← Product Code [LZG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG) · K240158

# Modular Medical MODD1 Insulin Delivery System (K240158)

_Modular Medical, Inc. · LZG · Sep 4, 2024 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K240158

## Device Facts

- **Applicant:** Modular Medical, Inc.
- **Product Code:** [LZG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG.md)
- **Decision Date:** Sep 4, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5725
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The Modular Medical MODD1 Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

## Device Story

MODD1 Insulin Delivery System is a body-worn, software-controlled infusion pump for diabetes management. System components include a reusable pump, single-use 3.0mL insulin cartridge with integrated battery, adhesive pad, and infusion set. User programs basal delivery schedules via MMI App on smartphone (iOS); pump interface manages bolus delivery, status checks, and suspension. Pump uses gear motor rotation of a fixed-position camshaft to drive insulin from reservoir to infusion set. Software monitors dispense output via multiple sensors; provides audio-visual alarms for malfunctions, low volume, or occlusions. Device communicates via BLE and NFC. Healthcare providers use device history for clinical decision-making; patients benefit from automated, programmable insulin delivery. Used in home environment.

## Clinical Evidence

Bench testing only. No clinical trials performed. Evidence includes risk management (ISO 14971), human factors validation (IEC 62366-1), insulin compatibility (Humalog U-100), biocompatibility (ISO 10993-1), sterility validation, electrical safety/EMC (IEC 60601-1/1-2, RTCA DO-160G), wireless coexistence (AAMI TIR69, IEEE/ANSI C63.27), and software/cybersecurity verification/validation.

## Technological Characteristics

Motor-driven (multiple piston) infusion pump; internal non-rechargeable coin cell battery; dimensions 1.51" x 2.38" x 0.56"; weight 28g; IP24 water resistance. Connectivity via BLE and NFC. Software-controlled gear motor camshaft mechanism. Sterilization via gamma radiation for disposable components. Complies with IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1, IEC 62304.

## Regulatory 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.

## Predicate Devices

- t:slim® Insulin Delivery System ([K160056](/device/K160056.md))

## Reference Devices

- UnoMedical Comfort™ disposable insulin infusion set
- 3mL sterile syringe ([K110771](/device/K110771.md))
- 26-gauge sterile needle ([K021475](/device/K021475.md))
- Inserter ([K163400](/device/K163400.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K240158

B Applicant

Modular Medical, Inc.

C Proprietary and Established Names

Modular Medical MODD1 Insulin Delivery System

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LZG | Class II | 21 CFR 880.5725 | CH – Clinical Chemistry  |

E Purpose for Submission:

New device

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications For Use below

B Indication(s) for Use:

The Modular Medical MODD1 Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

C Special Conditions for Use Statement(s):

This device is for prescription use only.

The MODD1 System is contraindicated for:

1. Diagnosing Diabetes Mellitus.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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2. Use by patients who do NOT have adequate hearing and/or vision to allow recognition of all functions of the MODD1 System including Status and Alarms.
3. Use by patients who cannot manage their Diabetes therapy.
4. Use by patients unwilling to take a minimum of four (4) blood glucose readings per day.
5. Use by patients who are unable to use the MODD1 System in accordance with this User Guide.
6. Use by patients who are not capable of following the User Guide
7. Use by patient populations requiring basal rates greater than 4 U/hr or less than 0.5U/hr

Consistent drops of the Pump and/or exposure to personal care products such as lotions and sunscreens can result in significantly reduced Pump lifetime if also exposed to water. This may lead to severe hyperglycemia or Diabetic Ketoacidosis (DKA).

## III Device Description

The device is an insulin pump that is worn adhered to the user's body through an adhesive patch with a short infusion set. The subject device consists of a pump mechanism (reusable, up to 90 days), an insulin cartridge assembly (sterile single use, up to 72 hours), an adhesive pad (single use, up to 72 hours), an infusion set (sterile single use, up to 72 hours), and a smartphone application (reusable, indefinite length of time) contained on an iPhone operating iOS 16 or later. The infusion set is distributed by Modular Medical. There are previously cleared 3rd party components that are able to be used with the subject device including a syringe (BD; K110771), a needle (BD; K021475), and the Ypsomed Orbit Inserter (Ypsomed; K163400).

