Insulin Syringes

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 24, 2024 CHIRANA T. Injecta % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs. Colorado 80918 ## Re: K242434 Trade/Device Name: Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: November 26, 2024 Received: November 26, 2024 ## Dear Nathan Wright: 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); 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 medical devices and radiation-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). {2}------------------------------------------------ Sincerely, Shruti N. Mistry -S Shruti Mistry 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 Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242434 Device Name Insulin Syringes Indications for Use (Describe) The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☒ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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." {4}------------------------------------------------ # K242434 -510(K) SUMMARY | Preparation Date: | December 24, 2024 | |--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Submitter Name: | CHIRANA T. Injecta, a.s.<br>Nám. Dr. Schweitzera 194<br>916 01 Stará Turá<br>Slovak Republic<br>Tel.: +421/32/7709 991 | | Contact Person:<br>Telephone Number:<br>Email Address: | Nathan Wright, RAC<br>Engineer & Regulatory Specialist, Empirical Technologies<br>719-351-0248<br>nwright@empiricaltech.com | | Trade Name: | Insulin Syringes | | Review Panel: | Drug Delivery and General Hospital Devices, and Human Factors (DHT3C) | | Regulation Name:<br>Regulation Number:<br>Product Code:<br>Device Class: | Piston Syringe<br>21 CFR 880.5860<br>FMF<br>Class II | | Regulation Name: | Hypodermic Single Lumen Needle | | Regulation Number: | 21 CFR 880.5570 | | Product Code:<br>Device Class: | FMI<br>Class II | | Predicate Device: | K201044, CHIRANA® Insulin Syringes (CHIRANA T. Injecta, a.s.) | | Reference Device: | K233794, Insulin Syringe (SPM Medicare Pvt. Ltd.) | | Reference Device: | K161170, BD Eclipse Hypodermic Needle (Becton, Dickinson and Company) | ### Purpose The CHIRANA® Insulin Syringes are being submitted in this special 510(k) with modifications to the previously cleared CHIRANA® Insulin Syringes (K201044) to update the syringe packaging options, and rename the syringe set. ### Device Description The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe. The following are the list of syringe and needle combinations offered. | Type | Syringe Volume | Needle Gauge | Needle Length(s) | Clearance Status | |--------------|----------------|--------------|---------------------|--------------------| | Insulin U40 | 0.3 mL | 29G | 12.7 mm | New Size | | | 0.3 mL | 30G | 12.7 mm | New Size | | | 0.5 mL | 29G | 12.7 mm | New Size | | | 0.5 mL | 30G | 12.7 mm, 8 mm | New Size | | | 1 mL | 27G | 12.7 mm | Cleared in K201044 | | | 1 mL | 29G | 12.7 mm | New Size | | | 1 mL | 30G | 12.7 mm, 8 mm, 6 mm | New Size | | | 0.3 mL | 29G | 12.7 mm | Cleared in K201044 | | | 0.3 mL | 29G | 8mm | New Size | | | 0.3 mL | 30G | 12.7 mm, 8 mm | New Size | | | 0.3 mL | 30G | 6 mm | Cleared in K201044 | | | 0.3 mL | 31G | 8 mm, 6 mm | Cleared in K201044 | | | 0.5 mL | 27G | 12.7 mm | New Size | | | 0.5 mL | 29G | 12.7 mm | Cleared in K201044 | | Insulin U100 | 0.5 mL | 29G | 8 mm | New Size | | | 0.5 mL | 30G | 12.7 mm | New Size | | | 0.5 mL | 30G | 8 mm, 6 mm | Cleared in K201044 | | | 0.5 mL | 31G | 8 mm, 6 mm | Cleared in K201044 | | | 1 mL | 25G | 12.7 mm | New Size | | | 1 mL | 26G | 12.7 mm | New Size | | | 1 mL | 27G | 12.7 mm | Cleared in K201044 | | | 1 mL | 27G | 8 mm | New Size | | | 1 mL | 28G | 12.7 mm, 8 mm | New Size | {5}------------------------------------------------ | 1 mL | 29G | 12.7 mm, 8 mm | Cleared in K201044 | |------|-----|---------------|--------------------| | 1 mL | 30G | 12.7 mm, 8 mm | Cleared in K201044 | | 1 mL | 30G | 6 mm | New Size | | 1 mL | 31G | 8 mm, 6 mm | Cleared in K201044 | | 1 mL | | Luer | Cleared in K201044 | #### Indications for Use