(91 days)
No
The device description focuses on mechanical and manual components for insulin delivery, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for the management of diabetes mellitus in adult persons requiring insulin, which directly treats a medical condition.
No
The device description indicates it is an "Insulin Delivery System" designed for the "subcutaneous, bolus delivery of insulin." Its function is to administer insulin, not to diagnose a condition or measure a physiological parameter to determine a disease state.
No
The device description explicitly lists multiple hardware components: Insulin Delivery Device (Patch), reusable Inserter, Fill Syringe and needle, Dose Count Reminder Card, and Change by Stickers. It also mentions construction from biocompatible plastics, elastomers, and stainless steel.
Based on the provided information, the CeQur Simplicity™ On-Demand Insulin Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The device is described as a system for subcutaneous delivery of insulin. It's a pump that administers a substance into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, etc.) or to provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CeQur Simplicity™ system's function is to deliver medication, which falls under the category of a therapeutic device.
N/A
Intended Use / Indications for 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.
Product codes
OPP
Device Description
The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
adult persons
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verfication and validation data reported in this 510(k), including those assessing biocompatibility, and human factors, demonstrate that the proposed change in labeling does not raise different questions of safety and effectiveness than those for the predicate device, and that the subject device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 18, 2024
CeQur SA Michael Simpson Vice President, Regulatory Affairs & Quality Assurance Ebenaustrasse 10 Horw Luzern, 6048 Switzerland
Re: K233447
Trade/Device Name: CeQur Simplicity™ On-Demand Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: OPP Dated: October 19, 2023 Received: October 19, 2023
Dear Michael Simpson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
CeQur Simplicity™ On-Demand Insulin Delivery System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) #: K233447
510(k) Summarv
Prepared on: 2023-12-21
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | CeQur SA |
|---|---|
| Applicant Address | Ebenaustrasse 10 Horw Luzern 6048 Switzerland |
| Applicant Contact Telephone | 404-276-5449 |
| Applicant Contact | Mr. Michael Simpson |
| Applicant Contact Email | mike.simpson@cequr.com |
21 CFR 807.92(a)(2)
| Device Trade Name | CeQur Simplicity™ On-Demand Insulin Delivery System |
|---|---|
| Common Name | Infusion pump |
| Classification Name | Pump, Infusion, Insulin Bolus |
| Regulation Number | 880.5725 |
| Product Code | OPP |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K163357 | One Touch Via™ On-Demand Insulin Delivery System | OPP |
| K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG | OPP |
21 CFR 807.92(a)(4)
Device Description SummaryThe CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Intended Use/Indications for 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The indications for use are the same as for the predicate device.
4
Technological Comparison
The technological characteristics of the subject device are the same as those of the predicate device.
The only modifications to the predicate device are to the device labeling. Specifically, the instructions for use and other applicable labeling for the subject device have been modified to allow up to 4 days (96 hours) of device wear, compared to up to 3 days (72 hours) for the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Verfication and validation data reported in this 510(k), including those assessing biocompatibility, and human factors, demonstrate that the proposed change in labeling does not raise different questions of safety and effectiveness than those for the predicate device, and that the subject device is as safe and effective as the predicate device.
The subject device is therefore deemed to be substantially equivalent to the predicate device.