JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE

• K Number: K124037
• Device Name: JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
• Manufacturer: JUNG RIM MEDICAL INDUSTRIAL CO., LTD
• Date Cleared: 2013-09-12 ( 258 days)
• Product Code: FMF FMI
• Regulation Number: 880.5860

Intended Use

Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Device Description

The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap. The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G) Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users. These are sterile (Eo gas sterilization). The devices are disposable, single use devices.

Predicate Devices

K113091, K072739

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a standard hypodermic syringe and needle, with no mention of AI or ML capabilities. The performance studies focus on meeting established ISO standards for syringes and needles.

Therapeutic

No
This device is for injecting or withdrawing fluids, which is a diagnostic or procedural tool, not a therapeutic agent itself.

Diagnostic

No

This device is a syringe with a needle, intended for injecting or withdrawing fluids from the body, which is a therapeutic or procedural function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (Barrel, Piston, Gasket, Needle, Needle cap) and refers to sterilization and physical testing standards (ISO standards), indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "to inject fluid into or withdraw fluid from body." This describes a direct interaction with the body for therapeutic or diagnostic purposes on the patient, not for testing samples outside the body.
• Device Description: The description details a syringe and needle, which are tools for administering or collecting substances from a living organism. It does not mention any components or functions related to analyzing biological samples in a laboratory setting.
• Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This syringe and needle do not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Product codes (comma separated list FDA assigned to the subject device)

FMF, FMI

Device Description

The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap.

The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G)

Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.

These are sterile (Eo gas sterilization). The devices are disposable, single use devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Single use hypodermic Syringe with needle have been designed and successfully tested to meet the applicable requirements outlined in ISO7886-1, ISO7864, ISO9626, ISO6009 and ISO594-1.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113091, K072739

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

JUNG RIM MEDICAL

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitted by :

September /02 / 2013

Kyu Lee / Overseas sales manager Jung Rim Medical Industrial Co., Ltd. #593-81, Sagok-Ri, Iwol-Myeon, Jincheon-Gun, Chungbuk, 365-820, Korea Phone : [phone] Fax : + 82 2 404 7989

Device Name : 2.

Trade Name

Jung Rim single use hypodermic Syringe with Needle .

• � Piston syringe - Classification : Class II - Classification Name Syringe, Piston - Product Code FMF .. - Regulation Number 21 CFR 880.5860 : : - Review Panel General Hospital
  :

SEP 12 2013

• � Hypodermic single lumen needle

- Classification	: Class II
- Classification Name	: Hypodermic single lumen needle
- Product Code	: FMI
- Regulation Number	: 21 CFR 880.5870
- Review Panel	: General Hospital

510(k) Summary

1

3. Predicate Device :

a) K number : K113091

• Manufacturer : Jiangyin Caina Technology Co., Ltd.

I ) Proposed Device Name: Syringes with or without needles

Classification: Class II

Product Code: FMF

Regulation Number: 21 CFR 880.5860

2. Proposed Device Name: Needles

Classification: Class II

Product Code: FMI

Regulation Numiber: 21 CFR 880.5570

b) K number : K072739

• Manufacturer : ShanDong WeiGao Group Medical Polymer Products Co., LTD

1. Proposed Device Name: Sterile Hypodermic Syringe for single use, with/without needle (1,2,3,5,10,20,30,50,100(ml))

Classification: Class II

Product Code: FMF

Regulation Number: 21 CFR 880.5860

2. Proposed Device Name: Sterile Hypodermic Needle for single use

(16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,29G)

Classification: Class H

Product Code: FMI

Regulation Numiber: 21 CFR 880.5570

2

4. Device Description :

The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap.

The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G)

Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.

These are sterile (Eo gas sterilization). The devices are disposable, single use devices.

5. Intended For Use :

1. The single us hypodermic syringe

The Single use hypodermic Syringe with needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

2) The Hypodermic needle

The Sterile hypodermic needle for single use is intended for use with syringes for general purpose fluid injection/aspiration

Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.

JUNG RIM MEDICAL

3

Image /page/3/Picture/1 description: The image shows the text "JUNG RIM MEDICAL" in a bold, sans-serif font. The text is black, and there is a horizontal line underneath it. To the left of the text is a logo that is partially visible.

6. Technological Characteristics :

The Single use hypodermic Syringe with needle and the predicate device have the identical technological characteristics and perform equivalently.

