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 hub of needle to the top of inside barrel. Four legs on the bottom of hub are caught on the swell part 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 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 has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).

AI/ML Overview

The provided text describes a medical device, the "Jeesung Safety Syringe and Single Use Needles," and its acceptance criteria, particularly focusing on biocompatibility and general performance standards.

Here's an analysis of the acceptance criteria and supporting studies, formatted as requested:

1. A table of acceptance criteria and the reported device performance

Test Item	Acceptance Criteria	Reported Device Performance
Biocompatibility Tests
Cytotoxicity test	Non-cytotoxicity (ISO10993-5:2009)	Non-cytotoxicity (Pass)
Hemolysis test	Non-hemolytic (ISO10993-4:2002(E), ISO10993-4:2002/Amd.1:2006)	Non-hemolytic (Pass)
Acute systemic toxicity test	No dead animals, No strange reaction animals (ISO10993-11:2006(E))	Non-acute systemic toxicity (Pass)
Skin sensitization test	Non-skin hypersensitivity reaction (ISO10993-10:2010(E))	There was non-skin hypersensitivity reaction. (Pass)
Pyrogen Test	Non-pyrogenicity (ISO 10993-11:2006, USP 38 NF 33 <85>)	Non-pyrogenicity (Pass), Endotoxin concentration < 4.0 EU/device
Intracutaneous reactivity test	Non-intracutaneous reactivity (ISO 10993-10:2010(E))	There was non-intracutaneous reactivity. (Pass)
Particulate matters	Particles does not greater than 10μm and greater than 25μm (USP <788>)	Particles greater than 10μm - 0 particle, Particles greater than 25μm - 0 particle
Syringe Performance (ISO7886-1:1993)
Inner/outside and structure	Surface is smooth / no particle and foreign substance	Surface is smooth / no particle and foreign substance
Graduated scale	Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm)	Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm) (These appear to be reported values rather than strict criteria, but imply meeting a standard)
Barrel	The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity	The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity (This appears to be reported value rather than strict criteria, but implies meeting a standard)
Piston(gasket)/plunger assembly	Design, fit of piston in barrel, fiducial line are suitable	Design, fit of piston in barrel, fiducial line are suitable
Liquid leakage	Pressure test – no leaked water / aspirate test – no leaked air	Pressure test – no leaked water / aspirate test – no leaked air
Lubricant	The quantity of lubricant: 0.18mg/cm³	The quantity of lubricant: 0.18mg/cm³ (This appears to be reported value rather than strict criteria, but implies meeting a standard)
Needle Performance (ISO7864:1993)
Inner/outside and structure	No scratch, no crack, smooth, no foreign materials, sharped needle edge	No scratch, no crack, smooth, no foreign materials, sharped needle edge
Measurement	Outside diameter of needle (e.g., 0.6000-0.673mm for 0.645mm), length of needle (e.g., 25(+1.5/-2.5)mm for 24.7mm)	Outside diameter of needle: 0.645mm for 0.6000-0.673 criteria, length of needle: 24.7mm for 25(+1.5/-2.5) criteria (These appear to be reported values rather than strict criteria, but imply meeting a standard)
Elasticity test	Needle returned after remove weight.	Needle returned after remove weight.
Flexural rigidity	Needle was not broken.	Needle was not broken.
Draw test	The union of the hub and needle tube was not broken.	The union of the hub and needle tube was not broken.
Stimulated Clinical Use Testing	Zero failure of the protective feature	Zero failure of the protective feature

2. Sample size used for the test set and the data provenance

Stimulated Clinical Use Testing: The sample size for this test was 500 subject devices.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the tests were conducted by the manufacturer as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described (biocompatibility, physical performance, simulated clinical use) are objective engineering and laboratory tests, not typically requiring expert ground truth establishment in the same way an AI diagnostic device would.

4. Adjudication method for the test set

This information is not applicable for the reported tests. The tests are based on objective measurements and predefined pass/fail criteria from international standards (ISO, USP).

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for this mechanical safety syringe.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a mechanical safety syringe, not an algorithm. The "Stimulated Clinical Use Testing" can be considered a standalone performance test for the device's safety mechanism without human-in-the-loop assessment in the context of an AI algorithm. Its purpose was to verify the function of the safety feature itself.

7. The type of ground truth used

The "ground truth" for the various tests relies on established and internationally recognized standards and specifications for medical devices.

