Sterile Hypodermic Syringes for Single Use with Safety Needles

K221073 · Sichuan Prius Biotechnology Co., Ltd. · MEG · Oct 4, 2022 · General Hospital

Device Facts

• Record ID: K221073
• Device Name: Sterile Hypodermic Syringes for Single Use with Safety Needles
• Applicant: Sichuan Prius Biotechnology Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Oct 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Hypodermic Syringes for Single Use with Safety Needles is 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

Manual, single-use hypodermic syringe with integrated safety needle; consists of barrel, plunger, piston, needle hub, and safety shield. Used by clinicians for fluid aspiration and injection. After needle withdrawal, user manually activates safety shield to cover needle, reducing accidental needlestick risk. Available in various volumes (1ml-100ml) and needle gauges (16G-30G). Materials include polypropylene, polyisoprene, and stainless steel (SUS304). Lubricated with polydimethylsiloxane. Sterilized via Ethylene Oxide (EO) to SAL 10^-6. Device performance verified against ISO 7886-1 and ISO 80369-7 standards.

Clinical Evidence

No clinical study included. Bench testing only. Includes simulated clinical study per FDA guidance on sharps injury prevention and ISO 23908. Biocompatibility (ISO 10993-1), sterility (ISO 11135), particulate matter (USP 788), and shelf-life (ASTM F1980) testing performed.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, hub, cap, shield), Polyisoprene (piston), Stainless Steel SUS304 (needle). Lubricant: Polydimethylsiloxane. Standards: ISO 7886-1 (syringe), ISO 80369-7 (connectors), ISO 7864/9626 (needles), ISO 10993 (biocompatibility). Sterilization: Ethylene Oxide (EO). Form factor: Manual piston syringe with integrated safety shield. Connectivity: None.

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic delivery. Intended for prescription use.

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)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.

October 4, 2022

Sichuan Prius Biotechnology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K221073

Trade/Device Name: Sterile Hypodermic Syringes for Single Use with Safety Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: August 26, 2022 Received: September 7, 2022

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.

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

{1}------------------------------------------------

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,

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K221073

### Device Name

Sterile Hypodermic Syringes for Single Use with Safety Needles

Indications for Use (Describe)

The Sterile Hypodermic Syringes for Single Use with Safety Needles is 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K221073 -510(k) Summary

- 1. Date of Preparation: 10/08/2022
- 2. Sponsor Identification

# Sichuan Prius Biotechnology Co., Ltd.

No.2 Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: Not registered yet

Contact Person: Yan Liu Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. TingtingSu (Alternative Contact Person)

# Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

{4}------------------------------------------------

### Identification of Proposed Device 4.

Trade Name: Sterile Hypodermic Syringes for Single Use with Safety Needles Common Name: Safety Piston Syringe with Needle

Regulatory Information Classification Name: Syringe, Antistick Classification: II Product Code: MEG Regulation Number: 21CFR 880.5860 Review Panel: General Hospital

Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;

Classification Name: Needle, Hypodermic, Syringe Lumen Classification: II; Product Code: FMI; Regulation Number: 21CFR 880.5570; Review Panel: General Hospital;

### న. Identification of Predicate Device

510(k) Number: K193526 Product Name: Syringe with Safety Needle

- 6. Device Description
The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

| Syringe Volume | Needle Sizes | | |
|----------------|--------------------|--------------|------|
| | Needle Length (mm) | Needle gauge | Wall |
| 1ml, | 32 | 16G | TW |
| 2ml, | 38 | 16G | TW |
| | | | |
| 3ml, | 32 | 18G | TW |
| 5ml, | 38 | 18G | TW |
| 10ml, | 32 | 19G | TW |
| 20ml, | 38 | 19G | TW |
| 30ml, | 32 | 20G | TW |
| 50ml, | 38 | 20G | TW |
| 60ml, | 32 | 21G | TW |
| 100ml | 38 | 21G | TW |
| | 32 | 22G | TW |
| | 38 | 22G | TW |
| | 19 | 23G | TW |
| | 25 | 23G | TW |
| | 32 | 23G | TW |
| | 19 | 24G | RW |
| | 25 | 24G | RW |
| | 32 | 24G | RW |
| | 16 | 25G | RW |
| | 19 | 25G | RW |
| | 25 | 25G | RW |
| | 13 | 26G | RW |
| | 16 | 26G | RW |
| | 19 | 26G | RW |
| | 13 | 27G | RW |
| | 16 | 27G | RW |
| | 19 | 27G | RW |
| | 13 | 28G | RW |
| | 16 | 28G | RW |
| | 13 | 29G | RW |
| | 16 | 29G | RW |
| | 13 | 30G | RW |
| | 16 | 30G | RW |

{5}------------------------------------------------

All gauges can be used with 1mL, 2mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL, 100mL syringe.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

- 7. Indication for Use

{6}------------------------------------------------

| Characterization | Proposed device | Predicate Device |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sterile Hypodermic Syringes for Single<br>Use with Safety Needles<br>K221073 | Syringe With Safety Needle<br>K193526 |
| Indication for Use | The Sterile Hypodermic Syringes for<br>Single Use with Safety Needles is intended<br>for use in the aspiration and injection of<br>fluids for medical purpose. After<br>withdrawal of the needle from the body,<br>the attached needle safety shield can be<br>manually activated to cover the needle<br>immediately after use to minimize risk of<br>accidental needlesticks. | The Syringe with Safety Needle is<br>intended for use in the aspiration and<br>injection of fluids for medical<br>purpose. After withdrawal of the<br>needle from the body, the attached<br>needle safety shield can be manually<br>activated to cover the needle<br>immediately after use to minimize<br>risk of accidental needle stick. |
| Prescription or<br>OTC (over the<br>counter) | Prescription use | Prescription use |

