(171 days)
The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.
The Omnipod GO Pod helps manage diabetes by providing continuous subcutaneous insulin delivery. To facilitate insulin dose titration and provide appropriate options across a wide range of daily insulin needs, the Omnipod GO Device will come in seven different models: 10, 15, 20, 25, 30, 35, and 40 units per day, with each model delivering insulin at a fixed rate over the 72hour life of the device. There is no ability to deliver a bolus dose of insulin using the Omnipod GO device. Like the proposed predicate device (V-GO Insulin Delivery System, K103825), Omnipod GO will be entirely self-contained in an on-body device that is single-use, sterile, and disposable. It is small, lightweight, and designed to the body via an adhesive pad. The adhesive backing keeps the device securely in place for up to 3 days (72 hours).
The provided text describes the Omnipod GO Insulin Delivery Device, but it does not contain specific acceptance criteria or the study details to prove the device meets those criteria, especially in the format of a table with reported device performance.
Here's what can be extracted from the document regarding performance and evaluation, and where information is missing:
Missing Information:
- Specific Acceptance Criteria Table: The document doesn't provide a table explicitly listing acceptance criteria for performance metrics (e.g., specific accuracy ranges they aimed for). It mentions "predetermined acceptance criteria were met" but doesn't detail what they were.
- Reported Device Performance: While it states the device delivers insulin accurately and detects occlusions, specific numerical performance results (e.g., X% accuracy, occlusion detection time) are not provided in the summary.
- Test Set Sample Size: The document refers to "human factors validation" and "performance testing" but does not specify the sample size used for these tests.
- Data Provenance (Test Set): Not explicitly stated whether the test data was retrospective or prospective, or its country of origin.
- Number of Experts & Qualifications (for Ground Truth): Not mentioned for any ground truth establishment.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned as being performed.
- Effect Size of Human Readers Improvement with AI: Not applicable as no MRMC study with AI assistance is mentioned.
- Standalone (Algorithm Only) Performance: The device is an insulin delivery device, not an AI diagnostic/screening algorithm, so this concept (algorithm only performance) doesn't directly apply in the typical sense for medical imaging or similar devices. Its performance is inherent to its physical operation.
- Type of Ground Truth Used: For mechanical performance, "ground truth" would implicitly be highly accurate measurements against known standards. For human factors, it would be based on participant observations and feedback. However, it's not explicitly detailed.
- Training Set Sample Size: Not applicable/not mentioned, as there is no mention of a machine learning model being "trained" in the typical sense for this device.
- How Ground Truth for Training Set was Established: Not applicable/not mentioned.
What is provided in the document:
The document outlines a series of non-clinical performance data categories and general statements about compliance and effectiveness.
Summary of Non-Clinical Performance Data (What was done, but not detailed results or acceptance criteria):
- Risk Management: Completed in accordance with ISO14971:2019. "Verification activities... demonstrated that the predetermined acceptance criteria were met." (Details of criteria and results are missing).
- Safety Assurance: Device utilizes an insulin pump design marketed with other Omnipod devices. Risk mitigations from previous devices are similarly implemented to provide safety against overdose and underdose (occlusion detection, delivery accuracy).
- Human Factors Validation: Followed IEC 62366:2015-1, HE75:2009, and FDA guidance. "A robust validation evaluation was performed to demonstrate safe and effective use... Results... demonstrate that the Omnipod GO has been found to be safe and effective." (Specific data, sample size, or acceptance criteria are missing).
- Software Validation: Performed in accordance with IEC 62304:2015 and FDA guidance.
- Cybersecurity: Analysis performed following FDA guidance.
- Performance Testing: "Demonstrated that the device delivers insulin accurately at various flow rates and that it can effectively detect when an occlusion occurs and promptly notify the user." (Specific metrics, acceptance criteria, and results are missing).
- Biocompatibility: Evaluation performed per ISO 10993-1:2018 (patient-contacting materials are the same as currently marketed Omnipod Pod devices).
- Sterilization: Product adoption completed into the family of devices under sterilization validation.
- Electrical Safety and EMC Testing: Performed to verify compliance with IEC 60601-1:2005 and IEC 60601-1-2.