Biocompatibility: Standards like ISO10993 (Cytotoxicity, Hemolysis, Systemic Toxicity, Skin Sensitization, Intracutaneous Reactivity) and USP <85> (Pyrogen Test) and USP <788> (Particulate Matters). The "ground truth" is that the device must meet the defined biological safety limits and particulate levels set by these standards.
Syringe and Needle Performance: Standards like ISO7886-1 and ISO7864 define the performance characteristics, dimensional tolerances, and structural integrity required for syringes and needles. The "ground truth" is adherence to these engineering specifications.
Stimulated Clinical Use Testing: The ground truth for this specific test was zero failure of the protective feature, meaning the safety mechanism must activate correctly every time as observed in the simulation.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no AI model, there is no training set or ground truth for a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2016

JeeSung Medical Co., Ltd. % Mr. Peter Chung Plus Global 300 Atwood Street, Pittsburgh, Pennsylvania 15213

Re: K152606

Trade/Device Name: Jeesung Safety Syringe and Single Use Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 9, 2016 Received: May 18, 2016

Dear Mr. 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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152606

Device Name

Jeesung Safety Syringe and Single Use Needles

Indications for Use (Describe)

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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K152606

510(k) Summary

[as required by 807.92]

1. Applicant

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. Contact Person: Peter Chung,
1. Tel: 412-687-3976
1. Email: peterchung210@gmail.com
1. Date of Preparation: June 22, 2016

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

K142435 3S Safety Syringe with/without Needle

4. 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 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 has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).

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5. Indication for Use

Comparison table
Category	JeeSung Medical Co.,Ltd	Sincere Medical Device Co., Ltd.
Element ofComparison	Submission Device(K152606)	Predicate DeviceK142435
Regulation no.	880.5860	880.5860
Product code	MEG	MEG
Common name	Syringe, Antistick Piston Syringe	Syringe, Antistick Piston Syringe
Class	Class II	Class II
Indication for use	Jeesung safety syringe and single useneedles is a sterile, single-use,disposable and non-reusable, manualretractable safety syringe intended forinjection of fluids into the body, whilereducing the risk of sharps injuries andthe potential for syringe reuse.	The 3S Safety Syringe with/withoutNeedle is a sterile, single-use,disposable and non-reusable, manualretractable safety syringe intendedfor injection of fluids into the body,while reducing the risk of sharpsinjuries and the potential for syringereuse.
Principle of Operation	There is a swell on the top of insidebarrel, which can be used to fix the hubof needle to the top of inside barrel.Four legs on the bottom of hub arecaught on the swell part on the top ofinside barrel when the hub is pulled.After using this syringe (such asinjecting medicine into body etc.), thehub of needle is pulled back to theinside of the barrel. Because the fourlegs of hub is bound to the top of theplunger which has a smaller swell partthan the top of inside barrel for beingcaught. Therefore, by pushing plungeruntil it makes a binding sound, the hubcan follow with the plunger. Then theplunger is broken off and the needlecannot be come out of the barrel. Thisrenders the needle unusable and safefrom accidental needle sticks.	The needle is contained within thesyringe barrel. After standardtechniques for injection, the plungeris withdrawn completely into thebarrel and snapped off and theneedle is contained within thepuncture-resistant barrel. Thisrenders the needle unusable and safefrom accidental needle sticks.
Syringe capacity	3cc	Various Sizes(smallest 0.5cc, largest 10cc)
Lubricant for Barrel	Silicone Oil	Silicone Oil
Barrel transparency	Transparent and Clear	Transparent and Clear
Gradation Legibility	Legible	Legible
Product configuration	BarrelPlungerGasketNeedle Hub	BarrelPlungerPistonNeedle Hub
Material		Needle Protect cap	Needle Sheath
	Barrel	Polypropylene	Polypropylene
	Plunger	Polypropylene	Polypropylene
	Piston(Gasket)	Elastomer	Elastomer
	Needle hub	Polycarbonate	Polypropylene
	Needle	Stainless steel	Stainless Steel
	Needle sheath(protect cap)	Polypropylene	Polypropylene
	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 (18, 19, 20, 21, 22, 23,24, 25, 27, 28, 29, 30, 31G)Needle length (8, 9, 11, 13, 16, 25,32, 38mm)

Lubricant for Needle		Silicone Oil	Silicone Oil
Sharp InjuryPrevention Features		Manual Retractable	Manual Retractable
Performances		Conforms to ISO7864 ISO7886	Conforms to ISO7864 ISO7886
Biocompatibility test		Conforms to ISO10993(ISO10993-4, ISO10993-5, ISO10993-10,ISO10993-11)	Conforms to ISO10993
Labeling		Meet the requirements of 21 CFR Part801	Meet the requirements of 21 CFRPart 801
Sterilization information		E.O gas sterilizationAssurance level : 10-6	E.O gas sterilizationAssurance level : 10-6