The pumping mechanism consists of a linear peristaltic pump that pushes a fixed amount of insulin (5 microliters or 0.5 Units) per cycle of the pump operating. The pump must be programmed through the MMI App installed on an Apple (iOS) smartphone by the pump user. Once a pump is programmed it can operate independently from the app and does not require a phone to be connected or paired with the pump unless new insulin delivery rates are being programmed.

The insulin cartridge exterior is a rigid cyclic olefin copolymer and supports the pistons that are manipulated by the pump and supports the coin cell battery. The interior of the insulin cartridge that has contact with insulin is flexible and has membranes that allows for air to enter the cartridge and push against the flexible membrane and for insulin to exit the cartridge via the infusion set.

## IV Substantial Equivalence Information:

### A Predicate Device Name(s):

The t:slim® Insulin Delivery System

### B Predicate 510(k) Number(s):

K160056

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C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K240158 | K160056  |
| --- | --- | --- |
|  Device Trade Name | Modular Medical MODD1
Insulin Delivery System | The t:slim® Insulin
Delivery System  |
|  General Device
Characteristic
Similarities |  |   |
|  Intended
Use/Indications For
Use | Subcutaneous delivery of
insulin at set and variable
rates, for the management of
diabetes mellitus in persons
requiring insulin. | Same  |
|  Operating
Environment | Home Use | Same  |
|  Insulin Delivery
Modes | Basal and Bolus | Same  |
|  Reservoir Volume | 3 mL | Same  |
|  General Device
Characteristic
Differences |  |   |
|  Intended User Age
Range | 18 years and greater | 6 years and greater  |
|  Bolus Dose Range | 2-20 units | 0.05-25 units  |
|  Basal Delivery Flow
Rates | 0.5 – 4 units/hour | 0.1-15 units/hour  |
|  Insulin Bolus
Calculator | No | Yes  |
|  Connectivity | BLE and NFC | BLE  |

V Standards/Guidance Documents Referenced:

Standards
- AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps

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- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management to medical devices
- AAMI HE75:2009/(R)2018, Human factors engineering - Design of medical devices
- RTCA DO-160 Environmental Conditions and Test Procedures for Airborne Equipment

FDA Guidance Documents:
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023)
- Applying Human Factors and Usability Engineering to Medical Devices (February 2016)
- Electromagnetic Compatibility (EMC) of Medical Devices (June 2022)
- Content of Premarket Submissions for Device Software Functions (June 2023)
- Use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (September 2023)

VI Performance Characteristics:

A. Analytical Performance

1. Basal Accuracy

The basal delivery accuracy of the pump was tested with water to simulate insulin for minimum, intermediate and maximum basal rate delivery performance for both new and aged pumps without any warm-up period. Both new pumps (n=15) and aged pumps (n=15) were tested for accuracy. Table 1 reports the typical basal performance (median) observed, along with the lowest and highest results observed for minimum, intermediate, and maximum basal rate settings for all pumps tested.

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Table 1.: Amount of fluid delivered after 1, 6, and 12 hours at minimum, intermediate, and maximum basal rate settings

|  Median Insulin Units Delivered, New Pumps n = 15  |   |   |   |
| --- | --- | --- | --- |
|  Basal Rate | 1 hour | 6 hours | 12 hours  |
|  0.5 U/hour [min, max] | 0.62 U [0.57, 0.65] | 3.16 U [3.03, 3.26] | 6.17 U [5.93, 6.39]  |
|  2.0 U/hour [min, max] | 2.10 U [2.02, 2.25] | 12.05 U [11.53, 12.78] | 24.05 U [22.88, 25.56]  |
|  4.0 U/hour [min, max] | 4.20 U [4.05, 4.45] | 24.51 U [23.47, 25.82] | 48.81 U [46.53, 51.58]  |
|  Median Insulin Units Delivered, Aged Pumps n = 15  |   |   |   |
|  0.5 U/hour [min, max] | 0.63 U [0.59, 0.65] | 3.19 U [3.03, 3.33] | 6.22 U [5.92, 6.58]  |
|  2.0 U/hour [min, max] | 2.17 U [2.03, 2.25] | 12.16 U [11.32, 12.82] | 24.14 U [22.48, 25.47]  |
|  4.0 U/hour [min, max] | 4.22 U [4.00, 4.51] | 24.33 U [22.94, 25.85] | 48.40 U [45.57, 51.37]  |

# 2. Bolus Accuracy

The bolus delivery accuracy of the pump was tested with water to simulate insulin for the minimum, intermediate, and maximum bolus amounts. Both new pumps  $(n = 15)$  and aged pumps  $(n = 15)$  were tested for accuracy. The pumps each were tested by delivering at minimum, intermediate, and maximum bolus volumes (0.05 U, 6.0 U, and 30 U).