Key Performance Claim related to Predicate Device Comparison (Table 1.01):
| Element of Comparison | Subject Device: Omnipod GO Insulin Delivery Device | Performance Claim/Difference |
|---|---|---|
Insulin Delivery Accuracy | +/- 5% | Improved from predicate's +/- 10% |
This is the only specific quantitative performance metric with a value mentioned in the entire document. The document implies this "improved" accuracy value meets the new device's acceptance criterion for insulin delivery accuracy.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 24, 2023
Insulet Corporation Danna Zylka Sr. Manager, Regulatory Affairs 100 Nagog Park Acton, Massachusetts 01720
Re: K223372
Trade/Device Name: Omnipod GO Insulin Delivery Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: March 9, 2023 Received: March 10, 2023
Dear Danna Zylka:
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 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
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- 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 mediation-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.
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K223372
Device Name Omnipod GO Insulin Delivery Device
Indications for Use (Describe)
The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.
| 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)
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Image /page/3/Picture/0 description: The image contains the logo for Omnipod. The word "omni" is in gray, and the word "pod" is in orange. Below the word "omnipod" is the phrase "simplify life" in gray. To the right of the word "omnipod" is an orange rounded rectangle.
5.0 510(K) SUMMARY
| Date prepared: | 24-April-2023 |
|---|---|
| 510(k) No. | K223372 |
| Submitter Name: | Insulet Corporation |
| Submitter Address: | 100 Nagog Park, Acton, MA 01720 |
| FDA Establishment Owner/OperatorNumber: | 9056196 |
| FDA Establishment RegistrationNumber: | 3014585508 |
| Contact Person: | Danna ZylkaSr. Manager, Regulatory Affairs |
| Phone: | (289) 863-8161 (office)(289) 795-9200 (direct) |
| Fax: | (978) 600-0120 |
| Device Trade / Proprietary Name: | Omnipod GO Insulin Delivery Device |
| Device Common Name: | Pump, Infusion, Insulin |
| Regulation Description: | Infusion pump |
| Regulation Medical Specialty: | Clinical Chemistry |
| Review Panel: | Clinical Chemistry |
| Product Code: | LZG (Infusion Pump) |
| Submission Type: | Traditional 510(k) |
| Regulation Numbers: | 21 CFR 880.5725 |
| Device Class: | Class II |
| Predicate device: | K103825, V-GO Insulin Delivery System |
| Reference device: | K211575, Omnipod DASH InsulinManagement System |
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Image /page/4/Picture/0 description: The image shows the Omnipod logo. The word "omnipod" is written in orange, with the words "simplify life" written in gray below it. To the right of the word "omnipod" is an orange shield.
5.1 Indications for Use
The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.
5.2 Device Description
The Omnipod GO Pod helps manage diabetes by providing continuous subcutaneous insulin delivery. To facilitate insulin dose titration and provide appropriate options across a wide range of daily insulin needs, the Omnipod GO Device will come in seven different models: 10, 15, 20, 25, 30, 35, and 40 units per day, with each model delivering insulin at a fixed rate over the 72hour life of the device. There is no ability to deliver a bolus dose of insulin using the Omnipod GO device. Like the proposed predicate device (V-GO Insulin Delivery System, K103825), Omnipod GO will be entirely self-contained in an on-body device that is single-use, sterile, and disposable. It is small, lightweight, and designed to the body via an adhesive pad. The adhesive backing keeps the device securely in place for up to 3 days (72 hours).
5.3 Summary of Technological Characteristics Compared to Predicate Device
The subject device has the same intended use (subcutaneous infusion of insulin for the management of diabetes) and similar indications for use, principles of operation, and use environment as the predicate device. Both the subject device and the predicate are prescription only, self-contained, sterile, patient-fillable, single-use disposable devices consisting of a tubeless insulin pump that subcutaneously delivers insulin to a user by automatically pumping insulin to the user at a specified rate over a specified time period. Both the predicate and subject device communicate current device status to the user using visual indicators on the device. The Omnipod GO device additionally communicates device status to the user via audible indicators.
The subject device and predicate device have similar operating principles to achieve the intended therapeutic effect. Both operate by providing force against the insulin reservoir plunger to deliver insulin to the user. The differences between the subject device and predicate device include the following: pumping mechanism, insulin delivery time period (24 hours versus
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72 hours), basal delivery rates, insulin delivery accuracy, insulin fill accessory, and alerts and alarm functions. These differences are further described in Table 1.01 below and are substantiated by including the Omnipod DASH (K211575) as a reference device as the same test methods were used to ensure the safety and effectiveness.
