The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification.

AI/ML Overview

This document is a 510(k) summary for a Disposable Sterile Needle, detailing its equivalence to a predicate device. It primarily focuses on regulatory compliance and performance testing against established standards for medical devices, rather than a clinical study comparing an AI system's performance to human readers. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test/training sets, number of experts, MRMC studies, AI effect size, standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and performance data related to the device's adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7864:2016 (Sterile Hypodermic Needles for Single Use)	Complies with ISO 7864:2016
ISO 9626:2016 (Stainless Steel Needle Tubing for Medical Devices)	Complies with ISO 9626:2016
ISO 6009:2016 (Hypodermic Needles Color Coding)	Complies with ISO 6009:2016 (Hub Color)
ISO 594-1:1986 (Luer Taper Fittings - General)	Complies with ISO 594-1:1986
ISO 594-2:1998 (Luer Taper Fittings - Lock)	Complies with ISO 594-2:1998
ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package)	Tests performed per ASTM F1929-15; pre-determined criteria met
ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials)	Tests performed per ASTM F88/F88M-15; pre-determined criteria met
USP <85> (Bacterial Endotoxins Test)	Tests performed; pre-determined criteria met
ISO 11135-1:2007 (EO Sterilization Development, Validation, Control)	Sterility validated in accordance with ISO 11135-1:2007; Achieved SAL of 10-6
ISO 10993 series (Biocompatibility)	Meets biocompatibility requirements for cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, material mediated pyrogenicity, hemocompatibility
ISO 14971:2007 (Risk Management)	Risk analysis conducted in accordance with ISO 14971:2007; pre-determined criteria met
Needle Length Tolerances (per ISO 7864 Section 4.10.2)	Meets 4.10.2 Tolerances requirements of ISO 7864
Needle Dimensions (per ISO 9626 Section 5.4)	All needle gauges meet 5.4 Dimensions requirements of ISO 9626

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

This document describes non-clinical performance testing against international standards for medical devices. It does not refer to a "test set" in the context of clinical data or AI model evaluation. The tests are conducted on samples of the manufactured device. The document does not specify the exact sample sizes used for each individual test (e.g., how many needles were tested for seal integrity or biocompatibility).

The data provenance is from the manufacturer's (Jiangsu Caina Medical Co., Ltd., China) internal testing/verification processes, conducted to demonstrate compliance with the referenced standards.

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

Not applicable. This document does not describe a clinical study requiring human experts to establish ground truth for a test set. The "ground truth" for this device's performance is compliance with the defined parameters and limits specified in the referenced international standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of clinical data or AI systems with human-in-the-loop for this type of device submission. Performance is assessed against quantitative and qualitative criteria defined by the standards.

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

Not applicable. This document describes a medical device (hypodermic needle), not an AI system or software that interacts with human readers.

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

Not applicable. This document is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to the specifications and performance criteria outlined in the cited international and national standards (e.g., ISO 7864, ISO 9626, ISO 6009, ISO 594, ASTM F1929, ASTM F88, USP <85>, ISO 11135, ISO 10993, ISO 14971). These standards define the acceptable physical properties, sterility, biocompatibility, and safety parameters for hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. This document does not describe an AI system requiring a training set.

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

Not applicable. This document does not describe an AI system requiring a training set.

Summary

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June 14, 2018

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120, China

Re: K172938

Trade/Device Name: Disposable Sterile Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 4, 2018 Received: May 8, 2018

Dear Diana Hong:

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.

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 (QS) regulation (21 CFR Part 820);

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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 comprehensive regulatory information about medical devices and radiation-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.

Alan M. Stevens -

Digitally signed by Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130 0189211, cn=Alan M. Stevens -S Date: 2018.06.14 13:35:06 -04'00'

Tina Kiang, Ph.D. for Acting 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) K172938

Device Name Disposable Sterile Needle

Indications for Use (Describe)

The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K172938 510(k) SUMMARY

Submitter:	Jiangsu Caina Medical Co., Ltd.No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425,China
Application Correspondent:	Ms. Diana HongGeneral ManagerMid-Link Consulting Co., LtdP.O. Box 120-119, Shanghai, 200120, ChinaTel: +86-21-22815850,Fax: 240-238-7587Email: info@mid-link.net
Preparation Date:	June 13, 2018
Trade Name:	Disposable Sterile Needle
Common or Usual Name:	Needle, Hypodermic, Single Lumen
Regulation Name:	Hypodermic Single Lumen Needle.
Regulation Number:	21 CFR 880.5570
Product Code:	FMI
Device Class:	Class II
Primary Predicate Device:	K072739; Jierui Syringes and Needles
	Note – K072739 is a bundled 510(k) submission containing a sterilehypodermic needle. K172938 is substantially equivalent to thesterile hypodermic needle component of K072739.

Indications for Use:

The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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Device Description:

Gauge	Hub Color	Product specification	Gauge	Hub Color	Product specification
33G	Black	33Gx6mm RWxLB	22G	Black	22Gx25mm RWxLB
		33Gx6mm RWxSB			22Gx25mm RWxSB
		33Gx6mm TWxLB			22Gx25mm TWxLB
		33Gx6mm TWxSB			22Gx25mm TWxSB
32G	DeepGreen	32Gx13mm RWxLB			22Gx25mm ETWxLB
		32Gx13mm RWxSB			22Gx25mm ETWxSB
		32Gx13mm TWxLB			22Gx38mm RWxLB
		32Gx13mm TWxSB			22Gx38mm RWxSB
		32Gx13mm ETWxLB			22Gx38mm TWxLB
		32Gx13mm ETWxSB			22Gx38mm TWxSB
30G	Yellow	30Gx25mm RWxLB			22Gx38mm ETWxLB
		30Gx25mm RWxSB			22Gx38mm ETWxSB
		30Gx25mm TWxLB	21G	DeepGreen	21Gx38mm RWxLB
		30Gx25mm TWxSB			21Gx38mm RWxSB
		30Gx25mm ETWxLB			21Gx38mm TWxLB
		30Gx25mm ETWxSB			21Gx38mm TWxSB
25G	Orange	25Gx25mm RWxLB			21Gx38mm ETWxLB
		25Gx25mm RWxSB			21Gx38mm ETWxSB
		25Gx25mm TWxLB	20G	Yellow	20Gx38mm RWxLB
		25Gx25mm TWxSB			20Gx38mm RWxSB

