Disposable Sterile Needle

K172938 · Jiangsu Caina Medical Co.,Ltd · FMI · Jun 14, 2018 · General Hospital

Device Facts

• Record ID: K172938
• Device Name: Disposable Sterile Needle
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: FMI · General Hospital
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

Disposable sterile needle for use with syringes/injection devices; facilitates fluid injection or aspiration. Components include needle tube (304 stainless steel), hub, and cap (polypropylene). Available in various gauges (18G-33G) and lengths (6mm-50mm) with long or short bevels. Used in clinical settings by healthcare professionals. Device connects to syringes via Luer taper. Benefits include sterile, single-use delivery of fluids or aspiration of samples. Performance verified against ISO standards for hypodermic needles, tubing, and Luer fittings.

Clinical Evidence

Bench testing only. Compliance verified with ISO 7864:2016 (sterile needles), ISO 6009:2016 (color coding), ISO 9626:2016 (tubing), ISO 594-1:1986/594-2:1998 (Luer fittings), and ISO 11135-1:2007 (EO sterilization). Biocompatibility testing per ISO 10993 series included cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility. Packaging integrity validated per ASTM F88/F88M-15 and ASTM F1929-15.

Technological Characteristics

Needle tube: 304 stainless steel. Hub/Cap: Polypropylene. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 7864:2016, ISO 9626:2016, ISO 6009:2016, ISO 594-1:1986, ISO 594-2:1998. Dimensions: 18G-33G, 6mm-50mm lengths. Bevels: Long (11°) and Short (17°).

Indications for Use

Indicated for use with syringes and injection devices for general purpose fluid injection/aspiration in patients requiring such procedures.

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

• Jierui Syringes and Needles (K072739)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 14, 2018

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120, China

Re: K172938

Trade/Device Name: Disposable Sterile Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 4, 2018 Received: May 8, 2018

Dear Diana Hong:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Alan M. Stevens -

Digitally signed by Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130 0189211, cn=Alan M. Stevens -S Date: 2018.06.14 13:35:06 -04'00'

Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172938

Device Name Disposable Sterile Needle

Indications for Use (Describe)

The Disposable Sterile Needle is 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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## K172938 510(k) SUMMARY

| Submitter: | Jiangsu Caina Medical Co., Ltd.<br>No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425,<br>China |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Ms. Diana Hong<br>General Manager<br>Mid-Link Consulting Co., Ltd<br>P.O. Box 120-119, Shanghai, 200120, China<br>Tel: [phone],<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | June 13, 2018 |
| Trade Name: | Disposable Sterile Needle |
| Common or Usual Name: | Needle, Hypodermic, Single Lumen |
| Regulation Name: | Hypodermic Single Lumen Needle. |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Device Class: | Class II |
| Primary Predicate Device: | K072739; Jierui Syringes and Needles |
| | Note – K072739 is a bundled 510(k) submission containing a sterile<br>hypodermic needle. K172938 is substantially equivalent to the<br>sterile hypodermic needle component of K072739. |

#### Indications for Use:

The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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### Device Description:

The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification. The product specifications are listed in following table.

| Gauge | Hub Color | Product specification | Gauge | Hub Color | Product specification |
|---------------------------------------------------------------------------------------------|----------------|-----------------------|-------|-----------------|-----------------------|
| 33G | Black | 33Gx6mm RWxLB | 22G | Black | 22Gx25mm RWxLB |
| | | 33Gx6mm RWxSB | | | 22Gx25mm RWxSB |
| | | 33Gx6mm TWxLB | | | 22Gx25mm TWxLB |
| | | 33Gx6mm TWxSB | | | 22Gx25mm TWxSB |
| 32G | Deep<br>Green | 32Gx13mm RWxLB | | | 22Gx25mm ETWxLB |
| | | 32Gx13mm RWxSB | | | 22Gx25mm ETWxSB |
| | | 32Gx13mm TWxLB | | | 22Gx38mm RWxLB |
| | | 32Gx13mm TWxSB | | | 22Gx38mm RWxSB |
| | | 32Gx13mm ETWxLB | | | 22Gx38mm TWxLB |
| | | 32Gx13mm ETWxSB | | | 22Gx38mm TWxSB |
| 30G | Yellow | 30Gx25mm RWxLB | | | 22Gx38mm ETWxLB |
| | | 30Gx25mm RWxSB | | | 22Gx38mm ETWxSB |
| | | 30Gx25mm TWxLB | 21G | Deep<br>Green | 21Gx38mm RWxLB |
| | | 30Gx25mm TWxSB | | | 21Gx38mm RWxSB |
| | | 30Gx25mm ETWxLB | | | 21Gx38mm TWxLB |
| | | 30Gx25mm ETWxSB | | | 21Gx38mm TWxSB |
| 25G | Orange | 25Gx25mm RWxLB | | | 21Gx38mm ETWxLB |
| | | 25Gx25mm RWxSB | | | 21Gx38mm ETWxSB |
| | | 25Gx25mm TWxLB | 20G | Yellow | 20Gx38mm RWxLB |
| | | 25Gx25mm TWxSB | | | 20Gx38mm RWxSB |
| | | | | | |
| | 25Gx38mm RWxLB | | | 20Gx38mm TWxLB | |
| | 25Gx38mm RWxSB | | | 20Gx38mm TWxSB | |
| | 25Gx38mm TWxLB | | | 20Gx38mm ETWxLB | |
| | 25Gx38mm TWxSB | | | 20Gx38mm ETWxSB | |
| Note: | | 18G | Pink | 18Gx50mm RWxLB | |
| RW = Regular Wall; TW = Thin Wall;<br>ETW= Extra Thin Wall<br>LB=Long Bevel; SB=Short Bevel | | | | 18Gx50mm RWxSB | |
| | | | | 18Gx50mm TWxLB | |
| | | | | 18Gx50mm TWxSB | |

