Sterile Safety Hypodermic Needles for Single Use

K231723 · Wepon Medical Technology Co., Ltd. · FMI · Sep 8, 2023 · General Hospital

Device Facts

• Record ID: K231723
• Device Name: Sterile Safety Hypodermic Needles for Single Use
• Applicant: Wepon Medical Technology Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Device Story

Sterile, single-use hypodermic needle with integrated manual safety shield; attaches to standard luer slip or luer lock syringes. Used by clinicians for fluid aspiration or injection. After withdrawal from patient, user manually activates safety shield to cover needle tip, reducing accidental needlestick risk. Device consists of stainless steel needle tube, polypropylene hub, and protective cover, lubricated with silicone oil. Provided sterile via EO sterilization.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, hemolysis, reactivity, systemic toxicity, pyrogenicity). Sterilization validated per ISO 11135. Performance testing conducted per ISO 7864, ISO 9626, ISO 80369-7, and ISO 23908. Particulate matter testing met USP <788> criteria.

Technological Characteristics

Materials: Stainless steel needle, polypropylene hub/sheath. Lubricant: Silicone oil. Connectivity: Luer slip/lock. Sterilization: EO (ISO 11135). Standards: ISO 7864 (needles), ISO 9626 (tubing), ISO 80369-7 (connectors), ISO 23908 (sharps protection), ISO 10993 (biocompatibility), ASTM F1980 (aging).

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic needle use.

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

• TK Safety Needle (K191644)

Submission Summary (Full Text)

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Wepon Medical Technology Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China

September 8, 2023

## Re: K231723

Trade/Device Name: Sterile Safety 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: June 8, 2023 Received: June 13, 2023

## Dear Esther Zhang:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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

Sincerely,

Alan Stern

CAPT Alan 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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## Indications for Use

510(k) Number (if known) K231723

Device Name

Sterile Safety Hypodermic Needles for Single Use

Indications for Use (Describe)

The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr><tr><td><span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | |

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# K231723

# Section 5 510(k) summary

#### l Submitter

Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500

Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030

Contact person: Di Zhao Deputy General Manager Phone: [phone] Email: [e-mail]

#### II Correspondent

Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: [e-mail]

#### III Device

| Trade Name: | Sterile Safety Hypodermic Needles for Single Use |
|--------------------|--------------------------------------------------|
| Common Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 21 CFR 880.5570 |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Device Class: | Class II |
| Product code: | FMI |

#### IV Predicate Devices

| Trade name: | TK Safety Needle |
|-------------------------|--------------------------------------------|
| Common name: | Hypodermic Single Lumen Needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K191644 |
| Manufacturer: | Anhui Tiankang Medical Technology Co., Ltd |

### V Device description

The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic

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needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.

| Connection type | Luer | | | | | | | | | | | |
|------------------------------|----------------------------|-------------|-------------------|-------------|---------------|--------------------|-------|------------|--------|-------|------|--|
| Color of needle hub | Yellow | Medium Grey | Brown | Orange | Middle Purple | Deep blue | Black | Deep green | Yellow | Cream | Pink | |
| Gauge | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19 G | 18 G | |
| Length of needle tube | | 1/2" | 1/2",<br>5/8", 1" | 5/8",<br>1" | 5/8",<br>1" | 1", 1 1/4", 1 1/2" | | | | | | |
| Length of needle covers (mm) | | 12.5 | 12.5,<br>16, 25 | 16, 25 | 16,<br>25 | 25, 32, 38 | | | | | | |
| Color of needle covers | Transparent | | | | | | | | | | | |
| Type of wall | Normal wall and thin wall | | | | | | | | | | | |
| Blade angle | Short bevel and long bevel | | | | | | | | | | | |

### VI Indications for use

The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

#### VII Comparison of technological characteristics with the predicate devices

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

| Device feature | Subject Device | Predicate Device<br>K191644 | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for use | The Sterile Safety<br>Hypodermic Needles for<br>Single Use are intended for<br>use in the aspiration and<br>injection of fluids for | The TK Safety Needle<br>device is intended for<br>use in the aspiration and<br>injection of fluids for<br>medical purposes. The | Comment 1 |

