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.

Device Description

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.
(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.

AI/ML Overview

This document is a 510(k) premarket notification for medical devices (syringes and needles), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain the kind of acceptance criteria and performance study details typically found for novel AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not present in this document.

This document details the following aspects relevant to the device clearance:

1. Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.
Instead, the "acceptance criteria" are compliance with established international standards for medical devices of this type. The "reported device performance" is the statement that the device "Complied with" these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance)
ISO 7886-1:2017: Sterile Hypodermic Syringes	Complied with
ISO 7864:2016: Sterile Hypodermic Needles	Complied with
ISO 9626:2016: Stainless steel needle tubing	Complied with
ISO 80369-7:2016: Small-bore connectors	Complied with
ISO 10993-1: Biocompatibility	Complied with
USP <788>: Particulate Matter	Met USP acceptance criteria
ASTM F1980: Accelerated Aging (for shelf-life)	Complied with (3-year shelf life)
EN ISO 11135: Ethylene Oxide Sterilization	Complied with
ISO 10993-7: Ethylene Oxide sterilization residuals	Complied with
USP <85>, <161>: Pyrogen Test (Endotoxin)	Complied with (Endotoxin)
ISTA 2017 2A: Simulated transportation test	Complied with (Integrity Test)

2. Sample Size and Data Provenance:

This document does not refer to "test sets" or "training sets" in the context of AI/ML models. The performance assessment is based on physical and chemical testing of the devices themselves, performed according to the listed ISO and USP standards.
The data provenance is from the manufacturer's internal testing as part of their regulatory submission for a physical medical device (needles and syringes), not AI/ML data. The manufacturer is Hwajin Medical Co., Ltd. from South Korea. The studies are non-clinical (laboratory/bench testing) and not specifically "retrospective" or "prospective" in the same sense as clinical trials or AI/ML data collection.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. Ground truth, in this context, refers to the established standards and test methods for physical properties and biocompatibility of medical devices. There are no "experts establishing ground truth" in the sense of image annotation or clinical diagnosis for an AI/ML model. The "experts" would be the scientists and engineers who developed and performed the standard tests to verify compliance.

4. Adjudication Method:

Not applicable. There is no human interpretation or adjudication process described as it would be for an AI/ML diagnostic output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done, as this is a submission for a physical medical device (syringe/needle), not an AI/ML diagnostic aid. Therefore, there is no effect size of human readers improving with AI assistance.

6. Standalone Performance:

Not applicable. This is a physical device, so the concept of "algorithm only without human-in-the-loop performance" does not apply. The device's "standalone" performance is its ability to meet the defined ISO and USP standards.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is compliance with internationally recognized medical device performance standards (ISO, USP, ASTM, EN), and biocompatibility testing results. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set." The product development and manufacturing processes conform to quality system regulations.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above.

Summary

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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

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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

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)

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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

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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

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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.

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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 DeviceSofjec Single use Needle,Single use Syringe withneedleK212635	Predicate DeviceSterile Hypodermic Syringefor Single Use with/withoutNeedle, Hypodermic Needlefor Single UseK190002	Secondary PredicateGreenmedi Safety FilterSyringeK173743
Indication forUse	Single use NeedleSingle use Needle is intendedfor use with syringes andinjection devices for generalpurpose fluidinjection/aspiration.Single use Syringe withNeedleSingle use Syringe withNeedle is intended to be usedfor medical purposes to injectfluid into or withdraw fluidfrom body.Membrane Filter SyringeMembrane Filter Syringe isintended to be used formedical purposes to injectfluid into or withdraw fluidfrom body. The filter operateswhen injecting the drug intothe human body to removeforeign substances from thedrug solutions.	Sterile Hypodermic Needlefor single useThe Sterile HypodermicNeedle for single use isintended for use with syringesand injection devices forgeneral purpose fluidinjection/ aspiration.Sterile Hypodermic Syringefor Single Use with/withoutNeedleThe Sterile HypodermicSyringe for Single Usewith/without Needle isintended to be used formedical purposes to injectfluid into or withdraw fluidfrom body.	The Greenmedi safety filtersyringe is intended to injectthe drug solutions into thehuman body. It is designed toprevent needle stick injuries.The 0.5um filter operateswhen injecting the drug intothe human body to removeforeign substances from thedrug solutions.
PrescriptionOnly or Overthe Counter	Prescription Only	Prescription Only	Prescription Only
	Proposed Device	Predicate Device - K190002	SE decision
Indicationsfor Use	Single use NeedleSingle use Needle is intended for use withsyringes and injection devices for generalpurpose fluid injection / aspiration.Single use Syringe with NeedleSingle use Syringe with Needle isintended to be used for medical purposesto inject fluid into or withdraw fluidfrom body.	Sterile Hypodermic Needle for singleuseThe Sterile Hypodermic Needle for singleuse is intended for use with syringes andinjection devices for general purposefluid injection/ aspiration.Sterile Hypodermic Syringe for SingleUse with/without NeedleThe Sterile Hypodermic Syringe forSingle Use with/without Needle isintended to be used for medical purposesto inject fluid into or withdraw fluid frombody.	Same
OperationMode	For manual use only	For manual use only	Same
Configuration	Single use NeedleProtective cap, Needle tube,Adhesives, Needle hubSingle use Syringe with NeedlePiston, Plunger, Barrel, (Needle)	Sterile HypodermicNeedle for single useProtective cap, Needle tube,Adhesives, Needle hubSterile Hypodermic Syringe for SingleUse with/without NeedlePiston, Plunger, Barrel, (Needle)	Same
Tip type	Luer Slip, Luer Lock	Luer Slip, Luer Lock	Same
Principle ofoperation	Normal	Normal	Same
Volume/Sizes	Single use Needle16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27,28, 29, 30 ,31(G)Single use Syringe with NeedleLuer slipSyringe Volume 1,2,2.5,3,5,10,20,30,50	Sterile HypodermicNeedle for single use18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,29, 30(G)Sterile Hypodermic Syringe for SingleUse with/without Needle	Difference
	Proposed Device	Predicate Device - K190002	SE decision
	Needle gauge	16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27,28, 29, 30 ,31 (G)	Luer slipSyringeVolume1,2,3,5,10,20,30,35,50,60(ml)
	Luer Lock
	Syringe Volume	1,2,2.5,3,5,10,20,1G,1W,1B(ml)	Luer LockSyringeVolume1,2,3,5,10,20,30,35,50,60(ml)
	Needle gauge	16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27,28, 29, 30 ,31(G)	Needlegauge18, 19, 20, 21, 22,23, 24, 25, 26, 27,28, 29, 30(G)

