SmartAdjust™ Technology

K241777 · Insulet Corporation · QJI · Aug 26, 2024 · Clinical Chemistry

Device Facts

• Record ID: K241777
• Device Name: SmartAdjust™ Technology
• Applicant: Insulet Corporation
• Product Code: QJI · Clinical Chemistry
• Decision Date: Aug 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1356
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Indications for Use

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

Device Story

Software-only medical device (iAGC) residing on Omnipod 5 ACE Pump and App; receives iCGM data via Bluetooth Low Energy. Algorithm calculates insulin delivery every 5 minutes based on user-customizable glucose targets (110–150 mg/dL). Operates in Automated Mode, Automated: Limited (no iCGM data), or Activity (temporary mode for exercise). Used by patients at home; requires prescription. Healthcare providers use output to manage insulin therapy. Benefits include automated glycemic control, reduced time above range, and improved HbA1c in type 2 diabetes patients.

Clinical Evidence

SECURE-T2D prospective, single-arm, multicenter study (N=343). Primary endpoint: HbA1c change from baseline (8.2%) to 13 weeks (7.4%), mean change -0.8% (p<0.001). Secondary endpoints: Time in range (70-180 mg/dL) increased from 45% to 66% (p<0.001). Safety: 1 severe hypoglycemia event; no DKA. Human factors summative study (N=16) confirmed safe use by intended users.

Technological Characteristics

Software-only interoperable automated glycemic controller. Connectivity: Bluetooth Low Energy (BLE). Hosting: Omnipod 5 Pod and Controller. Target glucose range: 110-150 mg/dL (customizable). Compatible with U-100 insulin (NovoLog, Humalog, Admelog). Firmware update capability: Over-the-Air.

Indications for Use

Indicated for management of type 1 diabetes mellitus in persons 2 years and older and type 2 diabetes mellitus in persons 18 years and older. Requires prescription; for single patient use.

Regulatory Classification

Identification

An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect ( *e.g.,* more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events. (ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices. (iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to ( *e.g.,* specification of glucose sensor performance) or accept commands from (*e.g.,* specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices. (vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( *e.g.,* validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller. (2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following: (i) Risk control measures to address device system hazards; (ii) Design decisions related to how the risk control measures impact essential performance; and (iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. (3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to connected devices; (ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices; (iii) Sharing of necessary state information between the controller and any connected devices ( *e.g.,* battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified; (v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and (vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance. (4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include: (i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices; (ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices ( *e.g.,* infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and (iv) Connectivity events ( *e.g.,* establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section. (6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section. (7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable. (8) The labeling required under § 809.10(b) of this chapter must include: (i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part. (ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe. (iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate. (iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section. (v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate. (vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section. (vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.

Predicate Devices

• SmartAdjust™ technology (K232741)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K241777

B Applicant

Insulet Corporation

C Proprietary and Established Names

SmartAdjust™ technology

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QJI | Class II | 21 CFR 862.1356 – Interoperable Automated Glycemic Controller | CH – Clinical Chemistry |

## E Purpose for Submission:

Modification to a cleared device to expand the indications for use to include adults aged 18 years and older with type 2 diabetes mellitus.

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values.

SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older.

SmartAdjust™ technology is intended for single patient use and requires a prescription.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Special Conditions for Use Statement(s):

Rx – For Prescription Use Only

- SmartAdjust™ technology should not be used by anyone under the age of 2 years old.
- SmartAdjust™ technology should also NOT be used in people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population.
- Do not use SmartAdjust™ technology in pregnant women, critically ill patients, and those on dialysis. The safety of the SmartAdjust™ technology has not been evaluated in these populations.
- Do not use SmartAdjust™ technology if you are taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia.
- Do not use SmartAdjust™ technology if you do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders.
- SmartAdjust™ technology used with the Omnipod 5 System is designed to use rapid-acting U-100 insulins. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog® (insulin aspart), Humalog® (insulin lispro), and Admelog® (insulin lispro) for use up to 72 hours (3 days). Before using a different insulin with the Omnipod 5 System, check the insulin drug label and consult your healthcare provider. Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace the Pod.
- SmartAdjust™ technology used with the Omnipod 5 System relies on accurate, current CGM values to determine your insulin needs. Always make sure you are using the CGM per manufacturer's instructions and do not extend the sensor wear beyond the recommended duration.
- Do NOT attempt to use the SmartAdjust™ technology with the Omnipod 5 System before you receive training. Inadequate training could put your health and safety at risk.
- Device components used with the SmartAdjust™ technology including the pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the SmartAdjust™ Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components.

III Device Description

SmartAdjust™ technology (the Omnipod 5 interoperable automated glycemic controller, iAGC) is a software-only medical device intended for the management of type 1 diabetes in people 2 years of age and older. With this submission, the sponsor intends to market the device to adults aged 18 years and older with type 2 diabetes as well. SmartAdjust™ technology is part of the Omnipod 5 System made of the following components:

- Omnipod 5 ACE Pump (pod) – product code QFG, most recently cleared under K231826
- SmartAdjust™ Technology – product code QJI, most recently cleared under K232741
- SmartBolus Calculator – product code QRX, most recently cleared under K231824

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- Integrated continuous glucose monitor (iCGM) – cleared for use with Dexcom G6 and G7, and Abbott Freestyle Libre 2

The SmartAdjust™ technology software resides on the Omnipod 5 ACE Pump (the Omnipod 5 Pod and Omnipod 5 App). The iAGC software is responsible for controlling insulin delivery via compatible ACE Pump when the system is in Automated Mode. iCGM data is transmitted from the iCGM to the ACE Pump via Bluetooth Low Energy technology. The SmartAdjust™ Technology uses this transmitted iCGM data in its calculations. The SmartAdjust™ technology can be turned off, and the Omnipod 5 ACE Pump will operate in Manual Mode, which delivers insulin based on healthcare provider (HCP) or user-defined basal programs.

