Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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. June 21, 2023 Cardinal Health 200, LLC Emily Hunter Senior Specialist, Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085 ## Re: K223376 Trade/Device Name: Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL. 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: Mav 24, 2023 Received: May 25, 2023 Dear Emily Hunter: 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Alan St CAPT Alan M. Stevens 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223376 #### Device Name Monoject Magellan Insulin Safety Syringe 1 ml, 31 G x 6mm (888189311 0); Monoject Magellan Insulin Safety Syringe 0.5ml, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3ml, 31G x 6mm (8881893130) #### Indications for Use (Describe) Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks. | 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. 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}------------------------------------------------ # K223376 510(k) Summary ### Submitter Information: Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085, USA Contact Person: Emily Hunter Phone: 847-887-6367 Email: emily.hunter()1(@cardinalhealth.com Date of Preparation: June 20, 2023 | Device | | |----------------------|--------------------------------------------------------| | TRADE NAME | Monoject™ Magellan™ Insulin Safety Syringe | | COMMON NAME | Insulin Syringe, with sharps injury prevention feature | | CLASSIFICATION NAME | Piston Syringe | | REGULATION NUMBER | 21 CFR 880.5860 | | REGULATORY CLASS | II | | PRODUCT CODES | MEG, FMF, FMI | | CLASSIFICATION PANEL | General Hospital | ### Predicate Device 510(k) Number: K061492 Device Name: Monoject™ Magellan™ Insulin Safety Syringe ### Device Description The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time. A complete list of the subject devices proposed model numbers is included in Table 1 | Product Code | Product Description | |--------------|-------------------------------------------------------------------| | 8881893130 | Monoject Magellan Insulin Safety Syringe, 0.3mL, 31G x 6mm needle | | 8881893150 | Monoject Magellan Insulin Safety Syringe, 0.5mL, 31G x 6mm needle | | 8881893110 | Monoject Magellan Insulin Safety Syringe, 1.0mL, 31G x 6mm needle | # Table 1: Proposed Subiect device model numbers ### Indications for Use Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks. {4}------------------------------------------------ ## Comparison of Technological Characteristics with the Predicate Device Subject Monoject Magellan Insulin Safety Syringe has similar materials, and identical design, components, technological characteristics, intended use, and indications for use as the predicate device. Biocompatibility evaluation and testing in conformance with ISO 10993 series standards was completed to verify similar materials. Differences exist in needle gauge, length, and wall thickness; needle of subject device is smaller, shorter, and thinner than needle of predicate. Differences have been verified in conformance with FDA recognized standard ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin. | Description | Subject Device | Predicate Device | Comparison | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Monoject Magellan | Kendall Monoject | | | | Insulin Safety Syringe | Magellan Insulin Safety | | | | K223376 | Syringe | | | | | K061492 | | | Indications for use | Monoject Magellan Insulin<br>Safety Syringes are intended<br>for delivery of U-100<br>insulin. The needle stick<br>prevention feature of the<br>device, once activated,<br>guards against accidental<br>needle-sticks. | The device is intended for<br>the delivery of U-100<br>insulin. The needle stick<br>prevention feature of the<br>device, once activated,<br>guards against accidental<br>needle-sticks. | Same | | Intended Use | Primarily intended for intra-<br>muscular, subcutaneous,<br>and/or intra-dermal<br>medication delivery.<br>Secondary use is a safety<br>feature that helps prevent<br>sharps injuries. | Primarily intended for intra-<br>muscular, subcutaneous,<br>and/or intra-dermal<br>medication delivery.<br>Secondary use is a safety<br>feature that helps prevent<br>sharps injuries. | Same | | Syringe Type | Piston Syringe | Piston Syringe | Same | | Principle<br>of<br>Operation | Manually extendable safety<br>shield, one handed<br>activation | Manually extendable safety<br>shield, one handed<br>activation | Same | | Specific Drug Use | Insulin | Insulin | Same | | Needle size | 31G | 29G, 30G | Different | | Needle length | 6mm (15/64") | 8mm (5/16")<br>13mm (1/2") | Different | | Wall thickness | Extra thin wall | Regular Wall | Different | | Needle bevel | Conforms to ISO 7864 | Conforms to ISO 7864 | Same | | Needle<br>Sheath<br>Color | Orange | Orange | Same | | Needle Lubricant | Silicone | Silicone | Same | | Needle Material | Type 304 Stainless Steel | Type 304 Stainless Steel | Same | | Syringe volumes | 0.3mL<br>0.5mL<br>1.0mL | 0.3mL<br>0.5mL<br>1.0mL | Same | | Barrel Lubricant | Silicone | Silicone | Same | | Description | Subject Device<br>Monoject Magellan<br>Insulin Safety Syringe<br>K223376 | Predicate Device<br>Kendall Monoject<br>Magellan Insulin Safety<br>Syringe<br>K061492 | Comparison | | Barrel Materials | Polypropylene | Polypropylene | Similar | | Barrel Nozzle | Fixed Needle | Fixed Needle | Same | | Barrel<br>Transparency | Clear | Clear | Same | | Safety Shield<br>Material | Polyethylene | Polyethylene | Same | | Sterilization<br>Method | Gamma Radiation | Gamma Radiation | Same | | SAL | 10-6 | 10-6 | Same | | Reuse Durability | Single use only | Single use only | Same | | Delivery Accuracy | Conforms to ISO 8537 | Conforms to ISO 8537 | Same | | Hub/Needle Bond<br>Strength | Conforms to ISO 8537 | Conforms to ISO 8537 | Same | | Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Same | ### Table 2: Comparison of Technological Characteristics of Subject Device with Predicate Device {5}------------------------------------------------ ### Biocompatibility Biocompatibility evaluation was conducted considering worst-case, clinical use, and potential repeat contact in conformance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Applicable testing was completed utilizing the ISO 10993 series standards following Good Laboratory Practices. Monoject™ Magellan™ Insulin Safety Syringes with permanently attached 31G x 6mm needle are concluded to be toxicologically acceptable for the intended use. ### Sterility Monoject™ Magellan™ Insulin Safety Syringes with permanently attached 31G x 6mm needle is sterilized using gamma irradiation to a sterility assurance level of 10 %. Devices are nonpyrogenic as determined by the Limulus Amebocyte Lysate (LAL) Test. Validation and testing was completed following FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile, ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, ANSI AAMI ST72:2019 Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing, and USP Chapter <85>, Bacterial Endotoxins Test. ## Performance Data ### Nonclinical tests Monoject™ Magellan™ Insulin Safety Syringes with permanently attached 31G x 6mm needle underwent evaluation following FDA Guidance documents and FDA recognized standards to support substantial equivalence determination: - Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes ● {6}------------------------------------------------ - ISO 8537:2016 Sterile single-use syringes with or without needle for insulin - . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - . ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - . ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - USP <788> Particulate Testing . ### Conclusion Results of non-clinical testing support the conclusion that Monoject™ Magellan™ Insulin Safety Syringes with permanently attached 31G x 6mm needle are as safe, as effective, and performs as well as the predicate device, therefore subject device is substantially equivalent to the predicate device.