Sol-Guard Auto-disable Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. May 4, 2023 Sol-Millennium Medical Inc. Ying Zhao Senior manager, Regulatory Affairs 315 Shawnee North Dr. Suite 100 Suwanee, Georgia 30024 ### Re: K220713 Trade/Device Name: Sol-Guard Auto-disable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: April 6, 2023 Received: April 7, 2023 ### Dear Ying Zhao: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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 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). 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) K220713 #### Device Name SOL-GUARD Auto-Disable Syringe Indications for Use (Describe) The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the Sol-Guard Auto-Disable Syringe is designed to prevent syringe and needle reuse. 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}------------------------------------------------ # 510(k) SUMMARY In accordance with 21 CFR 807.92(a) the following summary of information is provided: | Date Summary Prepared: | May 5, 2023 | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter/Applicant: | Sol-Millennium Medical Inc.<br>315 Shawnee North Dr.<br>Suite 100<br>Suwanee, GA 30024<br>Phone: 815-578-2200<br>Fax:<br>815-759-2548 | | Primary Contact Person: | Ying Zhao<br>Sol-Millennium Medical Inc.<br>Sr. Manager, Regulatory Affairs<br>Phone: 847-363-1264<br>Email: yzhao@sol-m.com | | Device Information | Trade/Device Name: Sol-GuardTM Auto-Disable Syringe<br>Regulatory Number: 21 CFR § 880.5860<br>Regulatory Name: Syringe, Piston<br>Regulatory Class: II<br>Product Code: FMF<br>Review Panel: General Hospital | | Predicate Device<br>Information | K153537<br>Manufacturer: Sol-Millennium Medical Inc.<br>Sol-M Insulin Syringe, Sol-M TB Syringe<br>The predicate device has not been subject to a design-related<br>recall. | {4}------------------------------------------------ ### Device Description: The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids. The auto-disable syringes are configured as follows. | Product Size | Needle Gauge | Needle length | |--------------|--------------|---------------| | 0.3ml | 23G | 1" | | 0.3ml | 23G | 1 1/2" | | 0.3ml | 25G | 1" | | 0.5ml | 23G | 1" | | 0.5ml | 23G | 1 1/2" | | 0.5ml | 25G | 1" | | 0.65ml | 26G | 3/8" | #### Indications For Use: The Sol-Guard™ Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse. ### Technological Charateristic The subject device is a standard 3-piece piston syringe with a permanently attached needle and with an auto-disable feature that prevents reuse of the syringe after injection by locking the plunger in place after injection. The syringe consists of a syringe barrel with a permanently attached needle, a plunger rod with an integral metal clip, and a rubber stopper (gasket). The subject device has a feature that passively activates upon delivering an injection of the nominal fixed dose to prevent subsequent reuse of the syringe and the needle. The passive activation is where the reuse prevention feature does not require an additional step by the user during injection to activate the protection feature. The reuse prevention is achieved using serrations on the internal wall of the barrel and a metal clip/claw on the plunger that automatically blocks the plunger once depressed so it cannot be retracted again. This is a single-use device. ### Comparison of Technological Characteristic The design and technological features of the Sol-Guard™ Auto-Disable Syringe, which is the subject of this Special 510(k), are the same as Sol-M Insulin Syringe and Sol-M TB Syringe {5}------------------------------------------------ previously cleared under K153537. The differences between the subject device and the predicate devices are the inclusion of the auto-disable feature that locks the plunger after injection. Table 1 presents a comparison of the devices' technology, features, and materials. | Element of Comparision | Proposed Device | Predicate Device (K153537) | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Sol-Guard™Auto-Disable Syringe | Sol-M Insulin Syringe, Sol-M TB | | | | Syringe | | Product Code | FMF | FMF | | Syringe Type | Piston, syringe | Piston, syringe | | Indication for use | The Sol-GuardTM Auto-Disable Syringe is<br>intended for aspiration and injection of fluids<br>into the body. In addition, the Sol-Guard™<br>Auto-Disable Syringe is designed to prevent<br>syringe and needle reuse. | TB Syringe is intended to be used for<br>medical purposes to inject fluids into or<br>withdraw fluids from the body.<br>Insulin Syringe with needle, with the<br>calibration unit of insulin for U-100, is<br>device intended for medical purposes | | | | for the manual aspiration of insulin, and<br>for the injection of insulin into parts of<br>the body below the surface of the skin. | | Intended Use | The SOL-GUARD™ Auto Disable syringes<br>are used to inject vaccine/medications into the<br>body by physicians, nurses, and other<br>qualified health care professionals. It is | TB Syringe is intended to be used for<br>medical purposes to inject fluids into or<br>withdraw fluids from the body. | | | designed with safety feature for the prevention<br>of the syringe reuse. | Insulin Syringe with needle, with the<br>calibration unit of insulin for U-100, is<br>device intended for medical purposes<br>for the manual aspiration of insulin, and<br>for the injection of insulin into parts of<br>the body below the surface of the skin. | | Principle of operation | Three-piece piston syringe.<br>Plunger is used to fill syringe<br>as well as discharge the fluid.<br>The Auto-Disable syringe has a fixed needle<br>and plunger rod with affixed metal clip which<br>is designed for the prevention of the syringe<br>and needle re-use by automatically activating<br>the clip and locking the plunger after injection. | Three-piece piston syringe.