← Product Code [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG) · K213134

# Accu-Chek Solo micropump system with interoperable technology (K213134)

_Roche Diabetes Care GmbH · QFG · Aug 10, 2023 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K213134

## Device Facts

- **Applicant:** Roche Diabetes Care GmbH
- **Product Code:** [QFG](/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG.md)
- **Decision Date:** Aug 10, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5730
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

The Accu-Chek Solo micropump system with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.

## Device Story

Accu-Chek Solo is a portable, programmable, patch-style insulin pump for subcutaneous delivery. System consists of a disposable reservoir/cannula/holder and a reusable pump unit. Device adheres to patient skin; controlled via connected device (e.g., smartphone/controller) using Bluetooth Low Energy. Physician prescribes basal/bolus rates; pump executes commands received from compatible automated insulin dosing software. Used in home settings by patients. Provides continuous insulin infusion; benefits include precise glycemic management. Healthcare providers review pump data to adjust therapy. System includes occlusion detection and alarm capabilities.

## Clinical Evidence

Bench-only and clinical performance testing. Bench testing included biocompatibility (ISO 10993), sterility (ISO 11135), electrical safety/EMC (IEC 60601 series), and insulin compatibility. Human factors validation performed per IEC 62366-1. Clinical study conducted to evaluate the safety, robustness, and pain profile of the cannula insertion process in subcutaneous fat tissue. Results confirmed the device meets all design specifications and performs equivalently to the predicate.

## Technological Characteristics

Portable patch pump; reusable pump unit with disposable reservoir/cannula. Materials biocompatible per ISO 10993. Energy source: battery-powered. Connectivity: Bluetooth Low Energy. Sterilization: Ethylene Oxide (ISO 11135). Insulin delivery: basal/bolus rates. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), IEC 62304 (software).

## Regulatory Identification

An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.

## Special Controls

Alternate controller enabled infusion pumps must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
*e.g.,* head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
*e.g.,* occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
*e.g.,* temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities 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 shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) 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 validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
*e.g.,* battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
*e.g.,* reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) 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 system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
*e.g.,* establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.

## Predicate Devices

- Omnipod DASH Insulin Management System with Interoperable Technology ([K191679](/device/K191679.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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K213134

B Applicant

Roche Diabetes Care GmbH

C Proprietary and Established Names

Accu-Chek Solo micropump system with interoperable technology

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Pump | 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 Accu-Chek Solo micropump system with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

C Special Conditions for Use Statement(s):

This device is for prescription use only.

This device should not be used by people who have an insulin sensitivity above 200 mg/dL/U.

It is the responsibility of the healthcare professional to decide whether the accuracy of the delivery rate is adequate for the patient in question.

The Accu-Chek Solo micropump system with interoperable technology is not intended for anyone unable or unwilling to:

- Test blood glucose (BG) levels at least 4 times per day or use a continuous glucose monitoring system reliably.
- Understand or follow the instructions for use of the micropump system.
- See their healthcare team regularly.

The user must not:

- Be exposed to high ambient temperatures on a regular basis.
- Have difficulty tolerating adhesive pads.
- Experience cannula occlusion often.
- Have impairments that would make it hard to notice visual, acoustic or vibration alarms.

Do not use the micropump system close to strong electromagnetic fields or ionizing radiation like X-rays, Magnetic Resonance Imaging (MRI) and computed tomography (CT). Stop the micropump and remove it from your body before you enter areas with electromagnetic or ionizing radiation.

The device is designed to use rapid-acting U-100 insulin. The Accu-Chek Solo micropump system with interoperable technology is compatible with the following U-100 insulins: Novolog, Apidra, Fiasp, and Humalog. Novolog, Fiasp and Humalog are compatible with the system for use up to 96 hours (4 days), and Apidra is compatible with the system for up to 48 hours (2 days).

III Device Description

The Accu-Chek Solo micropump system with interoperable technology is a portable programmable insulin micropump, which adheres to the patient's skin. The patch comprises a disposable reservoir, in which the insulin is stored, a reusable pump, which includes the pumping mechanism and electronic components, sterile consumables that include the reservoir assembly, a cannula assembly that comes in two cannula lengths of 6 mm and 9 mm and the pump holder which is an adhesive pad that adheres to the skin and fixes the cannula and the micropump in place. The micropump system also comes with a reusable insertion device which is used to attach the infusion assembly into the subcutaneous tissue. The recommended infusion sites include the abdominal region, upper arm, thigh, hip, lower back, and the buttocks.

