Sterile Syringe With Safety Needle

K211753 · Jiangxi Hongda Medical Equipment Group , Ltd. · MEG · Oct 14, 2021 · General Hospital

Device Facts

• Record ID: K211753
• Device Name: Sterile Syringe With Safety Needle
• Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Oct 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Syringe with Safety Needle is 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 needle sticks.

Device Story

Sterile single-use piston syringe with integrated hypodermic needle and manual safety sheath; used by clinicians for fluid aspiration and injection. Device consists of barrel, plunger, piston, needle hub, and safety sheath. After needle withdrawal, user manually activates safety shield to cover needle, reducing accidental needle stick risk. Available in various volumes (1ml-10ml) and needle gauges (18G-26G) with luer slip or luer lock connectors. EO sterilized. Bench testing confirms compliance with ISO 7886-1, ISO 7864, ISO 9626, and ISO 80369-7. Biocompatibility leveraged from predicate K163161.

Clinical Evidence

No clinical data. Bench testing only. Conformance demonstrated for ISO 7886-1 (syringe performance), ISO 7864/9626 (needle performance), ISO 80369-7/20 (connectors), and ISO 23908 (sharps injury protection). Packaging integrity validated per ASTM D4169-16, F1886/1886M-16, F88/F88-15, and F1929-15. Shelf life validated per ASTM F1980-16. EO residuals tested per ISO 10993-7.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), Polyisoprene (piston), SUS304 stainless steel (needle). Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 23908, ISO 11135, ISO 10993-7. Manual operation. Luer slip/lock connectors. EO sterilization (SAL 10^-6).

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic delivery or fluid withdrawal. Prescription use only.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Syringe with Safety Needle (K193526)

Reference Devices

• Sterile Single-Use Syringe With Needle (K163161)

Submission Summary (Full Text)

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October 14, 2021

Jiangxi Hongda Medical Equipment Group Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K211753

Trade/Device Name: Sterile Syringe with Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, MEG Dated: September 8, 2021 Received: September 14, 2021

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. 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.

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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) 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 medical devices and radiation-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.

For 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) K211753

Device Name Sterile Syringe with Safety Needle

#### Indications for Use (Describe)

The Sterile Syringe with Safety Needle is 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 needle sticks.

Type of Use (Select one or both, as applicable):

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K211753.510KSummary

- 1. Date of Preparation: 10/14/2021
- 2. Sponsor Identification

Jiangxi Hongda Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China

Contact Person:

Yang Xiaohua Position: Vice-general Manager Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China Tel: [phone], Fax: [phone] Email: [e-mail]

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| 4. | Identification of Subject Device: | Trade Name: Sterile Syringe with Safety Needle |
|----|-----------------------------------|------------------------------------------------|
| | Common Name: | Safety Piston Syringe with Needle |
| | Classification Name: | Syringe Antistick |
| | Classification: | II |
| | Product Code: | MEG |
| | Regulation Number: | 21 CFR 880.5860 |
| | Review Panel: | General Hospital |
| | Classification Name: | Piston Syringe |
| | Classification: | II |
| | Product Code: | FMF |
| | Regulation Number: | 21 CFR 880.5860 |
| | Review Panel: | General Hospital |
| | Classification Name: | Hypodermic single lumen needle |
| | Classification: | II |
| | Product Code: | FMI |
| | Regulation Number: | 21 CFR 880.5570 |
| | Review Panel: | General Hospital |
| 5. | Predicate Device | K193526, Syringe with Safety Needle |

#### Device Description 6.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

| Gauge | Length | Wall Type |
|-------|------------------|-----------|
| 26G | 13mm, 16mm | RW |
| 25G | 16mm, 25mm, 38mm | RW |
| 24G | 16mm, 25mm, 38mm | RW |
| 23G | 25mm, 32mm, 38mm | TW |
| 22G | 25mm, 32mm, 38mm | TW |
| 21G | 25mm, 32mm, 38mm | TW |
| 20G | 25mm, 32mm, 38mm | TW |
| 18G | 25mm, 32mm, 38mm | TW |

#### 7. 7. Indication for Use

| Characteristics | Subject Device | Predicate |
|-----------------|----------------|-----------|
|-----------------|----------------|-----------|

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| | Sterile Syringe with Safety Needle<br>K211753 | Syringe with Safety Needle<br>K193526 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The Sterile Syringe with Safety<br>Needle is intended for use in the<br>aspiration and injection of fluids for<br>medical purpose. After withdrawal of<br>the needle from the body, the<br>attached needle safety shield can be<br>manually activated to cover the<br>needle immediately after use to<br>minimize risk of accidental needle<br>sticks. | The Sterile Disposable Syringe with<br>Safety Needle is intended for use in<br>the aspiration and injection of fluids<br>for medical purpose. After<br>withdrawal of the needle from the<br>body, the attached needle safety<br>shield can be manually activated to<br>cover the needle immediately after<br>use to minimize risk of accidental<br>needle sticks. |
| Prescription<br>Only or Over<br>the counter | Prescription Only | Prescription Only |