The SmartAdjust™ technology has three states of operation: Automated Mode, Automated: Limited, and Activity. In Automated Mode, the system calculates insulin delivery every 5 minutes based on the user-customizable glucose target (110–150 mg/dL). Automated: Limited is enabled when the SmartAdjust™ technology is not receiving data from a connected iCGM for 20 minutes or more and during sensor warm-up. While in Automated: Limited, the user will receive no more than pre-programmed basal insulin. When a valid glucose value is received from the iCGM, the SmartAdjust™ technology will resume delivery of insulin in full Automated Mode. Activity is a temporary mode which the user may select for various time durations during automated mode up to 24 hours. With Activity, the algorithm reduces insulin delivery and sets a temporary glucose target to 150 mg/dL. Activity is intended for use during periods when insulin sensitivity is expected to be higher, such as during exercise.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

SmartAdjust™ technology

B Predicate 510(k) Number(s):

K232741

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K241777 | K232741 |
| --- | --- | --- |
| Device Trade Name | SmartAdjust™ Technology | SmartAdjust™ Technology |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | SmartAdjust™ Technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate | Same |

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| | controller enabled (ACE)
pumps to automatically
increase, decrease, and
pause delivery of insulin
based on current and
predicted glucose values. It
is intended for single patient
use and requires a
prescription. | |
| --- | --- | --- |
| General Device
Characteristic Differences | | |
| Intended Use Population | People with type 1 diabetes
aged 2 years and older and
people with type 2 diabetes
aged 18 years and older | People with type 1 diabetes
aged 2 years and older |

V Standards/Guidance Documents Referenced:

- ANSI AAMI ISO 14971:2019<br/>Medical devices – Application of risk management to medical devices
- ANSI AAMI HE75:2009/(R)2018<br/>Human factors engineering – Design of medical devices
- ANSI AAMI IEC 623-1:2015+AMD1:2020 (Consolidated Text)<br/>Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1
- ISO 14155 Third edition 2020-07<br/>Clinical investigation of medical devices for human subjects – Good clinical practice

VI Performance Characteristics:

A. Analytical Performance

The SmartAdjust™ technology is a software-only device, therefore analytical performance characteristics are not applicable.

B. Other Supportive Instrument Performance Characteristics Data

For the evaluation of the system in clinical studies, the SmartAdjust™ technology was installed on the OmniPod 5 ACE Pump (Pod) insulin pump with interoperable technology, which was paired with the Dexcom G6 integrated continuous glucose monitor (iCGM). Details on the performance characteristics of these devices can be found in public decision summaries for each device.

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Summary of Clinical Testing:

The SECURE-T2D clinical study was conducted to evaluate the SmartAdjust™ Technology in adults aged 18 years and older with type 2 diabetes.

| Study Feature | Description |
| --- | --- |
| Title | Safety and Efficacy of the OmniPod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes (SECURE-T2D) |
| Study Design | Single-arm, multicenter, prospective clinical study |
| Number of Sites | Twenty-one (21) sites in the United States |
| Population | 343 subjects aged 18 years and older who had been diagnosed with type 2 diabetes were enrolled. 289 participants completed the study.
Key Inclusion Criteria
• Aged 18-75 years old
• Diagnosed with T2D and on current insulin regimen for at least 3 months prior to screening
• Hemoglobin A1c (HbA1c) < 12% at screening
Key Exclusion Criteria
• Use of an AID pump in automated mode within 3 months prior to screening
• Episodes of severe hypoglycemia or diabetic ketoacidosis in the past 6 months
The recruitment goal for this study was to enroll a heterogenous subject pool reflective of the intended patient population. The study is notable for diversity of age, BMI, race/ethnicity, education, and income level in the subjects. There was also a range of diabetes duration, non-insulin medication, HbA1c, total daily dose, and carb-counting knowledge. |
| Protocol Overview/Synopsis | The study consisted of two phases:
1. 14-day standard therapy phase (baseline)
2. 13 weeks treatment on the Omnipod 5 System with planned meal and exercise challenges

For the standard therapy phase, current Dexcom G6 iCGM users could provide data from a 14-day period within the last 30 days. Non-Dexcom iCGM users wore a study iCGM, in blinded mode, to record glucose measurements over 14 days while subjects managed their diabetes at home per their usual routine and remained on their current multiple daily injection or pump therapy, and sensor, if applicable. |

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| | After completion of the standard therapy phase, subjects were trained on the Omnipod 5 System and transitioned to the hybrid-closed loop (HCL) therapy phase.