K213134 - Page 2 of 11

{2}

The pump is controlled via a connected Accu-Chek Guide Solo diabetes manager. The Accu-Chek Solo micropump system with interoperable technology is designed to deliver basal and bolus insulin doses at various rates, volumes, and patterns, as prescribed by the user's physician.

The micropump includes two "Quick Bolus Buttons" which allow for programming and delivering insulin directly by the insulin pump. To avoid an accidental or unintended triggering of an action, the buttons are placed at the opposite side panels of the micropump and need to be pressed simultaneously with two fingers. The micropump exclusively uses audible signals for pump specific notifications.

## IV Substantial Equivalence Information:

### A Predicate Device Name(s):

Omnipod DASH Insulin Management System with Interoperable Technology

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

K191679

### C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K213134 | K191679  |
| --- | --- | --- |
|  Device Trade Name | Accu-Chek Solo micropump system with interoperable technology | Omnipod DASH Insulin Management System with Interoperable Technology  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | Intended for the subcutaneous delivery of insulin at variable rates for the management of diabetes mellitus in people requiring insulin. Intended to be interoperable with connected devices including CGMs and automated insulin dosing algorithms. | Same  |
|  Operating Environment | Home Use | Same  |

K213134 - Page 3 of 11

{3}

|  Insulin Delivery Modes | Both basal and bolus | Same  |
| --- | --- | --- |
|  General Device Characteristic Differences |  |   |
|  Specific Drug/Biologic Use | U-100 Insulin.
System has been tested with Novolog, Humalog, Apidra, and Fiasp. | U-100 Insulin.
System has been tested with Novolog, Humalog, Admelog and Apidra.  |
|  Insulin Basal Rate Delivery Range | 0.1 – 25 U/hour | 0.05 – 30 U/hour  |
|  Insulin Bolus Delivery Range | Programmable from 0.2 - 35 U. Increments depend on the bolus amount. | Programmable from 0.05 - 30 U in 0.05 U increments.  |

V Standards/Guidance Documents Referenced:

- FDA Guidance “Infusion Pumps Total Product Life Cycle” dated December 2, 2014
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
- FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” dated May 11, 2005
- FDA Guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” dated October 2, 2014
- FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” dated September 6, 2017
- ISO 10993-1:2009 Biological Evaluation of Medical Devices: Evaluation and Testing
- ISO 10993-3:2014 Biological Evaluation of Medical Devices – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
- ISO 10993-17:2006 Biological Evaluation of Medical Devices – Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part 18: Chemical Characterization of Materials

K213134 - Page 4 of 11

{4}

- ISO 14971 Second Edition 2007-03-01 Medical Devices – Application of Risk Management to Medical Devices
- IEC 60601-1-1 Medical electrical equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2 Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances- Requirements and Tests
- IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8 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 60601-1-11 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 62304:2006 Medical Device Software – Software Life Cycle Processes
- IEC 62366-1:2015 Medical Devices – Part 1: Application Of Usability Engineering To Medical Devices
- ISO 11607-1:2017 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

VI Performance Characteristics:

A. Analytical Performance

1. Basal delivery accuracy

To assess basal delivery accuracy at 0.1 and 1.0 U/h, 24 aged micropumps and disposables (reservoir, cannula and pump holder assemblies) were tested. For 25 U/h, both aged and unaged pumps and disposables were equally pooled resulting in data from a total of 36 micropumps. Delivery accuracy was assessed by pumping insulin into a container on a scale and measuring the weight of the liquid at 1h, 6h, and 12h intervals for minimum and intermediate rates (0.1 and 1.0 U/hr) and 1h and 6h intervals for maximum rate (25 U/hr).

The following tables report 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.