- 8. Technological Characteristics

| | Table 1 Comparison of Technology Characteristics |
|--|--------------------------------------------------|
| | |

| ITEM | Subject Device K211753 | Predicate Device K193526 | Remark |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product Code | FMF<br>FMI<br>MEG | FMF<br>FMI<br>MEG | Same |
| Regulation No. | 21 CFR 880.5860<br>21 CFR 880.5570 | 21 CFR 880.5860<br>21 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Syringe with Safety<br>Needle is intended for use in the<br>aspiration and injection of fluids for<br>medical purpose. After withdrawal<br>of the needle from the body, the<br>attached needle safety shield can be<br>manually activated to cover the<br>needle immediately after use to<br>minimize risk of accidental needle<br>sticks. | The Sterile Disposable Syringe<br>with Safety Needle is intended<br>for use in the aspiration and<br>injection of fluids for medical<br>purpose. After withdrawal of<br>the needle from the body, the<br>attached needle safety shield<br>can be manually activated to<br>cover the needle immediately<br>after use to minimize risk of<br>accidental needle sticks. | Same |
| Configuration | Barrel<br>Plunger<br>Piston<br>Needle hub<br>Protective cap<br>Needle tube | Barrel<br>Plunger<br>Piston<br>Needle hub<br>Protective cap<br>Needle tube | Same |
| | Safety sheath | Safety sheath | |
| Operation Mode | For manual use only | For manual use only | Same |
| Safety Feature | Slide over the needle to prevent<br>from needle sticks | Slide over the needle to prevent<br>from needle sticks | Same |
| Single Use | Yes | Yes | Same |
| Label/Labeling | Complies with 21 CFR part 801 | Complies with 21 CFR part 801 | Same |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 1ml, 2ml, 3ml, 5ml, 10ml,<br>20ml, 30ml, 50ml, 60ml | Different/ See<br>Comment #1 |
| Connector Type | Luer Lock/ Luer slip | Luer Lock | Different/ See<br>Comment #2 |
| Syringe<br>Performance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same |
| Needle Gauge | 18G, 20G, 21G, 22G, 23G, 24G,<br>25G, 26G | 16G, 18G, 19G, 20G, 21G,<br>22G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | Different/ See<br>Comment #3 |
| Needle Length | 13mm, 16mm, 25mm, 32mm,<br>38mm | 13mm, 16mm, 20mm, 25mm,<br>32mm, 38mm | Different/ See<br>Comment #4 |
| Wall Type | TW: 18G, 20G, 21G, 22G, 23G<br>RW: 24G, 25G, 26G | TW: 16G, 18G, 19G, 20G, 21G,<br>22G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G<br>RW: 16G, 18G, 19G, 20G, 21G,<br>22G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | Different/ See<br>Comment #5 |
| Bevel Design | LB | LB/SB | Different/ See<br>Comment #6 |
| Needle<br>Performance | Complies with<br>ISO 7864<br>ISO 9626 | Complies with<br>ISO 7864<br>ISO 9626 | Same |
| Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 80369-7 | Same |
| Patient contact material | | | |
| Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Needle tube | Stainless Steel, SUS304 | Stainless Steel, SUS304 | |
| Biocompatibility | | | |
| Cytotoxicity | Comply with ISO 10993 standards,<br>biocompatibility was leveraged on<br>the data of K163161 | No cytotoxicity | Same |
| Irritation | | No intracutaneous reactivity | |
| Sensitization | | No skin sensitization | |
| Systemic Toxicity | | No systemic toxicity | |
| Hemolysis | | No Hemolysis | |
| Pyrogen | | No Pyrogen | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |

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Comment 1 - Syringe Volume

The syringe specification for the subject device is less than the predicate device. However, the specification can be covered by the predicate device. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886. Therefore, this difference is not considered to affect substantial equivalence.

#### Comment 2 - Luer Connector

The subject device is available in luer slip and luer lock two types connectors and luer lock connector is not covered by the predicate device. However, the luer connector has been tested per ISO 80369-7 and the test results demonstrate that the luer connector meets the requirements of ISO 80369-7. Therefore, this difference is not considered to affect substantial equivalence.

#### Comment 3 - Needle Gauge

The subject device has the additional gauge 24G compared to the predicate device, while other gauges can be covered by the predicate device. The needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.

### Comment 4 - Needle Length

The length specification of the subject device is within the range covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.

#### Comment 5 - Wall Type

The wall type of the subject device under the same needle gauge can be covered by the predicate device. In addition, the needle performance has been tested and results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.

#### Comment 6 - Bevel Design

The bevel design of the subject device can be covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.

#### Non-Clinical Test Conclusion 9.

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### A. Syringe

The sterile, single piston syringe described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

- A ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
### B. Anti- Stick Needle

The Sterile Antistick Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

- > ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.
- > 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 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods
- > ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

#### C. Biocompatibility

The patient contact materials of the subject device, Sterile Syringe with Safety Needle, are identical to the material of Sterile Single-Use Syringe With Needle as it was cleared in K163161in 03/20/2017. There are no differences in formulation, processing and sterilization, and no other chemicals have been added. (e.g., plasticizers, filters, cleaning agents, mold release agents, etc.). Therefore, new biocompatibility test was not conducted on the proposed device. Bacterial endotoxin limit and particulate testing were evaluated on the proposed device per following standards

- > USP <85> Bacterial Endotoxins Test
- > USP <788> Particulate Matter in Injections

### D. Sterility, Shipping, and Shelf-life

The subject devices were sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and the sterilization method was validated per over kill method as qualified in accordance ISO 11135:2014, Annex B.

Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.

Sterile Barrier Packaging Testing performed on the subject device:

○ Visual inspection ASTM F1886/1886M-16

o Seal strength ASTM F88/F88-15

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oDye penetration ASTM F1929-15

Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device

The EO ECH residue testing was performed on the subject device:

- A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- 10. Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Syringe with Safety Needle is substantially equivalent to the Syringe with Safety Needle with respect to the indications for use, target populations, treatment method, and technological characteristics.