(171 days)
No
The device delivers insulin at a fixed, preset basal rate and lacks a controller for user input or dynamic adjustments, indicating no AI/ML functionality.
Yes
The device is intended for the subcutaneous infusion of insulin to manage type 2 diabetes, which is a therapeutic intervention.
No.
The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin, managing diabetes by providing continuous subcutaneous insulin delivery at a preset basal rate. It does not perform any diagnostic function.
No
The device description explicitly states it is an "on-body device that is single-use, sterile, and disposable" and mentions physical components like an "adhesive pad." The performance studies also detail testing related to hardware aspects such as biocompatibility, sterilization, and electrical safety, indicating it is a physical medical device with embedded software, not a software-only device.
Based on the provided information, the Omnipod GO Insulin Delivery Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin. This is a direct delivery of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the mechanism of delivering insulin, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely therapeutic (delivering insulin).
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Omnipod GO device does not perform any such examination.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Insulin Delivery Accuracy: +/- 5%
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.
K103825, V-GO Insulin Delivery System
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.
K211575, Omnipod DASH Insulin Management System
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).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
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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
1
- 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
2
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/Operator | |
| Number: | 9056196 |
| FDA Establishment Registration | |
| Number: | 3014585508 |
| Contact Person: | Danna Zylka |
| Sr. 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 Insulin |
| Management 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 Insulin
Delivery Device (K103825) | Subject Device:
Omnipod GO Insulin
Delivery Device |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for continuous
subcutaneous infusion of 20
Units of insulin in one 24-hour
time period (0.83U/hr) and on-
demand bolus dosing in 2-Unit
increments (up to 36 Units per
one 24-hour time period) in adult
patients requiring insulin. (Note:
30 Unit/day and 40 Unit/day
models are also available) | Indicated 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. |
| Specific Drug/Biologic
Use | Rapid-acting U-100 Insulin
System has been tested with
NovoLog® and Humalog® | Rapid-acting U-100 Insulin
System has been tested with
NovoLog® Humalog®,
Admelog®, Fiasp® and
Lyumjev®. |
| Prescription Status | Prescription Only | Prescription Only |
| Pumping Mechanism | Mechanical, no software
Operate by providing force
against a plunger, which is
inserted into a cylindrical
reservoir filled with high viscosity
fluid. This force is directly
translated against the rear of the
delivery piston at the rear of the
insulin reservoir. | Electromechanical, software
Step Drive Mechanism is
activated by microprocessor;
turns leadscrew; presses on
syringe style reservoir to
deliver insulin through a
cannula into a patient's
subcutaneous tissue. |
| Insertion Needle | Integrated 30-gauge stainless
steel subcutaneous needle | Integrated 27-gauge
stainless steel subcutaneous
insertion needle and
flexible fluorinated ethylene |
| Element of Comparison | Predicate Device:
Veritas Inc. V-Go Insulin
Delivery Device (K103825) | Subject Device:
Omnipod GO Insulin
Delivery Device |
| Adhesion to Skin | Secured by an adhesive-backed
pad, which is attached to the
back of the pump. | Secured by an adhesive-
backed pad, which is
attached to the back of the
pump. |
| Administrative Sets and
Reservoir | Integrated reservoir and patient
activated cannula insertion
system. No separate infusion
set. EZ Fill accessory device
used to fill reservoir with insulin. | Integrated reservoir and
automatic cannula insertion
system. No separate infusion
set or reservoir. Fill
accessory device used to fill
reservoir with insulin. |
| Basal Insulin Delivery
Method and Rates | Once activated, the V-Go device
delivers a continuous infusion of
insulin 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 device
delivers a continuous
infusion of insulin at a fixed
rate.
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 Delivery
Accuracy | +/- 10% | +/- 5% |
| Bolus Delivery | On - demand with each press of
button. Each button press is 2
Units | No bolus delivery |
| Insulin Delivery Time
Period (Useful life) | Each device is specified for
insulin Units/day and is used in
a single 24-hour period.
24 hour useful life | Each device is
specified for # insulin
Units/day and is used for
three consecutive days (one
72-hour period).