Subjects participated in various challenges during the study:
1. Target glucose challenge: 64 study participants utilized 3 different glucose targets for 3 days each (150 mg/dL, 140 mg/dL, and 130 mg/dL).
2. Meal challenge: All study participants completed 4 days of a meal challenge that consisted of a meal that was ≥60 g of carbohydrates. Subjects gave a meal bolus with that meal on days 1 and 3 and skipped a meal bolus on days 2 and 4, and CGM metrics were compared 4 hours post meal.
3. Exercise challenge: All study participants underwent 3 exercise sessions on 3 days. Exercise consisted of 1 hour of mild intensity exercise and 30 minutes of moderate intensity exercise. Subjects did not change their glucose target before exercising. Subjects who consumed a meal prior to exercise followed their normal meal bolus routine (i.e., meal boluses were not adjusted to account for exercise), and 93% did not consume a snack prior to exercise. CGM metrics were assessed during exercise, 2 hours after exercise, and overnight after exercise.

As part of the study, subjects completed questionnaires to assess patient reported psychosocial outcomes: T2-Diabetes Distress Assessment System, Pittsburgh Sleep Quality Index, and the Hypoglycemia Confidence Scale. |
| --- | --- |
| Safety Results | There was 1 severe hypoglycemia event during the study period, which was attributed to a manual bolus request that was greater than necessary for the food that was consumed. The study algorithm stopped insulin delivery in the setting of a decreasing glucose an hour after the bolus was administered, but the subject still experienced a hypoglycemic event. The subject was able to correct this with oral carbohydrates.

There were no other severe hypoglycemia or diabetic ketoacidosis events during the study. There were 14 serious adverse events not related or unlikely to be related to the study device or treatments. |

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Participant Demographics

| | Standard Therapy
N = 320* | Treatment Period
N = 305 |
| --- | --- | --- |
| Age (yrs.) | | |
| <30 | 5 (2%) | 5 (2%) |
| 30-<45 | 45 (14%) | 43 (14%) |
| 45-<65 | 181 (57%) | 171 (56%) |
| ≥65 | 89 (28%) | 86 (28%) |
| Mean (SD) | 57 (11) | 57 (11) |
| Range | 20 to 75 | 20 to 75 |
| Sex – Female n (%) | 185 (58%) | 175 (57%) |
| Height^{a} (cm) – Mean (sd) | 169 (9) | 169 (9) |
| Weight^{a} (kg) – Mean (sd) | 100 (23) | 100 (23) |
| BMI^{a} (kg/m^{2}) | | |
| <30 | 88 (28%) | 84 (28%) |
| 30-<45 | 93 (29%) | 88 (29%) |
| 45-<65 | 73 (23%) | 70 (23%) |
| ≥65 | 66 (21%) | 63 (21%) |
| Mean (SD) | 35 (8) | 35 (8) |
| Range | 22 to 70 | 22 to 70 |
| Race | | |
| American Indian/Alaskan Native | 5 (2%) | 5 (2%) |
| Hispanic or Latino | 3 | 3 |
| Asian | 5 (2%) | 5 (2%) |
| Hispanic or Latino | 0 | 0 |
| Black/African-American | 77 (24%) | 72 (24%) |
| Hispanic or Latino | 0 | 0 |
| More than one race | 3 (<1%) | 3 (<1%) |
| Hispanic or Latino | 0 | 0 |
| Native Hawaiian/Other Pacific Islander | 2 (<1%) | 2 (<1%) |
| Hispanic or Latino | 0 | 0 |
| White | 208 (65%) | 198 (65%) |
| Hispanic or Latino | 48 | 45 |
| Unknown/Not Reported | 20 (6%) | 20 (7%) |
| Hispanic or Latino | 18 | 18 |
| Ethnicity | | |
| Hispanic | 69 (22%) | 66 (22%) |
| Non-Hispanic | 249 (78%) | 237 (78%) |
| Unknown/not reported | 2 (<1%) | 2 (<1%) |
| Education | | |
| < High School Diploma | 20 (6%) | 20 (7%) |
| High School Diploma | 82 (26%) | 79 (26%) |
| Technical/Vocational | 17 (5%) | 17 (6%) |
| Associate Degree | 60 (19%) | 56 (18%) |
| Bachelor’s Degree | 76 (24%) | 70 (23%) |
| Advanced Degree | 40 (13%) | 40 (13%) |
| Do not wish to provide | 25 (8%) | 23 (8%) |

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| Annual Household Income | | |
| --- | --- | --- |
| <$25,000 | 43 (13%) | 42 (14%) |
| $25,000-<$35,000 | 27 (8%) | 23 (8%) |
| $35,000-<$50,000 | 21 (7%) | 19 (6%) |
| $50,000-<$75,000 | 49 (15%) | 49 (16%) |
| $75,000-<$100,000 | 28 (9%) | 26 (9%) |
| $100,00-<$200,000 | 54 (17%) | 51 (17%) |
| $200,000 or more | 16 (5%) | 16 (5%) |
| Unknown | 16 (5%) | 16 (5%) |
| Does not wish to report | 66 (21%) | 63 (21%) |
| Health Insurance | | |
| Private | 170 (53%) | 161 (53%) |
| Medicaid | 28 (9%) | 27 (9%) |
| Medicare | 53 (17%) | 52 (17%) |
| Other government | 29 (9%) | 27 (9%) |
| No coverage | 18 (6%) | 18 (6%) |
| No answer | 22 (7%) | 20 (7%) |

$^{*}N = 343$ enrolled; however, expect for age, data are missing for $N = 23$ . Thus, this cohort includes $N = 320$ .
${}^{a}$ Values collected at Visit 4 (initiation of treatment period); all other values collected at Visit 1.