Table 2 below shows the number (and %) of boluses within the specified range of the minimum bolus, one intermediate bolus and the maximum bolus volume.

Table 2.: Amount of fluid delivered after bolus requests of 2, 10, and 20 units for new and aged pumps

|   | 2U Insulin Bolus Request, n=450 boluses, n=15 new pumps  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <25% | 25-75% | 75-90% | 90-95% | 95-105% | 105-110% | 110-125% | 125-175% | 175-250% | >250%  |
|  # in range | 0/450 | 0/450 | 13/450 | 63/450 | 350/450 | 24/450 | 0/450 | 0/450 | 0/450 | 0/450  |
|  % in range | 0% | 0% | 2.9% | 14.0% | 77.8% | 5.3% | 0% | 0% | 0% | 0%  |
|   | 10U Insulin Bolus Request, n=423 boluses n= 15 new pumps  |   |   |   |   |   |   |   |   |   |
|  # in range | 0/423 | 0/423 | 1/423 | 41/423 | 332/423 | 47/423 | 2/423 | 0/423 | 0/423 | 0/423  |
|  % in range | 0% | 0% | 0.2% | 9.7% | 78.5% | 11.1% | 0.5% | 0% | 0% | 0%  |

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|   | 20U Insulin Bolus Request, n=209 boluses n= 15 new pumps  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  # in range | 0/209 | 0/209 | 1/209 | 16/209 | 178/209 | 14/209 | 0/209 | 0/209 | 0/209 | 0/209  |
|  % in range | 0% | 0% | 0.5% | 7.7% | 85.2% | 6.7% | 0% | 0% | 0% | 0%  |
|   | 2U Insulin Bolus Request, n=450 boluses, n=15 aged pumps  |   |   |   |   |   |   |   |   |   |
|  # in range | 0/450 | 1/450 | 15/450 | 49/450 | 371/450 | 14/450 | 0/450 | 0/450 | 0/450 | 0/450  |
|  % in range | 0% | 0.2% | 3.3% | 10.9% | 82.4% | 3.1% | 0% | 0% | 0% | 0%  |
|   | 10U Insulin Bolus Request, n=423 boluses n= 15 aged pumps  |   |   |   |   |   |   |   |   |   |
|  # in range | 0/419 | 0/419 | 1/419 | 58/419 | 318/419 | 42/419 | 0/419 | 0/419 | 0/419 | 0/419  |
|  % in range | 0% | 0% | 0.2% | 13.8% | 75.9% | 10.0% | 0% | 0% | 0% | 0%  |
|   | 20U Insulin Bolus Request, n=209 boluses n= 15 aged pumps  |   |   |   |   |   |   |   |   |   |
|  # in range | 0/210 | 0/210 | 1/210 | 17/210 | 180/210 | 12/210 | 0/210 | 0/210 | 0/210 | 0/210  |
|  % in range | 0% | 0% | 0.5% | 8.1% | 85.7% | 5.7% | 0% | 0% | 0% | 0%  |

## 3. Occlusion Detection

The time to detection of complete occlusions was measured. Pumps were physically occluded by closing the patient end of the fluid path. After pumps alarmed, the occlusions were cleared, and the total amount of fluid delivered was measured. Unintended bolus after release of an occlusion is less than 3 U of insulin. Table 3 shows typical time to occlusion detection for new pumps under three different situations.

