The Sterile Hypodermic Needles for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Description

The proposed device, Sterile Hypodermic Needles For Single Use, consists of a needle tube, needle hub and protective cap. The needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the color complies with ISO 6009.The protective cap is made of PP and does not contact the patient. The conical fitting of Sterile Hypodermic Needles For Single Use is a luer that can be used with other medical devices which have 6% conical fitting. It is provided sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials. And the Hypodermic Needles For Single Use are individually packaged in a sterile Sterile barrier.

AI/ML Overview

This document is a 510(k) summary for a medical device (Sterile Hypodermic Needles for Single Use). It details the substantial equivalence of the proposed device to a predicate device, focusing on non-clinical performance and biocompatibility.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of international and national standards, which dictate the performance and safety requirements for sterile hypodermic needles. The "reported device performance" is essentially the statement that the device complies with these standards.

Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Standard/Requirement	Reported Device Performance
Performance (Physical)	ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods	"The test results demonstrated that the proposed device complies with... ISO 7864:2016"
	ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (Note: The document lists "Hypodermic needles for single use Colour coding for identification A" under 9626, but the predicate comparison correctly lists 9626:2016 as "Stainless steel needle tubing...")	"The test results demonstrated that the proposed device complies with... ISO 9626:2016"
	ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications	"The test results demonstrated that the proposed device complies with... ISO 80369-7:2021"
	ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods	"The test results demonstrated that the proposed device complies with... ISO 80369-20:2015"
Sterilization	Sterilization Assurance Level (SAL)	10^-6 (Same as predicate)
	Ethylene Oxide (EO) Sterilization method	EO (Same as predicate)
	ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals	"The test results demonstrated that the proposed device complies with... ISO 10993-7:2008"
Biocompatibility	ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (including Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity)	"The biocompatibility evaluation for the subject device was conducted in accordance with... ISO 10993-1," and "The evaluation of the above testing items meets the requirements." Test results demonstrated compliance with ISO 10993-4, -5, -10, -11.
	Pyrogenicity (Non-pyrogenic)	Non-pyrogenic (Same as predicate)
Particular Matter	USP <788>: Particulate Matter for injection	"Conforms to USP <788>: Particulate Matter for injection" and "Particulate testing per USP <788> is required to ensure the safe clinical application."
Packaging/Sterile Barrier	ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials. (Sterility)	"The test results demonstrated that the proposed device complies with... ASTM F88/F88M-15"
	ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration	"The test results demonstrated that the proposed device complies with... ASTM F1929-15"
Labeling	21 CFR Part 801 (General Labeling Requirements) -	"Meets the requirements of 21 CFR Part 801." (Same as predicate)

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets the acceptance criteria is a non-clinical performance testing study. This type of study demonstrates equivalence by showing that the proposed device performs comparably to a legally marketed predicate device against established performance and safety standards.

1. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual test (e.g., how many needles were tested for seal strength, how many samples for biocompatibility). It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, for each listed standard (ISO, ASTM, USP), there are usually defined sample size requirements for the tests prescribed within that standard.
Data Provenance: The document implies that the testing was performed by or for Zhejiang Kindly Medical Device Co., Ltd., based in Zhejiang Province, China. The testing appears to be retrospective, as it was completed before the 510(k) submission. No specific country of origin is mentioned for the data itself beyond the company's location.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: For this type of medical device (sterile hypodermic needles) and the nature of the non-clinical performance testing, "ground truth" is not established by human experts in the way it would be for AI/imaging diagnostics. Instead, the ground truth is defined by the objective, quantified pass/fail criteria outlined in the referenced international standards (e.g., flow rate requirements, needle stiffness, biocompatibility limits). The "experts" involved are presumed to be the qualified laboratory personnel conducting the tests and interpreting the results against the standard's specifications. Their qualifications are not explicitly stated.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None (Not Applicable): Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially for evaluating diagnostic performance (e.g., radiology reads where multiple experts might disagree). This non-clinical study relies on objective, measurable parameters against established standard criteria, so human adjudication in this sense is not relevant.

4. 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:

No (Not Applicable): An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images or data. This submission is for a physical medical device (hypodermic needles), not an AI diagnostic tool. Therefore, no MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No (Not Applicable): This question also pertains to AI algorithm performance. A hypodermic needle does not involve an algorithm, nor does it have "human-in-the-loop performance" in the sense of a software-assisted task.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Standard-defined Objective Criteria: The ground truth for this device is based on the objective, measurable pass/fail criteria specified within the referenced international standards (ISO, ASTM, USP). For example, a needle must meet specific force requirements for penetration, sterility levels, or biocompatibility limits as defined by these standards. This is fundamentally different from a diagnostic ground truth (e.g., confirmed pathology diagnosis for an image).

7. The sample size for the training set:

Not Applicable: This device is a physical product, not a machine learning model. Therefore, there is no "training set." The performance is validated through direct physical and chemical testing.

8. How the ground truth for the training set was established:

Not Applicable: As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2022

Zhejiang kindly Medical Devices Co., Ltd. % Amy Li Technical Director Shanghai Mind-Link Business Consulting Co., Ltd. Room A04, 14th Floor, No 699, Jiaozhou Road, Jingan District Shanghai, 200040 China

Re: K223334

Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 15, 2022 Received: November 1, 2022

Dear Amy Li:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
-S3

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K223334

Device Name

Sterile Hypodermic Needles for Single Use.

Indications for Use (Describe)

The Sterile Hypodermic Needles for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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K22334 510k Summary

1. Date of preparation: December 16, 2022
1. Sponsor Identification

Name: Zhejiang Kindly Medical Device Co., Ltd.