Table 1.01: Predicate Comparison
| Element of Comparison | Predicate Device:Veritas Inc. V-Go InsulinDelivery Device (K103825) | Subject Device:Omnipod GO InsulinDelivery Device |
|---|---|---|
| Indications for Use | Indicated for continuoussubcutaneous infusion of 20Units of insulin in one 24-hourtime period (0.83U/hr) and on-demand bolus dosing in 2-Unitincrements (up to 36 Units perone 24-hour time period) in adultpatients requiring insulin. (Note:30 Unit/day and 40 Unit/daymodels are also available) | Indicated for thesubcutaneous infusion ofinsulin at a preset basal ratein one 24-hour time periodfor 3 days (72 hours) inadults with type 2 diabetes. |
| Specific Drug/BiologicUse | Rapid-acting U-100 InsulinSystem has been tested withNovoLog® and Humalog® | Rapid-acting U-100 InsulinSystem has been tested withNovoLog® Humalog®,Admelog®, Fiasp® andLyumjev®. |
| Prescription Status | Prescription Only | Prescription Only |
| Pumping Mechanism | Mechanical, no softwareOperate by providing forceagainst a plunger, which isinserted into a cylindricalreservoir filled with high viscosityfluid. This force is directlytranslated against the rear of thedelivery piston at the rear of theinsulin reservoir. | Electromechanical, softwareStep Drive Mechanism isactivated by microprocessor;turns leadscrew; presses onsyringe style reservoir todeliver insulin through acannula into a patient'ssubcutaneous tissue. |
| Insertion Needle | Integrated 30-gauge stainlesssteel subcutaneous needle | Integrated 27-gaugestainless steel subcutaneousinsertion needle andflexible fluorinated ethylene |
| Element of Comparison | Predicate Device:Veritas Inc. V-Go InsulinDelivery Device (K103825) | Subject Device:Omnipod GO InsulinDelivery Device |
| Adhesion to Skin | Secured by an adhesive-backedpad, which is attached to theback of the pump. | Secured by an adhesive-backed pad, which isattached to the back of thepump. |
| Administrative Sets andReservoir | Integrated reservoir and patientactivated cannula insertionsystem. No separate infusionset. EZ Fill accessory deviceused to fill reservoir with insulin. | Integrated reservoir andautomatic cannula insertionsystem. No separate infusionset or reservoir. Fillaccessory device used to fillreservoir with insulin. |
| Basal Insulin DeliveryMethod and Rates | Once activated, the V-Go devicedelivers a continuous infusion ofinsulin at a fixed rate.Device models:20 Units/24 hr (0.83 U/hr)30 Units/24 hr (1.25 U/hr)40 Units/24 hr (1.67 U/hr) | Once activated, the devicedelivers a continuousinfusion of insulin at a fixedrate.Device models:10 Units/24 hr (0.42 U/hr)15 Units/24 hr (0.63 U/hr)20 Units/24 hr (0.83 U/hr)25 Units/24 hr (1.04 U/hr)30 Units/24 hr (1.25 U/hr)35 Units/24 hr (1.46 U/hr)40 Units/24 hr (1.67 U/hr) |
| Insulin DeliveryAccuracy | +/- 10% | +/- 5% |
| Bolus Delivery | On - demand with each press ofbutton. Each button press is 2Units | No bolus delivery |
| Insulin Delivery TimePeriod (Useful life) | Each device is specified for# insulin Units/day and is used ina single 24-hour period.24 hour useful life | Each device isspecified for # insulinUnits/day and is used forthree consecutive days (one72-hour period).72 hour useful life |
| Element of Comparison | Predicate Device:Veritas Inc. V-Go InsulinDelivery Device (K103825) | Subject Device:Omnipod GO InsulinDelivery Device |
| Insulin StatusNotifications, Alerts andAlarms | Device does not have any typeof notifications or alarms otherthan a visual gauge indicatingreservoir status | Audible and visual (LED)notifications/alerts/alarmsNotification Functions:• Pod Activation• Insulin DeliveryAdvisory Notification/Signal:• Cannula InsertionCountdown• Cannula InsertionImminent• Cannula InsertionAlert Functions:• Pod ExpirationAlarm Functions:• Hazard Alarm• Device Failure Alarm |
| Occlusion Detection | Viewing window allows visibilityof the insulin reservoir and agrey indicator in the windowindicates the flow of insulin asdemonstrated by the indicatormoving over time. | Occlusion algorithm monitorsfor increased resistance topumping and alarms if anocclusion is detected within5 units. |
| Operating RelativeHumidity | 20% to 90% | 20% to 85%, non-condensing |
| Operating Temperature | 40°F to 99°F (5°C to 37°C) | 41°F to 104°F (5°C to 40°C) |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 36 months | 18 months |
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Image /page/6/Picture/0 description: The image contains the logo for Omnipod. The word "omni" is in orange, followed by the word "pod" which is in white and contained within an orange shield shape. Below the word "omni" is the tagline "simplify life" in gray.
