Sterile Hypodermic Needles for Single Use

K223334 · Zhejiang Kindly Medical Devices Co., Ltd. · FMI · Dec 16, 2022 · General Hospital

Device Facts

• Record ID: K223334
• Device Name: Sterile Hypodermic Needles for Single Use
• Applicant: Zhejiang Kindly Medical Devices Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Sterile hypodermic needles for single use; used for fluid injection or aspiration. Device consists of stainless steel (SUS 304) needle tube, polypropylene hub, and protective cap. Features luer fitting for connection to syringes/devices with 6% conical fittings. Available in various gauges (31G-34G) and lengths. Used in hospitals and clinics by medical professionals and trained caregivers. Provided sterile via EO sterilization. Manual operation only; no electronic or automated components.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993), sterility, seal strength (ASTM F88/F88M), package integrity (ASTM F1929), and performance testing per ISO 7864, ISO 9626, and ISO 80369 series.

Technological Characteristics

Materials: Stainless steel (SUS 304) tube, Polypropylene (PP) hub/cap. Luer connector (6% conical fitting). EO sterilization (SAL 10^-6). Gauges: 31G-34G. Standards: ISO 7864, ISO 9626, ISO 80369-7/20, ISO 10993-1/4/5/7/10/11, USP <788>, ASTM F88/F88M, ASTM F1929.

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 (K211214)

Submission Summary (Full Text)

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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 ([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

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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)

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# 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

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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<br>type | Needle<br>gauge<br>(G) | Needle<br>length<br>(mm) | Wall type | Bevel | | Color |
|----------------|------------------------|--------------------------|-----------|---------------|-------------|------------|
| | | | | Long<br>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.

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- 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<br>K211214 | Comment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indication for use | The Sterile Hypodermic<br>Needles for single use are<br>intended for use with<br>syringes and injection<br>devices for general purpose<br>fluid injection/aspiration. | The Sterile Hypodermic<br>Needles for Single Use are<br>intended to be used with a<br>luer lock or luer slip<br>syringe and injection<br>devices for general purpose<br>fluid injection/aspiration. | Same |
| Product code | FMI | FMI | Same |
| Regulation<br>number | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Principle of<br>operation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and<br>trained care givers | Medical professionals and<br>trained care givers | Same |
| Environment of<br>use | Hospitals and clinics | Hospital and clinics | Same |
| Needle gauge | 31G, 32G, 33G, 34G | 30G, 27G, 26G, 25G, 24G,<br>23G, 22G, 21G, 20G, 19G,<br>18G | Different.<br>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 structure<br>and materials | Needle hub<br>Needle tube<br>Protective cap | Polypropylene<br>Stainless steel<br>Polypropylene | Needle hub<br>Needle tube<br>Protective cap | Polypropylene<br>Stainless steel<br>Polypropylene | Same |
| Needle hub color | Color-coded per ISO 6009. | | Color-coded per ISO 6009. | | Same |
| Single use | Yes | | Yes | | Same |
| Performance<br>specifications | Comply with:<br>ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods;<br>ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods;<br>ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications;<br>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 | The<br>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:<br>Evaluation and Testing<br>Within a Risk Management<br>Process," as recognized by<br>FDA and the "Use of<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", June<br>16, 2016. The Sterile<br>Hypodermic Needle for<br>Single Use of testing<br>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 | The<br>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:<br>Evaluation and Testing<br>Within a Risk Management<br>Process," as recognized by<br>FDA and the "Use of<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", June<br>16, 2016. The syringe of<br>testing included the<br>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 | Differe<br>nt.<br>analysi<br>s 3. |
| Labeling | Meets the requirements of<br>21 CFR Part 801. | Meets the requirements of<br>21 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.

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

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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
- 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.