Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System by Insulet Corporation

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 DASH 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.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

Device Description

The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading. programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).

The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.

Both systems are for prescription use only.

AI/ML Overview

The provided text describes modifications to the Omnipod Insulin Management System and Omnipod DASH Insulin Management System to include Lyumjev U100 insulin in their labeling as a compatible insulin. The submission emphasizes that the devices are substantially equivalent to their predicate devices cleared in K192659 because the only change is the addition of this new insulin and that performance testing demonstrates no adverse effect on safety when using Lyumjev U100.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format for the Lyumjev U100 insulin. Instead, it refers to broad performance categories and comparative characteristics with the predicate device. The core "acceptance criteria" can be inferred as demonstration that the device's performance (delivery accuracy, flow rates, etc.) is not negatively impacted and that the insulin's stability is maintained when used with Lyumjev U100.

Performance Category	Acceptance Criteria (Inferred)	Reported Device Performance
Drug Stability	The system should not adversely affect the insulin. Insulin stability should be maintained.	In-use stability testing conducted with Lyumjev U100 insulin verified and validated that the systems do not adversely affect the insulin.
Drug Compatibility	The system should be compatible with Lyumjev U100 insulin without negative interaction.	Leachables testing conducted with Lyumjev U100 insulin verified and validated that the systems do not adversely affect the insulin.
Safety	The use of Lyumjev U100 should have no effect on device safety.	A safety assurance case for the labeling change to add Lyumjev was provided for each system. Performance testing demonstrates that the use of Lyumjev has no effect on safety and effectiveness.
Effectiveness	The use of Lyumjev U100 should have no effect on device effectiveness (e.g., insulin delivery, blood glucose monitoring).	Performance testing demonstrates that the use of Lyumjev has no effect on safety and effectiveness. The devices maintain the same flow rates, delivery accuracy, and other specifications as the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the "in-use stability and leachables testing" conducted with Lyumjev U100 insulin. It also does not specify the country of origin of the data or whether the test was retrospective or prospective.

3. 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)

This information is not provided in the document. The testing described (drug stability/compatibility) is laboratory-based and does not involve human expert interpretation for ground truth establishment in the traditional sense of image analysis or diagnostic studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which do not appear to be the case here.

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

An MRMC comparative effectiveness study was not done. The device is an insulin management system, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The testing described (drug stability and compatibility) is inherently "standalone" in that it assesses the physical and chemical interaction between the device components and the insulin, independent of human interaction within the testing framework. However, this is not an "algorithm-only" performance as would be seen in AI device submissions. The submission is for hardware/software system compatibility with a new drug.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the stability and compatibility testing would be established through laboratory analytical methods (e.g., chemical assays, spectroscopic analysis) to determine the integrity and concentration of the insulin, as well as the presence of leached substances, compared against established specifications for the insulin and device materials. This is not expertise-based ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. This submission is for compatibility with a new insulin, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 13, 2021

Insulet Corporation Dennis Shay Regulatory Affairs Manager 100 Nagog Park Acton, MA 01720

Re: K211575

Trade/Device Name: Omnipod® Insulin Management System Omnipod DASH® Insulin Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG, NBW, NDC Dated: May 20, 2021 Received: May 21, 2021

Dear Dennis Shay:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211575

Device Name Omnipod Insulin Management System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K211575

Device Name Omnipod DASH Insulin Management System

Indications for Use (Describe)

The Omnipod DASH 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.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

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5.0 510(K) SUMMARY

Date prepared:	11 August 2021
Submitter Name:	Insulet Corporation
Submitter Address:	100 Nagog ParkActon, MA 01720
FDA EstablishmentOwner/Operator Number:	9056196
FDA Establishment RegistrationNumber:	3014585508
Contact Information:	Dennis Shay, PhDRegulatory Affairs Manager(978) 846-1247 (office)(978) 600-0120 (fax)
Device Trade / Proprietary Name:	Omnipod® Insulin Management SystemOmnipod DASH® Insulin ManagementSystem
Device Common Name:	Pump, Infusion, Insulin
Regulation Description:	Infusion pump
Regulation Medical Specialty:	Clinical Chemistry
Review Panel:	Clinical Chemistry
Product Code:	LZG (Infusion Pump)Subsequent:NBW (System, Test, Blood Glucose, Over theCounter)NDC (Calculator, Drug Dose)
Submission Type:	Traditional 510(k)
Regulation Number:	880.5725
Device Class:	Class II
Device predicate:	K192659 Omnipod Insulin ManagementSystem and Omnipod DASH InsulinManagement System

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5.1 Purpose of Submission

Modification to legally marketed devices to add Lyumiev U100 to the labeling as an insulin that is compatible with the systems.