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Image /page/7/Picture/0 description: The image contains the Omnipod logo. The word "omni" is in orange, followed by "pod" in white, set against an orange shield-like shape. Below the word "omnipod" is the tagline "simplify life™" in gray.
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Image /page/8/Picture/0 description: The image is a logo for Omnipod. The word "omnipod" is written in orange, with the words "simplify life" written in gray below it. To the right of the word "omnipod" is an orange shape that resembles a rounded rectangle.
5.4 Standards Compliance
The Omnipod GO Inspire device complies with the following standards as documented in the applicable documents provided in this 510(k) submission.
| Standard | Title | Edition in Effect |
|---|---|---|
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing within a Risk ManagementProcess | 2018/Cor.1:2010 |
| ISO 10993-3 | Biological Evaluation of Medical Devices - Part 3:Tests for Genotoxicity, Carcinogenicity andReproductive Toxicity | 2014 |
| ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5:Tests for in Vitro Cytotoxicity | 2009 |
| ISO 10993-6 | Biological Evaluation of Medical Devices - Part 6:Test for Local Effects After Implantation | 2016 |
| ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7:Ethylene Oxide Sterilization Residuals | 2008/Cor 1:2009 |
| ISO 10993-10 | Biological Evaluation of Medical Devices - Part 10:Tests for Irritation and Skin Sensitization | 2010 |
| ISO 10993-11 | Biological Evaluation of Medical Devices - Part 11:Tests for Systemic Toxicity | 2017 |
| ISO 10993-12 | Biological Evaluation of Medical Devices - Part 12:Sample preparation and reference materials | 2021 |
| ISO 10993-17 | Biological Evaluation of Medical Devices - Part 17:Methods for the establishment of allowable limitsfor leachable substances | 2002 |
| ISO 10993-18 | Biological Evaluation of Medical Devices - Part 18:Chemical characterization of materials | 2020 |
| ISO 11135 | Sterilization of health care products - Ethyleneoxide - Requirements for development, validationand routine control of a sterilization process formedical devices | 2014+A1:2018 |
| ISO 11737-1 | Sterilization of health care products -microbiological methods - part 1: Determination ofa population of microorganisms on product | 2018 |
| ISO 11607-1 | Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barriersystems and packaging systems | 2019 |
| Standard | Title | Edition in Effect |
| ISO 11607-2 | Packaging for Terminally Sterilized MedicalDevices - Part 2: Validation requirements forforming, sealing and assembly processes | 2019 |
| IEC 60601-1-2 | Medical Electrical Equipment- Part 1-2: CollateralStandard: Electromagnetic Disturbances -Requirements and Tests | Ed. 4.0: 2014 |
| ISTA 3A | Packaged-Products for Parcel Delivery SystemShipment 70 kg (150 lb) or Less | 2018 |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices | 2016 |
| ASTM D4169-16 | Standard Practice for Performance Testing ofShipping Containers and Systems | 2016 |
| ASTM F88/F88M-15 | Standard Test method for Peel Strength ofFlexible Barrier Materials | 2015 |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaksin Packaging by Internal Pressure (Bubble Test) | 2019 |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks inMedical Packaging by Dye Penetration | 2015 |
| F1886/F1886M-16 | Standard Test Method for Determining Integrity ofSeals for Flexible Packaging by Visual Inspection | 2016 |
| ASTM D903-98 | Standard Test method for Peel of StrippingStrength of Adhesive Bonds | 2017 |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: Collateralstandard: Usability | Ed. 3.1: 2013 |
| IEC 62366-1 | Medical Devices - Part 1: Application of usabilityengineering to medical devices | Ed. 1: 2015 |
| ISO 15223-1 | Medical devices - Symbols to be used withmedical device labels, labelling and information tobe supplied - Part 1: General requirements | Ed. 3: 2016 |
| ISO 14971 | Medical Devices - Application of RiskManagement to Medical Devices | Ed. 2: 2019 |
| IEC 60601-1 | Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance | Ed. 3.1: 2012 |
| ANSI/AAMIES60601-1 | Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance | 2012 |
| IEC 60601-1-8 | Medical Electrical Equipment - Part 1-8: CollateralStandard: Tests and Guidance for Alarm Systemsin Medical Electrical Equipment and MedicalElectrical Systems. | Ed. 2.1: 2012 |
| Standard | Title | Edition in Effect |
| IEC 60601-1-11 | Medical Electrical Equipment - Part 1-11:Collateral Standard: Requirements for MedicalElectrical Equipment and Medical ElectricalSystems Used in the Home HealthcareEnvironment | Ed. 2.0: 2015 |
| ISO 23908 | Sharps injury protection – Requirements and testmethods – Sharps protection features for single-use hypodermic needles, introducers for cathetersand needles used for blood sampling | 2011 |
| IEC 62304 | Medical Devices Software - (Software life cycleprocesses) | Ed. 1.1: 2015 |
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Image /page/9/Picture/0 description: The image shows the logo for Omnipod. The word "omni" is in orange, and the word "pod" is in white, with the "pod" being inside of an orange shield shape. Below the word "omnipod" is the tagline "simplify life" in gray.
