Sterile Hypodermic Needle for Single Use

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May 18, 2018 Jiangsu Shenli Medical Production Co., Ltd c/o Mr. Charles Mack IRC 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K180259 Trade/Device Name: Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: April 6, 2018 Received: April 17, 2018 Dear Charles Mack: 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. {1}------------------------------------------------ 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); 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Tina Kiang -s Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180259 Device Name Sterile Hypodermic Needle for Single Use Indications for Use (Describe) This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"> </span> Preservation Use (Part 21 CFR 601 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 331 Subpart C) | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY The assigned 510(k) number is: K180259 Date Prepared: 2018.05.15 ### I. Submitter: Name: Jiangsu Shenli Medical Production Co., Ltd. Address: No 20, Changzheng Road, Zhenglu, Changzhou City, Jiangsu Province, China 213111 Tel: + 86-519-88731071 Fax: + 86-519-88737101 Contact: Ms. Tina Cai, General Manager US Agent and Correspondent Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@irc-us.com ### II. Device: Trade/proprietary name: Sterile Hypodermic Needle for Single Use Common Name: needle, hypodermic, single lumen Classification Name: Hypodermic single lumen needle ### Classification Information: Product Code: FMI Device Class: II Regulation number: 21CFR880.5570 ### III. Predicate Device Information: | Manufacturer | Predicate Device | 510(k) Number | Submitted Device | |-------------------------------------|-----------------------|---------------|---------------------------------------------| | International Medsurg<br>Connection | IMC Hypodermic Needle | K102584 | Sterile Hypodermic Needle for<br>Single Use | ### IV. Device Description: The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below: | Name | Material | Material Specification | |--------------|-----------------------------------|------------------------------| | Needle tube | 304 stainless steel | SUS304 | | Needle hub | Polypropylene (PP) | R307Y | | Needle cap | Polypropylene (PP) | R307Y | | Hub colorant | Black Masterbatch | Carbon Black | | Lubricant | Medical Highly Activated Silicone | Highly Reactive Silicone Oil | | Adhesive | Ultraviolet adhesive | AA 3311 | {4}------------------------------------------------ The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (<24h). ## V. Intended use / Indication for Use: This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. ## VI. Comparison of Technological Characteristics with the Predicate Device | Feature | Subject Device | Predicate Device | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Jiangsu Shenli Medical Production Co.,<br>Ltd | International Medsurg Connections, Inc. | | FDA510(K)<br>Number | K180259 | K102584 | | Device Name | Sterile Hypodermic Needle for Single<br>Use | IMC Hypodermic Needle | | FDA Classification | 21CFR880.5570, Product code- FMI | 21CFR880.5570, Product code- FMI | | Indication for Use | This device is intended to inject fluids<br>into, or withdraw fluids from, parts of<br>the body below the surface of the skin. | This device is intended for use to inject<br>fluids into or withdraw fluids from parts<br>of the body below the surface of the skin. | | Needle Gauge and<br>Length | 22Gx1 1/2" | Gauge: 16G, 17G, 18G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G<br>Length: 1/2", 5/8", 3/4", 7/8", 1", 1 1/4",<br>1 1/2" | | Lubricant for<br>needle | Medical Highly Activated Silicone | Medical Highly Activated Silicone | | Adhesive | UV-cured Adhesive | Epoxy Resin | | Needle Hub Colors | 22G Black color | 16G White color<br>17G Red-violet color<br>18G Pink color<br>20G Yellow color<br>21G Deep green color<br>22G Black color<br>23G Deep blue color<br>24G Medium purple color<br>25G Orange color<br>26G Brown color<br>27G Medium gray color<br>28G Blue-green color | | | | | | | | 29G Red color<br>30G Yellow color | | Cover Dimensions | 1 1/2" size:54.3 (+1.5 -2.5) mm | 1/2 " size:40mm<br>5/8" size:40mm<br>3/4" size:40mm<br>7/8" size:40mm<br>1" size:40mm<br>1 ¼ " size:56mm<br>1 ½ " size:56mm | | Cover Color | Clear | Clear (for all gauges) | | Hub/needle Bond<br>Strength | Test Method: ISO 7894:1993<br>Meets Standard Criteria | Test Method: ISO 7894:1993<br>Meets Standard Criteria | | Tip Configuration | Bevel | Bevel | | Materials: | | | | Needle | Stainless Steel, SUS304 | Stainless Steel, SUS304 | | Needle Hub | Polypropylene (PP) | Polypropylene (PP) | | Needle cap | Polypropylene (PP) | Polypropylene (PP) | {5}------------------------------------------------ ### Summary of technological characteristics / performance The sterile hypodermic needle for single use has substantially equivalent indications for use and technological characteristics as the predicate device. - 1) The sterile hypodermic needle for single use have the same intended use/indication for use as the predicate device. - 2) The same technologies and test principles are used in sterile hypodermic needle for single use as the predicate