Table 5-1 Substantial equivalence discussion

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| Device feature | Subject Device | Predicate Device<br>K191644 | Comments | | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------|-----------|
| | medical purpose. After<br>withdrawal of the needle<br>from the body, the attached<br>needle safety shield can be<br>manually activated to cover<br>the needle immediately<br>after use to minimize risk of<br>accidental needlesticks. | TK Safety Needle is<br>compatible for use with<br>standard luer slip and<br>luer lock syringes.<br>Additionally, after<br>withdrawal of the needle<br>from the body, the<br>attached needle safety<br>shield can be manually<br>activated to cover the<br>needle immediately after<br>use to minimize risk of<br>accidental needle-stick. | | | |
| Product code | FMI | FMI | Identical | | |
| Regulation<br>number | 21 CFR 880.5570 | 21 CFR 880.5570 | Identical | | |
| Class | CLASS II | CLASS II | Identical | | |
| Principle of<br>operation | Normal | Normal | Identical | | |
| Needle gauge | 18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G,<br>30G | 16G、17G、18G、19G、<br>20G、21G、22G、23G、<br>24G、25G、26G、27G、<br>28G、29G、30G | Substantially<br>equivalent<br>Comment 2 | | |
| Length | 1/2", 5/8", 1", 11/4", 11/2" | 1/2" to 1 1/2" | | | |
| Type of wall | Thin wall and normal wall | From 16G to 23G: thin<br>wall<br>From 24G to 30G :<br>regular wall | | | |
| blade angle | Short bevel and long bevel | Bevel | | | |
| main structure<br>and materials | Needle hub<br>Needle tube<br>protective cover | Polypropylene<br>Stainless steel<br>Polypropylene | Needle Hub<br>Needle<br>Needle Sheath | Polypropylene<br>Stainless Steel<br>Polypropylene | Identical |
| Needle hub<br>Colors | Various Colors | Various Colors | Identical | | |
| Sharps injury | Needle safety shield | Needle safety shield | Identical | | |

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| Device feature | Subject Device | Predicate Device<br>K191644 | Comments |
|-------------------------------|------------------------------------------------|---------------------------------------------|-----------|
| Prevention<br>Features | | | |
| Lubricant for<br>Needle | Silicone Oil | Silicone Oil | Identical |
| Performance<br>specifications | Conforms to ISO 7864 | Conforms to ISO 7864 | Identical |
| Sterilization | EO sterilization | EO sterilization | Identical |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Identical |
| Labeling | Meet the requirements of<br>21<br>CFR Part 801 | Meet the requirements of<br>21 CFR Part 801 | Identical |

Discussion:

Comment 1

Minor rewording of the Intended use statement has been made. However, the general purpose of the device and its function remain unchanged. The subject devices are also compatible with standard slip tip and luer lock syringes, even though the IFU does not exclusively say that. The minor rewording of the Intended use statement does not raise different questions of safety and effectiveness.

## Comment 2

The subject device's needle gauge and needle length are smaller than the predicate device's needle gauge range of 16G to 30G and length range of 1/2" to 1 1/2". The type of wall and needle bevel are different from the predicate device. The range is within the same range as the predicate device. The differences do not raise new questions of safety and effectiveness.

#### VIII Performance data

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility testing

Biocompatibility of the Sterile Safety Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:

Cytotoxicity

ISO 10993-5: 2009

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| Skin sensitization | ISO 10993-10: 2010 |
|---------------------------|--------------------|
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |

Particulate matter testing was conducted in accordance with Method 1 of USP <788> Particulate Matter in Injections and met the USP acceptance criteria.

## Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Safety Hypodermic Needles for Single Use is determined based on stability study which includes ageing test.

The testing is performed according to the following standards:

- A ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- A ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- > ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- > ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

## Performance testing

Performance testing is performed according to the following standards:

- A ISO 7864:2016 Sterile Safety Hypodermic Needles for Single Use — Requirements and test methods
- A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
- > ISO 23908 Sharps Injury protection- Requirements and test methods
- A Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff

## IX Conclusion

The minor differences between the predicate and subject device do not raise any new or

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different questions of safety or effectiveness. The Sterile Safety Hypodermic Needles for Single Use are substantially equivalent to its predicate device (TK Safety Needle) with respect to the indications for use, treatment method and technological characteristics. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.