## Participant Diabetes History

| | Standard Therapy
N = 320* | Treatment Period
N = 305 |
| --- | --- | --- |
| Diabetes Duration (yrs.) | | |
| <5 | 18 (6%) | 14 (5%) |
| 5-<10 | 47 (15%) | 46 (15%) |
| 10-<20 | 132 (41%) | 128 (42%) |
| ≥20 | 123 (38%) | 117 (38%) |
| Median (IQR) | 17 (11, 24) | 17 (11, 24) |
| Range | 0.3 to 41 | 0.3 to 41 |
| Insulin Modality | | |
| Pump | 17 (5%) | 17 (6%) |
| Injections | 303 (95%) | 288 (94%) |
| Insulin | | |
| Basal/Bolus | 252 (79%) | 240 (79%) |
| Basal only | 66 (21%) | 63 (21%) |
| Pre-mix | 2 (<1%) | 2 (<1%) |
| Non-Insulin Glucose Lowering Medications of Interest^{a} - n (%) | | |
| GLP-1 | 178 (56%) | 168 (55%) |
| SGLT2 | 143 (45%) | 135 (44%) |
| DPP4 | 8 (3%) | 8 (3%) |
| GLP1 or SGLT2^{b} | 145 (45%) | 139 (46%) |
| GLP1 and SGLT2^{b} | 88 (28%) | 82 (27%) |

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| Prior Continuous Glucose Monitor Use | | |
| --- | --- | --- |
| Never | 80 (25%) | 75 (25%) |
| In past, but not current | 44 (14%) | 42 (14%) |
| Current | 196 (61%) | 188 (62%) |
| Duration of CGM use at Baseline | | |
| <3 months | 16 (8%) | 16 (9%) |
| 3-<6 months | 20 (10%) | 20 (11%) |
| 6 months-<1 year | 29 (15%) | 27 (14%) |
| 1-<2 years | 46 (23%) | 43 (23%) |
| 2-<5 years | 69 (35%) | 67 (36%) |
| >=5 years | 16 (8%) | 15 (8%) |
| HbA1c – Local | | |
| <8.0% | 160 (50%) | 152 (50%) |
| 8.0%-<9.0% | 76 (24%)0 | 72 (24%) |
| ≥9.0% | 84 (26%) | 81 (27%) |
| Mean (SD) | 8.2 (1.4) | 8.2 (1.4) |
| Range | 4.9 to 11.9 | 4.9 to 11.9 |
| Total Daily Insulin (U/kg/day) | | |
| Mean (SD) | 0.8 (0.5) | 0.8 (0.5) |
| Range | 0.1 to 2.9 | 0.1 to 2.9 |
| Severe Events | | |
| Severe hypoglycemia ever | 14 (4%) | 13 (4%) |
| Diabetic ketoacidosis ever | 18 (6%) | 16 (5%) |
| Hyperosmolar hyperglycemic state ever | 1 (<1%) | 1 (<1%) |
| c-Peptide^{c,d} (nmol/L) – Median (IQR) | 1.0 (0.6, 1.4) | 1.0 (0.6, 1.4) |
| Serum Creatinine^{c,e} (mg/dL) – Median (IQR) | 0.9 (0.7, 1.1) | 0.9 (0.7, 1.1) |
| GAD Antibody^{c,f} (IU/mL) – n (%) | | |
| <5.0 | 284 (93%) | 284 (93%) |
| 5.0< to <250 | 7 (2%) | 7 (2%) |
| ≥250 | 13 (4%) | 13 (4%) |

$^{*}N = 343$ enrolled; however, except for age, data are missing for $N = 23$. Thus, this cohort includes $N = 320$.
$^{a}$Not mutually exclusive. In the $N = 320$ cohort, 88 are on both SGLT2 and GLP1, 3 on both SGLT2 and DPP4, 2 on GLP1 and DPP4, and 1 on all 3. In the $N = 305$ cohort, 82 are on both SGLT2 and GLP1, 3 on both SGLT2 and DPP4, 2 on GLP1 and DPP4, and 1 on all 3.
$^{b}$Participants were enrolled with a goal of at least $20\%$ on SGLT or GLP1 and at least $5\%$ on both SGLT and GLP1.
$^{c}$Values collected at Visit 4.
$^{d}$Collected at Visit 4 only and missing for 5 participants.
$^{e}$Collected at Visit 4 only and missing for 3 participants.
$^{f}$Collected at Visit 4 only and missing for 1 participant.

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# Observed Results

The primary endpoint was the change in HbA1c from baseline (8.2%) to the end of 13 weeks of Omnipod 5 System use (7.4%). There was a mean change in HbA1c of -0.8% (P&lt;0.001), with a larger change in mean HbA1c for those with a higher baseline HbA1c. The table below shows the results of the primary safety and efficacy endpoints across the entire study population:

| | Baseline
N = 296 | End of Study
N = 296 | Mean Estimate and 95% CI for End of Study vs. Baseline
N = 296 | P-value for End of Study vs. Baseline (non-inferiority) |
| --- | --- | --- | --- | --- |
| HbA1c^{a}
mean (SD) | 8.2%
(1.3%) | 7.4%
(0.9%) | -0.8%
(-1.0%, -0.7%) | <0.001^{a,b} |

aTesting for non-inferiority with a NI limit of 0.3%.
bA sensitivity analysis was done using Rubin’s multiple imputation for the N=9 participants who dropped out without a 13-week HbA1c value. This gave the same point estimate, confidence interval and p-value as above: -0.8% (-1.0%, -0.7%); p&lt;0.001. Note, any HbA1c measurements outside the analysis window of 42-119 days (6-17 weeks) from AID initiation were treated as missing data.