	25Gx38mm RWxLB			20Gx38mm TWxLB
	25Gx38mm RWxSB			20Gx38mm TWxSB
	25Gx38mm TWxLB			20Gx38mm ETWxLB
	25Gx38mm TWxSB			20Gx38mm ETWxSB
Note:		18G	Pink	18Gx50mm RWxLB
RW = Regular Wall; TW = Thin Wall;ETW= Extra Thin WallLB=Long Bevel; SB=Short Bevel				18Gx50mm RWxSB
				18Gx50mm TWxLB
				18Gx50mm TWxSB

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Device Comparison of Technology

A technological comparison table is provided below that compares the subject device and predicate device:

Item		Proposed Device -K172938	Predicate Device - K072739	Comparison
		Disposable Sterile Needle	Jierui Syringes and Needles:Sterile Hypodermic NeedleComponent Only
Product Code		FMI	FMI	Same
Intended Use		The Disposable Sterile Needleis intended for usewith syringes and injectiondevices for general purposefluid injection/aspiration.	The Sterile Hypodermic Needle forsingle use is intended for use withsyringes and injection devices forgeneral purpose fluidinjection/aspiration	Same
Single Use		Yes	Yes	Same
Sterility Condition		EO Sterilization	EO Sterilization	Same
Material	NeedleTube	304 Stainless Steel	Stainless Steel	Different
	Cap	Polypropylene	Unknown	Different
	Hub	Polypropylene	Unknown	Different
Needle Gauge		18G,20G,21G,22G,25G,30G,32G,33G	16G,18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,29G	Different

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Needle Length	6mm, 13mm, 20mm, 25mm,38mm, 45mm, 50mm	13 mm, 16 mm, 19 mm, 25 mm, 32 mm, 38 mm	Different
Needle Edge/Bevel Angle	Long Bevel: angle 11 °Short Bevel: angle 17 °	Long bevelShort Bevel	Different
Needle Performance	Complies withISO 7864: 2016ISO 9626: 2016	Complies withISO 7864: 1993ISO 9626: 1991	Same
Luer Connector Performance	Complies withISO 594-1:1986ISO 594-2:1998	Complies withISO 594-1:1986ISO 594-2:1998	Same
Needle Hub Color	Complies with ISO 6009: 2016	Complies with ISO 6009: 2016	Same

Substantial Equivalence Discussion

The indications for use and intended use of the hypodermic needle component in the predicate bundled 510(k) K072739, are equivalent to the subject 510(k) device.

The differences between the subject device and the predicate device are the following:

Needle length
Although the needle length range of the subject device is larger than needle length range of the predicate device r, the needle length of the subject device meets 4.10.2 Tolerances requirements of ISO 7864. This difference does not raise different questions of safety and effectiveness
Needle Gauge
The subject device has 30G, 32G and 33G needle gauges, which are not included in the predicate device. All needle gauges of proposed device meet 5.4 Dimensions requirements of ISO 9626. This difference does not raise different questions of safety and effectiveness
Edge/Bevel angle ●
Although the /bevel angle of the predicate device is unknown, the edge/bevel angle of subject device are listed in the product labeling, and the end user can choose the needle per their preference. This difference does not raise different questions of safety and effectiveness

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Materials .
Although the materials of the subject device are different from those of the predicate device, the subject device has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. This difference does not raise different questions of safety and effectiveness

Based on the aforementioned modifications to the subject device device does not raise different types of safety and effectiveness questions when compared to the predicate device.

Performance Testing Summary

Non-clinical tests were conducted to verify that the proposed devices met all design specifications and are substantially equivalent (SE) to the hypodermic needle component of the predicate device. The test results demonstrated that the proposed devices comply with the following standards:

ISO 7864:2016, Sterile Hypodermic Needles for Single Use ●
ISO 6009: 2016 Hypodermic needles for single use Colour coding for identification ●
ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices ●
ISO 594-1:1986 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and ● Certain Other Medical Equipment - Part 1: General Requirements.
ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.
. ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier ● Materials.
USP <85> Bacterial Endotoxins Test
ISO 11135-1:2007 Sterilization of Health Care Products- Ethylene ● Oxide- Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

The Disposable Sterile Needle is supplied sterile for single use and are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years. Sterility was validated in accordance with ISO 11135-1:2007. Packaging tests were performed per ASTM F88/F88M-15 and ASTM F1929-15.

The Disposable Sterile Needle has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. The device

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was tested to the following biocompatibility endpoints: cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, and material mediated pyrogenicity, hemocompatibility.

A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.

In all testing, the pre-determined acceptance criteria were met.

Substantially Equivalence Conclusion

The subject device has the same intended use and technological characteristics as the predicate device. The performance of the device is supported by non-clinical testing and risk management activities. The Disposable Sterile Needle is Substantially Equivalent (SE) to the Sterile Hypodermic Needle component of the bundled 510(k), Jierui Syringes and Needles, cleared under K072739.

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).