(258 days)
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.
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.
The Jung Rim Medical "Jung Rim single use hypodermic Syringe with Needle" is a medical device intended for injecting or withdrawing fluids from the body. The acceptance criteria and the study verifying these criteria are detailed below:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material/Design Conformance: | |
| ISO 7886-1 (Syringes for single use - Part 1: Syringes for manual use) | Successfully met |
| ISO 7864 (Sterile hypodermic needles for single use) | Successfully met |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Successfully met |
| ISO 6009 (Hypodermic needles - Colour coding for identification) | Successfully met |
| ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements) | Successfully met |
| Biocompatibility: | |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) for devices categorized as External communicating devices, Limited exposure. | Successfully passed |
| Sterilization: | |
| ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) - using half-cycle method. | Validated using half-cycle method. |
| ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) - maximum levels of residues of ethylene oxide and ethylene chlorohydrins. | Will not exceed limits presented. |
| Shelf-life: | |
| Testing to support shelf-life of 5 years after sterilization. | Supports a shelf-life of 5-years after sterilization. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test outlined (ISO7886-1, ISO7864, etc.). It generally states that the device was "successfully tested" to meet the applicable requirements.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, beyond the fact that no prospective clinical trials were conducted.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This section is not applicable. The study involves performance testing against international standards for medical devices (syringes and needles), not a diagnostic or AI device where expert ground truth would be established for image or data interpretation. The ground truth for this device is the adherence to established engineering and material standards.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish a ground truth, such as in medical image analysis. For device performance testing against ISO standards, the results are typically quantitative and objectively measured against predefined thresholds, not subject to expert adjudication in this manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret data with and without AI assistance. The Jung Rim Medical device is a physical medical instrument (syringe and needle), and thus an MRMC study is not applicable.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. The device is a physical medical instrument, not an algorithm or AI system. Therefore, performance testing for an algorithm is not relevant.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is international standards and regulations (e.g., ISO7886-1, ISO7864, ISO9626, ISO6009, ISO594-1, ISO10993-1, ISO11135, ISO10993-7). The device's performance was measured against the specific requirements and specifications detailed within these standards to ensure safety and effectiveness.
8. Sample Size for the Training Set:
This section is not applicable. The device is a physical medical apparatus, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the reasons stated in point 8.
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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 : +82 2 404 7986 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
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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
- 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
- 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
- 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
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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 :
- 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
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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 MedicalPolymer 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 Syringewith needle is intended to be usedfor medical purposes to inject fluidinto or withdraw fluid from body. | Syringes with or without needleare intended to inject fluids into orwithdraw fluids from the body. | The sterile Hypodermic syringe forsingle Use With/without needle isintended to be used for medicalpurposes to inject fluid into orwithdraw fluid from body. | |
| Needles | The Sterile hypodermic needle forsingle use is intended for use withsyringes for general purpose fluidinjection/aspiration. | Needles are intended to be usedwith a legally marketed syringeintend to inject fluids into orwithdraw fluids from the body. | The Sterile Hypodermic needle forsingle use is intended for use withsyringes and injection devices forgeneral purpose fluidinjection/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 | |
| Tipconfiguration | 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 MedicalPolymer Products Co., LTD | ||
| 510(k) Number | NEW | K113091 | K072739 | ||
| Syringe | Barrel | lubricated polypropylene | lubricated polypropylene | lubricated polypropylene | |
| Plunger | polypropylene | polypropylene | polypropylene | ||
| Gasket | Styrene ethylene / Butylenecopolyme | 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 ofoperation | 1. Check that the syringe package isundamaged and unopened.Discard if damaged or opened.2. Peel open the end of the packageand remove the syringe.3. Wipe the top of the vial withalcohol and allow it to air dry.4. Remove the shield from theneedle.Do not move the plunger, and donot try to inject air into the vial, asthis 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 atall times.Do not draw air into the syringe.It may lead to an inaccurate dose.To fill the syringe, slowly pullthe plungerTo remove air bubbles, removethe needle from the vial.7. Holding the syringe upright, tapthe barrel to bring the bubblestowards the tip of the syringe.8. Then carefully push the plungerto the dose mark, thus expellingthe air bubble.9. Administer the injection10. Depress the plunger completelyto 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
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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 (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" (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 (800) 638-2041 or (301) 796-7100 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 ) : _ < 1 2 4 0 37
Device Name : Jung Rim single use hypodermic syringe with Needle
Indication 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 2) CFR 801 Subpart D) AND/OR
Over-The-Counter (Part 21 CFR 801 Subpart C)
JUNG RIM MEDICAL
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Richard C. Chapman | |
|---|---|
| 2013.09.12 | |
| 13:10:16 -04'00' |
| Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| fection Control, Dental Devices |
| 10(k) Number: | K124037 |
|---|---|
| --------------- | --------- |
Indication for use statement
Page 1 of 2
§ 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).