Sofjec

{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 & 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. February 13, 2023 Hwajin Medical Co.,Ltd. Jeon Hun Q.m.r 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu Cheonan-si. Chungcheongnam-do 31244 Korea. South Re: K212635 Trade/Device Name: Sofjec Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG, FMI Dated: January 11, 2023 Received: January 13, 2023 Dear Jeon Hun: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 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 M. Stevens -S3 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) K212635 Device Name Sofjec # Indications for Use (Describe) Single use Needle Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. # Single use Syringe with Needle Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Membrane Filter Syringe Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions. | 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Hwajin. The logo is black, except for two orange dots above the "J" in Hwajin. The "A" in Hwajin is stylized to look like an upside down "V". 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 # K212635- 510(k) Summary #### 1. Date Prepared February 13, 2023 #### Submitter's Information & Contact Person 2. - Name of Manufacturer: HWAJIN MEDICAL CO., LTD. - Address: 20, Seonsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnamdo, 31244, Republic of Korea - Contact Name: Jeon Sung Hun/Q.M.R - Telephone No.: +82-41-554-6181 - Fax No.: +82-41-554-7178 - Email Address: sh-jeon(@hwajinmedical.com #### 3. Trade Name, Common Name, Classification Common name: Syringe, Piston Trade name: Sofjec | Classification Description | 21 CFR Section | Product Code | Class | |----------------------------------|----------------|--------------|-------| | Syringe, Piston | 880.5860 | FMF | II | | Syringe, Antistick | 880.5860 | MEG | II | | Needle, Hypodermic, Single Lumen | 880.5570 | FMI | II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "HWAJIN" in a bold, sans-serif font. The letters are dark gray, except for two orange dots above the "J". The "A" is stylized with a triangle shape in the middle. The logo appears to be for a company or brand named Hwajin. Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 #### 4. Identification of Predicate Device(s) The identified predicate devices within this submission are shown as follow: Predicate device - K190002 - Sterile Hypodermic Syringe for Single Use, with/without needle, Sterile Insulin Syringe for Single Use, Sterile Hypodermic needle for Single use - K173743 Greenmedi Safety Filter Syringe ● #### 5. Description of the Device The device has three model with the following: - (1) Single use Needle(108 model codes including Sofjec-16-13) Single use Needle consist of Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization. Needle length according to gauge of Sofjec | No | Model name | Gauge | Needle length | |----|------------|-------|----------------------------| | 1 | Sofjec-16 | 16 | 13,16,19,25,32,38 | | 2 | Sofjec-17 | 17 | 13,16,19,25,32,38 | | 3 | Sofjec-18 | 18 | 13,16,19,25,32,38 | | 4 | Sofjec-19 | 19 | 13,16,19,25,32,38 | | 5 | Sofjec-20 | 20 | 13,16,19,25,32,38 | | 6 | Sofjec-21 | 21 | 13,16,19,25,32,38 | | 7 | Sofjec-22 | 22 | 13,16,19,25,32,38 | | 8 | Sofjec-23 | 23 | 13,16,19,25,32,38 | | 9 | Sofjec-24 | 24 | 13,16,19,25,32,38 | | 10 | Sofjec-25 | 25 | 13,16,19,25,32,38 | | 11 | Sofjec-26 | 26 | 13,16,19,25,32,38 | | 12 | Sofjec-27 | 27 | 13,16,19,25,32,38 | | 13 | Sofjec-28 | 28 | 13,16,19,25,32,38 | | 14 | Sofjec-29 | 29 | 4,5,6,10,13,16,19,25,32,38 | | 15 | Sofjec-30 | 30 | 4,5,6,10,13,16,19,25,32,38 | | 16 | Sofjec-31 | 31 | 4,5,6,10,13,16,19,25,32,38 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "HWAJIN" in a bold, sans-serif font. The letters are black, except for two orange dots above the "J". The "A" in the word is stylized with a caret symbol instead of a horizontal bar. 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 - (2) Single use Syringe with Needle (1734 model codes including HJ-1-16G-13) Single use Syringe with Needle consist of Syringe, Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization and the syringes are two type of Luer Slip and Luer Lock. These device are injecting the medicine with syringes. This device is finished biocompatibility test and performance test for safety. - (3) Membrane Filter Syringe(16 model codes including HJM-18-1) This devices are consists of membrane filter needle and syringe. Membrane filter needle is attached 0.5nm filtration membrane (Acrylic copolymer material). Syringe is two type. (Luer slip type and Luer lock type) This device is Filtering with syringes and injection device is finished biocompatibility test and performance test for safety. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Hwajin. The logo is in black text, except for two orange dots above the letter 'I'. The font is sans-serif and bolded. 