Jeesung Safety Syringe and Single Use Needles

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August 18, 2022 JeeSung Medical Co., Ltd. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213 Re: K212518 Trade/Device Name: Jeesung Safety Syringe and Single Use Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: July 13, 2022 Received: July 20, 2022 Dear Peter Chung: 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, CAPT Alan 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) K212518 Device Name Jeesung Safety Syringe and Single Use Needles Indications for Use (Describe) Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 # 1. Submitter information - 1) Company: JeeSung Medical Co.,Ltd. - 2) Address: 54, Mujini 1-gil, Daedeok-gu, Daejeon, Korea - 3) Tel: 82-42-932-6061 - 4) Fax: 82-42-932-6063 - 5) Prepared date : December 30, 2021 - 6) Contact Person: Peter Chung, 412-687-3976 - 7) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA - 8) Submission date : December 30, 2021 # 2. Device Information - 1) Trade Name: Jeesung Safety Syringe and Single Use Needles - 2) Common Name: Syringe, Antistick Piston Syringe - 3) Classification Name: Piston Syringe - 4) Product Code: MEG - 5) Regulation Number: 880.5860 - 6) Class of device: Class II - 7) Panel: General Hospital # 3. Predicate Device - 1) Trade Name: Jeesung Safety Syringe and Single Use Needles (K152606) - 2) Common Name: Syringe, Antistick Piston Syringe - 3) Classification Name: Piston Syringe - 4) Product Code: MEG - 5) Regulation Number: 880.5860 - 6) Class of device: Class II - 7) Panel: General Hospital # 4. Reason for Special 510(k) Submission The basis of this submission is to modify the capacity of syringe of Jeesung Safety Syringe And Single Use Needles. # 5. Device Description Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the top of inside barrel. Four legs on the bottom of hub are caught on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger. Then the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks. Jeesung Safety Syringe and Single Use Needles is available in the following sizes and capacities: Syringe Capacity(cc) : 1cc and 3cc Needle Gauge(G) : 23G, 25G The length of the needle(mm) : 8mm, 10mm, 16mm, 19mm, 25mm, 32mm, 38mm # 6. Intended Use Jeesung safety syringe and single use needles is a sterile, single-use, disposable, manual retractable safety syringe intended for injection of fluids into the risk of sharps injuries and the potential for syringe reuse. {4}------------------------------------------------ #### 7. Comparison of Technological characteristic with the predicate device The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence : - Indications for use The predicate and subject device have identical indications for use; both devices are indicated ' for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. - י Materials - The predicate and subject devices are both made of medical grade stainless steel needles. - י Design – The predicate and subject device have equivalence design. They are both made of the same materials. - . Performance Testing – Both the predicate and subject device were subjected to performance testing under the MEG product code to support substantial equivalence in terms of performance. | Element of<br>Comparison | Predicate Device | Subject Device | Comparison | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | Jeesung safety syringe and single<br>use needles | Jeesung safety syringe and single<br>use needles | | | | 510(k) Number | K152606 | K212518 | N/A | | | Regulation no. | 880.5860 | 880.5860 | SAME | | | Product code | MEG | MEG | SAME | | | Common name | Syringe, Antistick Piston Syringe | Syringe, Antistick Piston Syringe | SAME | | | Class | Class II | Class II | SAME | | | Indication for use | Jeesung safety syringe and single<br>use needles is a sterile, single-use,<br>disposable and non-reusable,<br>manual retractable safety syringe<br>intended for injection of fluids into<br>the body, while reducing the risk of<br>sharps injuries and the potential for<br>syringe reuse. | Jeesung safety syringe and single<br>use needles is a sterile, single-use,<br>disposable and non-reusable,<br>manual retractable safety syringe<br>intended for injection of fluids into<br>the body, while reducing the risk of<br>sharps injuries and the potential for<br>syringe reuse. | SAME | | | Principle<br>of Operation | There is a swell on the top of inside<br>barrel, which can be used to fix the<br>hub of needle to the top of inside<br>barrel. Four legs on the bottom of<br>hub are caught on the swell part on<br>the top of inside barrel when the hub<br>is pulled.