There was no statistically significant change in HbA1c between sex, income or education level, or other medication use. There was a significant change in HbA1c between different age, race/ethnicity, pre-study carb counting knowledge, and baseline HbA1c. Specifically, the most improvement in HbA1c was noted in Hispanic or other subjects, subject ages 31-45 years old, and subjects who did not carb count prior to this study. Finally, subjects with the highest starting baseline (HbA1c ≥ 9%) had the greatest improvement in HbA1c from a mean of 10.1% to 8.1%. The table below shows subgroup analyses for the change in HbA1c by baseline characteristics:

| | Standard Therapy | Treatment Period | Difference | Interaction P-Value* |
| --- | --- | --- | --- | --- |
| Gender | | | | |
| Female (N = 168) | | | | |
| Mean ± SD | 8.3 ± 1.4 | 7.4 ± 0.9 | -0.9 ± 1.1 | 0.73/0.54 |
| [Range] | 4.9 to 11.7 | 5.6 to 9.8 | -5.3 to 1.2 | |
| Male (N = 128) | | | | |
| Mean ± SD | 8.1 ± 1.2 | 7.3 ± 0.8 | -0.8 ± 1.0 | |
| [Range] | 6.2 to 12.0 | 5.7 to 10.6 | -5.1 to 2.8 | |
| Race/Ethnicity | | | | |
| Non-Hispanic White (N = 148) | | | | |
| Mean ± SD | 7.9 ± 1.1 | 7.2 ± 0.8 | -0.7 ± 0.9 | 0.03/0.004 |
| [Range] | 5.5 to 11.1 | 5.6 to 10.6 | -3.7 to 2.8 | |
| Non-Hispanic Black/African-American (N = 69) | | | | |
| Mean ± SD | 8.6 ± 1.4 | 7.8 ± 1.0 | -0.8 ± 1.0 | |
| [Range] | 5.3 to 12.0 | 5.6 to 9.8 | -3.4 to 1.2 | |
| Latino(x)/Hispanic (N = 65) | | | | |
| Mean ± SD | 8.5 ± 1.5 | 7.4 ± 0.9 | -1.2 ± 1.2 | |

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| [Range] | 4.9 to 11.9 | 5.7 to 9.5 | -5.3 to 0.8 | |
| --- | --- | --- | --- | --- |
| Other (N = 14) | Mean
8.5 ± 1.4
[Range]
7.0 to 11.7 | 7.3 ± 0.9
6.3 to 9.3 | -1.2 ± 1.2
-4.2 to 0.6 | |
| Age | | | | |
| 18-<30 years (N = 5) | Mean ± SD
7.5 ± 2.3
Range
4.9 to 11.1 | 7.2 ± 1.5
5.7 to 9.8 | -0.2 ± 0.8
-1.3 to 0.8 | 0.006/0.51 |
| 30-<45 years (N = 41) | Mean ± SD
8.8 ± 1.6
Range
5.3 to 11.7 | 7.4 ± 1.0
5.6 to 9.5 | -1.4 ± 1.3
-5.3 to 0.6 | |
| 45-<65 years (N = 166) | Mean ± SD
8.3 ± 1.2
Range
6.2 to 12.0 | 7.4 ± 0.9
5.6 to 10.6 | -0.8 ± 1.0
-3.4 to 2.8 | |
| ≥ 65 years (N = 84) | Mean ± SD
7.9 ± 1.1
Range
5.5 to 11.0 | 7.2 ± 0.8
5.7 to 9.1 | -0.6 ± 0.9
-5.1 to 0.9 | |
| Income | | | | |
| <$50,000/year (N = 81) | Mean
8.5 ± 1.5
[Range]
5.3 to 11.3 | 7.6 ± 1.0
5.6 to 9.8 | -0.9 ± 1.0
-5.1 to 1.2 | 0.80/0.54 |
| $50,000 -<$100,000/year (N = 72) | Mean
8.1 ± 1.2
[Range]
5.5 to 12.0 | 7.2 ± 0.7
5.6 to 9.8 | 0.9 ± 1.1
-5.3 to 0.9 | |
| $100,000-<$200,000/year (N = 51) | Mean
8.0 ± 1.0
[Range]
6.8 to 11.7 | 7.3 ± 0.8
5.8 to 9.7 | -0.7 ± 0.9
-3.4 to 0.7 | |
| ≥$200,000/year (N = 16) | Mean
8.3 ± 1.6
[Range]
6.2 to 11.6 | 7.3 ± 0.8
5.9 to 9.0 | -1.0 ± 1.3
-4.2 to 0.4 | |
| Unknown (N = 76) | Mean
8.2 ± 1.3
[Range]
4.9 to 11.9 | 7.4 ± 1.0
5.7 to 10.6 | -0.8 ± 1.1
-3.7 to 2.8 | |
| Education | | | | |
| High School/GED or Less (N = 95) | Mean ± SD
8.4 ± 1.3
[Range]
6.2 to 12.0 | 7.4 ± 1.0
5.6 to 10.6 | -1.0 ± 1.0
-3.4 to 2.8 | 0.72/0.18 |
| Technical/Vocational/Associates (N = 70) | Mean ± SD
7.9 ± 1.3
[Range]
4.9 to 11.3 | 7.1 ± 0.7
5.6 to 8.5 | -0.9 ± 1.1
-5.3 to 0.9 | |
| College Degree (N = 70) | Mean ± SD
8.3 ± 1.3
[Range]
6.2 to 11.9 | 7.6 ± 0.9
5.9 to 9.8 | -0.7 ± 1.0
-5.1 to 1.0 | |
| Advanced Degree (N = 40) | | | | |