K213134 - Page 5 of 11

{5}

Table 1: Amount of fluid delivered after 1, 6, and 12 hours with 0.1 U/hr (minimum) basal rate setting

|  0.1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours  |
| --- | --- | --- | --- |
|  Total expected delivery volume | 0.1 U | 0.6 U | 1.2 U  |
|  Median amount delivered [min, max] | 0.08 U
[0.04, 0.36] | 0.54 U
[0.33, 0.67] | 1.08 U
[0.69, 1.29]  |

Table 2: Amount of fluid delivered after 1, 6, and 12 hours with 1 U/hr (intermediate) basal rate setting

|  1 U/hr Basal Duration | 1 hour | 6 hours | 12 hours  |
| --- | --- | --- | --- |
|  Total expected delivery volume | 1.0 U | 6.0 U | 12.0 U  |
|  Median amount delivered [min, max] | 1.00 U
[0.54, 1.08] | 5.93 U
[5.26, 6.10] | 11.86 U
[11.18, 12.11]  |

Table 3: Amount of fluid delivered after 1, 6, and 12 hours with 25 U/hr (high) basal rate setting

|  25 U/hr Basal Duration | 1 hour | 6 hours  |
| --- | --- | --- |
|  Total expected delivery volume | 25 U | 150 U  |
|  Median amount delivered [min, max] | 25.15 U
[24.96, 25.31] | 149.19 U
[148.69, 149.81]  |

2. Bolus delivery accuracy

To assess bolus delivery accuracy, 36 pumps were tested by delivering at minimum, intermediate, and maximum bolus volumes (0.2 U, 1.0 U, 6.0, and 35 U). All four combinations of aged and unaged pump and disposables were tested in equal distribution. Each combination included 9 unique pumps which were used to test all 4 bolus amounts.

Tables 4-6 below show the number (and %) of boluses within the specified range of the minimum bolus, one intermediate bolus and the maximum bolus volume.

K213134 - Page 6 of 11

{6}

Table 4: Amount of fluid delivered after a 0.2 U bolus request (n=1619 boluses)

|  Units delivered after a 0.2 U bolus request (% of commanded units)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <0.05
(<25%) | 0.05 -0.15
(25-75%) | 0.15-0.18
(75-90%) | 0.18-0.19
(90-95%) | 0.19-0.21
(95-105%) | 0.21-0.22
(105-110%) | 0.22-0.25
(110-125%) | 0.25-0.35
(125-175%) | 0.35-0.5
(175-250%) | >0.5
(>250%)  |
|  Number and percent of boluses | 0/1619
(0.0%) | 89/1619
(5.5%) | 266/1619
(16.43%) | 333/1619
(20.57%) | 717/1619
(44.29%) | 104/1619
(6.42%) | 83/1619
(5.13%) | 27/1619
(1.67%) | 0/1619
(0%) | 0/1619
(0%)  |

Table 5: Amount of fluid delivered after a 6.0 U bolus request (n=216 boluses)

|  Units delivered after a 6.0 U bolus request (% of commanded units)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <1.50
(<25%) | 1.50-4.50
(25-75%) | 4.5-5.40
(75-90%) | 5.40-5.70
(90-95%) | 5.70-6.30
(95-105%) | 6.30-6.60
(105-110%) | 6.60-7.5
(110-125%) | 7.5-10.5
(125-175%) | 8.75-15.0
(175-250%) | >15.0
(>250%)  |
|  Number and percent of boluses | 0/216
(0.0%) | 0/216
(0.0%) | 0/216
(0.0%) | 1/216
(0.46%) | 215/216
(99.54%) | 0/216
(0.0%) | 0/216
(0.0%) | 0/216
(0.0%) | 0/216
(0.0%) | 0/216
(0.0%)  |

Table 6: Amount of fluid delivered after a 35 U bolus request (n=108 boluses)

|  Units delivered after a 35.0 U bolus request (% of commanded units)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | <8.75
(<25%) | 8.75-26.25
(25-75%) | 26.25-31.5
(75-90%) | 31.50-33.25
(90-95%) | 33.25-36.75
(95-105%) | 36.75-38.5
(105-110%) | 38.5-43.75
(110-125%) | 43.75-61.25
(125-175%) | 61.25-87.5
(175-250%) | >87.5
(>250%)  |
|  Number and percent of boluses | 0/108
(0.0%) | 0/108
(0.0%) | 0/108
(0.0%) | 0/108
(0.0%) | 108/108
(100%) | 0/108
(0.0%) | 0/108
(0.0%) | 0/108
(0.0%) | 0/108
(0.0%) | 0/108
(0.0%)  |

K213134 - Page 7 of 11

{7}

K213134 - Page 8 of 11

3. Occlusion detection

To assess occlusion detection performance and unintended bolus upon occlusion release performance, 16 micropumps were tested. Both aged and unaged lots of pump bases, reservoirs and cannula assembly and pump holder were used.

The following table depicts the typical (average) time to occlusion detection for three different situations when using U-100 insulin.

