CeQur Simplicity™ On-Demand Insulin Delivery System

K243273 · Cequr SA · OPP · Nov 13, 2024 · General Hospital

Device Facts

• Record ID: K243273
• Device Name: CeQur Simplicity™ On-Demand Insulin Delivery System
• Applicant: Cequr SA
• Product Code: OPP · General Hospital
• Decision Date: Nov 13, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

Device Story

CeQur Simplicity™ is a manual, single-use, wearable insulin delivery system for subcutaneous bolus dosing. System components include a disposable patch (Insulin Delivery Device), a reusable inserter, a fill syringe, and change-by stickers. Patient fills the patch with insulin using the syringe; uses the inserter to apply the patch to the skin and insert the cannula. Device provides positive volume displacement bolus delivery via button depression; each depression delivers 1U of insulin. Patch is worn for up to 96 hours. Device is intended for patient self-use to manage diabetes mellitus. Output is the physical delivery of insulin; patient monitors blood glucose independently to determine dosing needs. Benefits include simplified, on-demand bolus insulin administration without electronic components.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical performance testing demonstrating the device is as safe and effective as the predicate.

Technological Characteristics

On-demand insulin infusion pump. Mechanical actuation for 1U bolus delivery. Combines previously cleared pump mechanism and device housing designs. No changes to fundamental scientific technology.

Indications for Use

Indicated for patients requiring insulin delivery via an on-demand infusion pump system.

Regulatory Classification

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

• CeQur Simplicity™ On-Demand Insulin Delivery System (K233447)
• Finesse Personal Insulin Delivery Patch, Model FG-2000 (K093065)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243273

B Applicant

CeQur SA

C Proprietary and Established Names

CeQur Simplicity™ On-Demand Insulin Delivery System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OPP | Class II | 21 CFR 880.5725 - Infusion Pump | GH-General Hospital |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for a modification to a previously cleared device to enable a model that delivers a 1U bolus of insulin with each actuation of the device

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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buttons. This modification combines the 1U pump mechanism design originally cleared in 510(k) K093065 with the device design most recently cleared in 510(k) K233447.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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