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| | | | | |
| --- | --- | --- | --- | --- |
| Mean ± SD
[Range] | 8.1 ± 1.4
6.0 to 11.7 | 7.3 ± 0.9
5.9 to 9.3 | -0.8 ± 1.1
-4.2 to 0.6 | |
| Do not wish to provide (N = 21) | | | | |
| Mean ± SD
[Range] | 8.3 ± 1.3
6.2 to 10.7 | 7.5 ± 0.9
6.0 to 9.8 | -0.8 ± 1.1
-3.7 to 1.1 | |
| Insurance | | | | |
| Private (N = 159) | | | | |
| Mean ± SG
[Range] | 8.1 ± 1.3
4.9 to 12.0 | 7.3 ± 0.9
5.6 to 9.8 | -0.8 ± 1.0
-5.3 to 1.1 | |
| Other (N = 101) | | | | |
| Mean ± SG
[Range] | 8.2 ± 1.4
5.5 to 11.9 | 7.4 ± 1.0
5.8 to 10.6 | -0.8 ± 1.1
-5.1 to 2.8 | 0.50/0.69 |
| No coverage (N = 18) | | | | |
| Mean ± SG
[Range] | 9.1 ± 1.3
6.7 to 10.6 | 7.9 ± 0.8
5.7 to 9.0 | -1.2 ± 1.1
-2.8 to 1.0 | |
| No answer (N = 18) | | | | |
| Mean ± SG
[Range] | 8.4 ± 1.4
6.2 to 10.7 | 7.4 ± 0.7
6.0 to 9.1 | -0.9 ± 1.1
-3.7 to 0.4 | |
| Pre-Study Carb Counting
(excludes basal-only users) | | | | |
| Carb Counting (N = 49) | | | | |
| Mean ± SD
[Range] | 7.6 ± 1.0
5.5 to 11.7 | 7.2 ± 1.0
5.8 to 10.6 | -0.4 ± 0.9
-2.4 to 2.8 | |
| Fixed Dose (N = 108) | | | | |
| Mean ± SD
[Range] | 8.3 ± 1.4
5.3 to 11.6 | 7.4 ± 0.9
5.6 to 9.8 | -0.9 ± 1.1
-5.1 to 1.0 | |
| Sliding Scale (N = 46) | | | | |
| Mean ± SD
[Range] | 8.1 ± 1.4
4.9 to 12.0 | 7.3 ± 0.8
5.6 to 8.9 | -0.8 ± 1.0
-3.4 to 0.8 | 0.02/0.60 |
| Small/Medium/Large (N = 30) | | | | |
| Mean ± SD
[Range] | 8.2 ± 1.4
6.2 to 11.9 | 7.3 ± 0.9
5.7 to 9.4 | -0.9 ± 0.9
-2.7 to 0.4 | |
| Other (N = 1) | | | | |
| Mean ± SD
[Range] | NA
NA | NA
NA | NA
NA | |
| C-Peptide | | | | |
| <0.5 (N = 50) | | | | |
| Mean ± SD
[Range] | 8.2 ± 1.3
6.2 to 11.3 | 7.4 ± 0.8
5.7 to 9.6 | -0.8 ± 1.0
-3.7 to 0.6 | |
| 0.5-<1.0 (N = 105) | | | | |
| Mean ± SD
[Range] | 8.2 ± 1.5
4.9 to 11.7 | 7.4 ± 0.9
5.6 to 9.8 | -0.8 ± 1.1
-5.3 to 1.0 | 0.67/0.54 |
| 1.0-<1.5 (N = 75) | | | | |
| Mean ± SD
[Range] | 8.3 ± 1.2
6.3 to 11.9 | 7.3 ± 0.9
5.7 to 9.7 | -1.0 ± 0.9
-5.1 to 0.6 | |
| ≥1.5 (N = 61) | | | | |
| Mean ± SD
[Range] | 8.1 ± 1.3
5.3 to 12.0 | 7.3 ± 1.0
5.6 to 10.6 | -0.8 ± 1.1
-3.5 to 2.8 | |

