Sterile Hypodermic Needles for Single Use

K233037 · Zhejiang Kindly Medical Device Co., Ltd. · FMI · Dec 12, 2023 · General Hospital

Device Facts

• Record ID: K233037
• Device Name: Sterile Hypodermic Needles for Single Use
• Applicant: Zhejiang Kindly Medical Device Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Dec 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

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

Device Story

Sterile hypodermic needles for single use; stainless steel (SUS 304) needle tube; polypropylene hub; color-coded per ISO 6009. Used with syringes/injection devices for fluid injection or aspiration. Manual operation by medical professionals or trained caregivers in hospitals and clinics. Provided sterile via EO sterilization (SAL 10^-6). Available in various gauges (14G-34G) and lengths (4-50mm). Features luer lock fitting for connection to syringes. Protective caps prevent needle sharpness; hard pack or paper-film packaging maintains sterility. Device facilitates medication delivery or fluid withdrawal, benefiting patients through reliable, sterile access for injections.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ISO 7864, ISO 9626, ISO 80369-7/20, ISO 10993 series (biocompatibility), and USP <788> (particulate matter).

Technological Characteristics

Materials: Stainless steel (SUS 304) tube, polypropylene (PP) hub/cap. Dimensions: 14G-34G, 4-50mm length. Luer lock connection (6% conical fitting). Sterilization: EO (SAL 10^-6). Standards: ISO 7864, ISO 9626, ISO 80369-7, ISO 80369-20, ISO 10993-1/4/5/7/10/11, USP <788>, ASTM F88/F88M-15, ASTM F1929-15.

Indications for Use

Indicated for use with syringes and injection devices for general purpose fluid injection/aspiration by medical professionals and trained caregivers.

Regulatory Classification

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.

Predicate Devices

• Sterile Hypodermic Needles for Single Use (K180417)
• Sterile Hypodermic Needles for Single Use (K223334)

Submission Summary (Full Text)

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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).

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

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# 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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#### K233037 510k Summary

- 1. Date of preparation: December 1, 2023
- 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. Predicate devices

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

Regulation Number: 21 CFR 880.5570

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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.

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

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- 8. 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<br>Polypropylene | Needle hub<br>Polypropylene | Needle hub<br>Polypropylene | Same |
| | Needle tube<br>Stainless steel | Needle tube<br>Stainless steel | Needle tube<br>Stainless steel | Same |
| | Protective cap<br>Polypropylene | Protective cap<br>Polypropylene | Protective cap<br>Polypropylene | Different. Analysis 3. |
| | Hard pack (Butt-end | | | |
| | lower<br>protective<br>cap, upper<br>needle<br>protective<br>cap) | | | |
| Needle hub<br>color | Color-coded per ISO 6009. | Color-coded per ISO 6009. | Color-coded per ISO 6009. | Same |
| Single use | Yes | Yes | Yes | Yes |
| Performance<br>specifications | Comply with:<br>ISO 7864 Sterile<br>hypodermic needles for<br>single use - Requirements<br>and test methods;<br>ISO 9626:2016 Stainless<br>steel needle tubing for the<br>manufacture of medical<br>devices -Requirements and<br>test methods;<br>ISO 80369-7:2021<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications –<br>Part 7: Connectors for<br>intravascular or hypodermic<br>applications;<br>ISO 80369-20:2015<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications -<br>Part 20: Common test<br>methods | Complies with:<br>ISO 7864:2016 Sterile<br>hypodermic needles for single<br>use - Requirements and test<br>methods;<br>ISO 9626:2016 Stainless steel<br>needle tubing for the<br>manufacture of medical<br>devices -Requirements and<br>test methods;<br>ISO 80369-7:2021<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications –<br>Part 7: Connectors for<br>intravascular or hypodermic<br>applications;<br>ISO 80369-20:2015<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications - Part<br>20: Common test methods | Comply with:<br>ISO 7864 Sterile hypodermic<br>needles for single use -<br>Requirements and test<br>methods;<br>ISO 9626:2016 Stainless<br>steel needle tubing for the<br>manufacture of medical<br>devices -Requirements and<br>test methods;<br>ISO 80369-7:2021<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications –<br>Part 7: Connectors for<br>intravascular or hypodermic<br>applications;<br>ISO 80369-20:2015<br>Small-bore connectors for<br>liquids and gases in<br>healthcare applications - Part<br>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<br>evaluation for the subject<br>device was conducted<br>in accordance with the<br>International Standard ISO<br>10993-1 "Biological<br>Evaluation of Medical<br>Devices - Part 1: Evaluation<br>and Testing Within a Risk<br>Management Process” as | The biocompatibility<br>evaluation for the subject<br>device was conducted<br>in accordance with the<br>International Standard ISO<br>10993-1 "Biological<br>Evaluation of Medical Devices<br>- Part 1: Evaluation and<br>Testing Within a Risk<br>Management Process” as | The biocompatibility<br>evaluation for the subject<br>device was conducted<br>in accordance with the<br>International Standard ISO<br>10993-1 "Biological<br>Evaluation of Medical<br>Devices - Part 1: Evaluation<br>and Testing Within a Risk<br>Management Process” as | Different.<br>Analysis 4. |
| Labeling | recognized by FDA and the<br>"Use of International<br>Standard ISO 10993-1<br>"Biological evaluation of<br>medical devices- Part 1:<br>Evaluation and testing<br>within a risk management<br>process", June 16, 2016.<br>The Sterile Hypodermic<br>Needle for Single Use of<br>testing included following:<br>Cytotoxicity;<br>Skin sensitization;<br>Hemolysis;<br>Intracutaneous reactivity;<br>Acute systemic toxicity;<br>Pyrogenicity.<br>The evaluation of the above<br>testing items meets the<br>requirements<br>And Conforms to USP<br><788>: Particulate Matter<br>for injection | recognized by FDA and the<br>"Use of International Standard<br>ISO 10993-1 "Biological<br>evaluation of medical devices-<br>Part 1: Evaluation and testing<br>within a risk management<br>process", June 16, 2016.<br>The syringe of testing<br>included the following tests:<br>Cytotoxicity;<br>Skin sensitization;<br>Hemolysis;<br>Intracutaneous reactivity;<br>Acute systemic toxicity;<br>Pyrogenicity.<br>The evaluation of the above<br>testing items meets the<br>requirements | recognized by FDA and the<br>"Use of International<br>Standard ISO 10993-1<br>"Biological evaluation of<br>medical devices- Part 1:<br>Evaluation and testing<br>within a risk management<br>process", June 16, 2016.<br>The Sterile Hypodermic<br>Needle for Single Use of<br>testing included following:<br>Cytotoxicity;<br>Skin sensitization;<br>Hemolysis;<br>Intracutaneous reactivity;<br>Acute systemic toxicity;<br>Pyrogenicity.<br>The evaluation of the above<br>testing items meets the<br>requirements<br>And Conforms to USP <788>:<br>Particulate Matter for injection | |
| | Meets the requirements of<br>21 CFR Part 801. | Meets the requirements of 21<br>CFR Part 801. | Meets the requirements of 21<br>CFR Part 801. | Same |

## Table 19-2 Comparison of Technology Characteristics

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## 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.

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## 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 <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.

## 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

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> 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 <788>: 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.