<br>After using this syringe (such as<br>injecting medicine into body etc.),<br>the hub of needle is pulled back to<br>the inside of the barrel. Because the<br>four legs of hub is bound to the top<br>of the plunger which has a smaller<br>swell part than the top of inside<br>barrel for being caught. Therefore,<br>by pushing plunger until it makes a<br>binding sound, the hub can follow<br>with the plunger. Then the plunger is<br>broken off and the needle cannot be<br>come out of the barrel. This renders<br>the needle unusable and safe from<br>accidental needle sticks. | There is a swell on the top of inside<br>barrel, which can be used to fix the<br>hub of needle to the top of inside<br>barrel. Four legs on the bottom of<br>hub are caught on the swell part on<br>the top of inside barrel when the hub<br>is pulled.<br>After using this syringe (such as<br>injecting medicine into body etc.),<br>the hub of needle is pulled back to<br>the inside of the barrel. Because the<br>four legs of hub is bound to the top<br>of the plunger which has a smaller<br>swell part than the top of inside<br>barrel for being caught. Therefore,<br>by pushing plunger until it makes a<br>binding sound, the hub can follow<br>with the plunger. Then the plunger is<br>broken off and the needle cannot be<br>come out of the barrel. This renders<br>the needle unusable and safe from<br>accidental needle sticks. | SAME | | | Syringe capacity | 3cc | 1cc, 3cc | Different;<br>1cc is added for<br>the subject<br>device | | | Lubricant for Barrel | Silicon Oil | Silicon Oil | SAME | | | Barrel transparency | | Transparent and Clear | Transparent and Clear | SAME | | Product configuration | | Barrel<br>Plunger<br>Gasket<br>Needle Hub<br>Needle<br>Needle Protect cap | Barrel<br>Plunger<br>Gasket<br>Needle Hub<br>Needle<br>Needle Protect cap | SAME | | Material | Barrel<br>Plunger<br>Piston(Gasket)<br>Needle hub<br>Needle<br>Needle sheath<br>(protect cap) | Polypropylene<br>Polypropylene<br>Elastomer<br>Polycarbonate<br>Stainless steel<br>Polypropylene | Polypropylene<br>Polypropylene<br>Elastomer<br>Polycarbonate<br>Stainless steel<br>Polypropylene | SAME | | | Needle Gauge and<br>Length | | Needle gauge (18, 19, 20, 21, 22, 23,<br>24, 25, 26, 27, 28, 29, 30G)<br>Needle length (8, 10, 13, 16, 19, 25,<br>32, 38mm) | Needle gauge (23G, 25G)<br>Needle length (8, 10, 13, 16, 19, 25,<br>32, 38mm) | | | Lubricant for Needle | Silicon Oil | Silicon Oil | SAME | | | Sharp Injury<br>Prevention Features | Manual Retractable | Manual Retractable | SAME | | | Performances | Conforms to ISO7864, ISO7886 | Conforms to ISO7864, ISO7886 | SAME | | Biocompatibility test | | Conforms to ISO10993<br>(ISO10993-4, ISO10993-5,<br>ISO10993-10, ISO10993-11) | Conforms to ISO10993<br>(ISO10993-4, ISO10993-5,<br>ISO10993-10, ISO10993-11) | SAME | | Labeling | | Meet the requirements of 21 CFR<br>Part 801 | Meet the requirements of 21 CFR<br>Part 801 | SAME | | Sterilization information | | E.O gas sterilization<br>Assurance level : 10-6 | E.O gas sterilization<br>Assurance level : 10-6 | SAME | The table below provides comparison of key features of the subject and predicate devices. {5}------------------------------------------------ There are some differences in syringe capacity and needle gauge between the predicate device and the subject device. The subject device is available in 1cc and 3cc. In case of needle gauge, only 23G are available for the subject device. To confirm that these differences do not impact the performance and safety of the predicate device, performance test and biocompatibility test were carried out. Test results were acceptable. Therefore, we can conclude that the subject device is substantially equivalent to the predicate device. #### 8. Performance Data The following performance testing has been conducted to support determinal equivalence of the subject device. This includes biocompatibility testing of the component, sterf-life study, performance testing as required under the MEG product code. #### Needle performance Testing - . Appearance - 트 Limits for acidity or alkalinity - 트 Limits for extractable metals - " Lubricant - ' Graduated scale - Numbering of scales - Barrel - Plunger stopper/plunger assembly ■ - Nozzle - . Dead space {6}------------------------------------------------ - . Freedom from liquid/air leakage - Force to operate the piston - . Fit of plunger stopper/plunger in barrel #### Biocompatibility Testing - Cytotoxicity test ■ - . Intracutaneous Reactivity Test - . Acute Systemic Toxicity Test - . Pyrogen Test - 트 Hemolysis Test - I Skin Sensitization study - . Particulate matters #### Sterilization Validation - EO Sterilization Validation in accordance with ISO 11135 ' #### Shelf Life Study - Accelerated Aging . - Packaging Integrity test #### Packaging Process Validation Study - Sealing condition . #### Shipping Validation Study - ISTA 2018 Integrity Test Procedure 2A, ASTM D4169-16. " #### Clinical Testing - Clinical testing was not required to support substantial equivalence. . # 8. Conclusion The proposed device has identical indications for use to the predicate devices have similar technological characteristics such as safety features and materials of manufacture. Appropriate performance testing was conducted to support determination of substantial equivalence of the results of this testing demonstrates that the subject device is substantially equivalent in safety and performance to the predicate device.