SoloSmart Injection Pen Adapter (SoloSmart®)

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January 12, 2024 Biocorp Production Alexia Garin Vice President & Regulatory Affairs Zi Lavaur -La Béchade Issoire, 63500, France Re: K231820 Trade/Device Name: SoloSmart Injection Pen Adapter (SoloSmart®) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG Dated: December 20, 2023 Received: December 20, 2023 Dear Alexia Garin: 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}------------------------------------------------ 2 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); 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-safety-reportingcombination-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, Shruti N. Mistry -S Shruti Mistry, MS Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231820 Device Name SoloSmart Injection Pen Adapter (SoloSmart®) ### Indications for Use (Describe) The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors. The following Injection pens are compatible: | DEVICE MODEL NAME | INSULIN BRAND NAME | MOLECULE NAME | MOLECULE CONCENTRATION | |----------------------------------------------------------------|--------------------|------------------------------|------------------------| | SoloSmart<br>designed for<br>Solostar® SANOFI<br>Injection pen | Lantus | GLARGINE | 100 IU/mL | | | Toujeo | | 300 IU/mL | | | Admelog | LISPRO | 100 IU/mL | | | Apidra | GLULISINE | 100 IU/mL | | | Soliqua 100/33 | GLARGINE AND<br>LIXISENATIDE | 100 IU/mL<br>+33mcg/mL | Type of Use *(Select one or both, as applicable)* | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------|-----------------------------------------------------------| |------------------------------------------------------------|-----------------------------------------------------------| **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary) - 1. Prepared By: Alexia Garin 2. - Date Prepared: December 20, 2023 - 3. Trade/Proprietary Name: SoloSmart Injection Pen Adapter (SoloSmart®) - 4. Common/Usual Name: Iniection Data Capture Device Piston Syringe 5. Classification Name: - 21 CFR 880.5860 - 6. Predicate Device: K222689, Biocorp Production, Mallya Injection Pen Adapter Product Code: QOG - 7. Biocorp Production Applicant: ZI Lavaur La Béchade 63500 Issoire - France - Substantial Equivalence: The SoloSmart® device is substantially equivalent to the Mallya 8. (K222689). The device has the same indication for use, intended use and same fundamental scientific technology. - 9. Technological Characteristics: The Solosmart® Injection Pen Adapter has the same technological characteristics as the predicate device to capture and transmit dosing information. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected. Both the SoloSmart® and the predicate device use same Low Energy Bluetooth (BLE) communication technology and same protocol to pair and transmit the information to a mobile device with a compatible app. - 10. Physical description: The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package. - 11. Indications for Use: The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors. The following Injection pens are compatible: | DEVICE MODEL | INSULIN BRAND<br>NAME | MOLECULE NAME | MOLECULE<br>CONCENTRATION | |--------------------------------------------------------------------|-----------------------|------------------------------|------------------------------| | SoloSmart®<br>designed for<br>SoloStar®<br>SANOFI<br>injection pen | Lantus | GLARGINE | 100 IU/mL | | | Toujeo | GLARGINE | 300 IU/mL | | | Admelog | LISPRO | 100 IU/mL | | | Apidra | GLULISINE | 100 IU/mL | | | Soliqua 100/33 | GLARGINE AND<br>LIXISENATIDE | GLARGINE AND<br>LIXISENATIDE | {4}------------------------------------------------ #### 12. Substantial Equivalence discussion: | Attribute | Subject Device | Predicate | Discussion/Comments | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | SoloSmart® | Mallya | - | | | | Data Capture and Transmission Technology | | | 510(k) Number | K231820 | K222689 | - | | Device Classification | Class 2 - QOG | Class 2 - QOG | | | Indication for Use | Indicated for the<br>capture and wireless<br>transmission of dosing<br>information from<br>compatible reusable<br>and disposable pen<br>injectors. | Indicated for the<br>capture and wireless<br>transmission of dosing<br>information from<br>compatible reusable<br>and disposable pen<br>injectors. | | | Single patient Use | Yes | Yes | | | Reusable Device | Yes | Yes | | | Intended Use | Intended to be used<br>by patients in the<br>same use<br>environment as their<br>compatible injection<br>pen. | Intended to be used<br>by patients in the<br>same use<br>environment as their<br>compatible injection<br>pen. | same | | Prescription use | No | No | | | User Group | User of Compatible<br>Injection Pens;<br>includes diabetes<br>patients | User of Compatible<br>Injection Pens;<br>includes diabetes<br>patients | | | User Feedback | Electronic - LED<br>(light) | Electronic - LED<br>(light) and Audible<br>(Beeps) | Both provide visible<br>feedback (light).<br>Removal of audible<br>feedback was<br>confirmed as<br>unnecessary in a HF<br>Validation study | | Wireless<br>Connectivity | Bluetooth Low Energy<br>(BLE) | Bluetooth Low Energy<br>(BLE) | Same connectivity BLE<br>protocol | | Control or impact<br>Drug delivery | No | No | | | Fluid Pathway<br>Contact | None | None | same | | Software controlled | Yes | Yes | same | | Dose Recorded | Calculated based on<br>dose set | Calculated based on<br>dose set | Change from two-part<br>to one part device | | Information<br>Transmitted | Dialed dose, and time<br>and date of injection | Dialed dose, and time<br>and date of injection | necessitated and<br>enabled changes to the | | Mechanism for<br>Recording dose<br>dialed | Sense dose dialed<br>through rotation of<br>dosing mechanism<br>during dose<br>administration | Sense dose dialed<br>through rotation of<br>dosing mechanism<br>during dose setting | hardware and software<br>to capture, record and<br>transmit the dose<br>delivered, rather than | | Differentiates Prime<br>vs. Dose | Yes | Yes | only the dose that was<br>set (dialled). | | Battery | Non-Replaceable;<br>Rechargeable | Non-Replaceable;<br>Rechargeable | Same type of battery<br>with same design input<br>specification regarding<br>battery | | Lifetime | Up to 3 years of use<br>from manufacturing<br>date | 2 years of use | Extended lifetime | {5}------------------------------------------------ #### 13. Performance Data Data on the following testing were generated verifying the design of the device: - . Bench testing on performance, using ISO 11608-1 as a guide. - Dose accuracy of pen is not affected by SoloSmart® . - . Recording and transmission Accuracy - Dose Prime Differentiation . - . Complete Dose Notification - . Incomplete Injection Identification - Physical Interaction with pen, including force to mount, maintain and remove . SoloSmart® - Biocompatibility - ISO 10993-1 and FDA quidance; permanent contact with intact skin - Lifetime The product met test criteria to verify it will operate/function for 2 years (Use . Lifetime) following storage for up to two years (Shelf Life). - Electrical safety, EMC and Radiocommunication - IEC 60601-1 and appropriate collateral requirements from IEC 60601-2 and IEC 60601-1-11 - Cybersecurity Testing and Software Verification and Validation per FDA Guidelines #### 14. Human factor validation Biocorp performed a HF Validation study to confirm the usability of SoloSmart device form factor and associated instructions for use per FDA guidance. #### 15. Conclusion Biocorp as concluded that the evidences documented during design control activities supports that the SoloSmart is substantially equivalent to the predicate for specific indications and technological characteristics of the predicate device with regards to the data recording and transmission. - 16. Contact person: Alexia Garin, pms@biocorp.fr +33 473 557050