Same between proposed device and the predicate is applicable.

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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.

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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.

NeedleLengths	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.

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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 HypodermicNeedle for single use		Different
		Part	Raw material	Part	Raw material
		Protective cap	PP	Piston	Isoprene Rubber
		Hub	PPPigment	Barrel	PP
		Needle	Stainless Steel(SUS 304L)	Plunger	PP
		Silicone	Polydimethylsiloxane	Needle Cover	PP
				Needle	Stainless Steel (SUS304)
		Single use Syringe with Needle			Sterile Hypodermic Syringe for SingleUse with/without Needle
		Barrel	Polypropylene (PP)		Part	Raw material
		Gasket	Thermoplastic elastomer		Protective cap	PP
		Plunger	Polypropylene (PP)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 followingThe 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 ethyleneoxide gas SAL = 10-6			Sterilized by ethyleneoxide gas SAL = 10-6		Same
Product performance	Complied withISO 7886-1ISO 7864ISO 9626			Complied withISO 7886-1ISO 7864ISO 9626		Same

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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
Indicationsfor Use	Membrane Filter SyringeMembrane Filter Syringe is intended to beused for medical purposes to inject fluid intoor withdraw fluid from body. The 0.5nm filteroperates when injecting the drug into thehuman body to remove foreign substancesfrom the drug solutions.	The Greenmedi safety filter syringe isintended to inject the drug solutions intothe human body. It is designed to preventneedle stick injuries. The 0.5um filteroperates when injecting the drug into thehuman body to remove foreignsubstances from the drug solutions.	Same
OperationMode	For manual use only	For manual use only	Same
Configuration	Membrane Filter SyringeNeedle, Protective cap, Filter, Bushing,Syringe (Barrel, Gasket, Plunger)	Needle, Lubricant For needle, Hub,Protective Cap, Barrel, Lubricant Forbarrel, Plunger, Gasket, Filter, Checkvalve	Different
Different-ConfigurationThe configuration of proposed syringe with needle is similar as predicate device, considering the needle may becomedisengaged from the syringe when activating the syringe with luer-slip connector, therefore the proposedsyringe doesn't have the configuration of barrel with check valve. We think the difference on configuration will not raisenew questions on safety and effectiveness of the proposed device.
Principle ofoperation	Normal	Normal	Same
Volume/Sizes	Membrane Filter SyringeLuer slip:1,2,2.5,3,5,10,20,30,50(ml)Luer Lock:1,2,2.5,3,5,10,20,50(ml)18G Only	2ml, 3ml, 5ml, 10ml23G	Difference
Different- Syringe Volume and Connector TypeThe 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.
NeedleLengths	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.

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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 SyringeCover	Polypropylene (PP)		LubricantFor needle	Silicone Oil
		Hub	Polypropylene (PP)		Hub	Polypropylene	Different
			Pigment		Protectivecap	Polypropylene
		Filter	Membrane(Polydimethylsiloxane)		Barrel	Polypropylene
		Plunger	Polypropylene(Pink)		LubricantFor barrel	Silicone Oil
					Plunger	Polypropylene (green)
		Gasket	Thermoplastic elastomer		Gasket	Thermoplastic elastomer
					Filter	Membrane
				Checkvalve	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 Syringe0.5nm			5μm		Different
Performance testing was done on the filter to ensure that the filter achieve its intended use without affecting theflow of the drug solutions into the body. Different does not affect intended use. It is only different the filter spec.
Sterilizationmethod andSAL	Sterilized by ethyleneoxide gas SAL = 10-6			Sterilized by ethyleneoxide gas SAL = 10-6		Same

	Complied with			Complied with
Productperformance	ISO 7886-1			ISO 7886-1		Same
	ISO 7864			ISO 7864
	ISO 9626

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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
1. 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.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).