72 hour useful life |
| Element of Comparison | Predicate Device:
Veritas Inc. V-Go Insulin
Delivery Device (K103825) | Subject Device:
Omnipod GO Insulin
Delivery Device |
| Insulin Status
Notifications, Alerts and
Alarms | Device does not have any type
of notifications or alarms other
than a visual gauge indicating
reservoir status | Audible and visual (LED)
notifications/alerts/alarms
Notification Functions:
• Pod Activation
• Insulin Delivery
Advisory Notification/Signal:
• Cannula Insertion
Countdown
• Cannula Insertion
Imminent
• Cannula Insertion
Alert Functions:
• Pod Expiration
Alarm Functions:
• Hazard Alarm
• Device Failure Alarm |
| Occlusion Detection | Viewing window allows visibility
of the insulin reservoir and a
grey indicator in the window
indicates the flow of insulin as
demonstrated by the indicator
moving over time. | Occlusion algorithm monitors
for increased resistance to
pumping and alarms if an
occlusion is detected within
5 units. |
| Operating Relative
Humidity | 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 Management | ||
| Process | 2018/Cor.1:2010 | |
| ISO 10993-3 | Biological Evaluation of Medical Devices - Part 3: | |
| Tests for Genotoxicity, Carcinogenicity and | ||
| Reproductive 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 limits | ||
| for 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 - Ethylene | |
| oxide - Requirements for development, validation | ||
| and routine control of a sterilization process for | ||
| medical devices | 2014+A1:2018 | |
| ISO 11737-1 | Sterilization of health care products - | |
| microbiological methods - part 1: Determination of | ||
| a population of microorganisms on product | 2018 | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices |
- Part 1: Requirements for materials, sterile barrier
systems and packaging systems | 2019 |
| Standard | Title | Edition in Effect |
| ISO 11607-2 | Packaging for Terminally Sterilized Medical
Devices - Part 2: Validation requirements for
forming, sealing and assembly processes | 2019 |
| IEC 60601-1-2 | Medical Electrical Equipment- Part 1-2: Collateral
Standard: Electromagnetic Disturbances -
Requirements and Tests | Ed. 4.0: 2014 |
| ISTA 3A | Packaged-Products for Parcel Delivery System
Shipment 70 kg (150 lb) or Less | 2018 |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices | 2016 |
| ASTM D4169-16 | Standard Practice for Performance Testing of
Shipping Containers and Systems | 2016 |
| ASTM F88/F88M-
15 | Standard Test method for Peel Strength of
Flexible Barrier Materials | 2015 |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks
in Packaging by Internal Pressure (Bubble Test) | 2019 |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in
Medical Packaging by Dye Penetration | 2015 |
| F1886/F1886M-16 | Standard Test Method for Determining Integrity of
Seals for Flexible Packaging by Visual Inspection | 2016 |
| ASTM D903-98 | Standard Test method for Peel of Stripping
Strength of Adhesive Bonds | 2017 |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: Collateral
standard: Usability | Ed. 3.1: 2013 |
| IEC 62366-1 | Medical Devices - Part 1: Application of usability
engineering to medical devices | Ed. 1: 2015 |
| ISO 15223-1 | Medical devices - Symbols to be used with
medical device labels, labelling and information to
be supplied - Part 1: General requirements | Ed. 3: 2016 |
| ISO 14971 | Medical Devices - Application of Risk
Management to Medical Devices | Ed. 2: 2019 |
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance | Ed. 3.1: 2012 |
| ANSI/AAMI
ES60601-1 | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance | 2012 |
| IEC 60601-1-8 | Medical Electrical Equipment - Part 1-8: Collateral
Standard: Tests and Guidance for Alarm Systems
in Medical Electrical Equipment and Medical
Electrical Systems. | Ed. 2.1: 2012 |
| Standard | Title | Edition in Effect |
| IEC 60601-1-11 | Medical Electrical Equipment - Part 1-11:
Collateral Standard: Requirements for Medical
Electrical Equipment and Medical Electrical
Systems Used in the Home Healthcare
Environment | Ed. 2.0: 2015 |
| ISO 23908 | Sharps injury protection – Requirements and test
methods – Sharps protection features for single-
use hypodermic needles, introducers for catheters
and needles used for blood sampling | 2011 |
| IEC 62304 | Medical Devices Software - (Software life cycle
processes) | 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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Image /page/11/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 rounded rectangle.
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.