5.2 Device Description

Both systems are for prescription use only.

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5.2.1 Indications for Use

5.2.1.1 Omnipod Insulin Management System

The glucose measurements should not be used for the diagnosis 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.

5.2.1.2 Omnipod DASH Insulin Management System

The Omnipod DASH 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.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

The subject devices have the same intended use and indications for use as their predicates.

5.3 Summary of Technological Characteristics Compared to Predicate Device

The subject devices are identical to the predicate devices cleared in K192659. There have been no modifications to the materials, design, sterilization method, software, or manufacturing processes. The only difference is adding Lyumjev™ U100 insulin to the labeling as an insulin that has been tested and found safe to use with both systems.

5.4 Performance Data

The following performance testing data were provided in support of the substantial equivalence determination.

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Drug Stability and Compatibility 5.4.1

In-use stability and leachables testing was conducted with Lyumjev U100 insulin to verify and validate that the systems do not adversely affect the insulin.

ર.ર Safety Assurance Case

A safety assurance case for the labeling change to add Lyumjev was provided for each system as recommended in the FDA Guidance: Infusion Pumps Total Product Life Cycle.

The stated goal of the Omnipod Insulin Management System safety assurance case is:

The Omnipod Insulin Management System with blood glucose monitor and dose calculator is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis.

The stated goal of the Omnipod DASH Insulin Management System safety assurance case is:

The Omnipod DASH Insulin Management System with dose calculator is acceptably safe for the infusion of U100 insulin that is approved for use in pumps, for use in the home setting by people with diabetes mellitus who require insulin on a daily basis.

Additions to the safety assurance cases from the predicate devices' cases include the use of the device with Lyumjev U100.

5.5.1 Risk Management

Risk Management was completed in accordance with ISO 14971:2007- Medical Devices-Application of Risk Management to Medical Devices. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the devices are safe for use.

5.5.2 Standards Compliance

The Omnipod Insulin Management System and the Omnipod DASH Insulin Management System comply with the following standards as documented in the predicate devices (K192659) and in the applicable test reports provided in this 510(k) submission.

ISO 10993-1 (2018)- 4th Edition Biological Evaluation of Medical Devices- Part 1: . Evaluation and Testing within a Risk Management Process
ISO 14971 Second Edition (2007) Medical Devices- Application of Risk Management . to Medical Devices

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Summary of Substantial Equivalence to the Predicate 5.6

The devices described in this 510(k) are equivalent to those cleared in K192659. The equivalence is based upon the fact that the subject and predicate devices have the same principals of operation, technological characteristics and, indications for use. The only difference between the subject and predicate devices is the addition of Lyumjev U100 to the labeling as an insulin that is compatible with the systems. The following tables below illustrate the equivalence of the subject devices to their predicate.

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ElementOfComparison	Subject Device:Omnipod InsulinManagement System	Predicate Device:Omnipod InsulinManagement System(K192659)	Discussion
Intended Use	Intended for subcutaneousdelivery of insulin at setand variable rates for themanagement of diabetesmellitus in personsrequiring insulin and forthe quantitativemeasurement of glucosein fresh whole capillaryblood (in vitro).The glucose measurementsshould not be used for thediagnosis of or screeningfor diabetes. The PDMglucose meter is intendedfor single-patient use andshould not be shared.Abbott FreeStyle test stripsare used with the built-inFreeStyle meter for thequantitative measurementof blood glucose in freshwhole capillary blood fromthe finger, upper arm andpalm. Abbott FreestyleControl Solutions are usedto verify that the meter andtest strips are workingtogether properly and thatthe test is performedcorrectly.	Intended for subcutaneousdelivery of insulin at setand variable rates for themanagement of diabetesmellitus in personsrequiring insulin and forthe quantitativemeasurement of glucose infresh whole capillaryblood (in vitro).The glucose measurementsshould not be used for thediagnosis of or screening fordiabetes. The PDM glucosemeter is intended for single-patient use and should notbe shared.Abbott FreeStyle test stripsare used with the built-inFreeStyle meter for thequantitative measurement ofblood glucose in freshwhole capillary blood fromthe finger, upper arm andpalm. Abbott FreestyleControl Solutions are usedto verify that the meter andtest strips are workingtogether properly and thatthe test is performedcorrectly.	Same
SpecificDrug/BiologicUse	U-100 Insulin.System has been testedwith NovoLog, Humalog,Apidra, Admelog, Fiasp,and Lyumjev	U-100 Insulin.System has been testedwith NovoLog, Humalog,Apidra, Admelog, andFiasp	Lyumjev U100 is aFast-acting InsulinLispro-aabc.Performance testingdemonstrates that theuse of Lyumjev hasno effect on safety
PrescriptionStatus	Prescription Device	Prescription Device	Same
ComponentsandAccessories	Pump (Pod), hand-heldcontroller (PDM) withintegrated Freestyle bloodglucose meter. Accessoriesinclude batteries, teststrips, lancets, controlsolution, prep pads andcarry pouch.	Pump (Pod), hand-heldcontroller (PDM) withintegrated Freestyle bloodglucose meter. Accessoriesinclude batteries, teststrips, lancets, controlsolution, prep pads andcarry pouch.	Same
Infusionpump	Pod, fill syringe, fill needle	Pod, fill syringe, fill needle	Same
PumpingMechanism	Step Drive Mechanism isactivated bymicroprocessor; turnsleadscrew; presses onsyringe style reservoir.	Step Drive Mechanism isactivated bymicroprocessor; turnsleadscrew; presses onsyringe style reservoir.	Same
AdministrativeSets And	Integrated reservoir andpatient activated cannulainsertion system.	Integrated reservoir andpatient activated cannulainsertion system.	Same
Non-FluidPathwayMaterials	Pod Housing:PolycarbonateAdhesive: BiocompatibleMedical Grade AcrylicAdhesive with a Non-woven Polyester Backing	Pod Housing:PolycarbonateAdhesive: BiocompatibleMedical Grade AcrylicAdhesive with a Non-woven Polyester Backing	Same

