaneousdelivery of insulin at set and variable rates for the management ofdiabetes mellitus in persons requiring insulin and for the quantitativemeasurement of glucose in fresh whole capillary blood (in vitro) from thefinger. | |
| The glucose measurements should not be used for the diagnosis of orscreening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. | ||
| Abbott FreeStyle test strips are used with the built in FreeStyle meter forthe quantitative measurement of blood glucose in fresh whole capillaryblood from the finger, upper arm and palm. Abbott FreeStyle ControlSolutions are used to verify that the meter and test strips are workingtogether properly and that the test is performed correctly. |
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Capillary blood (in vitro).
The OmniPod Insulin Management system consists of two main components:
- . The Personal Diabetes Manager (PDM)
- The OmniPod (Pod) .
The Personal Diabetes Manager (PDM) handles all processes for the operation of the OmniPod System. The display uses full text language to prompt the user through the set up process. It is also utilized to initialize and program the Pod with the user's custom based insulin profile, to check the pod status, and initiate a bolus dose of insulin. Using the PDM the user can also make temporary changes to the insulin delivery profile. After set-up and initiation, the Pod will run independently of the PDM.
The PDM device incorporates the Freestyle glucose meter. The PDM receives blood glucose readings that are measured using the Freestyle blood glucose meter via an internal serial interface. The blood glucose data is stored and can be displayed by the PDM. The integrated glucose test meter is intended to be used with Abbott Freestyle test strips.
The Pod is the disposable component of the system. The Pod is intended to be filled with rapid acting insulin U-100. The brands of insulin that can be utilized with the Pod are as follows: Novolog@/NovoRapid®, Humalog®, or Apidra®.
Once the Pod has been filled with a minimum volume of insulin the tubing in the pump is primed. Once primed the user is instructed to remove the adhesive backing and place the Pod adhesive side down on the body. Once in place, the needle punctures the injection site and the cannula is deployed for insulin delivery.
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| 7.8Summary ofchanges to thepredicate device | Several changes were made to the OmniPod System since it was originally cleared via K042792. Following is a summary of the changes that were made to the PDM component of the system since it was originally cleared via K042792.Replacement of the LCD with a color version. A modified device shell and combined function of the Home and Power On/Off buttons into one button. Addition of USB port Removal of two “hard” buttons – Blood Glucose Records button and Food Database button. Changes to the Software User Interface: New home screen. Customized BG tags New status screen. New confirmation screen Update to labeling to indicate that the OmniPod System may be used with Abbott Freestyle test strips. |
|---|---|
| --------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
7.9 Summary of supporting data
The intent of this premarket notification was to submit data to support that the glucose meter that is incorporated into the device can be used with the GDH-FAD glucose test strips that have been recently cleared by Abbott Diabetes Care. This premarket notification also includes verification data to support the changes to the device since it was cleared via K042792.
Table 7.1 provides a summary of the tested that was completed to verify performance of the GDH-FAD strip with the OmniPod System and to support changes that were made to the OmniPod System since it was initially cleared.
Table 7.1 Summary of Supporting Verification/ Clinical Testing
| Test ReportReference | Summary of Testing |
|---|---|
| TP/TR09-217 | Verification of meter functionality was completed inaccordance with ISO 15917:2003. |
| TP/TR10-067 | 75 subjects at two sites were evaluated. Wholecapillary blood was collected and measured by thesubject and by a trained user. The results were alsocompared to a glucose reference sample measuredwith the YSI 2300 Stat Plus device. Subject's werealso asked to rate the use of the device |
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| TP/TR10-326 | Cleaning/ Disinfection testing of the meter wascompleted to demonstrate that the device could bedisinfected appropriately and remain functional aftermultiple cycles. |
|---|---|
| TP/TR08-078TP/TR08-233TP/TR09-21 | Software verification, unit testing, code reviews. |
| TP/TR07-273 | EMC testing to demonstrate compliance to 60601-1-2 |
| TP/TR07-176TP/TR07-177TP/TR07-178TP/TR07-179 | Hardware verification testing |
The data presented above demonstrates that the device is safe and effective and is substantially equivalent to the predicate device cleared via K042792.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Susan Finneran Senior Director Clinical and Regulatory Affairs Insulet Corporation 9 Oak Park Drive Bedford. Massachusetts 01730
DEC 1 5 2011
Re: K111669
Trade/Device Name: OmniPod® Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: December 9, 2011 Received: December 12, 2011
Dear Ms. Finneran:
We have reviewed your Section 510(k) premarket notification of intent-to-market-the-devicereferenced 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.
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Page 2 - Ms. Finneran
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anton V. m.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, 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):_K111669
Device Name:_OmniPod® Insulin Management System
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 whole capillary blood (in vitro) from the finger,
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test aring are working together properly and that the test is performed correctly.
Prescription Use ✓ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kathleen E. Abbott fakcc
. Wision of Anesmesiology, General Hostifal
Page 1 of __
510(k) Number: K111669
§ 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).