### 8. Technology Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate.

| Technological<br>Characteristic | Table 1 Comparison of Technology Characteristics<br>Proposed device | Predicate Device | |
|---------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | Sterile Hypodermic Syringes for | Syringe With Safety Needle | Remark |
| | Single Use with Safety Needles | K193526 | |
| | K221073 | | |
| Configuration | Barrel | Barrel | Same |
| | Plunger | Plunger | |
| | Piston | Piston | |
| | Needle hub | Needle hub | |
| | Protective cap | Protective cap | |
| | Needle | Needle | |
| | Safety shield | Safety shield | |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,<br>30ml, 50ml, 60ml, 100ml | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml,<br>60ml | Different<br>See<br>comment<br># 1 |
| | | | |
| Connector Type | Luer Lock/ Luer Slip | Luer Lock | Different<br>See<br>comment<br># 2 |
| Syringe<br>Performance | Complied with<br>ISO 7886-1 | Complied with<br>ISO 7886-1 | Same |
| Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 80369-7 | Same |
| Needle<br>Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | Same |
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G, 28G,<br>29G, 30G | 16G, 18G, 19G, 20G, 21G, 22G,<br>23G, 25G, 26G, 27G, 28G, 29G,<br>30G, 31G | Similar<br>See<br>comment<br># 3 |
| Needle Length | 13mm, 16mm, 19mm, 25mm,<br>32mm, 38mm | 13mm, 16mm, 20mm, 25mm,<br>32mm, 38mm | Similar<br>See<br>comment<br># 4 |
| Wall type | TW: 16G, 18G, 19G, 20G, 21G,<br>22G, 23G<br>RW: 24G, 25G, 26G, 27G, 28G,<br>29G, 30G | TW: 16G, 18G, 19G, 20G, 21G,<br>22G, 23G, 25G, 26G, 27G, 28G,<br>29G, 30G, 31G<br>RW: 16G, 18G, 19G, 20G, 21G,<br>22G, 23G, 25G, 26G, 27G, 28G,<br>29G, 30G, 31G | Similar<br>See<br>comment<br># 5 |
| Bevel Design | LB/SB | LB/SB | Same |
| Barrel | Polypropylene (PP) | Polypropylene (PP) | Same |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Needle | Stainless Steel SUS304 | Stainless Steel SUS304 | Same |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same |
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | Same |
| Safety shield | Polypropylene (PP) | Polypropylene (PP) | Same |
| Lubricants | Polydimethylsiloxane | Polydimethylsiloxane | Same |

### Table 1 Comparison of Technology Characteristic

{7}------------------------------------------------

Discussions of differences in technological characteristics Comment #1 – Syringe Volume

{8}------------------------------------------------

The proposed device is available in three additional syringe volumes, which are 2ml, 50ml and 100ml. For proposed 2ml and 50ml syringe, these two specifications can be covered by the predicate device. And 100ml syringe is out of the volume range of predicate device. This does not change the intended use and does not raise new questions of safety and effectiveness. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886.

# Comment #2- Connector Type

The subject device is available in luer slip and luer lock connectors and luer slip connector is not covered by the predicate device. This does not change the intended use and does not raise new questions of safety and effectiveness. 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.

### 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. Additionally, the needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

### Comment #4 - Needle Length

The needle length of proposed device is similar as the needle length of predicate device. The proposed needle length can be covered in the range of predicate device. In addition, the needle performance has been tested and the results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

# Comment #5— Wall Type

The proposed device is available in thin wall and normal wall. The predicate device also has thin wall and normal wall. There are more needle gauges for the predicate device than for the proposed device under the same wall type, and the needle gauges for the proposed device can be covered by the predicate device. In addition, the wall type of proposed devices have been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.

### 9. Non-Clinical Test Conclusion

The device described in this summary the Sterile Hypodermic Syringes for Single Use with Safety Needles.were tested and demonstrated to be in conformance with the following FDA recognized standards:

- 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
- A ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.

{9}------------------------------------------------

- > ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
- > ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use- Part 1: Syringes for manual use

# Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

### Safety Feature Test

The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.

### Biocompatibility testing

In accordance with ISO10993-1 the syringe and needle are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24hrs). The following testing was conducted:

- > Cytotoxicity
- Irritation >
- > Skin Sensitization
- A Acute Systemic Toxicity
- > Pyrogen
- > Hemolysis
- > Material Mediated Toxicity

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

# Sterility, Shipping, and Shelf -life

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10th. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life.

- . Sterile Barrier Packaging performed on the proposed device:
- Visual Inspection ASTM F1886 / F1886M-16
- 0 Seal Strength ASTM F88/F88-15
- o Dye penetration ASTM F1929-15
- . Simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and

{10}------------------------------------------------

sterile device.

. Shelf-life of 5-years is validated using FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

- 10. Clinical Test Conclusion
No clinical study is included in this submission.

- 11. Substantially Equivalent (SE) 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 Syringes for Single Use with Safety Needles is as safe, as effective, and performs as well as the legally marketed predicative device cleared under K193526.