Fluid PathwayMaterials	Perfluorocopolymer (FEP)	Perfluorocopolymer (FEP)	Same
	Silicone Lubricants	Silicone Lubricants
	Stainless Steel	Stainless Steel
	Silicone Rubber	Silicone Rubber
	Polypropylene	Polypropylene
	Polyvinylchloride (PVC)Cyclic Olefin Copolymer	Polyvinylchloride (PVC)Cyclic Olefin Copolymer
	Polypropylene & EPDMRubber (non-latex)	Polypropylene & EPDMRubber (non-latex)
	Polyisoprene	Polyisoprene
	Flow RatesandProfiles	Basal: 0.05 -30 units/hourin 0.05 unit increments.
Bolus: 0.05 - 30 units in0.05 unit increments.7 Basal Profiles		Bolus: 0.05 - 30 units in0.05 unit increments.7 Basal Profiles
MaximumBolusFlow Rate	1.5 units per minute	1.5 units per minute	Same
DeliveryAccuracy	Basal: ± 5% at rates ≥ 0.05U/hrBolus: ± 5% for all setvalues ≥ 1.0 unit, ± 0.05unit for set values < 1.0unit	Basal: ± 5% at rates ≥ 0.05U/hrBolus: ± 5% for all setvalues ≥ 1.0 unit, ± 0.05unit for set values < 1.0unit	Same
Sterilization	EOSAL 10-6	EOSAL 10-6	Same
BG AssayMethod	CoulometricElectrochemical Sensor	CoulometricElectrochemical Sensor	Same
CalibrationEquivalent	Plasma Equivalent	Plasma Equivalent	Same
Hematocrit	15% to 65%	15% to 65%	Same
Sample	Whole Blood, Capillary	Whole Blood, Capillary	Same
Sample Size	300 nanoliters (1/3 or .3microliter)	300 nanoliters (1/3 or .3microliter)	Same
Result Range	20-500 mg/dL	20-500 mg/dL	Same
Test Time	Average of 7 seconds	Average of 7 seconds	Same

Table 5-1: Substantial Equivalence Comparison Table for the Omnipod Insulin Management System.

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Table 5-2: Substantial Equivalence Comparison Table for the Omnipod DASH Insulin Management System

