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

The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (<24h).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needle for Single Use" by Jiangsu Shenli Medical Production Co., Ltd. The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (IMC Hypodermic Needle, K102584).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, a "Sterile Hypodermic Needle for Single Use," the acceptance criteria are based on compliance with various international standards for medical devices, particularly those related to hypodermic needles, biocompatibility, and sterility. The reported device performance is that it meets all these standards.

Acceptance Criteria Category	Specific Acceptance Criteria (Standard/Method)	Reported Device Performance
Performance Standards	ISO 9626: Stainless steel needle tubing for medical devices - Requirements and test methods	Meets standard criteria
	ISO 7864: Sterile hypodermic needles for single use - Requirements and test Methods	Meets standard criteria
	ISO 594-1: Conical fittings with a 6% (Luer) taper - Part 1: General requirements	Meets standard criteria
	ISO 594-2: Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings	Meets standard criteria
	ISO 6009: Hypodermic needles for single use - Colour coding for identification	Meets standard criteria
Biocompatibility	ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process	Complies with ISO10993-1
	ISO 10993-5: In Vitro Cytotoxicity (MTT Method)	Complies with standard criteria
	ISO 10993-10: Skin Sensitization (GPMT Method)	Complies with standard criteria
	ISO 10993-10: Intracutaneous Reactivity Test	Complies with standard criteria
	ISO 10993-11: Acute Systemic Toxicity	Complies with standard criteria
	ISO 10993-4: Coagulation test (APTT, PT, TT, Fibrinogen)	Complies with standard criteria
	ISO 10993-4: Complement activity (C3a, SC5b-9) Test	Complies with standard criteria
	ASTM F756-13: Hemolytic Properties Test	Complies with standard criteria
	ISO 10993-11 / USP 40 <151>: Material-Mediated Pyrogenicity (Rabbit pyrogen test)	Complies with standard criteria
Sterilization	ISO 11135-1: Ethylene oxide sterilization - Requirements for development, validation, and routine control	Complies with standard criteria
	ISO 11737-1: Sterilization of medical devices - Microbiological methods - Part 1: Determination of bioburden	Complies with standard criteria
	ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility	Complies with standard criteria
	ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide residuals	Complies with standard criteria
	AAMI / ANSI ST72: Bacterial endotoxins - Test methods	Complies with standard criteria
Product Specifications	Hub/needle Bond Strength: ISO 7894:1993	Meets Standard Criteria
	SAL (Sterility Assurance Level)	10-6 (meets standard)
Package Integrity & Shelf Life	Tensile seal strength, package verification, vacuum leak, dye penetration, agar contact-attack, accelerated aging	Test results provide evidence of compliance to standards

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of AI/ML, but rather refers to various "performance testing" conducted to meet specific standards. For each of these tests (e.g., biocompatibility tests, physical performance tests), the sample sizes used are not explicitly stated in this summary document. The document states that the data is from "Jiangsu Shenli Medical Production Co., Ltd." in Changzhou City, Jiangsu Province, China, indicating the country of origin of the data. The studies are prospective in nature, as they involve testing the newly developed device against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission is for a traditional medical device (hypodermic needle) and does not involve AI/ML. Therefore, the concept of "ground truth established by experts" in the context of interpretation of results (like in image analysis) is not directly applicable here. The "ground truth" for this device's performance is objective compliance with pre-defined international standards and physical/chemical test parameters. These standards are developed and overseen by international bodies and qualified experts in the field of medical device manufacturing and safety. The expertise lies in the development of these standards and the execution and interpretation of the tests by qualified testing laboratories.

4. Adjudication Method for the Test Set

Not applicable, as this is a traditional medical device submission, not an AI/ML algorithm requiring expert adjudication of results. The "adjudication" is essentially the determination of whether the device's performance metrics meet the specified quantitative and qualitative requirements of the applicable international standards. This is typically done by qualified laboratory personnel and regulatory reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission is for a physical medical device (hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance improvement are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective adherence to internationally recognized consensus standards and validated test methods. This includes:

Quantitative measurements: e.g., bond strength, dimensions, chemical residue levels (Ethylene Oxide).
Qualitative biological responses: e.g., absence of cytotoxicity, sensitization, hemolysis.
Sterility levels: Demonstrated by achieving a specific Sterility Assurance Level (SAL).

The ground truth is not subjective expert consensus on interpretations but rather the objective compliance with predefined, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)
Preservation Use (Part 21 CFR 601 Subpart D)	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 MedsurgConnection	IMC Hypodermic Needle	K102584	Sterile Hypodermic Needle forSingle Use

IV. Device Description:

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.,Ltd	International Medsurg Connections, Inc.
FDA510(K)Number	K180259	K102584
Device Name	Sterile Hypodermic Needle for SingleUse	IMC Hypodermic Needle
FDA Classification	21CFR880.5570, Product code- FMI	21CFR880.5570, Product code- FMI
Indication for Use	This device is intended to inject fluidsinto, or withdraw fluids from, parts ofthe body below the surface of the skin.	This device is intended for use to injectfluids into or withdraw fluids from partsof the body below the surface of the skin.
Needle Gauge andLength	22Gx1 1/2"	Gauge: 16G, 17G, 18G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G, 28G, 29G, 30GLength: 1/2", 5/8", 3/4", 7/8", 1", 1 1/4",1 1/2"
Lubricant forneedle	Medical Highly Activated Silicone	Medical Highly Activated Silicone
Adhesive	UV-cured Adhesive	Epoxy Resin
Needle Hub Colors	22G Black color	16G White color17G Red-violet color18G Pink color20G Yellow color21G Deep green color22G Black color23G Deep blue color24G Medium purple color25G Orange color26G Brown color27G Medium gray color28G Blue-green color

		29G Red color30G Yellow color
Cover Dimensions	1 1/2" size:54.3 (+1.5 -2.5) mm	1/2 " size:40mm5/8" size:40mm3/4" size:40mm7/8" size:40mm1" size:40mm1 ¼ " size:56mm1 ½ " size:56mm
Cover Color	Clear	Clear (for all gauges)
Hub/needle BondStrength	Test Method: ISO 7894:1993Meets Standard Criteria	Test Method: ISO 7894:1993Meets 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.
1. The same technologies and test principles are used in sterile hypodermic needle for single use as the predicate device.
1. The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness than the predicate devices.
1. 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: 2009MTT Method
Skin Sensitization	ISO10993-10: 2010GPMT Method:Guinea PigMaximization Test (0.9% Sodium Chloride and corn oil Extract)
Intracutaneous Reactivity Test	ISO10993-10: 2010Intracutaneously inject the extract to rabbit (0.9% Sodium Chlorideand corn oil Extract)
Acute Systemic Toxicity	ISO10993-11: 2006Extract to cause acute systemic toxicity in mouse (0.9% SodiumChloride and corn oil Extract)
Coagulation test	ISO10993-4: 2002Amd1:2006(E)Test the values of APTT, PT, TT, Fibrinogen after wholeblood extracting.
Complement activity (C3a, SC5b-9) Test	ISO10993-4: 2002Amd1: 2006(E)Test the values of C3a, SC5b-9 after whole blood extracting.
Hemolytic Properties Test	ASTM F756-13.Calculate the values of blank corrected % hemolysis after calciumand magnesium-free PBS
Material- Mediated Pyrogenicity	ISO 10993-11 :2006.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).

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).