Table 7: Timing of occlusion detection alarms
|   | Typical time to occlusion detection | Maximum time to occlusion detection  |
| --- | --- | --- |
|  25 U Bolus | 1 minute 11 seconds | 5 minutes 16 seconds  |
|  1.0 U/hr Basal | 3 hour 29 minutes | 7 hours 45 minutes  |
|  0.1 U/hr Basal | 26 hours 53 minutes | 71 hours  |

After pumps alarmed, the occlusions were cleared and the total amount of fluid delivered was measured. Typical volumes were less than 3 U.

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 ACE 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 tests were conducted with the Accu-Chek Solo micropump system with interoperable technology. All study participants received training that was consistent with the training that patients would receive with the commercial product. Usability evaluations assessed comprehension and usability of the device for critical device tasks. Results of the study demonstrated that the micropump system is validated for its intended use.

{8}

K213134 - Page 9 of 11

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 FDA special controls for alternate controller enabled infusion pumps for the disposable cassette, pump and the disposable cassette packaging and dust cover. All endpoints were tested adequately, and results were acceptable.

4. Sterility

The Accu-Chek Solo reservoir assembly, cannula assembly and pump holder are provided sterile. These components are terminally sterilized in its final package using Ethylene Oxide and the process has been validated to ensure a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11135: 2014.

5. Insulin Compatibility and Stability

The Accu-Chek Solo micropump system was found to be compatible with U-100 insulin Novolog (insulin aspart), Fiasp (insulin aspart), Humalog (insulin lispro) for up to 4 days and with Apidra (insulin glulisine) for up to 2 days.

6. Additional Bench Testing

In addition to the performance testing described above, mechanical testing, simulated use testing, and other device verification testing was conducted to demonstrate that the system meets its intended use and is safe, reliable, and all safety and reliability critical requirements have been adequately verified. Summaries for reliability, safety, and verification testing follow:

|  Testing to Support System Reliability  |
| --- |
|  Durability of pumping mechanism  |
|  Pump Bolus Button  |
|  Buzzer  |
|  Inserter  |
|  Pump-reservoir interface  |
|  Power supply  |
|  Against chemical stressors (e.g. sunscreens, insect repellents)  |
|  Testing to Support System Safety  |
| --- |
|  Environmental Safety Testing to 60601-1-11  |
|  Safety and Essential Performance Testing to 60601-1  |
|  Occlusion Detection Testing  |
|  Leakage Testing  |
|  Alarms Testing  |
|  Data Handling Testing  |

{9}

|  Pump Activation and Deactivation Testing  |
| --- |
|  Pump/Diabetes Manager Connectivity Testing  |
|  User Guide Testing  |
|  Incidental Delivery  |
|  Worst Case Accuracy  |
|  Testing to Support System Verification  |
| --- |
|  Environmental Safety Testing to 60601-1-11  |
|  Safety and Essential Performance Testing to 60601-1  |
|  Occlusion Detection Testing  |
|  Buzzer Testing  |
|  User Guide Testing  |
|  Insulin Delivery Verification Testing  |
|  Environmental conditions Testing  |
|  Ingress protection and protection against sweat  |
|  Cleaning Test  |

7. Electromagnetic Compatibility and Wireless Coexistence

Electromagnetic compatibility, electromagnetic immunity and wireless coexistence testing was performed for the pump. All tests demonstrated that the device would perform as expected in the home healthcare environment.

8. Basic Safety and Essential Performance (Electrical Safety)

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. Data Logging

The sponsor provided a summary of pump and controller logging capability which enable the device to record critical events including insulin delivery, pump commands and confirmations, connectivity states, malfunctions, and alarms. These were reviewed and found to be adequate.

10. Interoperability

A plan and approach for interoperability were provided according to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices" and determined to be adequate to support and clearly specify expectations, requirements, and interface specifications to potential interoperable devices. In addition, their plan covered their approach to working with connected device companies regarding contractual approaches, interfaces for data communication and exchange, and post-market

K213134 - Page 10 of 11

{10}

reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events).

The sponsor additionally provided validated software protocols intended to ensure secure, accurate, and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected devices. These protocols were reviewed and found to be adequate.

## 11. Software and Cybersecurity

Detailed Information on software and cybersecurity of the device was reviewed and found acceptable.

## 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.

K213134- Page 11 of 11

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K213134](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QFG/K213134)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com