Sterile Hypodermic Needles for Single Use

• K Number: K223334
• Device Name: Sterile Hypodermic Needles for Single Use
• Manufacturer: Zhejiang kindly Medical Devices Co., Ltd.
• Date Cleared: 2022-12-16 ( 45 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

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.

Predicate Devices

K211214

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, materials, and sterilization of a standard hypodermic needle, with no mention of AI or ML capabilities.

Therapeutic

No
A hypodermic needle is used for fluid injection/aspiration, which is a diagnostic or procedural function, not a therapeutic one.

Diagnostic

No
The device is described as an accessory for "general purpose fluid injection/aspiration" and its components and testing standards focus on the physical and material properties for this purpose, not on diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components (needle tube, hub, cap) made of materials like stainless steel and polypropylene, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "for general purpose fluid injection/aspiration." This describes a device used to introduce or remove substances from the body, which is a direct interaction with the patient.
• Device Description: The description details a needle, hub, and cap, all components designed for physical interaction with the patient's body during injection or aspiration.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body for therapeutic or diagnostic procedures like injection or aspiration.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FMI

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical professionals and trained care givers / Hospitals and clinics

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

• 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
• 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
• 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 : Particulate Matter for injection
• ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
• ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211214

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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 ([e-mail]) or phone [phone] 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

2

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.

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

K22334 510k Summary

• 1. Date of preparation: December 16, 2022
• 2. 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: [phone]

Email: [e-mail]

• 3. Designated submission correspondent
     Ms. Amy Lee (Primary Contact Person) Mind-Link Consulting Co., Ltd. Tel: [phone]

Email: [e-mail]

• 4. 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

4

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.

• 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.

| Nozzle
type | Needle
gauge
(G) | Needle
length
(mm) | Wall type | Bevel | | Color |
|----------------|------------------------|--------------------------|-----------|---------------|-------------|------------|
| | | | | Long
Bevel | 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.

5

• 7. 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 device
K211214 | Comment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indication for use | The Sterile Hypodermic
Needles for single use are
intended for use with
syringes and injection
devices for general purpose
fluid injection/aspiration. | The Sterile Hypodermic
Needles for Single Use are
intended to be used with a
luer lock or luer slip
syringe and injection
devices for general purpose
fluid injection/aspiration. | Same |
| Product code | FMI | FMI | Same |
| Regulation
number | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Principle of
operation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and
trained care givers | Medical professionals and
trained care givers | Same |
| Environment of
use | 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

6

	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 structure
and materials	Needle hub
Needle tube
Protective cap	Polypropylene
Stainless steel
Polypropylene	Needle hub
Needle tube
Protective cap	Polypropylene
Stainless steel
Polypropylene	Same
Needle hub color	Color-coded per ISO 6009.		Color-coded per ISO 6009.		Same
Single use	Yes		Yes		Same
Performance
specifications	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

7

SAL	10-6	10-6	Same
Pyrogen	Non-pyrogenic	Non-pyrogenic	Same
Biocompatibility	The
biocompatibility
evaluation for the subject
device was conducted
in accordance with the
International Standard ISO
10993-1 "Biological
Evaluation of Medical
Devices – Part 1:
Evaluation and Testing
Within a Risk Management
Process," as recognized by
FDA and the "Use of
International Standard ISO
10993-1 "Biological
evaluation of medical
devices- Part 1: Evaluation
and testing within a risk
management process", June
16, 2016. The Sterile
Hypodermic Needle for
Single Use of testing
included following:
Cytotoxicity;
Skin sensitization;
Hemolysis;
Intracutaneous reactivity;
Acute systemic toxicity;
Pyrogenicity.
The evaluation of the above
testing items meets the
requirements
And Conforms to USP
: Particulate Matter
for injection	The
biocompatibility
evaluation for the subject
device was conducted
in accordance with the
International Standard ISO
10993-1 "Biological
Evaluation of Medical
Devices – Part 1:
Evaluation and Testing
Within a Risk Management
Process," as recognized by
FDA and the "Use of
International Standard ISO
10993-1 "Biological
evaluation of medical
devices- Part 1: Evaluation
and testing within a risk
management process", June
16, 2016. The syringe of
testing included the
following tests:
Cytotoxicity;
Skin sensitization;
Hemolysis;
Intracutaneous reactivity;
Acute systemic toxicity;
Pyrogenicity.
The evaluation of the above
testing items meets the
requirements	Differe
nt.
analysi
s 3.
Labeling	Meets the requirements of
21 CFR Part 801.	Meets the requirements of
21 CFR Part 801.	Same

SE Analysis 1: Needle gauge

8

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 . Particulate testing per USP 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.

8. 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

9

• 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 : 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
• 9. 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.