Add.: No 758, 5th Binhai Road, Binhai Industrial Park, Longwan, Wenzhou City,

Zhejiang Province.

Contact Person: Zhang Qian

Position: Technical Manager

Tel: +86 13858871856

Email: zhangqian@kdlchina.com

1. Designated submission correspondent
  Ms. Amy Lee (Primary Contact Person) Mind-Link Consulting Co., Ltd. Tel: +86 15721449974

Email: amy.li@mind-link.net

1. Identification of Proposed Device
  Trade Name: Sterile Hypodermic Needles For Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Review Panel: General hospital

5. Indication for use statement

The Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

6. Device description

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6.1 The proposed device includes different specifications.
Models of Sterile Hypodermic Needles For Single Use shown in Table 5-1 are available in various models according to different needle gauge.

Nozzletype	Needlegauge(G)	Needlelength(mm)	Wall type	Bevel		Color
				LongBevel	Short Bevel
Luer lock	31	20,13, 8, 6,	RW	11°±2°	17°±2°	White
		5, 4	TW	11°±2°	17°±2°
Luer lock	32	20,13, 8, 6,	TW	11°±2°	17°±2°	Deep green
		5,4
Luer lock	33	13, 8, 6, 5,	RW	11°±2°	17°±2°	Black
		4	TW	11°±2°	17°±2°
Luer lock	34	13, 8, 6, 5,	RW	11°±2°	17°±2°	Orange
		4	TW	11°±2°	17°±2°

Table 5-1 Models of Sterile Hypodermic Needles For Single Use

6.2 Label requirement

The label shall meet the requirements of 21 CFR Part 801.

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1. Comparison of technological characteristics with the predicate devices
  The Sterile Hypodermic Needles for Single Use have the same intended use, technology, and design; and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Hypodermic Needles for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.

Component	Proposed device	Predicate deviceK211214	Comment
Indication for use	The Sterile HypodermicNeedles for single use areintended for use withsyringes and injectiondevices for general purposefluid injection/aspiration.	The Sterile HypodermicNeedles for Single Use areintended to be used with aluer lock or luer slipsyringe and injectiondevices for general purposefluid injection/aspiration.	Same
Product code	FMI	FMI	Same
Regulationnumber	21 CFR 880.5570	21 CFR 880.5570	Same
Class	II	II	Same
Principle ofoperation	For manual use only	For manual use only	Same
Intended user	Medical professionals andtrained care givers	Medical professionals andtrained care givers	Same
Environment ofuse	Hospitals and clinics	Hospital and clinics	Same
Needle gauge	31G, 32G, 33G, 34G	30G, 27G, 26G, 25G, 24G,23G, 22G, 21G, 20G, 19G,18G	Different.Analysis 1.
Length	20mm, 13mm, 8mm, 6mm	1/2", 5/8", 1", 1 1/4", 1	Different

Table 5-2 Comparison of Technology Characteristics

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	5mm, 4mm	1/2"	nt.
			Analysi s 2.
Type of wall	Normal wall or thin wall.	Normal wall or thin wall.	Same
Blade angle	Short bevel and long bevel.	Short bevel and long bevel.	Same
Main structureand materials	Needle hubNeedle tubeProtective cap	PolypropyleneStainless steelPolypropylene	Needle hubNeedle tubeProtective cap	PolypropyleneStainless steelPolypropylene	Same
Needle hub color	Color-coded per ISO 6009.		Color-coded per ISO 6009.		Same
Single use	Yes		Yes		Same
Performancespecifications	Comply with:ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods;ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods;ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications;ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods		Complies with ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods, ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods, ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications, ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods		Same
Sterilization	EO		EO		Same

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SAL	10-6	10-6	Same
Pyrogen	Non-pyrogenic	Non-pyrogenic	Same
Biocompatibility	Thebiocompatibilityevaluation for the subjectdevice was conductedin accordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices – Part 1:Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process", June16, 2016. The SterileHypodermic Needle forSingle Use of testingincluded following:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirementsAnd Conforms to USP<788>: Particulate Matterfor injection	Thebiocompatibilityevaluation for the subjectdevice was conductedin accordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices – Part 1:Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process", June16, 2016. The syringe oftesting included thefollowing tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirements	Different.analysis 3.
Labeling	Meets the requirements of21 CFR Part 801.	Meets the requirements of21 CFR Part 801.	Same

SE Analysis 1: Needle gauge

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The subject device has additional needle gauge sizes (31G, 32G, 33G, 34G) compared with predicate device. This difference does not raise new or different questions of safety or effectiveness.

SE Analysis 2: Needle length

The subject device has different needle lengths as compared to the predicate device. This difference does not raise new or different questions of safety or effectiveness.

SE Analysis 3: Biocompatibility

The proposed device and the predicate device were both tested per the ISO 10993-series. The proposed device also tested particulates per USP <788>. Particulate testing per USP <788> is required to ensure the safe clinical application. Therefore, this difference is not considered to affect the Substantially Equivalency (SE) between the proposed and predicate devices.

Non-clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods

ISO 9626:2016 Hypodermic needles for single use Colour coding for identification A
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare application -- Part 7: Connectors for intravascular or hypodermic application
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

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ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  - USP <788>: Particulate Matter for injection A
- ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible A Barrier Materials.(Sterility)
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
1. Clinical Testing

No clinical study is included in this submission.

10. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Hypodermic Needles for Single Use is substantially equivalent to the Sterile Hypodermic Needles for Single Use (K211214) with respect to the indications for use, materials, design, and technological characteristics.

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).