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| Missing (N = 5) | Mean ± SD
[Range] | 8.5 ± 0.3
8.2 to 8.9 | 7.8 ± 0.4
7.4 to 8.3 | -0.7 ± 0.5
-1.2 to -0.2 | |
| --- | --- | --- | --- | --- | --- |
| SGLT2 | | | | | |
| Yes (N = 130) | Mean ± SD
[Range] | 8.2 ± 1.3
5.5 to 12.0 | 7.4 ± 0.9
5.7 to 10.6 | -0.8 ± 1.1
-4.2 to 2.8 | 0.50/0.54 |
| No (N = 166) | Mean ± SD
[Range] | 8.3 ± 1.4
4.9 to 11.9 | 7.4 ± 0.9
5.6 to 9.8 | -0.9 ± 1.0
-53 to 0.8 | |
| GLP1 | | | | | |
| Yes (N = 164) | Mean ± SD
[Range] | 8.1 ± 1.2
5.3 to 11.9 | 7.3 ± 0.8
5.6 to 9.7 | -0.8 ± 1.0
-5.3 to 1.2 | 0.50/0.51 |
| No (N = 132) | Mean ± SD
[Range] | 8.4 ± 1.4
4.9 to 12.0 | 7.5 ± 1.0
5.6 to 10.6 | -0.9 ± 1.1
-5.1 to 2.8 | |
| DDP4 | | | | | |
| Yes (N = 8) | Mean ± SD
[Range] | 7.7 ± 1.4
6.2 to 10.8 | 7.4 ± 0.8
5.9 to 8.3 | -0.4 ± 1.0
-2.5 to 0.7 | 0.33/0.54 |
| No (N = 288) | Mean ± SD
[Range] | 8.2 ± 1.3
4.9 to 12.0 | 7.4 ± 0.9
5.6 to 10.6 | -0.9 ± 1.0
-5.3 to 2.8 | |
| ≥1 Agent | | | | | |
| Yes (N = 219) | Mean ± SD
[Range] | 8.2 ± 1.3
5.3 to 12.0 | 7.3 ± 0.9
5.6 to 10.6 | -0.8 ± 1.0
-5.3 to 2.8 | 0.50/0.60 |
| No (N = 77) | Mean ± SD
[Range] | 8.4 ± 1.4
4.9 to 11.7 | 7.5 ± 0.9
5.6 to 9.8 | -0.9 ± 1.0
-5.1 to 0.8 | |
| Baseline HbA1c (%) | | | | | |
| <7.0% (N = 42) | Mean ± SD
[Range] | 6.5 ± 0.4
4.9 to 6.9 | 6.5 ± 0.6
5.6 to 7.7 | -0.0 ± 0.5
-1.2 to 1.0 | <0.001/NA |
| 7.0-7.9% (N = 104) | Mean ± SD
[Range] | 7.5 ± 0.3
7.0 to 7.9 | 7.1 ± 0.6
5.8 to 10.6 | -0.4 ± 0.6
-2.0 to 2.8 | |
| 8.0-8.9% (N = 82) | Mean ± SD
[Range] | 8.5 ± 0.3
8.0 to 8.9 | 7.6 ± 0.8
6.0 to 9.8 | -0.8 ± 0.7
-2.5 to 1.1 | |
| ≥9.0% (N = 68) | Mean ± SD
[Range] | 10.1 ± 0.9
9.0 to 12.0 | 8.1 ± 0.9
5.9 to 9.8 | -2.1 ± 1.0
-5.3 to 0.0 | |

*P-values compare the change in outcome between the characteristic levels. The first P-value is without adjusting for baseline outcome and the second P-value is with adjusting for baseline outcome.

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Key secondary endpoints of the study included mean glucose and percent time in range (70-180 mg/dL). There was a significant increase in the time in range from 45% to 66% and improvement in the time above range (&gt;250 mg/dL) from 20% to 7%. There was an increase in the time below range (&lt;54 mg/dL) from 0.01% to 0.04%. The table below shows the hierarchical CGM metrics and patient reported outcomes for the entire study population:

| | Standard Therapy (N = 299)* | Treatment Period (N = 299)* | Change in CGM Metrics |
| --- | --- | --- | --- |
| Glucose Hours-Median (IQR) | 336 (319, 336) | 1921 (1736, 2016) | - |
| Mean glucose (mg/dL) | | | |
| Mean (SD) | 202 (50) | 170 (24) | -32 (39) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | -32 (-37, -28) |
| % time 70-180 mg/dL | | | |
| Mean (SD) | 45% (25%) | 66% (17%) | 20% (20%) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | 20% (18%, 22%) |
| % time 70-140 mg/dL | | | |
| Mean (SD) | 21% (18%) | 33% (17%) | 12% (16%) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | 12% (10%, 13%) |
| % time ≥ 300 mg/dL | | | |
| Robust ^ Mean (SD) | 7.9% (10.3%) | 1.9% (2.4%) | -5.3% (7.9%) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | -5.3% (-6.3%, -4.4%) |
| % time > 250 mg/dL | | | |
| Robust ^ Mean (SD) | 20% (22%) | 7% (8%) | -12% (17%) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | -12% (-14%, -11%) |
| % time > 180 mg/dL | | | |
| Mean (SD) | 54% (25%) | 34% (17%) | -20% (20%) |
| P-value | - | - | <0.001 |
| (95% CI) | - | - | -20% (-22%, -18%) |
| % time <70 mg/dL | | | |
| Robust ^ Mean (SD) | 0.2% (0.3%) | 0.2% (0.2%) | 0.0% (0.03) |
| Non-inferiority P-value | - | - | <0.001 |
| (NI margin = 2.0%) | - | - | |
| (95% CI) | | | 0.0% (-0.1%, 0.0% |
| % time <54 mg/dL | | | |
| Robust ^ Mean (SD) | 0.01% (0.02%) | 0.04% (0.05%) | 0.01% (0.05%) |
| Non-inferiority P-value | - | - | <0.001 |
| (NI margin = 0.5%) | - | - | |
| (95% CI) | | | 0.01% (0.00%, 0.01%) |
| T2-DDAS total intensity score† | N = 305 | N = 301 | N = 301 |
| Mean (SD) | 2.5 (1.0) | 2.2 (0.9) | |
| P-value | - | - | -0.3 (0.9) |