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# Device Comparison of Technology

A technological comparison table is provided below that compares the subject device and predicate device:

| Item | | Proposed Device -K172938 | Predicate Device - K072739 | Comparison |
|---------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Disposable Sterile Needle | Jierui Syringes and Needles:<br>Sterile Hypodermic Needle<br>Component Only | |
| Product Code | | FMI | FMI | Same |
| Intended Use | | The Disposable Sterile Needle<br>is intended for use<br>with syringes and injection<br>devices for general purpose<br>fluid injection/aspiration. | The Sterile Hypodermic Needle for<br>single use is intended for use with<br>syringes and injection devices for<br>general purpose fluid<br>injection/aspiration | Same |
| Single Use | | Yes | Yes | Same |
| Sterility Condition | | EO Sterilization | EO Sterilization | Same |
| Material | Needle<br>Tube | 304 Stainless Steel | Stainless Steel | Different |
| | Cap | Polypropylene | Unknown | Different |
| | Hub | Polypropylene | Unknown | Different |
| Needle Gauge | | 18G,20G,21G,22G,25G,30G,32<br>G,33G | 16G,18G,19G,20G,21G,22G,23G,2<br>4G,25G,26G,27G,29G | Different |

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| Needle Length | 6mm, 13mm, 20mm, 25mm,<br>38mm, 45mm, 50mm | 13 mm, 16 mm, 19 mm, 25 mm, 32 mm, 38 mm | Different |
|----------------------------|---------------------------------------------------|---------------------------------------------------|-----------|
| Needle Edge/Bevel Angle | Long Bevel: angle 11 °<br>Short Bevel: angle 17 ° | Long bevel<br>Short Bevel | Different |
| Needle Performance | Complies with<br>ISO 7864: 2016<br>ISO 9626: 2016 | Complies with<br>ISO 7864: 1993<br>ISO 9626: 1991 | Same |
| Luer Connector Performance | Complies with<br>ISO 594-1:1986<br>ISO 594-2:1998 | Complies with<br>ISO 594-1:1986<br>ISO 594-2:1998 | Same |
| Needle Hub Color | Complies with ISO 6009: 2016 | Complies with ISO 6009: 2016 | Same |

#### Substantial Equivalence Discussion

The indications for use and intended use of the hypodermic needle component in the predicate bundled 510(k) K072739, are equivalent to the subject 510(k) device.

The differences between the subject device and the predicate device are the following:

- Needle length
Although the needle length range of the subject device is larger than needle length range of the predicate device r, the needle length of the subject device meets 4.10.2 Tolerances requirements of ISO 7864. This difference does not raise different questions of safety and effectiveness

- Needle Gauge
The subject device has 30G, 32G and 33G needle gauges, which are not included in the predicate device. All needle gauges of proposed device meet 5.4 Dimensions requirements of ISO 9626. This difference does not raise different questions of safety and effectiveness

- Edge/Bevel angle ●
Although the /bevel angle of the predicate device is unknown, the edge/bevel angle of subject device are listed in the product labeling, and the end user can choose the needle per their preference. This difference does not raise different questions of safety and effectiveness

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- Materials .
Although the materials of the subject device are different from those of the predicate device, the subject device has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. This difference does not raise different questions of safety and effectiveness

Based on the aforementioned modifications to the subject device device does not raise different types of safety and effectiveness questions when compared to the predicate device.

# Performance Testing Summary

Non-clinical tests were conducted to verify that the proposed devices met all design specifications and are substantially equivalent (SE) to the hypodermic needle component of the predicate device. The test results demonstrated that the proposed devices comply with the following standards:

- ISO 7864:2016, Sterile Hypodermic Needles for Single Use ●
- ISO 6009: 2016 Hypodermic needles for single use Colour coding for identification ●
- ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices ●
- ISO 594-1:1986 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and ● Certain Other Medical Equipment - Part 1: General Requirements.
- ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier ● Materials.
- USP <85> Bacterial Endotoxins Test
- ISO 11135-1:2007 Sterilization of Health Care Products- Ethylene ● Oxide- Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

The Disposable Sterile Needle is supplied sterile for single use and are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years. Sterility was validated in accordance with ISO 11135-1:2007. Packaging tests were performed per ASTM F88/F88M-15 and ASTM F1929-15.

The Disposable Sterile Needle has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. The device

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was tested to the following biocompatibility endpoints: cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, and material mediated pyrogenicity, hemocompatibility.

A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.

In all testing, the pre-determined acceptance criteria were met.

#### Substantially Equivalence Conclusion

The subject device has the same intended use and technological characteristics as the predicate device. The performance of the device is supported by non-clinical testing and risk management activities. The Disposable Sterile Needle is Substantially Equivalent (SE) to the Sterile Hypodermic Needle component of the bundled 510(k), Jierui Syringes and Needles, cleared under K072739.