device. - 3) The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness than the predicate devices. - 4) Although some specifications are slightly different than the predicate device (adhesive and hub color additive), changes have been verified and validated as part of performance testing and are included as part of this submission. Performance information and evidence of compliance to recognized standards demonstrate the device is substantially equivalent to the predicate device. Biocompatibility testing includes cytotoxicity, sensitization, acute systemic toxicity, coagulation, complement activity (C3a, SC5b-9), hemolytic properties tests, and material-mediated pyrogenicity. For the package integrity and shelf life, tensile seal strength test, package verification test, vacuum leak {6}------------------------------------------------ test, dye penetration test, agar contact-attack test as well as accelerated aging testing is included. The test results provide evidence that the subject device complies with the same applicable standards as predicate device and is substantially equivalent to the predicate device. | Feature | Subject Device | Predicate Device | |--------------------|--------------------------|--------------------------| | Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | | Sterilization | EO | EO | | Sterile | Yes | Yes | | SAL | $10^{-6}$ | $10^{-6}$ | | Disposable | Yes | Yes | | Single Patient Use | Yes | Yes | Based upon the intended use, and upon the similarity of materials, product configuration and administration, it can be concluded the sterile hypodermic needle for single use is substantially equivalent to the identified predicate device. ### VII. Performance Data Performance testing was provided in support of the substantial equivalence determination and to validate and verify that sterile hypodermic needle for single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards. #### Performance Testing The device meets all performance standards for Sterile Hypodermic Needle: - . ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods - I ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test Methods - l ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements - 트 ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings - ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification For the finished device, it meets the defined performance requirements through bench testing. #### Biocompatibility The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: External Communicating Device - Blood Path, Indirect - Limited Contact Duration (<24h). The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1 same as predicate device. {7}------------------------------------------------ | Verification Test | Standards/Method | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | In Vitro Cytotoxicity | ISO10993-5: 2009<br>MTT Method | | Skin Sensitization | ISO10993-10: 2010<br>GPMT Method:<br>Guinea Pig<br>Maximization Test (0.9% Sodium Chloride and corn oil Extract) | | Intracutaneous Reactivity Test | ISO10993-10: 2010<br>Intracutaneously inject the extract to rabbit (0.9% Sodium Chloride<br>and corn oil Extract) | | Acute Systemic Toxicity | ISO10993-11: 2006<br>Extract to cause acute systemic toxicity in mouse (0.9% Sodium<br>Chloride and corn oil Extract) | | Coagulation test | ISO10993-4: 2002Amd1:2006(E)<br>Test the values of APTT, PT, TT, Fibrinogen after whole<br>blood extracting. | | Complement activity (C3a, SC5b-9) Test | ISO10993-4: 2002Amd1: 2006(E)<br>Test the values of C3a, SC5b-9 after whole blood extracting. | | Hemolytic Properties Test | ASTM F756-13.<br>Calculate the values of blank corrected % hemolysis after calcium<br>and magnesium-free PBS | | Material- Mediated Pyrogenicity | ISO 10993-11 :2006.<br>Rabbit pyrogen test; USP 40 <151> Pyrogen Test; | ### Sterility Information Summary of Sterilization Validation is provided in the table below: | Sterilization Method: | Ethylene Oxide Sterilization | |-----------------------|--------------------------------------------------------------------------------------| | | ISO11135-1: Sterilization of health care products - ethylene oxide - part 1: | | | requirements for the development, validation, and routine control of a sterilization | | | process for medical devices. | | | ISO11737-1: Sterilization of medical devices - Microbiological methods - Part 1: | | | Determination of the population of microorganisms on product. | | Standards: | ISO11737-2: Sterilization of medical devices - Microbiological methods -- Part 2: | | | Tests of sterility performed in the validation of a sterilization process. | | | ISO 10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene | | | Oxide Residuals. | | | AAMI / ANSI ST72: Bacterial endotoxins - Test methods, routine | | | monitoring, and alternatives to batch testing. | # VIII. Conclusions: The non-clinical data demonstrate that the sterile hypodermic needle for single use perform as intended in the specified use conditions. Based on the information provided in this submission, Jiangsu Shenli Medical Production Co., Ltd. believes that the sterile hypodermic needle for single use is substantially equivalent to the predicate (K102584) IMC Hypodermic Needle (International Medsurg Connection).