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 #### 6. Indications for Use | Characteristics | Subject Device<br>Sofjec Single use Needle,<br>Single use Syringe with<br>needle<br>K212635 | Predicate Device<br>Sterile Hypodermic Syringe<br>for Single Use with/without<br>Needle, Hypodermic Needle<br>for Single Use<br>K190002 | Secondary Predicate<br>Greenmedi Safety Filter<br>Syringe<br>K173743 | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Indication for<br>Use | Single use Needle<br>Single use Needle is intended<br>for use with syringes and<br>injection devices for general<br>purpose fluid<br>injection/aspiration.<br>Single use Syringe with<br>Needle<br>Single use Syringe with<br>Needle is intended to be used<br>for medical purposes to inject<br>fluid into or withdraw fluid<br>from body.<br>Membrane Filter Syringe<br>Membrane Filter Syringe is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw fluid<br>from body. The filter operates<br>when injecting the drug into<br>the human body to remove<br>foreign substances from the<br>drug solutions. | Sterile Hypodermic Needle<br>for single use<br>The Sterile Hypodermic<br>Needle for single use is<br>intended for use with syringes<br>and injection devices for<br>general purpose fluid<br>injection/ aspiration.<br>Sterile Hypodermic Syringe<br>for Single Use with/without<br>Needle<br>The Sterile Hypodermic<br>Syringe for Single Use<br>with/without Needle is<br>intended to be used for<br>medical purposes to inject<br>fluid into or withdraw fluid<br>from body. | The Greenmedi safety filter<br>syringe is intended to inject<br>the drug solutions into the<br>human body. It is designed to<br>prevent needle stick injuries.<br>The 0.5um filter operates<br>when injecting the drug into<br>the human body to remove<br>foreign substances from the<br>drug solutions. | | | Prescription<br>Only or Over<br>the Counter | Prescription Only | Prescription Only | Prescription Only | | | | Proposed Device | Predicate Device - K190002 | SE decision | | | Indications<br>for Use | Single use Needle<br>Single use Needle is intended for use with<br>syringes and injection devices for general<br>purpose fluid injection / aspiration.<br><br>Single use Syringe with Needle<br>Single use Syringe with Needle is<br>intended to be used for medical purposes<br>to inject fluid into or withdraw fluid<br>from body. | Sterile Hypodermic Needle for single<br>use<br>The Sterile Hypodermic Needle for single<br>use is intended for use with syringes and<br>injection devices for general purpose<br>fluid injection/ aspiration.<br><br>Sterile Hypodermic Syringe for Single<br>Use with/without Needle<br>The Sterile Hypodermic Syringe for<br>Single Use with/without Needle is<br>intended to be used for medical purposes<br>to inject fluid into or withdraw fluid from<br>body. | Same | | | Operation<br>Mode | For manual use only | For manual use only | Same | | | Configuration | Single use Needle<br>Protective cap, Needle tube,<br>Adhesives, Needle hub<br><br>Single use Syringe with Needle<br>Piston, Plunger, Barrel, (Needle) | Sterile Hypodermic<br>Needle for single use<br>Protective cap, Needle tube,<br>Adhesives, Needle hub<br><br>Sterile Hypodermic Syringe for Single<br>Use with/without Needle<br>Piston, Plunger, Barrel, (Needle) | Same | | | Tip type | Luer Slip, Luer Lock | Luer Slip, Luer Lock | Same | | | Principle of<br>operation | Normal | Normal | Same | | | Volume/Sizes | Single use Needle<br>16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27,<br>28, 29, 30 ,31(G)<br><br>Single use Syringe with Needle<br>Luer slip<br>Syringe Volume 1,2,2.5,3,5,10,20,30,50 | Sterile Hypodermic<br>Needle for single use<br>18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,<br>29, 30(G)<br><br>Sterile Hypodermic Syringe for Single<br>Use with/without Needle | Difference | | | | Proposed Device | Predicate Device - K190002 | SE decision | | | | Needle gauge<br> | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30 ,31 (G) | Luer slip<br>Syringe<br>Volume<br>1,2,3,5,10,20,30,35,50,60<br>(ml) | | | | Luer Lock | | | | | | Syringe Volume | 1,2,2.5,3,5,10,20,1G,1<br>W,1B(ml) | Luer Lock<br>Syringe<br>Volume<br>1,2,3,5,10,20,30,35,50,60<br>(ml) | | | | Needle gauge | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30 ,31(G) | Needle<br>gauge<br>18, 19, 20, 21, 22,<br>23, 24, 25, 26, 27,<br>28, 29, 30(G) | | Same between proposed device and the predicate is applicable. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Hwajin. The logo is in black font, except for two orange dots above the letter 'I'. The letter 'A' is stylized to look like an upside down 'V'. Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 #### Determination of Substantial Equivalence 7. There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the Sofjec and the predicate devices: # Table 1. General Comparison of Syringe with Needle. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for HWAJIN. The logo is in black text, except for two orange dots above the letter 'J'. The letter 'A' is stylized to look like an upside down 'V'. 