Element OfComparison	Subject Device:Omnipod DASH InsulinManagement System	Predicate Device:Omnipod DASHInsulin ManagementSystem(K192659)	Discussion
	Intended for subcutaneousdelivery of insulin at set andvariable rates for themanagement of diabetesmellitus in persons requiringinsulin.	Intended forsubcutaneous delivery ofinsulin at set andvariable rates for themanagement of diabetesmellitus in personsrequiring insulin.	Same
Intended Use	Additionally, the OmnipodDASH System isinteroperable with acompatible blood glucosemeter to receive and displayglucose measurements.	Additionally, theOmnipod DASH Systemis interoperable with acompatible bloodglucose meter to receiveand display glucosemeasurements.
SpecificDrug/BiologicUse	U-100 Insulin.System has been tested withNovoLog, Humalog, Apidra,Admelog, Fiasp, and Lyumjev	U-100 Insulin.System has been testedwith NovoLog, Humalog,Apidra, Admelog, andFiasp	LyumjevU100 is aFast-actingInsulinLispro-aabc.Performancetestingdemonstratesthat the useof Lyumjevhas no effecton safety andeffectiveness.
PrescriptionStatus	Prescription Device	Prescription Device	Same
Componentsand Accessories	Pump (Pod), hand-heldcontroller (PDM), carry case,BLE compatible blood glucosemeter.	Pump (Pod), hand-heldcontroller (PDM), carrycase, BLE compatibleblood glucose meter.	Same
Pump/PDMCommunication	Bluetooth Low Energy (BLE)	Bluetooth Low Energy(BLE)	Same
Infusion pump	Pod, fill syringe, fill needle	Pod, fill syringe, fill needle	Same
PumpingMechanism	Step Drive Mechanism isactivated by microprocessor;turns leadscrew; presses onsyringe style reservoir.	Step Drive Mechanism isactivated bymicroprocessor; turnsleadscrew; presses onsyringe style reservoir.	Same
AdministrativeSets andReservoir	Integrated reservoir and patientactivated cannula insertionsystem.	Integrated reservoir andpatient activated cannulainsertion system.	Same
Flow Rates andProfiles	Basal: 0.05 - 30 units/hourin0.05 unit increments.Bolus: 0.05 - 30 units in 0.05unit increments.12 Basal Profiles	Basal: 0.05 - 30units/hourin 0.05 unitincrements.Bolus: 0.05 - 30 units in0.05 unit increments.12 Basal Profiles	Same
MaximumBolus FlowRate	1.5 units per minute	1.5 units per minute	Same
DeliveryAccuracy	Basal: $\pm$ 5% at rates ≥ 0.05U/hrBolus: $\pm$ 5% for all set values ≥1.0 unit, $\pm$ 0.05 unit for setvalues < 1.0 unit	Basal: $\pm$ 5% at rates ≥ 0.05U/hrBolus: $\pm$ 5% for all setvalues ≥ 1.0 unit, $\pm$ 0.05unit for set values < 1.0unit	Same
PowerRequirements	Disposable Batteries - PodRechargeable Battery - PDM	Disposable Batteries - PodRechargeable Battery -PDM	Same
Non-FluidPathwayMaterials	Pod Housing: PolycarbonateAdhesive: BiocompatibleMedical Grade AcrylicAdhesive with a Non-wovenPolyester Backing	Pod Housing:PolycarbonateAdhesive: BiocompatibleMedical Grade AcrylicAdhesive with a Non-woven Polyester Backing	Same
Fluid PathwayMaterials	Perfluorocopolymer (FEP)Silicone LubricantsStainless Steel	Perfluorocopolymer (FEP)Silicone LubricantsStainless Steel	Same
	Silicone RubberPolypropylenePolyvinylchloride (PVC) CyclicOlefin CopolymerPolypropylene & EPDM Rubber(non-latex)Polyisoprene	Silicone RubberPolypropylenePolyvinylchloride (PVC)Cyclic Olefin CopolymerPolypropylene & EPDMRubber (non-latex)Polyisoprene
AlarmFunctions	Hazard Alarms• Empty Reservoir• Occlusion• Pump Error• System Error• Auto Off• Low Battery WarningPod expiration (80 hours)	Hazard Alarms• Empty Reservoir• Occlusion• Pump Error• System Error• Stuck Key• Auto Off• Low Battery WarningPod expiration (80 hours)	Same
OperatingRelativeHumidity	20 to 85%	20 to 85%	Same
OperatingTemperature	41°F to 104°F (5°C to 40°C)	41°F to 104°F (5°C to 40°C)	Same
MeasurementUnits (bloodglucosereading)	mg/dL	mg/dL	Same
Memory	90 days-worth of information on averageInsulin deliveryBlood glucose resultsCarbohydrate intakeAlarms	90 days-worth of information on averageInsulin deliveryBlood glucose resultsCarbohydrate intakeAlarms	Same
Sterilization	EO SAL 10-6	EO SAL 10-6	Same
Shelf life	18 months	18 months	Same

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Insulet Corporation Omnipod and Omnipod DASH Insulin Management System Traditional 510(k)

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5.7 Substantial Equivalence Conclusion

The subject Omnipod Insulin Management System and Omnipod DASH Insulin Management System use the same technology, modes of operation, and indications for use as the devices cleared in K192659. The only difference between the subject and predicate devices is the addition of Lyumjev U100 to the labeling as an insulin that is compatible with the systems. Insulin stability and compatibility testing demonstrate that the subject devices are as safe, as effective, and perform as well or better than the predicate devices. Therefore, the subject devices are substantially equivalent to the predicate devices.

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).