6. Predicate Device Comparison Table

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The proposed and predicate devices are the same indications for use, principle of operation, Lubricant for Barrel, product configuration, lubricant for needle, sharp injury prevention feature. The proposed device syringe capacity includes 3cc which are within the range of the predicate syringe 0.5cc to 10cc. The subject device needle sizes are 18-30G and needle length 8, 10, 13, 16, 19, 25, 32, 38mm which are within the range of predicate needle gauge 18-31G and needle length 8-38mm. Therefore, these differences do not affect substantially equivalency between the proposed devices and predicate device.

7. Performance Data

No	Test item	Test method
		Test criteria	Test result (pass / failure)
1	Cytotoxicity test	ISO10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitrocytotoxicity, Test on extracts methodNon-cytotoxicity	Non- cytotoxicity (Pass)
2	Hemolysis test	ISO10993-4: 2002(E) Biological evaluation of medical devices - Part 4: Selection for testsfor interactions with blood, Evaluation of hemolytic properties of medical and theircomponentsNon-hemolyticISO10993-4: 2002/Amd.1 : 2006 Biological evaluation of medical devices – Part 4:Selection of tests for interactions with blood AMENDMENT 1 Annex C.6 Hemolysistesting General considerationsRefer to test report	Non-hemolytic (Pass)There was non-hemolytic.
3	Acutesystematictoxicitytest	ISO10993-11: 2006(E) Biological evaluation of medical devices -- Part 11: Tests forsystemic toxicity, 5. Acute systemic toxicityNo dead animalsNo strange reaction animals	Non-acute systemic toxicity (Pass)

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4	Skinsensitizationtest	ISO10993-10: 2010(E), Biological evaluation of medical devices Part 10: Teat for Irritationand sensitization. Guinea pig Maximization test (GPMT)
		Non-skin hypersensitivityreaction	There was non-skin hypersensitivity reaction. (Pass)
5	Pyrogen Test	ISO 10993-11 :2006, Biological evaluation of medical devices, Test for systemic, Annex(F)Information on material-mediated pyrogens
		Non-pyrogenicity	Non-pyrogenicity (Pass)
		USP 38 NF 33 <85> Bacterial Endotoxin test "Gel clot method"
		Concentration of the reactionsolution is determined as (-)	As a result of the reaction, all the concentration ofthe test solution were determined as (-). Therefore,endotoxin concentration of the test sample is lessthan 4.0 EU/device.
6	Intracutaneousreactivity test	ISO 10993-10 :2010(E), Biological evaluation of medical devices, Test for irritation andskin sensitization, Animal Intracutaneous(intradermal) reactivity Test.
		Non-intracutaneous reactivity	There was non-intracutaneous reactivity. (Pass)
7	Particulatematters	USP <788> Particulate Matter in Injections
		Particles does not greater than10μm and greater than 25μm	Particles greater than 10μm - 0 particleParticles greater than 25μm - 0 particle

Based on the above testing results, the subject devices are biocompatible.

		Test items	Result summary
1	Syringe(ISO7886-1 : 1993)	Inner/outside and structure	Surface is smooth / no particle and foreign substance
		Graduated scale	Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm)
		Barrel	The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity
		Piston(gasket)/plunger assembly	Design, fit of piston in barrel, fiducial line are suitable
		Liquid leakage	Pressure test – no leaked water / aspirate test – no leaked air
		Lubricant	The quantity of lubricant :0.18mg/cm³
2	Needle(ISO7864 :1993)	Inner/outside and structure	No scratch, no crack, smooth, no foreign materials, sharped needle edge
		Measurement	Outside diameter of needle : 0.645mm for 0.6000-0.673 criteria / length of needle : 24.7mm for 25(+1.5/-2.5) criteria
		Elasticity test	Needle returned after remove weight.
		Flexural rigidity	Needle was not broken.
		Draw test	The union of the hub and needle tube was not broken.
3	Stimulated Clinical Use Testing report		As a result of a simulated clinical use study using 500 subject devices, the number of failure of the subject devices safety feature is not founded and resulted to zero failure of the protective feature.

Based on the result of the above syringe, needle testing and stimulated clinical use testing, the proposed devices are satisfied with all the acceptance criteria.

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8. Conclusion

Both subject and predicate devices have the same Indications for Use. Based on the result of the device comparison and performance data, the proposed devices are determined to be Substantially Equivalent (SE) 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).