Predicate Devices

Reference Devices

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 therapeutic device is one that treats a disease or condition. This device, a hypodermic needle, is for general purpose fluid injection/aspiration, which is a delivery mechanism, not a therapeutic action itself.

Diagnostic

No

Explanation: The device description clearly states its intended use is "for general purpose fluid injection/aspiration," which are therapeutic or procedural actions, not diagnostic ones. There is no mention of it being used to gather information for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components made of stainless steel and polypropylene, and the performance studies focus on physical characteristics and material standards, indicating it is a hardware device.

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 physical needle and its components, designed for direct use with syringes and injection devices.
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 diagnostic, monitoring, or compatibility purposes. IVDs are typically used in vitro (outside the body) to analyze these specimens.

Therefore, this device is a medical device used for direct patient care, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FMI

Device Description

The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper.
The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6.
Additionally, each component is made from properly tested raw materials.

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 A Package by Dye Penetration

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K180417, K223334

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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). On the left is the Department of Health & 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.

Zhejiang Kindly Medical Device Co., Ltd. % Amy Li Technical Director Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. Jingan 201803 China

Re: K233037

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 19, 2023 Received: September 25, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. 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

2

Indications for Use

510(k) Number (if known) K233037

Device Name Sterile Hypodermic Needles For Single Use

Indications for Use (Describe)

Sterile Hypodermic Needle 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

K233037 510k Summary

1. Date of preparation: December 1, 2023
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@kdIchina.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

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. Predicate devices

(1) 510(K) number: K180417
Trade Name: Sterile Hypodermic Needles For Single Use

Regulation Number: 21 CFR 880.5570

4

Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Review Panel: General hospital

(2) 510(K) number: K223334

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

Indication for use statement 6.

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

7. Device description

The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper.

The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6.

Additionally, each component is made from properly tested raw materials.

5

6.1 The proposed device includes different specifications.
Models of Sterile Hypodermic Needles For Single Use shown in Table 19-1 are available in various models according to different needle gauge and different needle length.

| Nozzle
type | Needle
Gauge
(G) | Wall type | Designated
metric size
(mm) | ID min
(mm) | Needle
length
(mm) | Long
Bevel | Short
Bevel | Color of
needle hub |
|----------------|--- | Luer lock | 14 50 | 11°±2° | | 50 | 11°±2° | Luer lock | 15 50 | 11°±2° | | 50 | 11°±2° | Luer lock | 16 50 | 11°±2° | | 50 | 11°±2° | Luer lock | 17 50 | 11°±2° | | 50 | 11°±2° | Luer lock | 18 38, 50 | 11°±2° | | 38, 50 | 11°±2° | Luer lock | 19 50 | 11°±2° | | 50 | 11°±2° | Luer lock | | Luer lock | 20 | | | Luer lock | 21 | | | Luer lock | 22 | | | Luer lock | 23 | | | Luer lock | 24 | Luer lock | 25 | | | Luer lock | 26 | | | Luer lock | 27 | | | Luer lock | 28 | | | Luer lock | 29 | | | Luer lock | 30 | | | Luer lock | 31 | | | Luer lock | 32 green |
| Luer lock | 33 | | | Luer lock | 34 | | ---------------------|-----------|-----------------------------------|----------------|--------------------------|---------------|----------------|------------------------|
| RW | 2.10 | 1.500 | 25, 32, 38,
| 17°±2° | Pale Green |
| TW | 2.10 | 1.600 | 25, 32, 38,
| 17°±2° | |
| RW | 1.80 | 1.300 | 25, 32, 38,
| 17°±2° | Blue-grey |
| TW | 1.80 | 1.460 | 25, 32, 38,
| 17°±2° | |
| RW | 1.60 | 1.100 | 25, 32, 38,
| 17°±2° | White |
| TW | 1.60 | 1.283 | 25, 32, 38,
| 17°±2° | |
| RW | 1.40 | 0.950 | 25, 32, 38,
| 17°±2° | Red-violet |
| TW | 1.40 | 1.156 | 25, 32, 38,
| 17°±2° | |
| RW | 1.20 | 0.790 | 13, 25, 32,
| 17°±2° | Pink |
| TW | 1.20 | 0.910 | 13, 25, 32,
| 17°±2° | |
| RW | 1.10 | 0.648 | 25, 32, 38,
| 17°±2° | Cream |
| TW | 1.10 | 0.750 | 25, 32, 38,
| 17°±2° | |
| RW | | | | | | |
| RW | 0.90 | 0.560 | 25, 32, 38, 50 | 11°±2° | / | Yellow |
| TW | | 0.635 | | 11°±2° | / | |
| RW | 0.80 | 0.490 | 25, 32, 38, 50 | 11°±2° | / | Deep Green |
| TW | | 0.547 | | 11°±2° | / | |
| RW | 0.70 | 0.390 | 25, 32, 38, 50 | 11°±2° | / | Black |
| TW | | 0.440 | | 11°±2° | / | |
| RW | 0.60 | 0.317 | 8, 25, 38 | 11°±2° | / | Deep Blue |
| TW | | 0.370 | | 11°±2° | / | |
| RW | 0.50 | 0.280 | 20, 25 | 11°±2° | / | Med Purple |
| RW | 0.55 | 0.232 | | 11°±2° | / | Orange |
| TW | | 0.292 | 16, 25, 38 | 11°±2° | / | |
| RW | 0.50 | 0.232 | 9, 13, 16 | / | 17°±2° | Brown |
| TW | | 0.292 | | 11°±2° | / | |
| RW | 0.45 | 0.184 | 6, 8, 9, 12, 13, 15, 20 | / | 17°±2° | Medium gery |
| TW | | 0.241 | | 11°±2° | / | |
| RW | 0.40 | 0.133 | 6, 8, 12, 15 | / | 17°±2° | Blue-green |
| TW | | 0.190 | | 11°±2° | / | |
| RW | 0.36 | 0.133 | 6, 8, 12, 15 | 11°±2° | 17°±2° | Red |
| TW | | 0.190 | | 11°±2° | 17°±2° | |
| RW | 0.30 | 0.133 | 6, 8, 9, 12, 13, 15 | 11°±2° | 17°±2° | Yellow |
| TW | | 0.165 | | 11°±2° | 17°±2° | |
| RW | 0.25 | 0.114 | 20,13, 8, 6, 5,4 | 11°±2° | 17°±2° | White |
| TW | | 0.125 | | 11°±2° | 17°±2° | |
| TW | 0.23 | 0.105 | 20,13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Deep
| RW | 0.20 | 0.089 | 13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Black |
| TW | | 0.105 | | 11°±2° | 17°±2° | |
| RW | 0.18 | 0.064 | 13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Orange |
| TW | | 0.091 | | 11°±2° | 17°±2° | |

