(91 days)
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.
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.
The provided document does not contain specific acceptance criteria or details of a study proving the device meets said criteria.
Instead, it describes the CeQur Simplicity™ On-Demand Insulin Delivery System and its substantial equivalence determination by the FDA based on modifications to labeling allowing for extended wear time (up to 4 days/96 hours, compared to 3 days/72 hours for the predicate device).
Here's a breakdown of the information that is and is not present, with regards to your request:
1. A table of acceptance criteria and the reported device performance:
* Not provided. The document states that "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." However, it does not specify what those acceptance criteria were or what performance metrics were achieved.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not provided. The document mentions "Verfication and validation data" but does not detail the sample sizes, data provenance, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not applicable/Not provided. This device is an insulin delivery system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set in the way you describe. The "ground truth" for its performance would likely relate to objective measurements of insulin delivery accuracy, biocompatibility, and user-factor performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology image interpretation) to establish a consensus ground truth. This is not directly relevant to the testing of an insulin delivery device's technical specifications or user experience.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic systems where human readers interpret cases. This device is an insulin delivery system, not an AI diagnostic tool, so such a study would not be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a manual, user-filled, positive volume displacement bolus dosing pump, not an algorithm. Therefore, "standalone" algorithm performance testing is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not explicitly stated in detail. For a medical device like this, the "ground truth" for performance would generally involve:
* Objective measurements: E.g., insulin delivery accuracy (volume delivered vs. intended), flow rates, mechanical integrity, battery life (if applicable).
* Biocompatibility testing: In vitro and in vivo tests to ensure the materials are safe for contact with the body.
* Human factors validation: User studies to ensure safe and effective operation by typical users.
* The document generally refers to "biocompatibility, and human factors" data.
8. The sample size for the training set:
* Not applicable/Not provided. This device is an electro-mechanical system, not an AI/machine learning model that undergoes "training."
9. How the ground truth for the training set was established:
* Not applicable. As above, there is no "training set" for this type of device.
In summary: The provided FDA 510(k) clearance letter and summary are focused on establishing substantial equivalence to existing predicate devices for an insulin delivery system, primarily based on a labeling change (extended wear time). It asserts that "Verfication and validation data" were submitted for biocompatibility and human factors, demonstrating that the change does not raise new safety or effectiveness concerns, but it does not provide the specific details of these studies, including acceptance criteria, sample sizes, or performance metrics.
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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).
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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
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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)
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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.
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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.
§ 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).