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.

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.

AI/ML Overview

The provided text details a 510(k) submission for the Jeesung Safety Syringe and Single Use Needles, a Class II medical device. However, the document does not contain the specific acceptance criteria and detailed device performance results that you requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9.

This document is a regulatory submission summary that outlines the device, its intended use, comparison to a predicate device, and a list of the types of performance testing conducted. It states that "Test results were acceptable" but does not provide the quantitative acceptance criteria or the reported performance values.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document lists the types of tests performed (e.g., limits for acidity, force to operate piston, cytotoxicity) but does not provide the specific "acceptance criteria" (e.g., "pH between X and Y," "force less than Z N") or the actual "reported device performance" (e.g., "pH was P," "force was Q N").
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical device performance, ground truth typically refers to established standards and physical measurements, and the document states conformance to ISO standards (e.g., ISO7864, ISO7886, ISO10993).
8. The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding the study:

Study Type: Performance testing (mechanical, chemical, biological) as required for a physical medical device under the MEG product code. This includes:
- Needle Performance Testing (e.g., Appearance, Limits for acidity/alkalinity, Extractable metals, Lubricant, Graduated scale, Barrel, Plunger stopper/plunger assembly, Nozzle, Dead space, 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, Hemolysis Test, 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).
Ground Truth for Physical Device Testing: Conformance to established international standards (ISO7864, ISO7886, ISO10993, ISO 11135, ISTA 2018, ASTM D4169-16) and relevant regulations (21 CFR Part 801).
Clinical Testing: "Clinical testing was not required to support substantial equivalence." This means no human subject studies were conducted for this 510(k) submission.
Conclusion: The manufacturer concluded that "The proposed device... have similar technological characteristics... Appropriate performance testing was conducted... results of this testing demonstrates that the subject device is substantially equivalent in safety and performance to the predicate device."

To obtain the specific quantitative acceptance criteria and detailed performance data, one would typically need to refer to the full 510(k) submission document, which is generally not publicly available in its entirety beyond the summary provided.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K212518

Device Name

Jeesung Safety Syringe and Single Use Needles

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter information

1. Company: JeeSung Medical Co.,Ltd.
1. Address: 54, Mujini 1-gil, Daedeok-gu, Daejeon, Korea
1. Tel: 82-42-932-6061
1. Fax: 82-42-932-6063
1. Prepared date : December 30, 2021
1. Contact Person: Peter Chung, 412-687-3976
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : December 30, 2021

2. Device Information

1. Trade Name: Jeesung Safety Syringe and Single Use Needles
1. Common Name: Syringe, Antistick Piston Syringe
1. Classification Name: Piston Syringe
1. Product Code: MEG
1. Regulation Number: 880.5860
1. Class of device: Class II
1. Panel: General Hospital

3. Predicate Device

1. Trade Name: Jeesung Safety Syringe and Single Use Needles (K152606)
1. Common Name: Syringe, Antistick Piston Syringe
1. Classification Name: Piston Syringe
1. Product Code: MEG
1. Regulation Number: 880.5860
1. Class of device: Class II
1. 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

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.

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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 ofComparison	Predicate Device	Subject Device	Comparison
	Jeesung safety syringe and singleuse needles	Jeesung safety syringe and singleuse 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 singleuse needles is a sterile, single-use,disposable and non-reusable,manual retractable safety syringeintended for injection of fluids intothe body, while reducing the risk ofsharps injuries and the potential forsyringe reuse.	Jeesung safety syringe and singleuse needles is a sterile, single-use,disposable and non-reusable,manual retractable safety syringeintended for injection of fluids intothe body, while reducing the risk ofsharps injuries and the potential forsyringe reuse.	SAME
Principleof Operation	There is a swell on the top of insidebarrel, which can be used to fix thehub of needle to the top of insidebarrel. Four legs on the bottom ofhub are caught on the swell part onthe top of inside barrel when the hubis pulled.After using this syringe (such asinjecting medicine into body etc.),the hub of needle is pulled back tothe inside of the barrel. Because thefour legs of hub is bound to the topof the plunger which has a smallerswell part than the top of insidebarrel for being caught. Therefore,by pushing plunger until it makes abinding sound, the hub can followwith the plunger. Then the plunger isbroken off and the needle cannot become out of the barrel. This rendersthe needle unusable and safe fromaccidental needle sticks.	There is a swell on the top of insidebarrel, which can be used to fix thehub of needle to the top of insidebarrel. Four legs on the bottom ofhub are caught on the swell part onthe top of inside barrel when the hubis pulled.After using this syringe (such asinjecting medicine into body etc.),the hub of needle is pulled back tothe inside of the barrel. Because thefour legs of hub is bound to the topof the plunger which has a smallerswell part than the top of insidebarrel for being caught. Therefore,by pushing plunger until it makes abinding sound, the hub can followwith the plunger. Then the plunger isbroken off and the needle cannot become out of the barrel. This rendersthe needle unusable and safe fromaccidental needle sticks.	SAME
Syringe capacity	3cc	1cc, 3cc	Different;1cc is added forthe subjectdevice
Lubricant for Barrel	Silicon Oil	Silicon Oil	SAME
Barrel transparency		Transparent and Clear	Transparent and Clear	SAME
Product configuration		BarrelPlungerGasketNeedle HubNeedleNeedle Protect cap	BarrelPlungerGasketNeedle HubNeedleNeedle Protect cap	SAME
Material	BarrelPlungerPiston(Gasket)Needle hubNeedleNeedle sheath(protect cap)	PolypropylenePolypropyleneElastomerPolycarbonateStainless steelPolypropylene	PolypropylenePolypropyleneElastomerPolycarbonateStainless steelPolypropylene	SAME
	Needle Gauge andLength		Needle gauge (18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30G)Needle length (8, 10, 13, 16, 19, 25,32, 38mm)	Needle gauge (23G, 25G)Needle length (8, 10, 13, 16, 19, 25,32, 38mm)
	Lubricant for Needle	Silicon Oil	Silicon Oil	SAME
	Sharp InjuryPrevention Features	Manual Retractable	Manual Retractable	SAME
	Performances	Conforms to ISO7864, ISO7886	Conforms to ISO7864, ISO7886	SAME
Biocompatibility test		Conforms to ISO10993(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11)	Conforms to ISO10993(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11)	SAME
Labeling		Meet the requirements of 21 CFRPart 801	Meet the requirements of 21 CFRPart 801	SAME
Sterilization information		E.O gas sterilizationAssurance level : 10-6	E.O gas sterilizationAssurance level : 10-6	SAME

The table below provides comparison of key features of the subject and predicate devices.

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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

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. 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.

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).