Table 19-1 Models of Sterile Hypodermic Needles For Single Use

6

7

8

1. Comparison of technological characteristics with the predicate devices
  The Sterile Hypodermic Needles for Single Use have 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 K180417	Predicate device K223334	Comment
Indication for use	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.	The Sterile Hypodermic Needles for single use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.	Same
Product code	FMI	FMI	FMI	Same
Regulation number	21 CFR 880.5570	21 CFR 880.5570	21 CFR 880.5570	Same
Class	II	II	II	Same
Principle of operation	For manual use only	For manual use only	For manual use only	Same
Intended user	Medical professionals and trained care givers	Medical professionals and trained care givers	Medical professionals and trained care givers	Same
Environment of use	Hospitals and clinics	Hospital and clinics	Hospitals and clinics	Same
Needle gauge	14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G	14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G	31G, 32G, 33G, 34G	Different. Analysis 1.
Length	4-50mm.	/	4mm, 5mm, 6mm, 8mm, 13mm, 20mm,	Different. Analysis 2.
Type of wall	Normal wall or thin wall.	Normal wall or thin wall.	Normal wall or thin wall.	Same
Blade angle	Short bevel and long bevel.	Short bevel and long bevel.	Short bevel and long bevel.	Same
Main structure and materials	Needle hub
Polypropylene	Needle hub
Polypropylene	Needle hub
Polypropylene	Same
	Needle tube
Stainless steel	Needle tube
Stainless steel	Needle tube
Stainless steel	Same
	Protective cap
Polypropylene	Protective cap
Polypropylene	Protective cap
Polypropylene	Different. Analysis 3.
	Hard pack (Butt-end
	lower
protective
cap, upper
needle
protective
cap)
Needle hub
color	Color-coded per ISO 6009.	Color-coded per ISO 6009.	Color-coded per ISO 6009.	Same
Single use	Yes	Yes	Yes	Yes
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	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	Same
Sterilization	EO	EO	EO	Same
SAL	10-6	10-6	10-6	Same
Pyrogen	Non-pyrogenic	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	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 | 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 | Different.
Analysis 4. |
| Labeling | 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 | 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 | 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 | |
| | Meets the requirements of
21 CFR Part 801. | Meets the requirements of 21
CFR Part 801. | Meets the requirements of 21
CFR Part 801. | Same |

Table 19-2 Comparison of Technology Characteristics

9

10

SE Analysis 1: Needle gauge

The subject device has additional needle gauge sizes(31-34) compared with predicate device(K180417), so add the secondary predicate(223334) to cover the smaller 31G-34G sizes. However, the all needle gauge(14G-34G) has been registered in FDA. And the proposed needles were tested in accordance with ISO 7864 and ISO 9626 and all test results meet the acceptance criteria per the standards. Therefore, this difference does not raise new or different questions of safety or effectiveness.

11

SE Analysis 2: Needle length

The subject device has different needle lengths compared with two predicate devices, but the needles were tested in accordance with ISO 7864 and ISO 9626 including the needle length, outer diameter and inner diameter, and all test results meet the acceptance criteria per the standards. Therefore, this difference does not raise new or different questions of safety or effectiveness.

SE Analysis 3: Main Structure

The proposed device and predicate device were both have protective cap to prevent needle sharpness, but the proposed device have another cap which is butt-end lower protective and assembled with upper needle protective cap sealing with a sticker as the sterile barrier to keep product sterility. Howeve, the main structure still same as predicate device. Therefore, this different is not considered to affect the Substantially Equivalency (SE) between the proposed and predicate devices.

SE Analysis 4: Biocompatibility

The proposed device and the two predicate devices all were 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.

9. 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:

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

12

ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare application --

Part 7: Connectors for intravascular or hypodermic application

A 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

A 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

A ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

A 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 A Package by Dye Penetration

10. Clinical Testing

No clinical study is included in this submission.

11. 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 (K180417, K223334) with respect to the indications for use, materials, design, and technological characteristics.