Device Name	Subject Device	Predicate Device #1	Predicate Device #2
Manufacturer	Jung Rim Medical Industrial Co.,
Ltd.	Jiangyin Caina Technology Co.,
Ltd.	ShanDong WeiGao Group Medical
Polymer Products Co., LTD
510(k) Number	NEW	K113091	K072739
Classification	Class II	Class II	Class II
Product code	FMF	FMF	FMF
Regulation Number	21 CFR 880.5860	21 CFR 880.5860	21 CFR 880.5860
Classification	Class II	Class II	Class II
Product code	FMI	FMI	FMI
Regulation Number	21 CFR 880.5870	21 CFR 880.5870	21 CFR 880.5870
Intended for use	Syringe	The Single use hypodermic Syringe
with needle is intended to be used
for medical purposes to inject fluid
into or withdraw fluid from body.	Syringes with or without needle
are intended to inject fluids into or
withdraw fluids from the body.	The sterile Hypodermic syringe for
single Use With/without needle is
intended to be used for medical
purposes to inject fluid into or
withdraw fluid from body.
	Needles	The Sterile hypodermic needle for
single use is intended for use with
syringes for general purpose fluid
injection/aspiration.	Needles are intended to be used
with a legally marketed syringe
intend to inject fluids into or
withdraw fluids from the body.	The Sterile Hypodermic needle for
single use is intended for use with
syringes and injection devices for
general purpose fluid
injection/aspiration.
Syringe	Syringe type	Piston syringe	Piston syringe	Piston syringe
	Tip type	Luer slip	Luer slip and Luer lock	Luer slip and Luer lock
	Volume	1ml 3ml 5ml 10ml 20ml 30ml 50ml	1,2,3,5,10,20,30,50 (ml)	1,2,3,5,10,20,30,50,100(ml)
Needle	Gauge	16G, 17G, 18G, 19G, 20G, 21G,
22G,23G, 24G, 25G, 26G, 27G, 28G,
29G, 30G, 31G	16G,18G,19G,20G,21G,22G,23G,
24G,25G,26G,27G,29G	16G,18G,19G,20G,21G,22G,23G,
24G,25G,26G,27G,29G
	Tip
configuration	Image: tip configuration	same	same
	Hub color	According to ISO 6009	According to ISO 6009	According to ISO 6009
		Device Name	Subject Device	Predicate Device #1	Predicate Device #2
		Manufacturer	Jung Rim Medical Industrial Co.,
Ltd.	Jiangyin Caina Technology Co.,
Ltd.	ShanDong WeiGao Group Medical
Polymer Products Co., LTD
		510(k) Number	NEW	K113091	K072739
	Syringe	Barrel	lubricated polypropylene	lubricated polypropylene	lubricated polypropylene
		Plunger	polypropylene	polypropylene	polypropylene
		Gasket	Styrene ethylene / Butylene
copolyme	Resin stopper	• Resin stopper
		Tubing	lubricated stainless (STS304)	lubricated stainless (STS304)	lubricated stainless (STS304)
	Needle	Hub	polypropylene	polypropylene	polypropylene
		Sheath	polypropylene	polypropylene	polypropylene
		Bonding	Epoxy bond	Epoxy bond	Epoxy bond
		Lubricant	Dimethylpolysiloxane	Dimethylpolysiloxane	Dimethylpolysiloxane
		Principle of
operation	1. Check that the syringe package is
undamaged and unopened.
Discard if damaged or opened.

2. Peel open the end of the package
   and remove the syringe.
3. Wipe the top of the vial with
   alcohol and allow it to air dry.
4. Remove the shield from the
   needle.
   Do not move the plunger, and do
   not try to inject air into the vial, as
   this will disable the syringe.
5. Pick up the vial and invert it.
   Insert needle into the vial.
6. Keep the needle tip in the fluid at
   all times.
   Do not draw air into the syringe.
   It may lead to an inaccurate dose.
   To fill the syringe, slowly pull
   the plunger
   To remove air bubbles, remove
   the needle from the vial.
7. Holding the syringe upright, tap
   the barrel to bring the bubbles
   towards the tip of the syringe.
8. Then carefully push the plunger
   to the dose mark, thus expelling
   the air bubble.
9. Administer the injection
10. Depress the plunger completely
    to deliver the dose. | Same | Same |
    | | | Biocompatibility | ISO10993-1 | ISO10993-1 | ISO10993-1 |
    | | | Sterilization | Ethylene oxide gas (SAL 10⁻⁶) | Ethylene oxide gas (SAL 10⁻⁶) | Ethylene oxide gas (SAL 10⁻⁶) |

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Jung Rim Syringe 510(K) Submission

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JUNG RIM MEDICAL

510(k) Summary

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Page 5 of 6

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JUNG RIM MEDICAL

Performance Testing

The Single use hypodermic Syringe with needle have been designed and successfully tested to meet the applicable requirements outlined in ISO7886-1, ISO7864, ISO9626, ISO6009 and ISO594-1.

Biocompatibility Testing

The material of the Single use hypodernic Syringe with needle have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.

Sterilization and Shelf-life Testing

Sterilization of the Single use hypodermic Syringe with needle has been validated using the half-cycle method as outlined in ISO11135.

The maximum levels of residues of ethylene oxide and ethylene chlorohydrins will not exceed the limits presented in ISO10993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization

Clinical Data

No prospective clinical trials were conducted in support of this Traditional 510(k)

8. Conclusion

Based on the information provided in this premarket notification of Jung Rim Medical Industrial Co., Ltd. Concludes that The Sterile Hypodermic Syringe for Single Use with needle is substantially equivalent to predicate devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MI) 20993-0002

September 12, 2013

Jung Rim Medical Industrial Company Limited C/O Mr. Kyu Lec 593-81. Sagok-Ri. Iwol-Myeon, Jincheon-Gun Chungbuk 365-820 Korea

Re: K124037

Trade/Device Name: Jung Rim Single Use Hypodermic Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: August 14, 2013 Received: August 15. 2013

Dear Mr. Lee:

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 mav 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

7

Page 2 - Mr. Lee

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 device-related 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary Si

Kwame Ulmer, M.S. Acting Division 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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Indication for use Statement

S10(k) Number ( If known ) : _