CeQur Simplicity™ On-Demand Insulin Delivery System

K233447 · Cequr SA · OPP · Jan 18, 2024 · General Hospital

Device Facts

• Record ID: K233447
• Device Name: CeQur Simplicity™ On-Demand Insulin Delivery System
• Applicant: Cequr SA
• Product Code: OPP · General Hospital
• Decision Date: Jan 18, 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, user-filled, positive volume displacement, bolus insulin delivery pump. System components include a sterile, single-use, disposable patch (Insulin Delivery Device), a reusable inserter, a sterile fill syringe, a dose count reminder card, and change-by stickers. The patient fills the patch with insulin using the syringe, then uses the inserter to apply the patch to the skin and implant the cannula into subcutaneous tissue. The device is worn for up to 4 days (96 hours) using biocompatible adhesive. The patient manually triggers bolus doses as needed. The device provides a simple, on-demand delivery method for insulin-dependent adults, facilitating glycemic management without complex electronics or programming.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, biocompatibility assessment, and human factors validation demonstrating the safety and effectiveness of the 96-hour wear duration.

Technological Characteristics

Wearable, patch-style, bolus-only insulin delivery device. Mechanical infusion pump mechanism. Subcutaneous delivery of rapid-acting insulin. Wear duration: up to 96 hours. No electronic or software-based control systems described.

Indications for Use

Indicated for subcutaneous, bolus insulin delivery for management of diabetes mellitus in adults requiring insulin.

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

• One Touch Via™ On-Demand Insulin Delivery System (K163357)
• FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG (K100947)

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

K233447

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 an extension of the duration of wear of the device from up to 3 days (72 hours) to up to 4 days (96 hours).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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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