Table 3. Timing of occlusion detection alarms

|  Operating Rate | Typical | Maximum  |
| --- | --- | --- |
|  Bolus (2U or greater) | 1 Minute 51 Seconds | 2 Minutes 19 Seconds  |
|  Basal (2U/hr) | 30 Minutes 29 Seconds | 31 Minutes 31 Seconds  |
|  Basal (0.5U/hr) | 2 Hours 0 Minutes | 2 Hours 0 Minutes  |

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B. Other Supportive Instrument Performance Characteristics Data

1. Hazard Analysis

A comprehensive hazard analysis was reviewed, in which design inputs and outputs, risks, and risk mitigations for hardware and software associated with proper functioning of the insulin pump were reviewed. The sponsor performed a hazard analysis to account for the unique intended use, design elements, and risks of their infusion pump. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated.

2. Human Factors

Human Factors validation testing was conducted in the United States and validated the safe and effective use of the device with 16 people who had Diabetes Mellitus aged 18 years or older and treated as an adult. There was a mix of insulin pump experience and naïve. Users had 5-42 years of diabetes management experience. The use of the system was validated only for users who can self-manage an insulin pump.

Users were provided 1 on 1 training by a trainer from Modular Medical that lasted up to 90 minutes and consisted of using the subject device with the trainer, using the quick start guide and the instructions for use, and reviewing the training slides. Training consisted of walking users through how to use the system and instructional materials followed by users demonstrating to the trainer how they would use the system and being able to complete all of the tasks associated with training. The trainer then made a final determination on a user being ready to use the subject device followed by a 1-hour decay period and subsequent Human Factors validation testing in a simulated home use environment.

During simulate use testing, users were provided with a smartphone that was capable of dialing a customer support number that was listed in the instructions for use and an employee of Modular Medical was available to answer the call if needed. Users were validated on their ability to use the subject device when provided clinical context without prompting from the moderator to complete specific tasks and included their ability to notice and resolve alarms.

Critical tasks were identified based on the clinical harm severities that could occur due to use error such as hypoglycemia, hyperglycemia, diabetic ketoacidosis, and infection.

3. Biocompatibility

Biocompatibility testing was performed per FDA Guidance Document: Use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” and results of the testing were found adequate.

4. Sterility

The insulin cartridge was sterilized with radiation and validated ANSI/AAMI/ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for

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development, validation, and routine control of a sterilization process for medical devices including Amendment 1 (2013) and Amendment 2 (2019).

## 5. Insulin Compatibility and Stability

Insulin compatibility studies were conducted on the subject device with Humalog U-100 insulin to demonstrate device material compatibility with the insulin, physicochemical stability of insulin when delivered through the device under simulated use conditions, and the continued ability of insulin to provide antimicrobial effectiveness after having been stored in the device.

## 6. Additional Bench Testing

In addition to the performance testing described above, mechanical testing and simulated use testing, the subject device was subjected to additional testing to verify its reliability to demonstrate that it could function for 90 days. This testing included cyclic reliability testing to simulate actual use of the pump including accelerated aging of insulin cartridges, simulation of packaging and shipping, vibration and shock testing, exposure to personal care products, cleaning, button presses, insulin cartridge changes, drops, and ingress testing. Functional testing included the ability of the pump to deliver insulin and detect occlusions. The reliability testing results supported that the device could function as intended for the intended duration, but that exposure to personal care products, drops, and subsequent exposure to water could impact pump survivability.

|  Testing to Support System Reliability  |
| --- |
|  Pump lifetime testing  |
|  Transient Temperature  |
|  Transient Pressure  |
|  Ingress Protection  |
|  Cleaning  |
|  Against mechanical stressors (e.g., vibrations, shock)  |
|  Against personal care products such as sunscreen and lotions  |
|  Delivery Accuracy and Occlusion Detection Testing  |

## 7. Electromagnetic Compatibility and Wireless Coexistence

Electromagnetic compatibility, electromagnetic immunity and wireless coexistence testing was performed for the pump. The subject device meets immunity requirements per RTCA DO-160 (Susceptibility Category T). The subject device was also tested per FDA recognized standard IEC 60601-1-2:2020. All tests demonstrated that the device would perform as expected in the home healthcare environment.

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8. **Basic Safety and Essential Performance**

The sponsor provided verification evidence for compliance with the IEC 60601-1 and applicable collateral standards. Verification results support the finding of substantial equivalent for this device.

9. **Software and Cybersecurity**

Detailed information on software was reviewed and found to be acceptable. The cybersecurity documentation supports that the device is cybersecure.

**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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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K240158](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZG/K240158)

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