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| (95% CI) | - | - | <0.001 |
| --- | --- | --- | --- |
| T2-DDAS total intensity score ≥2.0 | 201 (66%) | 167 (55%) | -0.3 (00.4, -0.2) |
| P-value | | | <0.001 |
| PSQI total score† | N = 304 | N = 300 | N = 294 |
| Mean (SD) | 7.3 (4.0) | 7.0 (4.1) | -0.4 (2.9) |
| P-value | - | - | 0.04 |
| (95% CI) | - | - | -0.4 (-0.7, 0.0) |
| PSQI total score >5.0 | 190 (63%) | 174 (59%) | |
| P-value | | | 0.10 |
| HCS total score | N = 305 | N = 300 | N = 300 |
| Mean (SD) | 3.2 (0.6) | 3.3 (0.6) | 0.1 (0.6) |
| P-value | - | - | NA# |
| (95% CI) | - | - | 0.1 (0.0, 0.1) |
| HCS total score <3.0 | 98 (32%) | 75 (25%) | |
| P-value | | | NA# |
| % time <70 mg/dL | | | |
| Robust * Mean (SD) | 0.2% (0.3%) | 0.2% (0.2%) | 0.0% (0.03) |
| Superiority P-value | - | - | NA# |
| (95% CI) | - | - | 0.0% (-0.1%, 0.0%) |
| % time <54 mg/dL | | | |
| Robust * Mean (SD) | 0.01% (0.02%) | 0.04% (0.05%) | 0.01% (0.05%) |
| Superiority P-value | - | - | NA# |
| (95% CI) | - | - | 0.01% (0.00%, 0.01%) |
| Coefficient of Variation | | | |
| Mean (SD) | 27.8% (6.3%) | 27.1% (5.1%) | -0.7% (5.6%) |
| P-value | - | - | NA# |
| (95% CI) | - | - | -0.7% (-1.4%, -.01%) |

*Based on the pre-specified criteria ("CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period."), N=299 for the glycemic metrics.
*Similar with medians, robust means do not add up; that is difference of medians is not the same as the median of the differences. On the other hand, standard means add up and thus any inconsistency noticed above is due to rounding.
†Lower scores indicate better outcomes (e.g., less stress/distress related to diabetes, better sleep quality).
#As part of the hierarchy testing and because of the p-value=0.10 for PSQI &gt; 5 the formal testing stopped, and p-values were not given for any outcomes further down on the list.

## Challenge Results

During this clinical study, subjects participated in up to 3 different challenges. Sixty-four subjects participated in a target glucose challenge in which they utilized 3 different glucose targets for 3 days each (150 mg/dL, 140 mg/dL, and 130 mg/dL). The mean time in range was the highest in the 150 mg/dL target group (66%) and was lower in the two remaining target groups (63% in both). There was no significant difference in time above 180 mg/dL or 250 mg/dL between all three groups and there was a mean of 0% time below 70 mg/dL and 54 mg/dL in all three groups.

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All subjects participated in the meal challenge which lasted 4 days and consisted of a meal that was ≥60 g of carbohydrates. Subjects gave a meal bolus on days 1 and 3 and skipped the meal bolus on days 2 and 4. CGM metrics were compared at 4 hours post meal. The mean time in range was elevated when given a bolus (55%) compared to without a bolus (44%). There was more time above range when the bolus was skipped, but no difference in time below range for the two different actions.

All subjects also participated in the exercise challenge in which they underwent 3 exercise sessions on 3 separate days. The exercise session consisted of 1 hour of mild intensity exercise and 30 minutes of moderate intensity exercise. Subjects did not change their glucose target, nor did they change their behavior for administering meal boluses prior to exercise if a meal was consumed, and 93% of them did not consume a snack prior to exercise. CGM metrics were assessed during exercise, 2 hours after exercise, and overnight after exercise. The mean time in range for all 3 timepoints was the same (73%) and time above 180 mg/dL was the same (27%). There was 0% time below 70 mg/dL and 54 mg/dL at all three timepoints. There was a slight increase in time above 250 mg/dL in the 2 hours post-exercise.

## Summary of Human Factors Validation Study

Human Factors validation tests were conducted with the Omnipod 5 App installed on a compatible mobile device. A total of 1 feasibility study and 3 formative studies were conducted. This Human Factors program consisted of an iterative design process of prototyping, testing, analyzing, and refining the Omnipod 5 System for the type 2 diabetes indication. Following the 4 total preliminary studies, the final device design was evaluated in the summative study performed with 16 representative participants interacting with the device in a simulated use environment. All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assess comprehension and usability of the device for critical device tasks. Results of the study demonstrated that the device could be used safely by intended users in the intended use environment.

## VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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