The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin. | Characteristic | Subject Device<br>Insulin Syringes | Predicate Device<br>CHIRANA® Insulin Syringes<br>K201044 | |------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Indications for Use | The Insulin Syringes are intended for<br>subcutaneous injection of U100 insulin or U40<br>insulin. | The CHIRANA® Insulin Syringes are intended<br>for subcutaneous injection of U100 insulin or<br>U40 insulin. | | Prescription Only or<br>Over the Counter | Both OTC and Rx Use | Over the Counter | The expanded use of the Insulin Syringes to include prescription use does not raise any new questions for safety and effectiveness when compared to the predicate device since their use would be under the authorization of a licensed practitioner. Other Insulin Syringes with the same indicated use as the SPM Medicare Insulin Syringes (K233794), have both prescription use and over-the-counter use. ### Technological Characteristics The table below includes a comparison of the technological characteristics between the new device of the predicate device: | | | Insulin Syringes | CHIRANA® Insulin Syringes | |------------------|--------------------|-------------------------------------------------------|-------------------------------------------------------| | Manufacturer | | CHIRANA T. Injecta | CHIRANA T. Injecta | | 510(k) Number | | Subject | K201044 | | Product Code | | FMF, FMI | FMF, FMI | | Design | Design | graduated barrel, plunger rod and needle/hub assembly | graduated barrel, plunger rod and needle/hub assembly | | | Volume | 0.3mL, 0.5mL, 1mL | 0.3mL, 0.5mL, 1mL | | | *Gauge | 25G, 26G, 27G, 28G, 29G, 30G, 31G | 27G, 29G, 30G, 31G | | | Length | 6 mm, 8 mm, 12.7 mm | 6 mm, 8 mm, 12.7 mm | | Materials | Needle | Stainless Steel 304 | Stainless Steel 304 | | | Barrel | Polypropylene | Polypropylene | | | Plunger | Polypropylene | Polypropylene | | | Hub Tip | Polystyrene | Polystyrene | | | Needle Cap | Polyethylene | Polyethylene | | | Protective End Cap | Polyethylene | Polyethylene | | | Cannula Lubricant | Medical Grade Silicone | Medical Grade Silicone | | Biocompatibility | | Conforming to ISO 10993-1 | Conforming to ISO 10993-1 | | Sterilization | | EO (ethylene gas) to SAL=10-6 | EO (ethylene gas) to SAL=10-6 | *The additional subject syringe sizes being added in this 510(k) include needle gauges 25G, 26G, and 28G which were not part of the previously cleared set. The new needle gauges fall within the range of needle sizes which the FDA has cleared use, such as the BD Eclipse Hypodermic Needle (K161170) ranging from18G to 30G and indicated for the general purpose for injection and aspiration of fluid (implicit of insulin) into the body below the skin. ### Performance Testing The sterile Insulin Syringes described in this summary were tested with the following methods: ISO 8537 Third edition: Sterile single-use syringes, with or without needle, for insulin ISO 7886-1 Second edition: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods ISO 7864 Fourth edition: Sterile hypodermic needles for single use - Requirements and test method #### Sterility, Shipping and Shelf-Life Sterilization validation per ISO 11135 Second edition: Sterilization of health-care products - Ethylene oxide -Requirements for ● {6}------------------------------------------------ the development, validation and routine control of a sterilization process for medical devices - . Packaging Stability - Shelf life of 5 years for single unit packaging is validated using the FDA recognized standard ASTM F1980-16 Standard Guide . for Accelerated Aging of Sterile Barrier Systems for Medical Devices ## Conclusions The differences in packaging options, sizes, and use between the subject device and the predicate device do not raise any new or different questions of safety or effectiveness. The subject Insulin Syringes are substantially equivalent to the CHIRANA® Insulin Syringes (K201044) with respect to the indications for use, target populations, treatment method, and technological characteristics.