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Image /page/10/Picture/0 description: The image shows the Omnipod logo. The word "omni" is in orange, and the word "pod" is in white inside an orange shield shape. Below the word "omni" is the tagline "simplify life" in gray.
5.5 Summary of Non-Clinical Performance Data
Performance testing on the Omnipod GO device included the following:
- Risk Management: Risk management was completed in accordance with . ISO14971:2019. Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met, and the device is safe for use.
- Safety Assurance: The Omnipod GO device utilizes an insulin pump design that о has been marketed with other Omnipod devices (Omnipod and Omnipod DASH Insulin Management Systems, pre-market filing (K211575). The Omnipod GO device features and functions have been significantly simplified from the previously marketed devices to serve the intended user and application. The notable difference in the Omnipod GO device is the absence of a controller device which is employed in the Omnipod and Omnipod DASH systems to set up insulin delivery parameters, program bolus dosing by the user and provide device status information. The majority of risk mitigations in the Omnipod and Omnipod DASH Pods related to insulin delivery are similarly implemented in the Omnipod GO device to provide safety against overdose and under dose situations (such as occlusion detection and delivery accuracy).
- Human Factors Validation: Insulet executed a comprehensive human factors and usability engineering process that followed and complied with the FDA-recognized standards IEC 62366:2015-1 and HE75:2009 as well as the FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices -Issued February 3, 2016. A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod GO device with intended users in the expected use
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environments, including associated training and accompanying documentation. The results of the validation demonstrate that the Omnipod GO has been found to be safe and effective for the intended users, uses, and use environments.
- Software Validation: Software verification and validation testing was performed in . accordance with IEC 62304:2015 and FDA's quidance document. General Principles of Software Validation - Issued January 11, 2002.
- Cybersecurity: A cybersecurity analysis was performed for the Omnipod GO device . following the FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical devices - Issued October 18, 2020, and the principles outlined in the FDA guidance, Postmarket Management of Cybersecurity in Medical Devices lssued December 28, 2020. Insulet has provided a software bill of materials and penetration testing.
- Performance Testing: Verification testing has demonstrated that the device delivers . insulin accurately at various flow rates and that it can effectively detect when an occlusion occurs and promptly notify the user.
- . Biocompatibility: All patient-contacting materials and manufacturing processes of the Omnipod GO device are the same as those of the currently marketed Omnipod Pod devices. A biocompatibility evaluation was performed in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.
- Sterilization: A product adoption was completed to adopt the Omnipod GO device into . the family of devices under the sterilization validation.
- Electrical Safety and EMC Testing: Testing was performed to verify that the Omnipod . GO device meets its requirement to comply with IEC 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: Collateral Standard: Electromagnetic Disturbances-Requirements and Tests.
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Image /page/12/Picture/0 description: The image shows the Omnipod logo. The word "omnipod" is written in orange, with the words "simplify life" written in gray below it. To the right of the word "omnipod" is an orange shield.
5.6 Substantial Equivalence Conclusion
After analyzing the intended use/indications for use, technological characteristics, and performance data, Insulet concludes that the Omnipod GO Insulin Delivery Device is substantially equivalent to the legally marketed Valeritas Inc. V-Go Insulin Delivery Device (K103825). While the subject device's technological characteristics differ slightly from the predicate, the differences do not raise different questions of safety and effectiveness as substantiated by the reference device (Omnipod DASH device cleared under K211575). Therefore, the Omnipod GO is substantially equivalent to the predicate device.
§ 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).