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 # Different- Syringe Volume and Connector Type The Syringe volume for proposed device is different from the predicate devices. However, this difference is just in dimension. Different volume device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the syringe volume of the proposed syringe is covered by the syringe volume of the predicate device. Therefore, this difference does not affect substantially equivalence on safety and effectiveness. | Needle<br>Lengths | 4, 5, 6, 10, 13, 16, 19, 25, 32, 38 (mm) | Difference | |-------------------|------------------------------------------|------------| | | 4-38mm | | # Different-Needle Size and Length The needle size and length for proposed device is different from the predicate device. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the needle length of the range of the needle length of the predicate device. The needle size of the syringe is very close to that of the comparison product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness with the predicate device. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "HWAJIN" in bold, dark gray letters. Above the letters "JI" are two orange dots. The font is sans-serif and the letters are closely spaced together. | Proposed Device | | | Predicate Device - K190002 | | SE decision | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------|-------------------------------|-----------------------------------------------------|------------------------------------------------------------------|--------------------------| | Materials | Single use Needle | | | Sterile Hypodermic<br>Needle for single use | | Different | | | | Part | Raw material | Part | Raw material | | | | | Protective cap | PP | Piston | Isoprene Rubber | | | | | Hub | PP<br>Pigment | Barrel | PP | | | | | Needle | Stainless Steel<br>(SUS 304L) | Plunger | PP | | | | | Silicone | Polydimethylsiloxane | Needle Cover | PP | | | | | | | Needle | Stainless Steel (SUS304) | | | | | Single use Syringe with Needle | | | Sterile Hypodermic Syringe for Single<br>Use with/without Needle | | | | | Barrel | Polypropylene (PP) | | Part | Raw material | | | | Gasket | Thermoplastic elastomer | | Protective cap | PP | | | | Plunger | Polypropylene (PP)<br>Pigment | | Needle tube | Stainless steel (SUS304) | | | | Silicone | Polydimethylsiloxane | | Adhesives | Epoxy resin | | | | Adhesives | Epoxy Resin | | Needle hub | PP | | The differences between the subject device and the predicate are the following<br>The color of the plunger is pink color. The difference does not affect substantially equivalence on safety and effectiveness with the predicate. | | | | | | | | Sterilization method and SAL | Sterilized by ethylene<br>oxide gas SAL = 10-6 | | | Sterilized by ethylene<br>oxide gas SAL = 10-6 | | Same | | Product performance | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | | | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | | Same | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Hwajin. The logo is in a dark gray color, with the letters "HWAJIN" in a bold, sans-serif font. Above the "JI" in Hwajin are two orange dots. The logo is simple and modern. 20, Seongsimwon-gil, Seongnam-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 | | Proposed Device | Predicate Device - K173743 | SE decision | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Indications<br>for Use | Membrane Filter Syringe<br>Membrane Filter Syringe is intended to be<br>used for medical purposes to inject fluid into<br>or withdraw fluid from body. The 0.5nm filter<br>operates when injecting the drug into the<br>human body to remove foreign substances<br>from the drug solutions. | The Greenmedi safety filter syringe is<br>intended to inject the drug solutions into<br>the human body. It is designed to prevent<br>needle stick injuries. The 0.5um filter<br>operates when injecting the drug into the<br>human body to remove foreign<br>substances from the drug solutions. | Same | | Operation<br>Mode | For manual use only | For manual use only | Same | | Configuration | Membrane Filter Syringe<br>Needle, Protective cap, Filter, Bushing,<br>Syringe (Barrel, Gasket, Plunger) | Needle, Lubricant For needle, Hub,<br>Protective Cap, Barrel, Lubricant For<br>barrel, Plunger, Gasket, Filter, Check<br>valve | Different | | Different-Configuration<br>The configuration of proposed syringe with needle is similar as predicate device, considering the needle may become<br>disengaged from the syringe when activating the syringe with luer-slip connector, therefore the proposed<br>syringe doesn't have the configuration of barrel with check valve. We think the difference on configuration will not raise<br>new questions on safety and effectiveness of the proposed device. | | | | | Principle of<br>operation | Normal | Normal | Same | | Volume/Sizes | Membrane Filter Syringe<br>Luer slip:<br>1,2,2.5,3,5,10,20,30,50(ml)<br>Luer Lock:<br>1,2,2.5,3,5,10,20,50(ml)<br><br>18G Only | 2ml, 3ml, 5ml, 10ml<br><br>23G | Difference | | Different- Syringe Volume and Connector Type<br>The Syringe volume for proposed device is different from the predicate devices. However, this difference is just in dimension. Different volume device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the syringe volume of the proposed syringe with covered by the range of the syringe volume of the predicate device. Therefore, this difference does not affect needle is substantially equivalence on safety and effectiveness. | | | | | Needle<br>Lengths | 4, 5, 6, 10, 13, 16, 19, 25, 32, 38 (mm) | 17mm | Difference | Table 2. General Comparison of Filter Syringe The needle size and length for proposed device is different from the predicate device. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use. Moreover, the needle length of the proposed syringe in the needle length of the predicate device. The needle size of the syringe is very close to that of the comparison product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness with the predicate device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Hwajin. The logo is black, except for two orange dots above the "I" in "Hwajin". The text is bold and sans-serif. | | Proposed Device | | | Predicate Device - K173743 | | SE decision | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------|------------------------------------|------------------------------------------------|-------------------------|-------------------------|-----------| | Materials | | | | | | | | | | | | | Part | Raw material | | | | | | | | Needle | STS304 | | | | | | Membrane Filter Syringe<br>Cover | Polypropylene (PP) | | Lubricant<br>For needle | Silicone Oil | | | | | Hub | Polypropylene (PP) | | Hub | Polypropylene | Different | | | | | Pigment | | Protective<br>cap | Polypropylene | | | | | Filter | Membrane<br>(Polydimethylsiloxane) | | Barrel | Polypropylene | | | | | Plunger | Polypropylene<br>(Pink) | | Lubricant<br>For barrel | Silicone Oil | | | | | | | | Plunger | Polypropylene (green) | | | | | Gasket | Thermoplastic elastomer | | Gasket | Thermoplastic elastomer | | | | | | | | Filter | Membrane | | | | | | | Check<br>valve | Silicon | | | | The differences between the subject device and the predicate are the following | | | | | | | | | The color of the plunger is pink color. The difference does not affect substantially equivalence on safety and effectiveness. | | | | | | | | | Filter spec. | Membrane Filter Syringe<br>0.5nm | | | 5μm | | Different | | | Performance testing was done on the filter to ensure that the filter achieve its intended use without affecting the<br>flow of the drug solutions into the body. Different does not affect intended use. It is only different the filter spec. | | | | | | | | | Sterilization<br>method and<br>SAL | Sterilized by ethylene<br>oxide gas SAL = 10-6 | | | Sterilized by ethylene<br>oxide gas SAL = 10-6 | | Same | | | | | | | | | | | | | Complied with | | | Complied with | | | | | Product<br>performance | ISO 7886-1 | | | ISO 7886-1 | | Same | | | | ISO 7864 | | | ISO 7864 | | | | | | ISO 9626 | | | | | | | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Hwajin. The logo is in black, except for two orange dots above the letter 'J'. The font is sans-serif and bold. Tel: +82 (41) 554 6181 Fax:+82 (41) 554 7178 # Non-Clinical Test Summary - 1) Biocompatibility Test The devices were tested for biocompatibility per ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Result of evaluation test for consideration Category: External communicating device Contact: Blood path, Indirect Contact duration: A-Limited (≤24) Test item: - . Cytotoxicity - In vitro hemolysis - Skin Sensitization ● - Pyrogen - ◆ Acute Toxicity - Intracutaneous reactivity ● Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injection and met the USP acceptance criteria. # 2) Performance Test - ISO 7864:2016 Sterile hypodermic needles for single use - ISO 7886-1:2017 Sterile Hypodermic Syringes For Single Use - ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices . - ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications - Patt 7: Connectors for intravascular or hypodermic applications - 3) Sterilization, Shelf-life Testing and Simulated Shipping - Shelf-life test for 3years: ASTM F1980:2002 Standard Guide for Accelerated Aging of Sterile medical ● device packages - Ethylene Oxide Sterilization Validation Test: EN ISO11135:2014 Sterilization of medical devices-Validation and routine control of sterilization by ethylene oxide sterilization. - Ethylene oxide gas residual test : ISO10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals - Pyrogen Test: Endotoxin: USP 39, <85> Bacterial Endotoxins Tests, USP 45, <161> Medical Devices - Bacterial Endotoxin and Pyrogen Tests - ISTA 2017 Integrity Test Procedure 2A: Simulated transportation test # Clinical Test Summary No clinical studies were considered necessary and performed. #### 8. Conclusion Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed predicate device.