<br>Plunger is used to fill syringe<br>as well as discharge the fluid. The<br>syringe has a fixed needle. | | Specific Drug Use | Vaccine/Medication | Insulin syringes - Insulin<br>TB syringes - General Use (included<br>vaccine/medication) | | Length | Assembly length 131mm | Assembly length 131mm | | Diameter | I.D. of barrel: 4.7mm | I.D. of barrel: 4.7mm | | Tip Type | Fixed Needle | Fixed Needle | | Volume | 0.3ml, 0.5ml, 0.65ml | Insulin Syringes - 0.3, 0.5, 1ml<br>TB Syringes - 0.5, 1 ml | | Needle Length | 3/8" to 1 1/2" | 5/16" to 1 1/2" | | Needle Gauge | 23-26 gauge | Insulin- 29-31 gauge<br>TB - 23-27 gauge | | Needle Tip Configuration | Hypodermic needle | Hypodermic needle | | Barrel Marking Specs | Graduated scale in ml for fixed dose | Insulin: graduated scale in U100<br>TB: graduated scale in ml | | Device Component | Barrel, piston, plunger, needle, needle cover,<br>metal clip | Barrel, piston, plunger, needle, needle<br>cover, metal clip | | Element of Comparision | Proposed Device | Predicate Device (K153537) | | | Sol-Guard™Auto-Disable Syringe | Sol-M Insulin Syringe, Sol-M TB<br>Syringe | | Graduation Legibility | Bold Markings | Bold Markings | | Needle Cover/Cap Dimensions | Needle cover length from 25mm to 49mm<br>based on nominal needle length | Needle cover length from 25mm to<br>49mm based on nominal needle length | | Needle Cover/Cap Color | Clear (transparent, not colored) | Insulin: Orange according to ISO 8537<br>TB: according to ISO 6009 except 25G<br>that needle cover is not colored | | Lubricant Composition | Dow Corning Medical<br>Silicone 360 | Dow Corning Medical<br>Silicone 360 | | Lubricant Amount/cm2 | ≤ 0.25 mg/cm2 | ≤ 0.25 mg/cm2 | | Barrel transparency | Clear | Clear | | Delivery Accuracy | Per Auto-disabled syringes for fixed-dose<br>immunization - ISO 7886-3:2020 | Insulin Syringes- Per ISO<br>8537:2016 | | | Hypodermic Syringes - Per<br>ISO 7886-1: 2016 | Hypodermic Syringes - Per<br>ISO 7886-1: 2016 | | Needle Cover/Cap Strength | Internal requirement: force to remove the<br>needle cover below 15N | Internal requirement: force to remove<br>the needle cover below 15N | | Hub/Needle bond Strength | Per ISO 7864 | Per ISO 7864 | | Biocompatibility | Per ISO 10993-1 | ISO 10993-1 | | Barrel | Polypropylene | Polypropylene | | Plunger | Polypropylene and SS 304 stainless (metal<br>clip) | Polypropylene | | Gasket/Stopper | IR rubber | IR rubber | | Needle | SS 304 | SS 304 | | Needle Cover/Cap | Polypropylene | Polypropylene | | Labeling | Per 21 CFR 801 | Per 21 CFR 801 | | Sterilization Method | EtO | EtO | | Sterility Level (SAL) | 10-6 | 10-6 | | Shelf Life | 5 years | 5 years | Table 1. Technology and features {6}------------------------------------------------ #### Sol-Millennium Medical Inc. Sol-Guard™ Auto-Disable Syringe ### Performance Testing Summary: Performance testing was conducted to support the addition of the auto-disable feature of the syringe. The Sol-Guard™ Auto-Disable Syringe has been subjected to Design Controls and tested to appropriate device specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device. #### Biocompatibility Testing Biocompatibility testing was leveraged from the predicate device submission since there was no change in the patient direct or in-direct contact components and no biological concern is introduced. #### Sterilization There was no change in the sterilization process or materials involved with the sterilization, and the sterility assurance level remains unchanged. The Microbiology Product Adoption was done in accordance with ISO 11135:2014 Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routine control of a sterilization process for medical devices and AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization. {7}------------------------------------------------ ## Shelf Life: Shelf-life verification studies were conducted at T=5 under accelerated aging conditions to verify that the claimed shelf life of 5years is supported. There were no failures identified and the test confirmed that the claimed expiration date is supported. # Summary of Non-Clinical Tests (Bench Testing) Sol-Millennium has conducted non-clinical testing according to the FDA consensus standards. The performance and design testing conducted serve as the basis for establishing substantial equivalence, the testing included the following. - ISO 7886-3:2020 Sterile hypodermic syringes for single use Part 3: Auto-disabled ● syringes for fixed-dose immunization - ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use The compatibility of the metal clip of the syringe to the plunger that provides the auto-disable feature for the subject device was considered the technological characteristic which introduced the greatest potential risk of the subject device. Potential functional performance risks include risk on the ability of the plunger to travel within the barrel, scale mark legibility, ability to maintain shelf-life, resulting in a delay in therapy, and inaccurate medication delivery. Compliance to ISO 7886-3 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization, in conjunction with ISO7886-1, serves as the mitigations to the identified safety concerns. The non-clinical testing included assessments related to device material biocompatibility, where it was deemed the metal clip does contact fluid or skin during its intended use. Results of non-clinical testing both validated the modifications made and served to mitigate the identified risks such that the subject device met requirements for its intended use demonstrating substantial equivalence to its predicate device. # Clinical Testing: Clinical studies were not deemed necessary to support the substantial equivalence decision ### Conclusion: Sol-Millennium considers the Sol-Guard™ Auto-Disable Syringe to be substantially equivalent to the predicate device. The subject device's intended use, indications for use, technology, and principles of operation are unchanged compared to the predicate device cleared under K153537. The addition of an auto-disable feature to prevent syringe and needle reuse does not change the effectiveness of the device and it does not represent a change in user tasks or interactions. The potential risks introduced by adding auto-disable feature were successfully mitigated by design control activities. The subject device is as safe and effective as the predicate device. Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices.